SurModics Announces First Human Use of Finale(TM) Prohealing Coating Technology on Nexeon MedSystems' PROTEX(TM) Coronary Stent System
EDEN PRAIRIE, Minn.--(BUSINESS WIRE)--
SurModics, Inc. (Nasdaq: SRDX), a leading provider of surface modification and drug delivery technologies to the healthcare industry, today announced that the PROTEX(TM) Coronary Stent System incorporating SurModics' proprietary Finale(TM) prohealing coating technology was used in the first-in-human trial evaluating the safety of the device for the treatment of coronary artery disease. The PROTEX stent was developed by Nexeon MedSystems, Inc. (formerly Paragon Intellectual Properties, LLC), a developer of medical technology for the treatment of cardiovascular disease. The first implant procedure was performed by Professor Eberhard Grube, Chief of Cardiology and Angiology, at the Heart Center Siegburg in Siegburg, Germany as part of Nexeon MedSystems' PROTEX I clinical trial.
SurModics' proprietary FINALE prohealing coating technology integrates extracellular matrix proteins that accelerate tissue repair through the body's own healing mechanisms by attracting endothelial cells from the surrounding tissue and circulating endothelial progenitor cells. The PROTEX Stent System utilizes Nexeon's unique low-profile (0.86mm) cobalt alloy coronary stent platform and is designed to address late stent thrombosis, a serious complication occurring in a small percentage of coronary stent cases, while also aiming to reduce restenosis, or the re-narrowing of the stented vessel. Further, the PROTEX Stent System may eliminate the need for long-term antiplatelet therapy, thereby decreasing costs and reducing bleeding risks to the patient.
"Our collaboration with SurModics, which began in July 2007, has gone exceedingly well and has enabled us to effectively and rapidly develop our prohealing coronary stent system," said Mark C. Bates, M.D., CEO of Nexeon. "We believe SurModics' FINALE prohealing coating technology holds promise to speed recovery of the normal vessel architecture and inner cell lining to significantly reduce the risk of late stent thrombosis, while also reducing restenosis. By combining this innovative technology with Nexeon's low-profile stent system, the PROTEX Coronary Stent System moves us one step closer to our ultimate goal of marketing a highly deliverable coronary stent with a biologic coating that has the efficacy of a drug-eluting stent without the long-term concern of late stent thrombosis."
"Today's announcement is a significant milestone for SurModics as it marks the first clinical experience with our FINALE prohealing coating technology," said Bruce Barclay, president and CEO of SurModics. "We have been impressed by the speed and capabilities Nexeon has demonstrated in developing this product and initiating human clinical trials. The prospects for this highly differentiated coronary stent system are significant and the unmet clinical need considerable. Further, our collaboration with Nexeon and the initiation of the PROTEX I clinical trial demonstrates our commitment to innovation and meeting the needs of our customers. We believe the stent market continues to offer significant opportunities to SurModics."
The PROTEX I clinical trial will enroll 50 patients at up to five sites in Europe. Follow-up examinations will be performed at 30 days, six months and nine months. The six-month follow-up examination will evaluate both neointimal volume by intravascular ultrasound (IVUS) and percent binary restenosis by angiography. Dr. William Wijns, M.D., of the Cardiovascular Center Aalst in Belgium, will serve as the principal investigator of the clinical trial.
"There is a significant clinical need for a low-restenosis stent that does not carry the late-thrombosis risk of drug-eluting stents," said Dr. Wijns. "I am excited about the potential of this type of breakthrough coating on a highly deliverable coronary stent."
About SurModics, Inc.
SurModics, Inc. is a leading provider of surface modification and drug delivery technologies to the healthcare industry. SurModics partners with the world's foremost medical device, pharmaceutical and life science companies to develop and commercialize innovative products that result in improved patient outcomes. Core offerings include: drug delivery technologies (coatings, microparticles, and implants); surface modification coating technologies that impart lubricity, prohealing, and biocompatibility capabilities; and components for in vitro diagnostic test kits and specialized surfaces for cell culture and microarrays. Current efforts include a sustained drug delivery system in human trials for treatment of retinal disease and the drug delivery polymer matrix on the first-to-market drug-eluting coronary stent. SurModics is headquartered in Eden Prairie, Minnesota and its Brookwood Pharmaceuticals subsidiary is located in Birmingham, Alabama. For more information about the company, visit www.surmodics.com. The content of SurModics' website is not part of this release or part of any filings the company makes with the SEC.
About Nexeon MedSystems, Inc.
Nexeon MedSystems, Inc. is committed to saving and improving lives through the development of breakthrough therapies for cardiovascular disease. With proven medical device industry engineering talent, a strong intellectual property portfolio and the leadership of a veteran interventional cardiologist, Nexeon has created an extensive pipeline of products that promise to bring physician-led innovation to common clinical problems. Privately held, the company is based in Charleston, W. Va., with a research and development innovation center in Carlsbad, Calif. For more information please visit www.nexeonmedsystems.com.
Safe Harbor for Forward-Looking Statements
This press release contains forward-looking statements. Statements that are not historical or current facts, including statements about beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties, and important factors could cause actual results to differ materially from those anticipated, including the following: (1) our reliance on third parties (including our customers and licensees) and their failure to successfully develop, obtain regulatory approval for, market and sell products incorporating our technologies may adversely affect our business operations, our ability to realize the full potential of our pipeline, and the company's ability to achieve our fiscal 2008 corporate goals; (2) costs or difficulties relating to the integration of the businesses of Brookwood Pharmaceuticals and BioFX Laboratories with SurModics' business may be greater than expected and may adversely affect the company's results of operations and financial condition; (3) developments in the regulatory environment, as well as market and economic conditions, may adversely affect our business operations and profitability; and (4) other factors identified under "Risk Factors" in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended September 30, 2007, and updated in our subsequent reports filed with the SEC. These reports are available in the Investors section of our website at www.surmodics.com and at the SEC website at www.sec.gov. Forward-looking statements speak only as of the date they are made, and we undertake no obligation to update them in light of new information or future events.
Source: SurModics, Inc.