Heraeus enters agreement to acquire NeoMetrics

ST. PAUL, Minnesota and PLYMOUTH, Minnesota, March 19, 2015 /PRNewswire/ — Heraeus Medical Components, a global business unit of Heraeus Holding GmbH, has executed a share purchase agreement to acquire 100% of the stock in NeoMetrics.  NeoMetrics, headquartered in Plymouth, Minnesota, specializes in designing and manufacturing guidewires and components for medical devices.  The company’s production facilities, in both Minnesota and Costa Rica, include cleanroom manufacturing and extensive guidewire fabrication technologies.  Closing of this transaction is expected to occur in the next 60 days.

“With this acquisition, Heraeus Medical Components will add new interventional technologies to augment their leadership position as a sourcing solution for the world’s medical device companies. We are excited about the potential growth opportunities within the interventional field,” said Dr. Nicolas Guggenheim, President of Heraeus Medical Components.  “NeoMetrics’ experience in the development of interventional and vascular access guidewires substantially builds upon our existing component capabilities.  We plan to use our combined expertise to bring new solutions for our medical device customers.”

“We are excited to become part of Heraeus Medical Components,” said Dave Liebl, President, NeoMetrics.  “Joining Heraeus will allow us to support our continued growth, including the opportunity to introduce our products and expertise to new markets.  Both companies share a culture of consistently exceeding customer expectations.”

The management team and employees of NeoMetrics will continue as part of Heraeus, contributing important domain expertise and ensuring continuity for customers.  Gene Champeau, co-founder and CEO of NeoMetrics will assist Heraeus in developing new business platforms and product strategies on a consulting basis. Heraeus intends to continue operation of both of the NeoMetrics facilities post-closing.

About NeoMetrics
NeoMetrics, headquartered in Plymouth, Minnesota, is a private company that was founded in 2001.  The company operates exclusively as an OEM partner of medical device companies. They specialize in designing, manufacturing and securing Regulatory clearance for interventional and vascular access guidewires. 

About Heraeus
Heraeus Medical Components is a global business unit of Heraeus Holding GmbH. Heraeus, the technology group headquartered in Hanau, Germany, is a global, private company with more than 160 years of tradition. We create high value solutions for our customers, strengthening their competitiveness for the long term. Our fields of competence include precious metals, materials and technologies, sensors, biomaterials and medical products, quartz glass, and specialty light sources.

In fiscal year 2013, Heraeus achieved product revenue of €3.6 billion and precious metals trading revenue of €13.5 billion. With some 12,500 employees in over 110 subsidiaries worldwide, Heraeus holds a leading position in its global markets.

Advanced Treatment of Peri-Implantitis Using the Lightwalker ATS Dual Wavelength Dental Laser Presented at the International Dental Show (IDS)

SAN CLEMENTE, Calif., March 18, 2015 /PRNewswire/ — At the International Dental Show (IDS) held in Cologne, Germany from 10-14 March, 2015, Ilay Maden, DMD, MSc, PhD presented on advanced treatment of peri-implantitis using the Lightwalker ATS Erbium and Nd:YAG dental laser (Fotona, www.fotona.com). The IDS is the largest dental exhibition in the world with 138,500 visitors from 151 countries and 2,201 exhibitors from 56 countries.

Over the past two decades the number of implants placed annually has grown significantly. With this surge of implants, dentists and patients are now dealing with new clinical challenges. Some implants were placed by practitioners who had limited training, implant systems were still improving, and patients were given a naive idea that implants were impervious to periodontal disease, cavities and other potential problems. We now know implant placements requires skill, training, experience, quality implant systems, and patient compliance. Implants, like any foreign object in the body, can attract bacteria, implants can be poorly placed, and many patients have not properly cared for them. Consequently today, there is a growing big need to treat peri-implantitis.

According to a report by the American Academy of Periodontology (AAP), “Recent reports revealed that peri-implant mucositis was present in 48 percent of implants followed from 9 to 14 years after placement.” And also “Research concerning peri-implantitis reported distinct differences in the incidence and prevalence from numerous authors with studies ranging from 6.61 percent disease prevalence over a 9-14 year period to 36.6 percent with a mean of 8.4 years after loading.”

