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.
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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.
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.
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