Claro Approval

September 21st, 2015

SHAWNEE, Kan., Bayer HealthCare LLC Animal Health announces the approval of Claro™ (15.0 mg/mL florfenicol, 13.3 mg/mL terbinafine, 2.0 mg/mL mometasone furoate) Otic Solution, the first single-dose therapy proven to effectively treat susceptible strains of common pathogens found in canine otitis externa.1 The product is expected to be available for sale exclusively to veterinarians in November.

Otitis externa is the second most common reason dog owners take their pet to a veterinarian2 and can be a frustrating disease for canine patients and their owners.  The condition is an inflammation of the ear canal that is often accompanied by secondary infections.  It frequently causes pain, itching, a strong odor and/or muffled hearing in affected dogs and typically requires client administration of ear medications at home.

Claro™ is intended to be a first-line otitis externa therapy that addresses the needs of veterinarians and dog owners.  It is a clear liquid solution featuring a fixed combination of antibacterial, antifungal, and anti-inflammatory ingredients that requires only one, veterinarian-administered treatment.  The unique single-dose treatment regimen eliminates veterinarian uncertainty about pet owner compliance and spares pet owners the frustrations of in-home application and multiple treatment visits.

Claro™ was developed by Piedmont Animal Health, Greensboro, NC, as part of a development partnership with Bayer.

CAUTION:
Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.  CLARO™ is contraindicated in dogs with known or suspected hypersensitivity to florfenicol, terbinafine hydrochloride, or mometasone furoate.

About Claro™
Claro™ is indicated for the treatment of canine otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).  One dose is administered to each affected ear in dogs of all sizes. Do not use Claro™ on dogs with known tympanic membrane perforation. Claro™ is contraindicated in dogs with known or suspected hypersensitivity to florfenicol, terbinafine hydrochloride or mometasone furoate.

About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of around EUR 20.0 billion (2014), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 60,700 employees (Dec 31, 2014) and is represented in more than 100 countries. More information is available atwww.healthcare.bayer.com.

About Piedmont Animal Health
Piedmont Animal Health (part of Piedmont Pharmaceuticals) is led by a team of seasoned veterinary pharmaceutical innovators that has developed, launched, or marketed more than 20 companion animal health products. Today, these products represent approximately 25 percent of the total revenue in the U.S. small animal veterinary segment. A leader in innovation, Piedmont is dedicated to developing products that improve compliance and ease of use. For more information, visit PiedmontAnimalHealth.com.

Sunshine Heart Initiates Animal Study on Applicability of C-Pulse Technology in the Treatment of Pulmonary Arterial Hypertension

September 9th, 2015

EDEN PRAIRIE, Minn., (GLOBE NEWSWIRE) — Sunshine Heart, Inc. (Nasdaq:SSH) announced today the commencement of a collaborative effort with Dr. Mark Slaughter and the University of Louisville to study the impact of the C-Pulse technology on the pulmonary circulation and right heart, specifically in the field of pulmonary hypertension and heart failure.

Pulmonary arterial hypertension (PAH) is a debilitating condition characterized by progressive increases in pulmonary vascular resistance and loss of elasticity of the pulmonary artery and large vessels. Patients with PAH suffer from poor quality of life, shortness of breath and greatly reduced functional capacity leading to right ventricular dysfunction and ultimately, right heart failure. PAH afflicts approximately 200,000 patients worldwide and places a significant burden on the healthcare system, with limited treatment options available and 5 year survival rates as low as 34%¹. PAH and right heart failure are also commonly associated with left heart failure. Approximately 50% of patients with systolic heart failure or preserved ejection fraction heart failure (HFpEF) have PAH with similar 5 year outcomes². PAH and right heart failure also continue to remain a significant risk in the left ventricular assist device patient population³.These studies hope to provide scientific rationale for a new application of current C-Pulse therapy by leveraging the existing technology to apply counterpulsation to the pulmonary artery in acute and chronic animal preparations. Biochemical, neurohormonal and pressure-volume data will be used to assess the effects of C-Pulse on pulmonary circulation and right and left heart properties. A fully implantable system may provide therapeutic options in HFpEF population with PAH where there are currently no approved treatments.

About the C-Pulse® Heart Assist System

The C-Pulse Heart Assist System, or C-Pulse System, an investigational device in the United States, Canada and countries that do not recognize the CE mark approval, utilizes the scientific principles of intra-aortic balloon counter-pulsation applied in an extra-aortic approach to assist the left ventricle by reducing the workload required to pump blood throughout the body, while increasing blood flow to the coronary arteries. Combined, these potential benefits may help sustain the patient’s current condition or, in some cases, reverse the heart failure process, thereby potentially preventing the need for later-stage heart failure devices, such as left ventricular assist devices (LVADs), artificial hearts or transplants. It may also provide relief from the symptoms of Class III and ambulatory Class IV heart failure and improve quality of life and cardiac function. Based on the results from our feasibility study, we also believe that some patients treated with our C-Pulse System may be able to stop using the device due to sustained improvement in their conditions as a result of the therapy.

Caution: Investigational device, limited by Federal (or United States) Law to Investigational use.

  1. D’Alonzo, GE et al. Ann Int Med 115: 342-349, 1991
  2. Miller WL et al. JACC HF 1(4): 290-299, 2013; Guazzi M. Circ. Heart Fail. 7: 367-377, 2014
  3. MacGowan, GA and Schueler, S. Curr Opin Cardiol 27(3); 296-300. 2012

Sunshine Heart Announces FDA Approves Key Protocol Amendment for COUNTER HF(TM) US Pivotal Study for C-Pulse(R) Heart Assist System

August 31st, 2015

EDEN PRAIRIE, Minn., (GLOBE NEWSWIRE) — Sunshine Heart, Inc. (NASDAQ:SSH) is pleased to announce the US Food and Drug Administration (FDA) has approved an amendment to the stopping rule criteria for the Company’s COUNTER HF™ pivotal study for its C-Pulse Heart Assist System®. The Agency has agreed to change this protocol from “all cause” deaths to specifically, mortality associated with device, procedure or therapy.

“Redefining COUNTER HF’s stoppage rule to be focused purely on C-Pulse related events is an important study protocol amendment as it greatly reduces our risk of having to pause the trial again due to unrelated C-Pulse mortality events,” commented Dave Rosa, President and Chief Executive Officer of Sunshine Heart.

Sunshine Heart previously announced on March 6, 2015 a temporary enrollment pause in accordance with the study’s original “stopping rule.” This particular protocol indicated that, in the event more than three of the first twenty subjects pass away for any reason, including non-device related deaths, the Company would work with the FDA to establish a plan before resuming enrollment. An independent Clinical Events Committee (CEC) determined that all four of the reported deaths were adjudicated as being non-device related and, on May 26th, the Company announced the FDA’s approval to resume enrollment in the COUNTER HF study.

Moving forward, the “stopping rule” has been amended such that COUNTER HF will be halted if more than seven of the first twenty implanted subjects pass away during device support within twelve months of implant. Importantly, in order for a study pause to occur, each mortality event will have to be adjudicated as possibly or definitely related to the procedure, therapy or device.

Individuals who are interested in exploring if they might qualify for COUNTER HF can visit www.HFClinicalStudy.com or call 1-888-978-8391.

About the COUNTER HF and OPTIONS HF Studies:

COUNTER HF is a prospective, randomized, multi-center clinical study. It is being conducted by heart failure and cardiac surgeon specialists in the United States. It is expected to randomize 388 patients in up to 40 clinical sites. The purpose of the study is to determine whether the C-Pulse System is a safe and effective treatment for heart failure patients who meet the following key study qualifications:

  • NYHA Class III or early Class IV heart failure*;
  • Ejection fraction ≤ 35% (measure of how well the heart pumps blood);
  • Taking appropriate heart failure medications as prescribed by doctor; and
  • Have been evaluated for cardiac resynchronization therapy with or without defibrillation (CRT, CRT-D) or implantable cardioverter defibrillator (ICD) therapy.

*New York Heart Class (NYHA) Class III or early Class IV: Very limited in daily activities or unable to do activities without discomfort. Become tired, short of breath, and have heart palpitations during physical activity. Note: Other qualifications apply and study doctors will determine who is eligible for the study.

OPTIONS HF is a post-market, multi-center, prospective, open label study that will include 50 patients in up to 15 European centers. The study is designed to observe clinical outcomes of heart failure patients treated with the C-Pulse system. The primary endpoint is comparable to the COUNTER HF study as it evaluates the rate of re-hospitalization due to worsening heart failure and heart failure related death in addition to many other traditional heart failure endpoints.

About the C-Pulse® Heart Assist System

The C-Pulse Heart Assist System, or C-Pulse System, an investigational device in the United States, Canada and countries that do not recognize the CE mark approval, utilizes the scientific principles of intra-aortic balloon counter-pulsation applied in an extra-aortic approach to assist the left ventricle by reducing the workload required to pump blood throughout the body, while increasing blood flow to the coronary arteries. Combined, these potential benefits may help sustain the patient’s current condition or, in some cases, reverse the heart failure process, thereby potentially preventing the need for later-stage heart failure devices, such as left ventricular assist devices (LVADs), artificial hearts or transplants. It may also provide relief from the symptoms of Class III and ambulatory Class IV heart failure and improve quality of life and cardiac function. Based on the results from our feasibility study, we also believe that some patients treated with our C-Pulse System may be able to stop using the device due to sustained improvement in their conditions as a result of the therapy.

Caution: Investigational device, limited by Federal (or United States) Law to Investigational use.

Datacastle RED v8 Available for Mobile Workforce Backup, Archiving and Insights

July 14th, 2015

dc_red_logo_rgb

 

 

Seattle, WA, – Datacastle®, a market leader for protecting enterprises from mobile workforce data loss and data breaches, today announced the latest version of its flagship product, Datacastle RED. Datacastle RED v8 provides enterprise customers even greater mobile workforce data protection via backup, archiving and insights.

Datacastle RED v8 includes:

  • Microsoft Enterprise Mobility Suite (EMS) Compatibility – Datacastle RED v8 integrates with Azure Active Directory for deployments and SSO, Microsoft Intune and SCCM for silent enterprise deployments, and provides mobile file access security with Azure Rights Management services compatibility
  • Mobile Dashboard – Optimized IT experience for managing Datacastle vault administrator functions from any tablet or smartphone
  • iOS Support – Datacastle RED provides a native app experience for backup and retrieval on Apple iPads and iPhones
  • Android Support – Datacastle RED provides a native app experience for backup and retrieve on Google Android tablets and smartphones
  • Windows 10 Ready – The Datacastle RED agent supports Windows 10 at launch

Datacastle RED v8 has been designed from the ground up to protect data at the frontier of the enterprise. Datacastle RED is optimized for network efficiency and security across smartphones, tablets, laptops, desktops, and ROBO file servers.

“Datacastle is excited to assist enterprise IT in bringing order and governance to the frontier of their organizations,” said Ron Faith, CEO of Datacastle. “The mobile workforce needs tools such as Datacastle RED to help them thrive and survive in this rapidly changing and threat-laden landscape.”