In his presentation, Dr. Maden noted, “As the number of dental implants being placed increases, even though many keep quiet about it, the reported number of cases with peri-implantitis is also increasing. The main cause of peri-implantitis is the colonisation of pathogen bacteria and the difficulty in cleaning the rough surface of implants.”

“Using the Lightwalker’s Er:YAG 2940nm wavelength, it is possible to clean the granulation tissues, both on the bone and implant surfaces, and thoroughly decontaminate the infected site. The erbium laser targets the water content to remove the granulation tissue selectively, due to its ability to use long pulse durations and lower peak power, while ablating the microorganisms on the surface of the bone. The bactericidal effect of low power Er:YAG on the surgical site is also effective against endotoxins and lipopolysaccharides, which provides the complete cleansing of the implant surface without chemicals or any surface modification on the implant. Er:YAG is used again with shorter pulse durations to activate bleeding and decorticating the bony wall of the defect.”

Dr. Maden will be presenting a webinar on using the Lightwalker for treating peri-implantitis on April 1st, 5:00PM Central European Time. Dentists can register for the webinar at:


Dr. Maden DMD MSc PhD studied dentistry from 1998-2003 and did his PhD studies for periodontology from 2003-2009 at the University of Istanbul. He has received his Master of Science degree for Lasers in Dentistry from Aachen University, Germany (2005-2007). Dr. Maden is the co-director, lecturer and trainer of Seesaw Dental Education and is also an Adjunct Faculty Member AALZ, an expert lecturer for Laser and Health Academy and a training instructor for International Continuing Education Center for Dental Implants, Nurnberg, Germany. Dr. Maden is currently authoring the Lasers In Periodontics chapter for the updated version of Evidence Based Dentistry on Laser Dentistry. He is a member of World Academy for Laser Education & Research in Dentistry, Turkish Dental Association, European Federation of Periodontology, Turkish Periodontology Association, Turkish Association of Aesthetic Dentistry Academy and British Dental Association.


Fotona has sold over 25,000 lasers around the world, with direct sales in the U.S, and distribution in over 60 countries. Fotona produces award winning lasers in dentistry, aesthetics, dermatology, gynecology & other medical fields. Fotona has one of the most highly educated workforces in the industry, with an exceptionally high number of PhDs specializing in laser and medical technology. Strong R&D capabilities have always been a key competitive advantage of the company, resulting in many patented solutions, including the Optoflex® articulated arm, QSP (Quantum Square Pulse) and VSP (Variable Square Pulse) technologies, Fotona SMOOTH® mode, Vacuum Cell technology, and many more.

The company manufactures all of its laser systems in-house, ensuring that each system is of the highest quality, reliability, ease-of-use and durability, in compliance with all applicable international standards. When you choose Fotona, you choose a company with a business philosophy to continuously Choose Perfection to meet the needs of a highly demanding marketplace. www.fotona.com

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Data Presented at ACC Demonstrates Benefits of Keystone Heart’s TriGuard(TM) Cerebral Protection Device During TAVR

– American College of Cardiology (ACC) Annual Scientific Session

CAESAREA, Israel and SAN DIEGO, Calif., March 17, 2015 /PRNewswire/ — Late breaking trials at the ACC include the data from the first randomized, multi-center DEFLECT III clinical trial, testing the TriGuard Cerebral Detection Device designed to protect the brain during cardiovascular procedures.

  • Use of the TriGuard was safe with numerically better in-hospital procedure safety
  • Patients protected with TriGuard during TAVR were more likely to be free of new brain lesions post- procedure, particularly when TriGuard was used during implantation of Edwards’ Sapien family of valves. Complete freedom from ischemic brain lesion was observed in 50% of TriGuard protected patients treated with Sapien 3 – an unprecedented level not previously reported in any study
  • On DW-MRI post-procedure, single and maximum brain lesion volume was reduced by about 40% as compared to control patients who did not have TriGuard protection
  • Neurocognitive decline was reduced post-procedure in patients protected with the TriGuard device and patients with protection had improved short-term and delayed memory at discharge

Keystone Heart today announced that its CE marked TriGuard™ Cerebral Protection Device has improved in-hospital safety outcomes and cognitive scores at discharge during Transcatheter Aortic Valve Replacement (TAVR), according to preliminary findings from the DEFLECT III trial presented at the 64th Annual Scientific Session of the ACC. Patients protected by the TriGuard device were also more likely to have complete freedom from ischemic brain lesions as assessed by Diffusion Weighted MRI (DW-MRI) post-procedure. Based on changes in NIH Stroke Scale, patients protected with TriGuard had 10% absolute reduction in stroke (4.9% vs. 14.3%). Minor strokes were under detected without detailed NIHSS assessment.

