2008-10-04 09:33:36 -
Bad Soden, Germany and Santa Rosa, CA, USA; September 26, 2008 - Medlogics Device Corporation announced that it has begun enrollment in a 258 patient single-arm prospective multi-center clinical trial ('COBRA II') using the COBRA Coronary Stent System at sites in Europe, Turkey and Israel. Nicolaus Reifart, MD, FESC, FACC, Professor and Chief of the Department of Internal Medicine, Interventional
Cardiology and Angiology at the Main-Taunus-Kliniken Bad Soden, conducted this first implants under the study. Data from the COBRA II Study will be utilized to support pre-market approval (PMA) for the Cobra stent from the U.S. Food and Drug Administration (FDA).
The COBRA II trial launch follows the launch of a separate post-market multi-center Clinical Registry -- 'COBRA I' -- intended to assess performance of the Cobra stent in another 100 patients. Interim results from the first fifty (50) patients enrolled in COBRA I have been impressive, with 0.0% major adverse cardiac events (MACE) reported through the initial 30 day follow up period. This initial trend, if continued, would compare favorably against more typical 30 day MACE rates of about 2.5% to 6.8% previously reported for the other leading bare metal stents. The encouraging initial clinical trend also confirms extensive pre-clinical animal study experience where Cobra demonstrated a low restenosis response more comparable to leading drug eluting stent controls than leading bare metal stent controls, but with lower vessel wall inflammation and necrosis than observed for the drug eluting stent controls. The COBRA I Registry allows for the inclusion of diabetic patients and patients with multi-vessel disease.
Professor Reifart, Principal Investigator for the COBRA II Trial, states: 'I have had the opportunity to use the Cobra stent both within and outside of the COBRA I, and now COBRA II, Studies. I continue to be impressed with the ability to deliver the Cobra stent in difficult arteries. I am very pleased to be part of both these studies as my initial enthusiasm for the Cobra stent continues to grow with more experience.'
Richard Klein, Medlogics' President states: 'Both the exciting initial trends seen in the COBRA I study and the COBRA II trial launch represent important milestones for Medlogics, and demonstrate our commitment to obtaining valuable clinical data while preparing to make Cobra widely available to patients world-wide, including in the United States.'
Mr. Klein further comments, 'Today's leading bare metal stents would long since have been antiquated by new improvements if not for the industry-wide diversion in pursuit of drug eluting stents. Yet bare metal stent usage remains prevalent, and the BMS market has expanded at the expense of drug eluting stent share.' This unexpected growth of BMS and contraction of DES resulted from concerns regarding death rates from late thrombus and extended anti-platelet requirements that had been associated with the two leading drug eluting stents. The future market share distribution between these two platforms is expected to be paced by the reception of new product offerings in the space. 'Medlogics has seized this opportunity to advance the stent architecture itself, and to provide the clinical community a significant improvement for this front-line bare metal stent choice between products,' adds Klein.
Dr. Simon Stertzer, Medlogics' Chairman of the Board, is also Professor Emeritus at Stanford University, and was also the initial founder of AVE (Arterial Vascular Engineering). Dr. Stertzer is also widely considered one of the pioneers of modern interventional cardiology and an early leader in conducting coronary angiography, angioplasty, and stenting.
Concerning the Cobra, Dr. Stertzer notes: 'the leading DES products are based completely on old stent designs, having thicker struts and bulkier, prothrombotic coatings, compared to any Cobra iteration. Based on the data we see so far, it looks like Cobra could well be that next generation stent that bridges the current gap between outdated bare metal designs and current problematic DES models.'
About Cobra
The Cobra stent is a cobalt super alloy bare metal stent designed with ultra-thin struts. Thinner struts have been correlated to lower restenosis rates in multiple independent studies, and also generally correlate to lower profiles for improved lesion access and crossing. However, reduced strut thickness can often result in compromised radial strength, integrity, and visibility in other stent designs. Cobra includes a novel stent architecture that combines with its super-alloy to enable a unique combination of significantly lower strut thickness, crossing profile, and recoil, while maintaining equivalent radial strength and visibility, versus the two leading bare metal stents on the market today. The Cobra stent has been approved for sale outside of the United States under a CE Mark since February 2008. The Cobra stent is not yet approved for sale in the United States.
About Medlogics Device Corporation
Medlogics, with headquarters in Santa Rosa, CA, is a privately funded company dedicated to providing safe, effective and clinically superior devices to patients and their physicians worldwide. In addition to the CE Marked bare metal Cobra™ Coronary Stent System, Medlogics is also developing multiple next-generation drug-eluting stent platforms to further advance the benefits of the Cobra stent in combination with novel drug-delivery approaches also proprietary to the company. As such, Medlogics is structured as a cardiovascular device company with a pipeline of product offerings at various stages of commercialization and development. To advance its goals and enterprise of product offerings under tight controls, Medlogics has established vertically integrated operations for drug carrier, stent, and catheter research & development and manufacturing.
COBRA™ and MEDLOGICS™ are exclusive trademarks and trade names of Medlogics Device Corporation, all rights reserved.