For a limited time, Datacastle RED v8 is available to qualified Microsoft Azure Enterprise Agreement (EA) customers license-free for one year. To learn more about taking advantage of this promotion go todatacastlered.com/cloud-options/special-offer/ .

Datacastle RED v8 is available today for on-premises, private cloud, or public cloud deployments directly from Datacastle or from one of Datacastle’s global network of partners. Datacastle RED smartphone and tablet clients are available for download from the Apple App Store or the Google Play Store (Datacastle RED vault required to activate). For more information call 425.996.9684 or email sales@datacastlered.com.

About Datacastle
Datacastle protects enterprises from mobile data loss and data breach with simplified and scalable hybrid cloud endpoint backup, archiving, and insights. Datacastle RED provides secure and auditable access to enterprise data on critical devices, anytime, anywhere. To learn more about Datacastle RED, visit www.datacastlered.com, follow on Twitter @Datacastle, or call 425.996.9684.

 

Sunshine Heart Announces FDA Approval to Resume Enrollment in Pivotal Study

May 26th, 2015

Sunshine Heart Announces FDA Approval to Resume Enrollment in COUNTER HF™ US Pivotal Study for C-Pulse® Heart Assist System

EDEN PRAIRIE, Minn.,  (GLOBE NEWSWIRE) — Sunshine Heart, Inc. (Nasdaq:SSH) is pleased to announce that the US Food and Drug Administration (FDA) has approved the resumption of patient enrollment in its COUNTER HF US pivotal study for the C-Pulse Heart Assist System. As such, the Company has already begun the process to provide all pivotal study centers with the information required for their Investigational Review Board to approve the continuation of study enrollment.

“Resuming enrollment in COUNTER HF has been our top priority and was accomplished within the timelines originally announced. The proposed protocol modifications have enhanced an already robust protocol, and should increase the likelihood of success. We are encouraged by our investigators’ enthusiasm as witnessed by the high site representation at our recent investigator meeting,” commented Dave Rosa, President and Chief Executive Officer of Sunshine Heart.

Earlier in February 2015 the FDA unconditionally approved an interim analysis for the COUNTER HF study, as a means to potentially reduce the approval timeline for the C-Pulse therapy. FDA approval to resume study enrollment will now allow the Company to progress expeditiously towards that goal.

Individuals who are interested in exploring if they might qualify for COUNTER HF can visit www.HFClinicalStudy.com or call 1-888-978-8391.

About the COUNTER HF and OPTIONS HF Studies:

COUNTER HF is a prospective, randomized, multi-center clinical study. It is being conducted by heart failure and cardiac surgeon specialists in the United States. It is expected to randomize 388 patients in up to 40 clinical sites. The purpose of the study is to determine whether the C-Pulse System is a safe and effective treatment for heart failure patients who meet the following key study qualifications:

  • NYHA Class III or early Class IV heart failure*;
  • Ejection fraction ≤ 35% (measure of how well the heart pumps blood);
  • Taking appropriate heart failure medications as prescribed by doctor; and
  • Have been evaluated for cardiac resynchronization therapy with or without defibrillation (CRT, CRT-D) or implantable cardioverter defibrillator (ICD) therapy.

*New York Heart Class (NYHA) Class III or early Class IV: Very limited in daily activities or unable to do activities without discomfort. Become tired, short of breath, and have heart palpitations during physical activity. Note: Other qualifications apply and study doctors will determine who is eligible for the study.

OPTIONS HF is a post-market, multi-center, prospective, open label study that will include 50 patients in up to 15 European centers. The study is designed to observe clinical outcomes of heart failure patients treated with the C-Pulse system. The primary endpoint is comparable to the COUNTER HF study as it evaluates the rate of re-hospitalization due to worsening heart failure and heart failure related death in addition to many other traditional heart failure endpoints.

About the C-Pulse® Heart Assist System

The C-Pulse Heart Assist System, or C-Pulse System, an investigational device in the United States, Canada and countries that do not recognize the CE mark approval, utilizes the scientific principles of intra-aortic balloon counter-pulsation applied in an extra-aortic approach to assist the left ventricle by reducing the workload required to pump blood throughout the body, while increasing blood flow to the coronary arteries. Combined, these potential benefits may help sustain the patient’s current condition or, in some cases, reverse the heart failure process, thereby potentially preventing the need for later-stage heart failure devices, such as left ventricular assist devices (LVADs), artificial hearts or transplants. It may also provide relief from the symptoms of Class III and ambulatory Class IV heart failure and improve quality of life and cardiac function. Based on the results from our feasibility study, we also believe that some patients treated with our C-Pulse System may be able to stop using the device due to sustained improvement in their conditions as a result of the therapy.

Caution: Investigational device, limited by Federal (or United States) Law to Investigational use.

Datacastle Provides a Year of FREE Endpoint Backup and Data Protection Licenses for Microsoft Azure Customers

May 20th, 2015

Microsoft Partner - Gold Cloud Platform

Seattle, WA,  – Datacastle, a market leader in enterprise endpoint backup and data protection, announced today a promotion of its Datacastle RED service, for qualifying Azure customers.

Datacastle RED helps protect enterprises from ransomware extortion, data loss and data breach through simplified and scalable endpoint backup and data protection, in the cloud. Datacastle’ s hybrid services running on Azure, enable enterprises to rapidly experience LAN-speed performance with the assurance of offsite, cloud-based recoverability and mobile access.

During the promotion, qualifying Azure customers are able to further the protections of their laptops, high-end tablets, and desktop computers from ransomware extortion, data loss, and data breaches, at no additional Datacastle license cost, for one year. The promotion is available to qualifying Azure customers in North America and Europe.

“No company should ever have to pay the extortion of Ransomware, CryptoLocker, or CryptoWall, for the data on their endpoints.” said Ron Faith, CEO, Datacastle. “The best way for companies to never pay such a ransom is to have a current backup with improved security stored on Azure using Datacastle RED.”

“Microsoft is committed to having a thriving independent software vendor (ISV) ecosystem on Azure.” Vibhor Kapoor, Director, Microsoft Azure Product Marketing. “Datacastle has attained Microsoft Gold Cloud Platform competency, building on top of Microsoft Azure’s hyper-scale, enterprise-grade hybrid services.”

To determine if you qualify and to take advantage of this promotion, customers can contact Datacastle at sales@datacastlered.com or at http://datacastlered.com/cloud-options/special-offer/.

About Datacastle
Datacastle protects enterprises from mobile data loss and data breach with simplified and scalable hybrid cloud endpoint backup and data protection. Datacastle RED provides secure and auditable access to enterprise data on critical devices, anytime, anywhere. To learn more about Datacastle RED, visit http://www.datacastlered.com, follow on Twitter @Datacastle, or call 425.996.9684.

UBI – Siemens announces full launch of Award Winning Xprecia Stride™ Coagulation Analyzer

May 14th, 2015

Siemens Healthcare Diagnostics, Inc. (“Siemens”) today announced the full commercial launch of the Xprecia Stride™  Coagulation Analyzer following successful completion of its limited European release. The system will now be marketed through Siemens’ extensive sales and distribution network in a growing number of markets, currently excluding the U.S. (which will require FDA 510(k) clearance).

In addition, Siemens has today announced that the Xprecia Stride™  Coagulation Analyzer has been awarded the internationally respected Red Dot Award for Product Design for 2015. The Red Dot Product Design Competition started in Germany in 1954 and its award, the ‘Red Dot,’ is an internationally recognised quality seal. See www.red-dot.org for further details on the Red Dot competition and the award.

The Xprecia Stride™  Coagulation Analyzer delivers hand-held Prothrombin time testing (PT/INR) for point of-care monitoring and management of the oral anticoagulation therapy (OAT), Warfarin. The product was specifically designed to meet the growing demand for fast and reliable PT/INR results in physician offices and walk-in clinics to help healthcare professionals make informed decisions about patient care. Universal Biosensors will be the manufacturer of PT/INR strips for Siemens at the Company’s plant in Rowville, Victoria.

“The Xprecia Stride™ Coagulation Analyzer is among the most radical, user-friendly redesigns of a point of-care coagulation analyzer since they became widely available more than 20 years ago. This analyzer includes a number of innovations and features not found on most other point-of-care analyzers,” said David Stein, Ph.D., CEO of Siemens Diagnostics Point of Care Business Unit.

A copy of the press release by Siemens is attached.

UBI CEO Paul Wright said: “We are thrilled that the limited release has gone well and that Siemens will now be rolling out the Xprecia Stride™  Coagulation Analyzer. The Red Dot Award is a clear validation of the product’s unique features that will deliver real benefits to patients and healthcare professionals.”

The limited European release of the Xprecia Stride™  Coagulation Analyzer was initiated in December 2014.

Patients using Warfarin require frequent testing to assess the clotting tendency of their blood. The Prothrombin time (PT/INR) test allows physicians to adjust patient doses for diet and lifestyle changes. The worldwide point-of-care coagulation testing market was estimated at about US$1 billion in 2014 and is forecast to grow by about 9% per annum to about US$1.4 billion by 2018. The point-of-care coagulation testing market is dominated by PT/INR testing, which represents about 65% of this market.

Datacastle Enters into OEM Agreement with 21Vianet for Cloud-based endpoint Data Protection in China

April 23rd, 2015

Seattle, WA,  – Datacastle, a market leader in enterprise endpoint backup and data protection, today announced it has signed a multi-year agreement with 21Vianet (Nasdaq:VNET) to allow 21Vianet to resell the Datacastle RED solution for laptop, desktop and tablet data protection. The new 21Vianet offering will be sold under the 21Vianet brand and will be offered as a Microsoft Azure, cloud-based solution in China.

Datacastle protects enterprises from ransomware extortion, data loss and data breach with simplified and scalable endpoint backup and data protection. Datacastle RED’s hybrid cloud deployment option with Microsoft Azure enables enterprises to rapidly experience LAN-speed performance with the assurance of offsite, cloud-based recoverability and mobile access.

“21Vianet is committed to bringing the worldwide best-in-class cloud solutions on Microsoft Azure in China.” said Wing Ker, president of Microsoft Cloud Operations at 21Vianet. “Enterprises in China will now have endpoint data protection option to protect against ransomware, data loss, and data breach through our partnership with Datacastle.”

21Vianet provides the world class reliable and safety cloud services to the business in China. It enables the global solution providers, such as Datacastle, to quickly enter into the china market without the headaches of localization, qualification, local support, etc. It also enables the customers in China to have the access to the solutions through 21Vianet’s strong channel networks.

“21Vianet is an outstanding partner for Datacastle in China.” said Ron Faith, CEO, Datacastle. “Given 21Vianet’s expertise operating Microsoft Azure in China and their trusted status as a data center service provider, customers in China will get the best performance, reliability and security.”

About Datacastle
Datacastle protects enterprises from mobile data loss and data breach with simplified and scalable hybrid cloud endpoint backup and data protection. Datacastle RED provides secure and auditable access to enterprise data on critical devices, anytime, anywhere. To learn more about Datacastle RED, visit http://www.datacastlered.com, follow on Twitter @Datacastle, or call 425.996.9684.