The First Report of the DEFLECT III Trial was presented in San Diego earlier today by Alexandra Lansky, MD, director of the Yale Cardiovascular Research Program, Yale School of Medicine, USA. DEFLECT III is the first multi-center randomized clinical trial of a neuro-protection device used during TAVR, designed to explore safety, detailed neurocognitive and DW-MRI surrogate efficacy endpoints. Conducted at 13 sites in 5 countries in Europe and Israel, DEFLECT III data demonstrated clear benefits on a number of endpoints in TAVR procedures performed using the TriGuard.

This data reinforces the results from DEFLECT I, which demonstrated a significant reduction of over 60% of new brain lesion volume in TriGuard protected TAVR procedures, compared with historical data on unprotected TAVR procedures.

In an announcement released by the American College of Cardiology (ACC), Dr. Lansky stated that “Protecting the brain has become a priority to improve our patients’ outcomes and this is a new focus in interventional cardiology. Our data show that TriGuard is probably at least as safe as control, it appears to improve neurocognition at discharge, and when the device is properly placed, patients have fewer lesions and the volume of lesion is greatly reduced.”

“When a patient undergoes a procedure to improve cardiovascular function, risks of damage to the brain should be minimized whenever possible. The new results from DEFLECT III and previous results from DEFLECT I show that the TriGuard has the potential to do so,” said Shuki Porath, President and CEO of Keystone Heart. “I am hopeful the results of the trial will promote the recognition of cerebral embolic protection importance, and use in TAVR and other cardiovascular procedures.”

Vince Burgess, Executive Chairman of Keystone Heart commented “Our objective since day one has been to help bring the stroke and silent stroke rates seen during TAVR down to a level that is equal to or below that observed during traditional valve replacement surgery. In this study, we have seen completely lesion free brains on DW-MRI in as many as 50% of patients when our device is used during implantation of the leading TAVR manufacturer’s latest generation valves. We are excited about the results of this study and we believe we are approaching our goal of helping to make this revolutionary procedure more widely available to patient populations.”

Keystone Heart’s TriGuard™ is the only cerebral protection device specifically designed to provide full coverage to all aortic arch takeoffs. The CE marked TriGuard™ Cerebral Protection Device is not yet commercially available in the USA.

About KeystoneHeart
Keystone Heart Ltd. is a medical device company developing and manufacturing cerebral protection devices to reduce the risk of stroke, neurocognitive decline and dementia caused by brain emboli associated with cardiovascular procedures.

The Company is focused on protecting the brain from emboli to reduce the risk of brain infarcts during TAVR, surgical valve replacement, atrial fibrillation ablation and other cardiovascular procedures. The TriGuard product pipeline is designed to help interventional cardiologists, electrophysiologists and cardiac surgeons to preserve brain reserve while performing these procedures.

Headquartered in Israel, Keystone Heart is dedicated to advancing patient care through innovative technology and clinical research. The Company’s management has extensive experience in the fields of interventional cardiology and medical devices.

Mr. Shuki Porath, President and CEO
Tel: +972-4-615-8000

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Philips spotlights IntelliSpace Cardiovascular image and information management solution at the American College of Cardiology Conference

-A connected cardiology solution that features Advanced Analytics and Diagnostic Guidance

-Provides physicians with the sophisticated tools to access, analyze and share cardiovascular images and information anytime, from virtually anywhere.

SAN DIEGO, March 16, 2015 /PRNewswire/ — Royal Philips (NYSE: PHG; AEX: PHIA) today announced the launch of IntelliSpace Cardiovascular, a web-enabled image and information management system (CVIS) with a single integrated workspace that produces a holistic view of the patient’s care continuum across the entire cardiovascular service line. The new solution provides cardiologists with sophisticated tools for diagnosis and planning of patient cardiovascular care.

Photo – http://photos.prnewswire.com/prnh/20150313/181616
Logo – http://photos.prnewswire.com/prnh/20140122/NE50581LOGO

“The new era of value-based care and population health management is requiring cardiologists to collaborate and share information more readily with other care team members across various care settings,” said Jeroen Tas, CEO, Healthcare Informatics Solutions and Services, Philips. “IntelliSpace Cardiovascular marks the next generation of cardiology imaging and innovation, serving as a layer of interoperability that allows all care team members to access data and sophisticated clinical applications within one workspace.”

Improving interoperability to enhance collaboration
By centralizing patient data from different areas of the hospital, IntelliSpace Cardiovascular helps facilitate a streamlined workflow and improve patient care. The new way information is displayed allows all care team members to view the patient’s history spanning diagnosis, treatment and therapy, fostering collaboration and potentially eliminating unnecessary and repetitive tests.

IntelliSpace Cardiovascular offers a suite of interoperable clinical modules designed to help improve workflow across the entire cardiovascular service line from virtually anywhere. Built-in echocardiography reporting features give cardiologists the ability to identify and eliminate inaccuracies within reports.

Guiding diagnostics through advanced analytics
Population health management is a challenge that requires access to a broad spectrum of data, including discrete information about a patient’s condition. IntelliSpace Cardiovascular includes built-in tools for analytics, which compile data into searchable and manageable information for physicians, administrators and researchers. The analytic capabilities provide insight into operational efficiency, productivity and population health, allowing care team members to focus more of their time on delivering the best possible patient care.

Philips will be featuring IntelliSpace Cardiovascular at the American College of Cardiology Conference in their booth #137.

For more information on the new Philips portfolio of solutions, visit www.philips.com/IntelliSpaceCardiovascular and follow the #ACC15 conversation via @Philips and @PhilipsHealth.

For further information, please contact:
Kathy O’Reilly
Philips Press Office
Tel: +1 978-659-2638
Mobile: +1 978-221-8919
Email: kathy.oreilly@philips.com 
Twitter: @kathyoreilly

Sabine Detiger
Philips Healthcare Informatics Communications
(mobile) +31 (0)6 15043894
Twitter: @sabinedetiger

About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a diversified health and well-being company, focused on improving people’s lives through meaningful innovation in the areas of Healthcare, Consumer Lifestyle and Lighting. Headquartered in the Netherlands, Philips posted 2014 sales of EUR 21.4 billion and employs approximately 105,000 employees with sales and services in more than 100 countries. The company is a leader in cardiac care, acute care and home healthcare, energy efficient lighting solutions and new lighting applications, as well as male shaving and grooming and oral healthcare. News from Philips is located at www.philips.com/newscenter.

Biometrics Key to Future Growth in Healthcare, Retail and Financial Markets

–Learn how industry-specific applications will develop in Frost & Sullivan’s upcoming live webinar

MOUNTAIN VIEW, Calif., March 12, 2015 /PRNewswire/ —


Tuesday, March 17, 2015 at 11:00 a.m. EDT


Online, with Complimentary Registration here: http://bit.ly/1G7Os0L.


Frost & Sullivan Measurement & Instrumentation Program Manager Aravind Seshagiri


Learn how industry-specific applications will develop in Frost & Sullivan's upcoming live webinar

Learn how industry-specific applications will develop in Frost & Sullivan’s upcoming live webinar

Photo – http://photos.prnewswire.com/prnh/20150311/181111

Biometric companies must plan for the future in order to compete in several different markets and industries. This is especially true as the market is currently witnessing an uptrend.

Join Frost & Sullivan’s upcoming complimentary webinar, “The Future of Biometrics,” to understand the potential of the market and its impact on current businesses. Industry leaders should attend this webinar to learn how biometrics will boost convergence and growth in other markets.

Questions this webinar will answer:

  • How will the market affect industries such as retail, finance and healthcare?
  • How will biometric technologies evolve?
  • What are future trends in the biometrics market?

Supporting Quote:
“Due to the numerous benefits they offer, biometric technologies will witness elevated growth and spur growth in several end-user segments,” said Frost & Sullivan Measurement & Instrumentation Program Manager Aravind Seshagiri. “Markets will move towards using biometrics in multiple combinations to ensure security remains intact.”