About 21Vianet
21Vianet Group, Inc. is the largest carrier-neutral internet data center services provider in China. 21Vianet provides hosting and related services, managed network services, cloud infrastructure services, and content delivery network services, improving reliability, security and speed of its customers’ internet infrastructure.21Vianet operated in 44 cities throughout China, servicing a diversified and loyal base of more than 2,000 customers that span many industries ranging from Internet companies to government entities and blue-chip enterprises to small- to mid-sized enterprises.

 

Sunshine Heart Receives FDA Approval for Interim Analysis of US Pivotal Trial

February 25th, 2015

Sunshine Heart Receives FDA Approval for Interim Analysis of U.S. Pivotal Trial of C-Pulse® Heart Assist System

EDEN PRAIRIE, Minn.,  (GLOBE NEWSWIRE) — Sunshine Heart, Inc. (Nasdaq:SSH) today announced it has received unconditional approval from the FDA to conduct an interim analysis of COUNTER HF, the Company’s U.S. pivotal study. The COUNTER HF study is a prospective, randomized, multi-center, controlled study that evaluates the safety and efficacy of the C-Pulse system for the treatment of NYHA Class III and ambulatory Class IV heart failure. Integral to the COUNTER HF study is the assessment of C-Pulse’s unique balloon counterpulsation treatment designed to improve heart function and reduce re-hospitalizations due to worsening heart failure.

“Today’s announcement is a significant achievement for the company as it offers the potential to dramatically reduce the development timeline for this important solution for heart failure. The FDA decision to approve this interim analysis is not only unconditional but also arrives earlier than the originally anticipated timeframe of end Q1 2015. We are grateful for the FDA’s rapid response to our submission and look forward to working with the Agency through the balance of the COUNTER HF study and on the development of the next generation, fully implantable C-Pulse system,” commented Dave Rosa, President and Chief Executive Officer of Sunshine Heart.

A key potential benefit of conducting the analysis is the prospect of reducing the overall duration of the study should COUNTER HF meet the higher statistical threshold of the interim analysis. The study is a prospective, randomized, multi-center clinical trial. It is being conducted by heart failure and cardiac surgeon specialists in the United States. It is expected to randomize 388 patients in up to 40 clinical sites. The purpose of the study is to determine whether the C-Pulse System is a safe and effective treatment for heart failure patients who meet the following key study qualifications:

  • NYHA Class III or early Class IV heart failure*;
  • Ejection fraction ≤ 35% (measure of how well the heart pumps blood);
  • Taking appropriate heart failure medications as prescribed by doctor; and
  • Have been evaluated for cardiac resynchronization therapy with or without defibrillation (CRT, CRT-D) or implantable cardioverter defibrillator (ICD) therapy.

*New York Heart Class (NYHA) Class III or early Class IV: Very limited in daily activities or unable to do activities without discomfort. Become tired, short of breath, and have heart palpitations during physical activity. Note: Other qualifications apply and study doctors will determine who is eligible for the study.

Individuals who are interested in learning more about the trial and if they might qualify for the study can visitwww.HFClinicalStudy.com or call 1-888-978-8391.

About the C-Pulse® Heart Assist System

The C-Pulse Heart Assist System, or C-Pulse System, an investigational device in the United States, Canada and countries that do not recognize the CE mark approval, utilizes the scientific principles of intra-aortic balloon counter-pulsation applied in an extra-aortic approach to assist the left ventricle by reducing the workload required to pump blood throughout the body, while increasing blood flow to the coronary arteries. Combined, these potential benefits may help sustain the patient’s current condition or, in some cases, reverse the heart failure process, thereby potentially preventing the need for later-stage heart failure devices, such as left ventricular assist devices (LVADs), artificial hearts or transplants. It may also provide relief from the symptoms of Class III and ambulatory Class IV heart failure and improve quality of life and cardiac function. Based on the results from our feasibility study, we also believe that some patients treated with our C-Pulse System may be able to stop using the device due to sustained improvement in their conditions as a result of the therapy.

Caution: Investigational device, limited by Federal (or United States) Law to Investigational use.

Datacastle Honored as Coolest Cloud Computing Vendor by CRN

February 11th, 2015

Top 100 Coolest Cloud Vendors

Seattle, WA,  – Datacastle, a market leader in enterprise endpoint backup and data protection, today announced it has earned recognition on The Channel Company’s CRN 100 Coolest Cloud Computing Vendors of 2015. This annual list recognizes some of the most innovative cloud companies supporting the IT channel today.

The 100 Coolest Cloud Computing Vendors honor is presented to companies based on their approach to creating innovative products, services or partner programs that have helped channel partners transform into true solution providers, ultimately helping customers take advantage of the ease of use, flexibility, scalability and savings that cloud computing offers. Datacastle RED is recognized for its hybrid cloud, enterprise class endpoint backup and data protection solution.

This year’s 100 Coolest Cloud Computing honorees are identified across five major categories including platforms, infrastructure, storage, security and software. This list is an effort to help solution providers navigate through the ambiguity of the cloud market to identify the vendors, products and services that can help elevate their cloud services offerings. Companies were chosen based on data and information gathered from solution provider nominations along with input from the CRN editorial team.

Datacastle protects enterprises from mobile data loss and data breach with simplified and scalable endpoint backup and data protection. Datacastle RED’s hybrid cloud deployment option with Microsoft Azure or IBM SoftLayer enables enterprises to rapidly experience LAN-speed performance with the assurance of offsite, cloud-based recoverability and mobile access.

“Widespread demand for cloud computing solutions is increasing across businesses of all shapes and sizes. As organizations become more willing to adopt cloud technology and services, experienced solution providers are in greater demand.” said Robert Faletra, CEO, The Channel Company. “The 100 Coolest Cloud Computing Vendors list enables solution providers to engage with companies who are poised to help them capitalize on these opportunities.”

“Datacastle is honored to be recognized as one of the Coolest Cloud Vendors of 2015 by CRN,” said Ron Faith, CEO, Datacastle. “Datacastle is experiencing triple digit, year over year growth as companies are recognizing the need to protect data at the edge of their networks in a cost effective and friction free manner for the end user.”

Coverage of the 100 Coolest Cloud Computing Vendors will be featured in the February 2015 issue of CRN and online at www.CRN.com.

About Datacastle
Datacastle protects enterprises from mobile data loss and data breach with simplified and scalable hybrid cloud endpoint backup and data protection. Datacastle RED provides secure and auditable access to enterprise data on critical devices, anytime, anywhere. To learn more about Datacastle RED, visit http://www.datacastlered.com, follow on Twitter @Datacastle, or call 425.996.9684.

About the Channel Company
The Channel Company, with established brands including CRN, XChange Events, IPED and SharedVue, is the channel community’s trusted authority for growth and innovation. For more than three decades, we have leveraged our proven and leading-edge platforms to deliver prescriptive sales and marketing solutions for the technology channel. The Channel Company provides Communication, Recruitment, Engagement, Enablement, Demand Generation and Intelligence services to drive technology partnerships.

Learn more at www.thechannelcompany.com.

Piedmont Animal Health Achieves Second FDA Approval In Less Than 18 Months

February 9th, 2015

Robust pipeline places company in position to be among top seven US companion animal veterinary pharmaceutical companies by 2020

GREENSBORO, N.C., –Piedmont Animal Health announces its second approval from the Food and Drug Administration for companion animals, new advantusTM (imidacloprid) soft chew, an oral flavored chewable flea medication for dogs.i The new animal drug application (NADA) is formulated in Piedmont’s patented soft chew invention, offering convenient, palatable dosing. The approval represents the second FDA approval for Piedmont and its first NADA approval. In June 2013, Piedmont announced the approval of quellinTM (carprofen) soft chews, an abbreviated new animal drug application (ANADA).ii

Rapid Product Development
“From start to finish, this product was developed on a rapid timeline, thanks to our talented and experienced team of professionals,” says Roland Johnson, Piedmont founder and CEO. “With more than 20 additional products in various stages of development, we expect a steady stream of new product approvals–some of which we project will be blockbusters once they are in the marketplace.”

Top Seven by 2020
Piedmont plans to commercialize more than 10 of its pipeline products, and, as with advantus, already holds out-licensing agreements with multiple global animal health pharmaceutical companies for the others. Based on independent market research, sales of Piedmont’s retained portfolio products are projected to reach $175 million annually by the end of 2020.iii “With a pipeline this rich, I fully anticipate that Piedmont will be among the top seven companion animal veterinary pharmaceutical companies in the U.S. in just over five years,” adds Johnson.

About Piedmont Animal Health
Piedmont Animal Health (part of Piedmont Pharmaceuticals) is led by a team of seasoned veterinary pharmaceutical innovators that has developed, launched, or marketed more than 20 companion animal health products. Today, these products represent approximately 25 percent of the total revenue in the U.S. small animal veterinary segment. A leader in innovation, Piedmont is dedicated to developing products that improve compliance and ease of use. For more information, visit PiedmontAnimalHealth.com and PiedmontPharma.com

i NADA 141-435, Approved by FDA
ii ANADA 200-555, Approved by FDA
iii Based on independent new product research conducted by AllPoints Research with 316 veterinary practices in Nov/Dec 2014

UBI – Launch of Siemens Xprecia Stride™ Coagulation Analyzer for the point of care

December 17th, 2014

Universal Biosensors, Inc. (ASX: UBI) is pleased to announce that Siemens Healthcare Diagnostics Inc. (“Siemens”) has initiated the European limited release of the Xprecia Stride™ Coagulation Analyzer, its first point-of-care coagulation testing product. The Xprecia Stride™ Coagulation Analyzer is a PT-INR testing system that incorporates UBI’s unique electrochemical sensing technology which offers high performance and ease-of-use in an affordable, handheld format. The product launch has triggered a milestone payment of US$1 million from Siemens to Universal Biosensors.

Universal Biosensors CEO Paul Wright said: “This is an important milestone for both Universal Biosensors and Siemens. We have been collaborating on the development of this product for more than three years and we are confident the Xprecia Stride™ Coagulation Analyzer will be well received in the point-of-care market.”

The system is used to monitor the application of the anti-coagulant therapy, Warfarin. Universal Biosensors is the exclusive manufacturer of PT-INR strips for Siemens at the Company’s existing plant in Rowville, Victoria.

It is estimated that up to ten million patients globally are taking Warfarin. Patients are prescribed the drug for a variety of reasons, including the treatment of blood clots in the veins or certain heart conditions which increase the likelihood of a potentially life-threatening clot forming. Patients on Warfarin require frequent testing to assess the clotting tendency of their blood. The Prothrombin Time (PT-INR) test allows physicians to adjust patient doses for diet and lifestyle changes.

The worldwide point-of-care coagulation testing market was estimated at ~US$1.0 billion in 2014 and is forecast to grow by ~9% per annum to ~US$1.4 billion by 2018.1 The coagulation testing market is dominated by PT-INR testing, which represents about 65% of this market. There are currently two major players in the POC Professional PT-INR testing market – Roche and Alere. The Xprecia Stride™ Coagulation Analyzer will represent Siemens’ first entry into this market.

On 9 December, UBI announced that the product had completed CE mark self-certification. The PT-INR test is the first of several tests in development with Siemens designed to bring laboratory-quality to the point-of-care.

CEO of Siemens Healthcare Point-of-Care business unit, Dr. David Stein said: “The Xprecia Stride™ Coagulation Analyzer is an exciting new product in an attractive market space for Siemens, extending our 30 years of leadership in hemostasis now to the point-of-care. Our teams have worked hard together to reach this important milestone in our collaboration which offers great opportunity to bring laboratory performance to near-patient testing.”

Blood coagulation testing system approved for the European market

December 9th, 2014

9 December 2014

Universal Biosensors, Inc. (ASX: UBI) is pleased to announce that Siemens Healthcare Diagnostics Inc. (“Siemens”) has received CE Mark approval for the Xprecia Stride™ Coagulation Analyzer, the first point-of-care coagulation analyzer developed in collaboration with Universal Biosensors.

The Xprecia Stride™ Coagulation Analyzer is a prothrombin time (PT-INR) testing system used to monitor the application of the anti-coagulant therapy, Warfarin. Universal Biosensors will exclusively manufacture PT-INR strips for Siemens at the Company’s existing plant in Rowville, Victoria.

The CE marking follows the receipt of two commercial orders from Siemens for the production and supply of PT-INR test strips by Universal Biosensors, and is the final step prior to product launch in Europe.

The CE marking is mandatory for any company prior to selling its product within the 31 countries operating in the European Economic Area. The CE marking indicates a product is fully compliant with all relevant EU legislation and can move freely within the European Economic Area.

It is estimated about ten million patients globally are taking Warfarin. Patients are prescribed the drug for a variety of reasons, including the treatment of blood clots in the veins or certain heart conditions which increase the likelihood of a potentially life-threatening clot forming. Patients on Warfarin require frequent testing of the clotting tendency of their blood. PT-INR testing allows physicians to adjust patient doses for diet and lifestyle changes.

According to recent research, the worldwide point-of-care coagulation testing market was estimated at around US$1.0 billion in 2014 and is forecast to grow by 9% per annum to US$1.4 billion by 2018.1 The coagulation testing market is dominated by PT-INR testing, which represents about 65% of this market.

Universal Biosensors CEO Paul Wright said: “Receipt of the CE marking is an important step prior to the market launch of this exciting new coagulation testing product developed in partnership with Siemens. We are looking forward to the launch of this new device and continue to work with Siemens to bring powerful and innovative systems to point-of-care testing.”

Enquiries:
Mr Paul Wright: 03 9213 9000
1 Espicom, “The Cardiology Point-of-Care Diagnostics Market to 2018”, July 2014

About Universal Biosensors
For additional information in relation to Universal Biosensors, refer to

http://www.universalbiosensors.com.

Universal Biosensors is a specialist medical diagnostics company, founded in 2001, that is focused on the development, manufacture and commercialisation of a range of in vitro diagnostic tests for point-of-care use. These tests capitalise on a technology platform which uses a novel electrochemical cell that can be adapted for multiple analytes and provide for enhanced measurements in whole blood.

Forward-Looking Statements
The statements contained in this release that are not purely historical are forward-looking statements within the meaning of the Exchange Act. Forward-looking statements in this release include statements regarding our expectations, beliefs, hopes, intentions or strategies regarding the proposed offering. All forward-looking statements included in this release are based upon information available to us as of the date hereof, and we assume no obligation to update any such forward-looking statement as a result of new information, future events or otherwise. Our actual results could differ materially from our current expectations. We cannot assure you when, if at all, the proposed offering will occur, and the terms of any such offering are subject to change. Factors that could cause or contribute to such differences include, but are not limited to, factors and risks disclosed from time to time in reports filed with the SEC.

Sunshine Heart Provides Update on OPTIONS HF EU Post-Market Study

December 1st, 2014

Austrian Site Achieves First Implant

EDEN PRAIRIE, Minn., Dec. 1, 2014 (GLOBE NEWSWIRE) — Sunshine Heart, Inc. (Nasdaq:SSH) announced today that the Company’s initial Austrian site for the OPTIONS-HF study has implanted its first patient with the C-Pulse System for moderate to severe heart failure. Prof. Dr. Herwig Antretter of the University of Innsbruck performed the operation, which took place on November 11th, 2014. A 92 minute surgical implantation procedure was successfully completed and the patient was discharged from the hospital 7 days post-surgery. This milestone marks the eleventh implantation of the C-Pulse System across fourteen activated EU centers participating in the OPTIONS HF post-market surveillance clinical study.

“The C-pulse system is an ideal addition for patients in the treatment of NYHA III and ambulatory IV stage heart failure,” said Prof. Dr. Antretter. “It is easy to implant the device, doesn´t need a heart lung machine, and allows for quick patient recovery. Our patient was extubated in the operating room, stayed just a couple of hours in the ICU, and was then transferred to a normal ward. We discharged him after only one week.”

The patient was selected in cooperation with Univ.-Doz. Dr. Gerhard Poelzl, F.E.S.C. a leading Heart Failure Cardiologist (department of Univ. Prof. Wolfgang-M. Franz, Internal Medicine III, Cardiology and Angiology) in the University Hospital of Innsbruck. The patient suffers from dilated cardiomyopathy with severe impairment of his left ventricle, low ejection fraction (EF < 25%) and has survived an extensive cardiopulmonary resuscitation due to sudden cardiac arrest in January 2014 without any neurological deficit. Despite his advanced age and his medical history, the patient remains highly active and employed.

“I’m extremely pleased that we have introduced the C-Pulse therapy to yet another key country. As discussed in our Q3 quarterly update, we continue to remain enthusiastic regarding the increased overall momentum for the OPTIONS HF study,” commented Dave Rosa, Sunshine Heart Inc. Chief Executive Officer.

The OPTIONS HF study is a post-market, multi-center, prospective, open label study that will include 50 patients in up to 15 European centers. The study is designed to observe clinical outcomes of heart failure patients treated with the C-Pulse system. The primary endpoint is comparable to the COUNTER HF trial as it evaluates the rate of re-hospitalization due to worsening heart failure and heart failure related death in addition to many other traditional heart failure endpoints.

About the C-Pulse® Heart Assist System

The C-Pulse Heart Assist System, or C-Pulse System, an investigational device in the United States, Canada and countries that do not recognize the CE mark approval, utilizes the scientific principles of intra-aortic balloon counterpulsation applied in an extra-aortic approach to assist the left ventricle by reducing the workload required to pump blood throughout the body, while increasing blood flow to the coronary arteries. Combined, these potential benefits may help sustain the patient’s current condition or, in some cases, reverse the heart failure process, thereby potentially preventing the need for later-stage heart failure devices, such as left ventricular assist devices (LVADs), artificial hearts or transplants. It may also provide relief from the symptoms of Class III and ambulatory Class IV heart failure and improve quality of life and cardiac function. Based on the results from our feasibility study, we also believe that some patients treated with our C-Pulse System will be able to stop using the device due to sustained improvement in their conditions as a result of the therapy.

Caution: Investigational device, limited by Federal (or United States) Law to Investigational use.

About Sunshine® Heart

Sunshine Heart, Inc. (Nasdaq:SSH) is an early-stage medical device company focused on developing, manufacturing and commercializing the C-Pulse System for treatment of Class III and ambulatory Class IV heart failure. Sunshine Heart has completed an approved U.S. Food and Drug Administration (FDA) feasibility clinical study of the C-Pulse System and presented the results in November 2011. In March 2012, the FDA notified the Company that it could move forward with an investigational device exemption (IDE) application. Sunshine Heart received unconditional approval from the FDA in November 2012 to initiate its pivotal study. In July 2012, Sunshine Heart received CE Mark approval for its C-Pulse System in Europe. Sunshine Heart is a Delaware corporation headquartered in Minneapolis with wholly owned subsidiaries in Australia and Ireland. The Company has been listed on the NASDAQ Capital Market since February 2012.

Forward-Looking Statements

Certain statements in this release are forward-looking statements that are based on management’s beliefs, assumptions, expectations, and information currently available to management. All statements that address future operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including, without limitation, our expectations with respect to future clinical study activities and results including patient enrollment in studies. These forward-looking statements are subject to numerous risks and uncertainties, including, without limitation, the possibility that our clinical studies do not meet their enrollment goals, meet their endpoints or otherwise fail, that regulatory authorities do not accept our application or approve the marketing of the C-Pulse System, the possibility that we may be unable to raise the funds necessary for the development and commercialization of our products, that we may not be able to commercialize our products successfully in the EU and the other risk factors described under the caption “Risk Factors” and elsewhere in our filings with the Securities and Exchange Commission. You should not place undue reliance on forward-looking statements because they speak only as of the date when made and may turn out to be inaccurate. We do not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. We may not actually achieve the plans, projections or expectations disclosed in forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements.

Piedmont Prepares For Veterinary Companion Animal Product Launches

November 19th, 2014

GREENSBORO, N.C.,  – Piedmont Pharmaceuticals, LLC, an innovative pharmaceutical company focused on veterinary market pharmaceuticals, today announced its hiring of Mr. Stan Cruitt as Vice President of Marketing Services. “We couldn’t be more pleased to have Stan join our team. His longstanding record of animal health pharmaceuticals launch success represents perfect timing as we at Piedmont are beginning to prepare for significant product launches,” said Roland Johnson, founder, CEO and Board member of Piedmont Pharmaceuticals. “His record on market and product evaluation, product positioning and communications/marketing strategies stands against the very best in the industry. Stan was honored as one of the top marketers in the US by Advertising Age and Newsweek after one of his major product launches”, adds Mr. Johnson.

Cruitt has held marketing, management and executive positions at Merck, Ciba and Novartis in the animal health industry and has been President and/or founder of three human healthcare startups. Cruitt is the latest addition to Piedmont’s growing cadre of industry leaders joining their management team. A team which now, in total, are responsible for the development and/or marketing and launch of many of the leading veterinary pharmaceuticals today; representing nearly a third of the total US sales dollars for the companion animal veterinary pharmaceutical industry.

“I’ve reviewed the Piedmont product development portfolio and can say with confidence that they have several products that will become the leader in their respective product categories in veterinary medicine” said Cruitt. “Each will be a prescription product and a valuable addition to the veterinarian’s treatment solution.”

“We have 25 new veterinary pharmaceutical products (New Animal Drug Application (NADA) and Abbreviated NADA (ANADA)) in various levels of development, with a steady stream of approvals expected annually through 2020,” adds Mr. Johnson.

About Piedmont Pharmaceuticals, LLC

Piedmont Pharmaceuticals, LLC, is an innovative development and marketing company focused on veterinary pharmaceuticals. Piedmont is a world-class animal health pharmaceutical company with an objective of being among the top seven largest companion animal pharmaceutical companies in the US by 2020. Towards accomplishing that goal, Piedmont is continuing to make significant progress with its current product development portfolio.