For more information email mireya.espinoza@frost.com your full name, job title, company name, telephone number, company email address and website, city, state and country or click here: http://bit.ly/1G7Os0L.

About Frost & Sullivan
Frost & Sullivan, the Growth Partnership Company, works in collaboration with clients to leverage visionary innovation that addresses the global challenges and related growth opportunities that will make or break today’s market participants.

Our “Growth Partnership” supports clients by addressing these opportunities and incorporating two key elements driving visionary innovation: The Integrated Value Proposition and The Partnership Infrastructure.

  • The Integrated Value Proposition provides support to our clients throughout all phases of their journey to visionary innovation including: research, analysis, strategy, vision, innovation and implementation.
  • The Partnership Infrastructure is entirely unique as it constructs the foundation upon which visionary innovation becomes possible. This includes our 360 degree research, comprehensive industry coverage, career best practices as well as our global footprint of more than 40 offices.

For more than 50 years, we have been developing growth strategies for the global 1000, emerging businesses, the public sector and the investment community. Is your organization prepared for the next profound wave of industry convergence, disruptive technologies, increasing competitive intensity, Mega Trends, breakthrough best practices, changing customer dynamics and emerging economies?

Contact Us: Start the discussion

Join Us: Join our community

Subscribe: Newsletter on “the next big thing”

Register: Gain access to visionary innovation

Mireya Espinoza
Corporate Communications – North America
P: +
F: +1.210.348.1003
E: mireya.espinoza@frost.com

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KIMREE E-cigarette Announcing a Multi-Model Partnership With Traders

SHENZHEN, China, March 12, 2015 /PRNewswire/ — KIMREE announced today a multi-model partnership project for its third refillable e-cigarette — JS044 to all traders in the world, after having successfully released the JS042 and JS043, two of the company’s flagship e-cigarettes.

Compared with JS042 and JS043 e-cigarettes, JS044 is smaller and more portable. When being asked what the JS044 highlights among thousands of competitors, an official at KIMREE responded, “Firstly, JS044 is the slimmest refillable e-cigarette in the world paired with a tiny body and exquisite design, making it more convenient to carry. Secondly, JS044 retains the function of adding e-liquid from the upper part of the atomizer. All the user needs to do is to unscrew the inhaler, which can help to reduce the wear and tare of the atomizer and battery. What’s more, JS044 doesn’t have a power button, allowing customers to vape without any complications.”

According to the official, JS044 inherits exclusive leak proof cap technology of KIMREE, taking advantage of a smooth round cap to avoid e-liquid leaking. This keeps the e-cigarette trendy as well as solving the e-liquid leakage problem when customers are vaping.

Meanwhile, the official also added that the company decided to choose a new business model — Zero Cost Boss that every partner can build his or her business and become a boss without any risk or cost. KIMREE will provide strong support to domestic traders as follows:

  1. An optional inventory model. Traders can build a more flexible and efficient inventory system based on their demands themselves; they can also choose to transfer the inventory process to KIMREE to avoid overstocking and maintain lower operating costs.
  2. Company assisted shipping. Any order can be shipped directly from KIMREE to your clients, lowering the logistics time and cost.
  3. Simple and convenient distribution. The company has managed all the processes so any trader can create his or her own business just with a cell phone.
  4. Zero risk. Traders can transfer any part of risk to the company, to assure their own profits.

For more information about the program and products involved, please contact us.

Contacts: Wendy
Tel: +86-755-83218756
Tel: +86-13651470626
Email: wendy@kimree.com
Email: andre@kimree.com

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/kimree-e-cigarette-announcing-a-multi-model-partnership-with-traders-300049456.html

CREDIT II Stent Trial Completes Enrollment

SINGAPORE, March 11, 2015 /PRNewswire/ — JW Medical Systems Limited (“JWMS”), a fully-owned subsidiary of Biosensors International Group, Ltd. (“Biosensors” or the “Company”) (Bloomberg: BIG SP; Reuters: BIOS.SI; SGX: B20), has announced completion of patient enrollment in CREDIT II, the first randomized controlled trial (“RCT”) involving the EXCEL II coronary stent. EXCEL II is the latest generation in the EXCEL family of biodegradable polymer drug-eluting stents (“BP-DES”), the leading BP-DES brand in China. Incorporating JWMS’ latest technology, the EXCEL II stent features an abluminal coating of sirolimus combined with an optimized PLA biodegradable polymer, and is deployed from a new delivery system.