Datacastle Achieves Microsoft Gold Cloud Competency

November 19th, 2014

Datacastle demonstrates best-in-class capability and market leadership through demonstrated technology success and customer commitment.

Seattle, WA — Datacastle®, a market leader in enterprise endpoint backup and data protection, today announced it has attained a Gold Cloud Platform Competency, demonstrating a “best-in-class” ability and commitment to meet Microsoft Corp. customers’ evolving needs in today’s dynamic business environment and distinguishing itself within the top 1 percent of Microsoft’s partner ecosystem.

To earn a Microsoft Gold Competency, partners must successfully complete exams (resulting in Microsoft Certified Professionals) to prove their level of technology expertise, and then designate these certified professionals uniquely to one Microsoft competency, ensuring a certain level of staffing capacity. They also must submit customer references that demonstrate successful projects (along with implementing a yearly customer satisfaction study), meet a revenue commitment (for most Gold Competencies), and pass technology and/or sales assessments.

Datacastle protects enterprises from mobile data loss and data breach with simplified and scalable endpoint backup and data protection. Datacastle RED’s hybrid cloud deployment option with Microsoft Azure enables enterprises to rapidly experience LAN-speed performance with the assurance of offsite, cloud-based recoverability and mobile access.

“This Microsoft Gold Cloud Platform Competency showcases our expertise in and commitment to today’s technology market and demonstrates our deep knowledge of Microsoft and its products,” said Ron Faith, CEO, Datacastle. “We plan to accelerate our customers’ success in adopting the cloud by serving as technology advisors for their business demands.”

“By achieving a Gold Competency, partners have demonstrated the highest, most consistent capability and commitment to the latest Microsoft technology,” said Phil Sorgen, Corporate Vice President, Worldwide Partner Group at Microsoft Corp. “These partners have a deep expertise that puts them in the top 1 percent of our partner ecosystem, and their proficiency will help customers drive innovative solutions on the latest Microsoft technology.”

Attaining the Microsoft Cloud Platform Competency demonstrates partner expertise in building, integrating and/or extending Windows-based applications and infrastructure solutions in the cloud using the Microsoft Azure cloud platform. With more than 57 percent of the Fortune 500 using Microsoft Azure, the Microsoft Cloud Platform Competency can help partners take advantage of the growing demand for infrastructure and software as a service solutions. Equipped with exclusive training, partners can help customers deploy solutions that increase customer productivity and profitability.
The Microsoft Partner Network helps partners strengthen their capabilities to showcase leadership in the marketplace on the latest technology, to better serve customers and to easily connect with one of the most active, diverse networks in the world.

About Datacastle
Datacastle protects enterprises from mobile data loss and data breach with simplified and scalable hybrid cloud endpoint backup and data protection. Datacastle RED provides secure and auditable access to enterprise data on critical devices, anytime, anywhere. To learn more about Datacastle RED, visit http://www.datacastlered.com, follow on Twitter @Datacastle, or call 425.996.9684.

Datacastle Announces Datacastle RED v7

September 17th, 2014

Datacastle brings eDiscovery support, Legal Hold, and rapid hybrid cloud deployment enhancements to enterprise endpoint data protection

Press Release: Datacastle – Wed, 17 Sep, 2014 9:45 AM EDT

SEATTLE, Sept. 17, 2014 /PRNewswire/ — Datacastle®, a market leader for protecting enterprises from endpoint data loss and data breaches, today announced the latest version of its flagship product, Datacastle RED. Datacastle RED v7 provides enterprise customers even greater hybrid cloud deployment options with data backup and replication on Microsoft Azure, as well as support for eDiscovery and Legal Hold processes.

Datacastle RED v7 includes:

  • Rapid Deployment Support – enhanced hybrid cloud deployment on Microsoft Azure, enterprise deployment integrations with Active Directory, LDAP, silent installation, and single sign-on (SAML v2)
  • eDiscovery Support – support EDRM process for laptops, high-end tablets, and desktops backup data
  • Legal Hold – the ability to flag laptops, tablets, and desktops for long term data retention
  • Administrative Restore Flexibility – provide the ability for system administrators to have many secure restore options and targets

“It was important for us to quickly protect our endpoint data without disrupting employee’s productivity,” said Jason Tavarez, Senior Director of IT, Achievement First. “Datacastle RED on Microsoft Azure deployed within 30 days to our enterprise infrastructure with Azure SQL and georedundant cloud storage. We experienced rapid time to protection without impacting our end users.”

“As organizations move their solutions to the cloud, they need a platform that offers scale and reliability,” said Kim Akers, General Manager, Microsoft Corp. “We are pleased that Datacastle RED has chosen to take advantage of the geographic breadth, operational excellence, and scale of Microsoft Azure for enterprise customers.”

“Datacastle is excited to bring rapid time to value for our customers and partners deploying on a global, enterprise class cloud platform such as Microsoft Azure,” said Ron Faith, CEO of Datacastle. “Our customers are looking beyond backup and desire to derive greater insights and value from their backup vaults.”

Datacastle RED v7 is available today for on-premises, private cloud, or public cloud deployments directly from Datacastle or from one of Datacastle’s global network of partners. For more information call 425.996.9684 or email sales@datacastlered.com.

About Datacastle

Datacastle protects enterprises from mobile data loss and data breach with simplified and scalable hybrid cloud endpoint backup and data protection. Datacastle RED provides secure and auditable access to enterprise data on critical devices, anytime, anywhere. To learn more about Datacastle RED, visit http://www.datacastlered.com, follow on Twitter @Datacastle, or call 425.996.9684.

ThreatMetrix to Provide Location Detecting Solution to Businesses in Accordance with Office of Foreign Assets Control (OFAC) Regulations

September 3rd, 2014

September 3, 2014

The ThreatMetrix TrustDefender™ Cybercrime Protection Platform Will Help Institutions Meet the Treasury Office’s International Business Regulations

San Jose, CA – September 3, 2014 – ThreatMetrix®, the fastest-growing provider of context-based security and advanced fraud prevention solutions, today announced it will work with businesses to ensure they are compliant with the Office of Foreign Assets Control (OFAC) regulations that prohibit business transactions with embargoed or restricted countries or entities.

To be compliant with OFAC regulations, businesses must know the true location of their business clientele and customers, which becomes increasingly challenging for businesses such as banks, as customers frequently disguise their locations in an effort to maintain privacy and protect personal data, among other reasons. Unfortunately, cybercriminals frequently use proxy servers, TOR networks and other methods to hide their locations. Most companies use outdated technologies such as IP addresses to determine the customer’s location, but cybercriminals have sophisticated techniques to alter their IP addresses and make it appear like they are located in a friendly country by OFAC standards. Businesses can face fines up to $250,000 per incident or twice the value of the offending transactions, whichever is greater, for violating OFAC regulations.

“We’re addressing a major gap and solving a growing problem in the way business is conducted,” said Bert Rankin, chief marketing officer, ThreatMetrix. “Banks and institutions are significantly impacted when OFAC regulations are violated. France’s largest bank, BNP Paribas, for instance, was recently fined $8.9 billion. This doesn’t have to happen. Our SaaS-based fraud prevention solution is easy to implement and can provide measurable financial benefits to the businesses, in addition to protecting their reputations.”

The ThreatMetrix solution is built on the ThreatMetrix TrustDefender™ Cybercrime Protection Platform will help banks and other organizations significantly enhance their ability to comply with OFAC regulations by detecting location spoofing and identifying users’ true locations. The platform’s real-time trust analytics enable context-aware security, and combine device, identity, and behavioral analytics with collaborative feedback from millions of users across thousands of sites to accurately identify good users and block out cybercriminals, stopping organizations from unwittingly violating OFAC regulations.

The TrustDefender platform provides organizations with an accurate assessment of suspicious account registrations and transactions, and the ability to instantly determine if a request or transaction should be blocked, prohibited, accepted or held for manual review. Leveraging global intelligence from the world’s most comprehensive database, the ThreatMetrix® Global Trust Intelligence Network (The Network), the platform is able to detect hidden proxies, Virtual Private Networks (VPNs) and other methods used to conceal customers’ true locations.

ThreatMetrix utilizes real-time advanced device profiling and data from The Network to detect proxy use and evaluate the entire context surrounding each transaction. This includes:

  • Device analytics: Composed of uniquely identifying each device, determining its location, association with the user, and ties to criminal activity or hacker rings; detecting the presence of proxies, anonymizers, bots or malware; and exposing other anomalies that may indicate fraudulent locations, hacking or a compromised device.
  • Identity analytics: Pinpointing the end user’s association(s) with trusted entities, or any history or affiliation with crime, fraud, or hacking activities.
  • Behavior analytics: Analyzes normal login patterns such as login frequencies, locations, typical access times, login names, and devices used.

ThreatMetrix Resources

ThreatMetrix Selected as One of CIOReview100’s Most Promising Technology Companies

August 19th, 2014

August 19, 2014

 Context-Based Security and Advanced Fraud Prevention Provider Recognized for Powerful, Flexible and Cost-Effective Security Solutions

San Jose, CA – August 19, 2014 – ThreatMetrix®, the fastest-growing provider of context-based security and advanced fraud prevention solutions, today announced it has been recognized by CIOReview as one of the “100 Most Promising Technology Companies in the U.S.”

CIOReview100 is an annual list selected by a panel comprised of top CEOs, CIOs and industry analysts including the CIOReview editorial board to honor the top 100 technology companies in the U.S. This year, the list honored the most promising technology companies for their use of powerful next generation technologies such as cloud, mobile and big data. The list distinguishes companies that enable their customers to break through old performance barriers and improve their businesses.

“Recognition by the CIOReview100 serves as validation of our continued innovation in context-based authentication and advanced fraud prevention,” said Bert Rankin, chief marketing officer, ThreatMetrix. “While we are incredibly invested in protecting our customers’ businesses from fraudsters, we also place equal weight on making sure we maintain a great customer experience for their users in the process. Our fraud and security solutions leverage a collective network to provide real-time insights, blocking out potential threats without adding additional authentication steps for good users.”

In July 2014, ThreatMetrix announced the addition of a new patent that builds off of its cookieless device identification, using fuzzy matching technology to globally recognize trusted customers and cybercriminals.ThreatMetrix is committed to building trust on the Internet, which requires frequently updating and enhancing its solutions with patented technologies. Through the frequent addition of patents that help companies identify, recognize and thwart attackers, ThreatMetrix helps to keep businesses secure and prevent cybercriminals from compromising online identities.

For a full list of winners, visit http://cioreview100.cioreview.com/.

In addition to being named to the CIOReview100, ThreatMetrix has been recognized through several additional awards so far this year:

  • Recognized as a Silver Winner in the “Enterprise Product of the Year – Software” Category by the Best in Biz Awards 2014 International
  • Named to the 2014 AlwaysOn Global 250 Top Private Companies List
  • Named to the 2014 Lead411 Hottest Companies in Silicon Valley list
  • Products Guide (NPG) 2014 Hot Companies and Best Product Award Winner for the “Best Products and Services – Information Security and Risk Management” category and also in the “Best Products and Services – Security Software” category.
  • Judges Choice for Best Overall Fraud/Security Solution at the 2014 CardNotPresent.com (CNP) Awards for the ThreatMetrix TrustDefender Cybercrime Protection Platform
  • A 2014 Info Security Products Guide Global Excellence Award for Most Innovative Company of the Year (Security)
  • 2014 Cyber Defense Magazine Award Winner in 2 Categories: Most Innovative Anti-Malware Appliances Solution & Best Product Network Access Control Solution

ThreatMetrix Resources

Sunshine Heart’s C-Pulse(R) System Allows Father to Attend Daughter’s Wedding

August 19th, 2014

EDEN PRAIRIE, Minn., Aug. 19, 2014 (GLOBE NEWSWIRE) —

Sunshine Heart, Inc. (Nasdaq:SSH) today announced that the current condition of a heart failure patient implanted with the C-Pulse® System improved after six weeks of treatment, allowing him to attend his daughter’s wedding. The patient, Ross Swift, a 54 year-old grandfather from Devon, U.K., received C-Pulse at Harefield Hospital in London and is participating in the OPTIONS HF study, a post-market surveillance study being conducted in countries in Western Europe. C-Pulse system received the CE Mark in 2012. The story was reported in an article published today in The Daily Mail, titled, Me and My Operation: Pump that squeezes your arteries to help fight heart failure. The surgical procedure was carried out by André Simon, M.D., director of transplantation at Royal Brompton & Harefield NHS Foundation Trust

“When I received the C-Pulse System, immediately I could tell there was a difference. When I breathed, it felt clearer. I had more color in my face and my family said my attitude changed,” said Mr. Swift. “I feel more positive. I find day-to-day activities, which used to wear me out, much easier to get on with and recover from afterwards.

“The wedding was amazing. Everybody was crying knowing what we had been through. Walking my daughter down the aisle was something a few months ago we didn’t believe was possible.”

The C-Pulse System’s design is based on an extra-aortic balloon cuff counter-pulsation therapy that is applied outside of the bloodstream and assists the heart by reducing the workload of the left ventricle. During inflation of the balloon cuff, blood flow is increased to the coronary arteries, thereby providing additional oxygen which is vital to a failing heart. During deflation of the balloon cuff, the workload or pumping required by the left ventricle is reduced. The balloon’s inflation and deflation is synchronized to the patient’s heart rhythm, similar to a pacemaker.

“The C-Pulse System is a treatment option that has not previously been available for this particular group of heart failure patients,” said Dr. Simon “The aim of implanting the system is to help slow the deterioration of a failing heart, which can relieve heart failure symptoms and improve their quality of life. At Harefield Hospital we see lots of patients with heart failure who are limited in their everyday activities, such as walking to the shops or taking part in family activities, but many of these patients are not sick enough to need a heart transplant.”

Sunshine Heart is currently enrolling patients in clinical studies in the U.S. and Europe for treatment of moderate to severe heart failure. The OPTIONS HF clinical study is a post-market, multi-center, prospective, surveillance study in up to fifteen European centers. The study is designed to observe long-term clinical outcomes of heart failure patients treated with the C-Pulse System. Concurrently, the company’s COUNTER HF™ US pivotal study is underway and designed to achieve commercial approval of the C-Pulse System in the United States.

More information regarding the US COUNTER™ HF clinical study can be found at: http://hfclinicalstudy.com/index.htm

More information regarding the European OPTIONS HF clinical study can be found at: http://clinicaltrials.gov/ct2/show/NCT01872949?term=NCT01872949&rank=1

Heart failure treatment gives man ‘a life again’

August 18th, 2014

August 8, 2014

Ross SwiftRoss Swift said his life had improved, but he remains on the organ transplant list

A Devon man fitted with a new device aimed at supporting a failing heart, says it means he has “a life again”.

Ross Swift, 54, from Ivybridge, is believed to be the first UK patient to receive the Sunshine Heart implant, which helps reduce the organ’s pumping workload.

Mr Swift said the device meant he had was able to walk his daughter down the aisle at her wedding this month.

One expert said the device added a “tremendous amount of quality of life”.

The implant, called the C-Pulse, involves a cuff or balloon which is placed on the ascending aorta and works by reducing the workload of the left ventricle.

During inflation of the balloon, blood flow is increased to the coronary arteries. The cuff then compresses and releases the aorta, helping the heart to function.

Although it requires the wearing of an external pack, Mr Swift said his new lease of life was not something he had not thought possible prior to having the device being fitted at the Royal Brompton & Harefield NHS Foundation Trust.

Mr Andre Simon, director of heart transplantation at the trust, said Mr Swift had been fitted with the device as part of a study.

He said: “It works in harmony with the heart … the heart gets more blood and it gets easier for the heart to work.”

Ross SwiftMr Swift said the device meant he was able to participate in the wedding of his daughter

Although Mr Swift remains on an organ transplant list, he said the device meant he was more mobile and able to join in the celebrations for his daughter Hayley’s wedding in Ugborough on 9 August.

He said: “I was just sick looking out of the window, watching the leaves fall, thinking: ‘This is it, I’ve not got long to go’.

“Now I’ve got a life again and, hopefully, a heart will come along in the next two years and I can start again.”

Mr Simon said: “It’s better than we expected or hoped.

“It may not prolong life, but it does add a tremendous amount of quality of life.”

ThreatMetrix Extends Mobile and Web Context-Based Security and Fraud Prevention Innovation with Patent

July 29th, 2014

July 29, 2014

 Latest Patent Will Continue to Build Trust on the Internet Using Global Intelligence

San Jose, CA – July 29, 2014 – ThreatMetrix®, the fastest-growing provider of context-based security and advanced fraud prevention solutions, today announced the United States Patent and Trademark Office has granted the company a new patent for its ability to accurately differentiate between trusted customers and cybercriminals across mobile and web interactions.

The new patent is U.S. Patent 8,782,783: “Method and System for Tracking Machines on a Network Using Fuzzy GUID (Globaly Unique Identifier) Technology.” This is a continuation of a previous patent that provides the cornerstone technology for ThreatMetrix industry leading cookieless device identification and global device recognition. The new patent expands ThreatMetrix global identification technology beyond network and device attributes to include broader attributes such as account, identity and transaction details to build a complete picture of an online persona. The unique fuzzy matching capability of the patent creates a reliable, anonymous global identifier, enabling persistent global tracking and classification of malicious mobile and web devices and activities on the Internet, regardless of how underlying attributes change.

“Cybercriminals are learning to disguise themselves online in the same way thieves wear gloves to mask fingerprints at a crime scene,” said Alisdair Faulkner, chief products officer, ThreatMetrix. “As cyberattacks become more sophisticated, we must evolve our defenses even faster to best detect and keep out cybercriminals, which is where this patented technology comes into play. Without the ThreatMetrix Fuzzy GUID patent, companies lose sight of both good customers and criminals when they change their IP Address, delete cookies or change their mobile or browser settings.”

Companies that have implemented first generation device fingerprinting technologies find they are brittle and limited to account or application-centric identification and have no cross-channel or global view of who they are doing business with. Existing ThreatMetrix customers already take advantage of this patented technology to stop account breaches and eliminate fraud while reducing user friction.

ThreatMetrix is committed to enhancing cybersecurity through patented technology and continuous product updates. Over the past several years, ThreatMetrix has released a number of patents, securing the company’s spot as an industry leader in building trust on the Internet. ThreatMetrix’s previously granted patents include:

  • U.S. Patent 8,141,148: “Method and System for Tracking Machines on a Network Using Fuzzy GUID Technology” This patent – which provides the basis for the new patent – provides the technology for device identification and global recognition regardless of cookie deletion and copying. This technology is available through ThreatMetrix SmartID™, which utilizes unique device attributes to identify visitors that have wiped cookies, use private browsing or changed IP addresses.
  • U.S. Patent 8,176,178: “Method for Tracking Machines on a Network Using Multivariable Fingerprinting of Passively Available Information” This patent detects fraudsters using proxies or virtual private networks (VPNs) through the most advanced device recognition risk assessment. The technology provides a complete view of each device, taking into account the device’s historical behavior and broader context.

In addition to its latest patent, ThreatMetrix secured $20 million in Series E in March to broaden the reach of the company’s context-based authentication and advanced fraud prevention solutions. With the ThreatMetrix TrustDefender™ Cybercrime Protection Platform, ThreatMetrix combines comprehensive data collection, behavioral analytics and ThreatMetrix® Global Trust Intelligence Network (The Network) to differentiate between authentic and fraudulent activity and protect its customers in real time.

ThreatMetrix Resources

Piedmont Pharmaceuticals Announces New Chairman of the Board

July 15th, 2014

Piedmont Pharmaceuticals Announces New Chairman of the Board

GREENSBORO, N.C., (July 15, 2014) – Piedmont Pharmaceuticals, LLC, an innovative specialty pharmaceutical company focused on animal health and human therapeutics, today announced its Board of Directors and shareholders have elected industry veteran Dennis Steadman chairman and member of the Board of Directors effective immediately.

“There is no better person than Dennis Steadman to help Piedmont Pharmaceuticals as we transition the company to a fully integrated research and development, marketing and sales pet health business,” said Roland Johnson, founder, CEO and member of the Board of Directors of Piedmont Pharmaceuticals, LLC. “His strategic vision, combined with operational experience ranging from capital funding and product development, to building and leading commercial organizations is exactly what Piedmont Pharmaceuticals needs as the company enters its next phase of growth.”

Steadman, an experienced animal health executive was the founder and CEO of Velcera, Inc., a pet health company that achieved sales of $60 million within the first year of launch and was acquired in 2013 for $160 million. Prior to Velcera, he held executive and consulting positions for more than 35 years, including Vice President, North American Operations and Global Management Committee Member with Merial Ltd., a leading global animal health company, multiple domestic, international and global executive positions with Merck animal health, and more than a decade with a consulting subsidiary of Chase Manhattan Bank. Steadman holds a master’s degree in Agricultural Economics and a bachelor’s degree in Business Management from Pennsylvania State University and has completed the Executive Program in Finance at the Harvard Business School.

“Piedmont has one of the largest and most impressive pet prescription product portfolios in the industry today including the first of its kind soft chew pet drug delivery platform,” said Dennis Steadman. “Piedmont has now built itself to the brink of breakthrough value and material industry impact and I look forward to helping accelerate the company’s success.”

About Soft Chew Formulation

In 2013, the US Food and Drug Administration’s Center for Veterinary Medicine approved Piedmont Pharmaceuticals’ invention of a canine soft chew formulation containing a veterinary medicine. The flavored soft chew formulation contains carprofen and is labeled for the relief of pain and inflammation from osteoarthritis and the control of post-operative pain in dogs. It is the first and only flavored, soft and chewable medicine in the pain category. The soft chew formulation provides pet owners with a convenient and friendly way to medicate dogs.