CREDIT II compares the EXCEL I and II coronary stents, with a primary endpoint of late lumen loss at nine months. Enrollment of 432 patients in China was recently completed.

“I am delighted to have completed patient enrollment in this important trial so quickly,” commented Principal Investigator Dr. Yaling Han, ShenYang PLA General Hospital, ShenYang, China. “The first generation EXCEL stent demonstrated excellent safety and efficacy. Based on that experience and the preliminary results of the CREDIT FIM trial, we expect even better long term safety and efficacy results from EXCEL II.”

Simon Li, CEO of JWMS added: “JWMS has been a leader in the Chinese drug eluting stent market for many years. The EXCEL II stent will continue that legacy, based on solid clinical evidence from studies such as CREDIT. “

CREDIT II is part of the Chinese EXCEL II clinical trial program which has enrolled over 1100 patients in three trials across 40 centers. Excel II’s First in Man (“FIM”) study, CREDIT I, started enrollment in Mar 2013 and has completed one year follow-up. Treatment with EXCEL II demonstrated excellent 4-month & 12-month late lumen loss and sustained effectiveness, with rapid endothelialization. Both OCT and angiographic results suggested outstanding safety and efficacy with EXCEL II. CREDIT I results were published in Catheterization and Cardiovascular Interventions (“CCI”) earlier this year. A third trial, CREDIT III, is gathering data from a single arm registry that has enrolled 637 patients to date.

Media/Investor Relations Contact
Tel: +6562135777
Email: ir@biosensors.com

About Biosensors International Group, Ltd

Biosensors International Group, Ltd. develops, manufactures and markets innovative medical devices, aiming to improve patients’ lives through pioneering medical technology that pushes forward the boundaries of innovation.

Founded in 1990, the Company was listed on the Mainboard of the Singapore Stock Exchange in 2005. The Group currently operates through three business units (“BU”): the Cardiovascular BU, composed primarily of Excel™, BioFreedom™, the BioMatrix™ family of drug-eluting stents, and stent technologies such as BA9™; the Cardiac Diagnostic BU, including Spectrum Dynamics products that offer advanced medical imaging and clinical solutions to help interventional cardiologists determine the most appropriate treatment for patients; and the Critical Care Products BU, including critical care catheters, hemodynamic monitoring, and related devices used during heart surgery procedures, vascular surgery procedures and intensive care treatment.

The Group has operations worldwide and is headquartered in Singapore.

For more information, please visit www.biosensors.com.

JW Medical Systems Limited

JWMS is a fully-owned subsidiary of Biosensors International Group, Ltd. Established in Weihai, Shandong, China in 2003, JWMS is an international company focusing on the R&D, manufacturing and marketing of high-tech interventional products. Today, JWMS is transforming patient care and health in China through their innovative products and services.

Forward-Looking Statements

Certain statements herein include forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements generally can be identified by the use of forwardlooking terminology, such as “may,” “will,” “expect,” “intend,” “estimate,” “anticipate,” “believe,” “project” or “continue” or the negative thereof or other similar words. All forward looking statements involve risks and uncertainties, including, but not limited to, customer acceptance and market share gains, competition from companies that have greater financial resources; introduction of new products into the marketplace by competitors; successful product development; dependence on significant customers; the ability to recruit and retain quality employees as Biosensors grows; and economic and political conditions globally. Actual results may differ materially from those discussed in, or implied by, the forward-looking statements. The forward-looking statements speak only as of the date of this release and Biosensors assumes no duty to update them to reflect new, changing or unanticipated events or circumstances.

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/credit-ii-stent-trial-completes-enrollment-300048875.html

LEADERS Free Japan Trial Completes Enrollment

SINGAPORE, February 9, 2015 /PRNewswire/ — Biosensors International has announced completion of patient enrollment in LEADERS Free Japan, a revolutionary trial involving BioFreedom™, the company’s novel polymer and carrier-free drug-coated stent (DCS).