About Piedmont Pharmaceuticals, LLC
Piedmont Pharmaceuticals, LLC, is a strategic development and licensing company focused on animal health and human therapeutics with specific expertise in parasitology and drug delivery systems.

For more information visit http://www.piedmontpharma.com/OurCompany/

 

ThreatMetrix Named One of the Hottest Companies in Silicon Valley by Lead411

July 8th, 2014

July 8, 2014

411Leads Award

Context-Based Security and Advanced Fraud Prevention Provider Recognized for Tremendous Annual Growth and Recent Funding

San Jose, CA – July 8, 2014 – ThreatMetrix®, the fastest-growing provider of context-based security and advanced fraud prevention solutions, today announced it has been recognized as one of the 2014 “Hottest Companies in Silicon Valley” by Lead 411.

Lead411’s “Hottest Companies in Silicon Valley” list recognizes privately held companies in the software, wireless, Internet, hardware and media industries within Silicon Valley. Each company must have either doubled its revenue over the past two years or received more than $5 million in funding in the past two years.

This list originally started with over 1816 companies and was narrowed down to the top 87.

“We’re thrilled to be recognized as one of the fastest-growing software companies in Silicon Valley,” said Bert Rankin, chief marketing officer, ThreatMetrix. “Our fraud and security solutions collect valuable information and provide real-time insights to protect against account takeover, payment fraud, fraudulent account registration and multi-channel Web fraud. As cybercriminals become increasingly sophisticated, businesses must leverage a collective network to protect against online threats and our recent round of funding serves as validation of the high level of trust in our solution.”

In March 2014 ThreatMetrix secured $20 million in Series E funding led by Adams Street Partners. Through theThreatMetrix® Global Trust Intelligence Network (The Network) – the world’s largest network of shared intelligence –ThreatMetrix is positioned to effectively protect businesses and individuals against cybercrime without disrupting the user experience. The Network enables businesses to share anonymized information across business boundaries to deliver the most comprehensive risk assessment in real-time.

“This year’s Hottest Silicon Valley Award winners are stronger than ever. We expect to see large growth and ‘big things’ from this group,” said Tom Blue, Lead411 CEO.

For a full list of winners, visit http://www.lead411.com/awards/2014/silicon-valley.html.

ThreatMetrix Resources

About ThreatMetrix

ThreatMetrix builds trust on the Internet by offering market-leading advanced fraud prevention and frictionless context-based security solutions. These solutions authenticate consumer and workforce access to mission critical applications using real-time identity and access analytics that leverage the world’s largest trusted identity network.

ThreatMetrix secures enterprise applications against account takeover, payment fraud, fraudulent account registrations, malware, and data breaches. Underpinning the solution is the ThreatMetrix® Global Trust Intelligence Network, which analyzes over 500 million monthly transactions and protects more than 160 million active user accounts across 2,500 customers and 10,000 websites.

The ThreatMetrix solution is deployed across a variety of industries, including financial services, enterprise, e-commerce, payments, social networks, government and insurance.

For more information, visit www.threatmetrix.com or call 1-408-200-5755.

Join the cybersecurity conversation by visiting the ThreatMetrix blogFacebookLinkedIn and Twitter pages.

About Lead411
Lead411 provides information, news, and research about U.S. companies and their executives. Founded in 2001, its goal has been to focus on quality corporate data that is valid and useful rather than producing as many company records as possible. In addition, Lead411 tracks company news in order to alert its customers about venture financing, new hires, hiring plans, etc. Customers include Gartner, Administaff and ADP.

© 2014 ThreatMetrix. All rights reserved. ThreatMetrix, TrustDefender ID, TrustDefender Cloud, TrustDefender Mobile, TrustDefender Client, the TrustDefender Cybercrime Protection Platform, ThreatMetrix Labs, and the ThreatMetrix logo are trademarks or registered trademarks of ThreatMetrix in the United States and other countries. All other brand, service or product names are trademarks or registered trademarks of their respective companies or owners.

Bayer introduces first FDA-approved soft chew in canine osteoarthritis pain management

July 1st, 2014

July 1st 2014

http://www.prnewswire.com/news-releases/bayer-introduces-first-fda-approved-soft-chew-in-canine-osteoarthritis-pain-management-265366951.html

Sunshine Heart Appoints Brian Brown as Senior Vice President of Operations and Technology

June 16th, 2014

Sunshine Heart Appoints Brian Brown as Senior Vice President of Operations and Technology

EDEN PRAIRIE, Minn., June 16, 2014 (GLOBE NEWSWIRE) — Sunshine Heart, Inc. (Nasdaq:SSH) today announced the appointment of Brian Brown to the position of Senior Vice President of Operations and Technology. In this capacity, Mr. Brown will manage the Company’s R & D program for its flagship C-Pulse® Heart Assist System, a medical device addressing Class III and ambulatory Class IV heart failure. Additionally, Mr. Brown will be responsible for operations inclusive of internal and contracted manufacturing.

Mr. Brown comes to Sunshine Heart after serving as R & D, Vice President Cardiovascular at Boston Scientific for the past 10 years. Prior to joining Boston Scientific in 1994, he held multiple engineering and managerial roles at SciMED Life Systems Inc., a developer and marketer of medical devices used principally to treat cardiovascular disease which was acquired by Boston Scientific.

“Brian brings a broad range of experiences covering all aspects of transforming new technologies into marketable products. His specific role in leading the technology transition from an early stage development company to one of the largest cardiovascular device corporations in the world is extremely valuable to an emerging company such as Sunshine Heart,” said Dave Rosa, Chief Executive Officer of Sunshine Heart.

Mr. Brown has spent 24 years in the medical device industry including senior managerial roles at Boston Scientific where he most recently held the position of R & D, Vice President, Cardiovascular from 2004-2014, and SciMED Life Systems which was acquired by Boston Scientific in 1994. Boston Scientific is an international, publicly traded company headquartered in Boston, MA focused on the design, manufacture, and sale of minimally invasive medical devices in the areas of disposable devices (single use), permanent implants, and combination drug devices. The Interventional Cardiology business unit represents a $2B division of the company’s greater than $7B of annual revenue. As R & D, VP of Cardiovascular, Brian directed the multisite worldwide research and development activities for the accelerated multi-billion dollar launches of implantable stents, drug delivery technologies, disposable catheters and adjunctive devices. Mandates typically evolved from early exploratory work, to technology development projects, to product commercialization, followed by line extensions or sustaining activities. Brian holds a Bachelor of Science, Mechanical Engineering with an emphasis on electro -mechanical automation from North Dakota State University.

About the C-Pulse® Heart Assist System

The C-Pulse Heart Assist System, or C-Pulse System, an investigational device in the United States, Canada and countries that do not recognize the CE mark approval, utilizes the scientific principles of intra-aortic balloon counterpulsation applied in an extra-aortic approach to assist the left ventricle by reducing the workload required to pump blood throughout the body, while increasing blood flow to the coronary arteries. Combined, these potential benefits may help sustain the patient’s current condition or, in some cases, reverse the heart failure process, thereby potentially preventing the need for later-stage heart failure devices, such as left ventricular assist devices (LVADs), artificial hearts or transplants. It may also provide relief from the symptoms of Class III and ambulatory Class IV heart failure and improve quality of life and cardiac function. Based on the results from our feasibility study, we also believe that some patients treated with our C-Pulse System will be able to stop using the device due to sustained improvement in their conditions as a result of the therapy.

Caution: Investigational device, limited by Federal (or United States) Law to Investigational use.

About Sunshine® Heart

Sunshine Heart, Inc. (Nasdaq:SSH) is an early-stage medical device company focused on developing, manufacturing and commercializing the C-Pulse System for treatment of Class III and ambulatory Class IV heart failure. Sunshine Heart has completed an approved U.S. Food and Drug Administration (FDA) feasibility clinical study of the C-Pulse System and presented the results in November 2011. In March 2012, the FDA notified the Company that it could move forward with an investigational device exemption (IDE) application. Sunshine Heart received unconditional approval from the FDA in November 2012 to initiate its pivotal study. In July 2012, Sunshine Heart received CE Mark approval for its C-Pulse System in Europe. Sunshine Heart is a Delaware corporation headquartered in Minneapolis with wholly owned subsidiaries in Australia and Ireland. The Company has been listed on the NASDAQ Capital Market since February 2012.

Forward-Looking Statements

Certain statements in this release are forward-looking statements that are based on management’s beliefs, assumptions, expectations, and information currently available to management. All statements that address future operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including, without limitation, our expectations with respect to future clinical study activities and results including patient enrollment in studies. These forward-looking statements are subject to numerous risks and uncertainties, including, without limitation, the possibility that our clinical studies do not meet their enrollment goals, meet their endpoints or otherwise fail, that regulatory authorities do not accept our application or approve the marketing of the C-Pulse System, the possibility that we may be unable to raise the funds necessary for the development and commercialization of our products, that we may not be able to commercialize our products successfully in the EU and the other risk factors described under the caption “Risk Factors” and elsewhere in our filings with the Securities and Exchange Commission. You should not place undue reliance on forward-looking statements because they speak only as of the date when made and may turn out to be inaccurate. We do not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. We may not actually achieve the plans, projections or expectations disclosed in forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements.

Nokia buys compact radio systems expert Mesaplexx

June 5th, 2014

Espoo, Finland – Nokia confirms that it has recently completed the acquisition of the Australian company Mesaplexx Pty Ltd in order to boost its radio capabilities in the Networks business. Mesaplexx has unique know-how in developing compact, high performance radio frequency (RF) filter technology for the mobile industry.

Nokia is continually improving its radio systems whilst making them smaller, lighter and more efficient. The Nokia Flexi family of radio access base stations offers cutting-edge solutions that balance energy efficiency, power output and form factor. Adding the very advanced Mesaplexx technology can enhance them further, potentially reducing small cells form factor by 30% or more.

Every base station needs RF filters, for example to ensure that spectrum can be shared within the same geographical area and that the same antenna can serve for both transmit and receive purposes. The Mesaplexx expertise could help improve radio performance, leading to higher capacity and more efficient networks. This technology would also help reduce overall cost and power consumption and keep radio signal loss to a minimum.

“Those familiar with radio technologies know that while there has been a lot of progress in recent years, filters are one area where new innovations can still yield significant improvements in performance,” said Marc Rouanne, executive vice president, Mobile Broadband at Nokia. “This company’s stand-out expertise has the potential to achieve that.”

With this transaction, Nokia continues to invest in technology innovation for the best mobile broadband experience.

About Nokia

Nokia invests in technologies important in a world where billions of devices are connected. We are focused on three businesses: network infrastructure software, hardware and services, which we offer through Networks; location intelligence, which we provide through HERE; and advanced technology development and licensing, which we pursue through Technologies. Each of these businesses is a leader in its respective field.

Through Networks, Nokia is the world’s specialist in mobile broadband. From the first ever call on GSM, to the first call on LTE, we operate at the forefront of each generation of mobile technology. Our global experts invent the new capabilities our customers need in their networks. We provide the world’s most efficient mobile networks, the intelligence to maximize the value of those networks, and the services to make it all work seamlessly. www.nsn.com / www.company.nokia.com

 

ThreatMetrix Wins Judges Choice for Best Overall Fraud/Security Solution at 2014 CNP Awards

May 28th, 2014

TrustDefender™ Cybercrime Protection Platform Recognized for Offering Unified Intelligence with Integrated Cybercrime Protection Platform

CNP Award

San Jose, CA – May 28, 2014 – ThreatMetrix®, the fastest-growing provider of context-based security and advanced fraud prevention solutions, today announced that the TrustDefender™ Cybercrime Protection Platform won the Judges Choice for Best Overall Fraud/Security Solution at the 2014 CardNotPresent.com (CNP) Awards.

The CNP Award for Best Overall Fraud/Security Solution recognizes the provider that most efficiently reduced costs related to fraud in card-not-present transactions by identifying as much potential fraudulent activity as possible while enabling merchants to accept as many transactions as possible. The awards were announced during the CNP Expo, held May 19-22 in Orlando.

“Significant growth in e-commerce and mobile payments continues to spur innovation and excellence from the technology providers serving card-not-present merchants,” said CardNotPresent.com Founder & CEO Steve Casco. “That growth is reflected in this year’s CNP Awards, which had a record number of nominations and a record number of votes for Customer Choice nominees. The CNP Awards have become the standard by which companies, programs and services around the world are being recognized and judged now and in the future.”

The panel of five judges chose the TrustDefender Cybercrime Protection Platform because, in addition to taking the usual measures, including malware detection and device identification, to make e-commerce transactions secure, the platform detects fraud by analyzing online identities and their associated devices in real time to identify between authentic and fraudulent transactions.

“At ThreatMetrix, we constantly enhance our solutions to enable businesses to stay one step ahead of growing cybercrime threats,” said Bert Rankin, chief marketing officer, ThreatMetrix. “Between account takeover, payment fraud, identity spoofing and other threats, businesses need a way to quickly and efficiently identify suspicious behavior related to online transactions without driving away trusted customers. Our platform leverages the most comprehensive global data repository of fraud intelligence with unprecedented analytics to protect web and mobile-based e-commerce transactions.”

In 2013, ThreatMetrix launched several breakthrough technologies to support its platform, including ThreatMetrix™ Trust Tags and ThreatMetrix™ Persona ID. Trust Tags enable businesses to anonymously review and validate customer credentials and past behaviors to allow frictionless access while simultaneously preventing cybercrime. Additionally, Persona ID enables businesses to evaluate expected customer behavior based on industry standards. The platform was updated again in March 2014, with an extension that delivers sophisticated trust analytics through endpoint and context intelligence, as well as enhanced mobile location-based authentication and jailbreak detection.

The TrustDefender platform is built on the ThreatMetrix® Global Trust Intelligence Network (The Network), which profiles tens of millions of users and their devices every day to differentiate between authentic and suspicious transactions and online activity. The Network provides analytics in real time, evaluating logins, payments, new account registrations and remote access attempts.

To learn more about the ThreatMetrix TrustDefender Cybercrime Protection Platform, visithttp://www.threatmetrix.com/platform/trustdefender-cybercrime-protection-platform/.

ThreatMetrix Resources

• Whitepaper: Combating Cybercrime – A Collective Global Approach

• Webinar: The Cost to E-Commerce from Credit Card Data Breaches

• Datasheet: Eliminate Fraudulent Account Registration

About ThreatMetrix

ThreatMetrix builds trust on the Internet by offering market-leading advanced fraud prevention and frictionless context-based security solutions. These solutions authenticate consumer and workforce access to mission critical applications using real-time identity and access analytics that leverage the world’s largest trusted identity network.

ThreatMetrix secures enterprise applications against account takeover, payment fraud, fraudulent account registrations, malware, and data breaches. Underpinning the solution is the ThreatMetrix® Global Trust Intelligence Network, which analyzes over 500 million monthly transactions and protects more than 160 million active user accounts across 2,500 customers and 10,000 websites.

The ThreatMetrix solution is deployed across a variety of industries, including financial services, enterprise, e-commerce, payments, social networks, government and insurance.

For more information, visit www.threatmetrix.com or call 1-408-200-5755.

Join the cybersecurity conversation by visiting the ThreatMetrix blogFacebookLinkedIn and Twitter pages.

Rio Tinto to deploy 6.7MW solar PV + storage at off-grid mine

May 22nd, 2014

By  on 22 May 2014

A ground-breaking, $23.4 million project to cut out daytime diesel consumption at Rio Tinto bauxite mine at Weipa could unlock billions of dollars of similar investments in the mining industry – which is weighed down by soaring energy costs.

Mining giant Rio Tinto is to host a $23.4 million solar PV plus storage facility at its Weipa bauxite mine, that is the first of its type and scale in the world and could unleash billions of dollars of similar investment.

Rio Tinto Alcan – with the help of the Australian Renewable Energy Agency – is to install a 1.7MW solar PV array at its Weipa bauxite mine later this year, and then add a further 5MW of solar PV and battery storage.

The Weipa mine (pictured) is located on the Cape York Peninsula at the very northern tip of eastern Australia, and relies on expensive diesel that has to be shipped in.

The first phase of the solar project – to be built with First Solar thin-film modules and constructed by Australian solar firm Ingenero – is expected to reduce daytime diesel demand from the mine’s 26MW diesel generator by up to 20 per cent.

However, the addition of more solar and storage to balance out intermittency could reduce daytime diesel consumption altogether at certain times.

The Weipa project was the first of around 70 submissions  – worth several billion dollars of investment – from mining operators in Australia for funding for such ground breaking projects under ARENA’s $400 million remote energy program.

The ending of the commodities boom has made miners more focused on energy costs. Rio Tinto recently announced the closure of the Groote Eylandt mine in Northern Territory because it was being crushed by fuel costs. Solar and other technologies are now emerging as viable alternatives, even with the diesel excise exemption enjoyed by the mining industry.

ARENA, which has been marked for closure by Tony Abbott’s ultra conservative government in Australia, is committing $10.3 million over the two phases of the project.

ARENA CEO Ivor Frischknect said it is critical as part of a “show and tell” exercise that will help make miners understand the technology, accept its reliability, and identify where further cost cuts are made. This will lead to reduced costs in future projects, and ultimately remove the need for any government support.

“We need a few of these projects to show how cost-effective they can be,” Frischknecht told RenewEconomy.

“Transporting fuel long distances for generators is dangerous and subject to variable weather conditions – it is a costly, unpredictable arrangement that doesn’t make good economic sense.

“However, miners need to be confident about the integration of such technology, EPC contractors need to learn about the difficulties of delivering modules in such remote locations, and (sub contractors) don’t know yet what they don’t know.

“I think this is just the tip of the iceberg … energy security is a big deal for miners. ARENA sees mining as a huge potential off-grid user of renewable energy in Australia and congratulates Rio Tinto Alcan for paving the way for other mining operations to adopt renewable energy and offset diesel use through this landmark demonstration project.”

Whether ARENA gets to spend more on its remote mining energy program may depend on support in the Senate, which could reject the repeal bill being prepared by the Abbott government (which had made a pre-election promise to retain ARENA).

Frischknect said it was unclear how many such projects would need to be funded in such a way to unleash further unsubsidized investment from the mining community.  “There has been a lot of discussion about that, it could be that we need to sign on all the majors to enable the key internal decision-making.”

Jack Curtis, the head of business development for First Solar in Australia, says there has been a tipping point in the mining community in the last six months, where the big operators have realized that solar can provide an economic alternative to soaring diesel and gas prices.

“We think that this will show that solar can go mainstream,” Curtis said. He expected other large companies to follow, not just in Australia, but in other solar rich mining regions. “Rio Tinto wouldn’t be doing this if it was a one-off effort,” he said.

First Solar modules were used to construct Australia’s first utility-scale solar farm in Australia, the 10MW Greenough River project near Geraldton, and the largest solar farms under construction, the combined 153MW facilities at Broken Hill and Nyngan in NSW.

Miners in Chile have begun to install solar PV projects, and even Australia’s Fortescue Metals recently tendered for a 3MW solar PV project to help power its Christmas Creek mining camp at its large Cloudbreak iron ore mine in the Pilbara. BHP Billion considered a range of renewable technology options, including solar and geothermal, in planning for its now deferred expansion of the Olympic Dam mine in South Australia.

Other solar technologies, such as solar thermal with storage being developed by Solar Reserve and Australia’s Vast Solar, also see off-grid mining applications.

Gareth Manderson, the general manager of operations at Rio Tinto Alcan’s Weipa mine, said the hybrid diesel/PV solution will introduce to the site “a reliable source of electricity, with low maintenance requirements.”

The first phase of the project is scheduled to be completed later this year, with phase two set for 2017. Rio Tinto Alcan will buy the electricity under a 15-year power purchase agreement.

A total of 18,000 modules will be mounted on steel and aluminium structures in the first phase, generating  2,620MWh of electricity each year for use in the mine and the processing plant. The specifications of the storage component have yet to be worked out.

US solar giant and Rio Tinto agree on Australian-first solar project

May 22nd, 2014
  • KERRIE SINCLAIR  THE COURIER-MAIL  MAY 22, 2014 12:00AM

ONE of the world’s biggest solar panel makers, US-based First Solar, is set to next month start building a $23.4 million solar power plant at Weipa after sealing a power purchase deal with miner Rio Tinto as well as federal funding.

It is the first time in Australia that a mining company has adopted renewable energy to power a mining operation.

Rio Tinto said the 6.7 megawatt solar photovoltaic solar farm would provide power to the Rio Tinto Alcan Weipa bauxite mine, processing facilities as well as the township on the Western Cape York Peninsula.

“We expect the use of solar power will reduce Weipa’s annual carbon dioxide emissions by around 1600 tonnes,” a Rio Tinto Alcan official said.

First Solar and its partner, Queensland-based solar power company Ingenero, are investing $12.1 million in the project, with a total of $11.3 million conditionally committed by the Australian Renewable Energy Agency.

ARENA was set up by the Gillard government in 2012 to independently manage Australia’s renewable energy program. The Abbott government wants to abolish the agency but would need to pass a repeal Act through parliament.

An ARENA spokesman yesterday said projects with funding agreements in place with the agency “will not be affected by funding changes” in future and it “continues to be business as usual for ARENA”.

The project’s first stage will be completed in January, with 18,000 PV solar panels forming a 1.7 megawatt solar farm that will be supplemented by diesel generation.

By the end of stage two, the solar farm will also have battery storage, which will mean up to 100 per cent of diesel-generated electricity can be replaced by solar power.

Jack Curtis, First Solar’s vice president of business development for Asia-Pacific, said: “First Solar is delighted to be working with Rio Tinto, ARENA and Ingenero on this landmark project that demonstrates how solar PV can be used to power the resources sector.”