LEADERS Free is the world’s first prospective, randomised double-blind clinical trial employing only a one-month course of dual anti-platelet therapy (DAPT) after implantation of an active stent. The trial is focused on patients at high risk of bleeding, and has been designed to confirm that BioFreedom is as safe as a bare-metal stent (BMS) in this patient group, while delivering the anti-restenotic benefit of a drug-eluting stent (DES). LEADERS Free Japan, a prospective, multi-centre open-label trial, is applying the same patient selection criteria and duration of DAPT as LEADERS Free, but with simply a BioFreedom treatment arm.

The objective of LEADERS Free Japan is to confirm that the safety and efficacy of BioFreedom in Japanese patients is equivalent to that observed in patients of other ethnicities, as assessed in the active (BioFreedom) arm of LEADERS Free. Safety is being measured by the composite of cardiac death, myocardial infarction and definite/probable stent thrombosis at one year, and efficacy by the incidence of clinically driven target lesion revascularization at one year.

LEADERS Free Japan has enrolled 140 patients identified as having a high risk of bleeding, from 12 centres across the country. All patients are being prescribed only one month of DAPT.

“I am delighted to have completed patient enrollment in this groundbreaking study,” commented Principal Investigator Dr. Shigeru Saito, Shonan Kamakura General Hospital, Kanagawa, Japan. “It is a unique clinical trial, not only for the stent itself but for the unprecedented trial design and the challenging patient population. We expect to gain valuable scientific and clinical findings from the trial, potentially showing the BioFreedom technology offers unique clinical benefits for our patients.”

“We hope that the results from LEADERS Free Japan will show, for the first time, that a drug-coated stent can be used safely and effectively with only one month of DAPT in Japanese patients at high risk of bleeding,” added Dr Philip Urban, Principal Investigator for LEADERS Free.

LEADERS Free has enrolled 2466 patients identified as having a high risk of bleeding from 68 sites across Europe, Asia, Australia and Canada. Patients in both arms of the trial are being prescribed only one month of DAPT. Primary endpoint data is expected later this year, and follow up is planned out to two years.

BioFreedom represents the latest development in Biosensors’ stent technology, featuring an abluminal coating of Biolimus A9™ (BA9™) without the use of a polymer or other carrier. BA9 is a highly lipophilic anti-restenotic drug developed by Biosensors specifically for use with stents. LEADERS Free Japan will be the first clinical trial ever conducted by Biosensors of a BA9-coated stent in Japan. In its First in Man (“FIM”) study, treatment with BioFreedom demonstrated excellent 12-month late lumen loss and sustained safety up to five years, including absence of definite and/or probable stent thrombosis.

BioFreedom has received CE Mark approval and is currently available in select markets. Biosensors has also received conditional IDE approval to conduct a US-based clinical trial of BioFreedom, designed to collect additional safety and effectiveness data.

Media/Investor Relations Contact
Tel: (65) 6213 5777
Email: ir@biosensors.com

About Biosensors International Group, Ltd

Biosensors International develops, manufactures and markets innovative medical devices for interventional cardiology and critical care procedures.

With the BioMatrix™ family of drug-eluting stents and the Axxess™ self-expanding bifurcation stent, we are a leader in the global coronary stent market. These stents incorporate Biolimus A9™ (BA9™), an anti-restenotic drug developed specifically for use with stents and patented by Biosensors, together with a unique abluminal biodegradable polymer coating, which fully degrades into carbon dioxide and water after six to nine months as it releases BA9. The BioMatrix family features workhorse stent platforms for a broad range of lesions, and Axxess employs a self-expanding stent platform specifically designed for treating bifurcation lesions.

The BioFreedom™ drug-coated stent, which has received CE Mark approval, underscores our technology leadership in the field of coronary stents. BioFreedom is the world’s first polymer and carrier -free stent with BA9. Chroma™, a cobalt chromium bare-metal stent featuring an innovative platform design, offers exceptional deliverability without any compromise on radial strength or recoil.

Our drug-eluting balloon range complements the stent portfolio and offers interventional cardiologists a broader range of treatment options.

For more information, please visit www.biosensors.com

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/leaders-free-japan-trial-completes-enrollment-300032762.html