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4 Month Clinical Results of PLUS-ONE First in Man Trial Demonstrate Safety and Feasibility of Medlogics’ Cobra™ Coronary Stent Coated with Very Low Dose Paclitaxel and Synergy™ Bioabsorbable Silica Matrix Coating

Washington, D.C. and Santa Rosa, CA USA; October 22, 2008 – Last week during the Drug Eluting Stent Summit taking place at the TCT (Transcatheter Cardiovascular Therapeutics) Conference, Dr. Jose Antonio Condado released the four month results from the “PLUS-ONE” first in man (FIM) coronary clinical trial utilizing Medlogics’ drug eluting stent (DES), Cobra-P, which delivers a very low dose of paclitaxel from a novel bioabsorbable coating on a new stent platform. The average reference vessel diameter was 2.58 mm and the acute performance resulted in 100% procedural, lesion and device success. The four month results included clinical patient status, in addition to quantitative coronary angiography (QCA) and IVUS measurements of the treated vessels. Of the 30 patients enrolled, 29 (96.7%) of the patients were free of any major adverse cardiac events (MACE), whereas only one patient (3.3%) experienced a MACE due to a lesion revascularization. The in-stent and in-segment late loss were 0.32 mm and 0.18 mm respectively and the binary angiographic restenosis rate was 0% in the patients treated per the protocol. According to Dr. Condado, “These clinical results are very encouraging and in line with other DES on the market. The exciting aspects of this very thin strut stent are the bioabsorbable coating and the small amount of drug contained in Cobra-Paclitaxel, both of which have several potential long-term advantages over other commercially available drug eluting stents.”

These impressive clinical results observed in the PLUS-ONE trial build upon the foundation of data that Medlogics continues to gather to demonstrate the benefits expected from the unique combination of next-generation improvements to each major aspect of this Cobra-P DES product: ultra-thin stent and bioabsorbable polymer-free coating platforms with very low-dose drug elution. The Cobra-P DES system utilizes the CE Marked “Cobra™” cobalt chromium super-alloy stent with very thin (71 µm) struts. This novel stent platform is coated with a fully bioabsorbable “Synergy™” coating that is a polymer-free silica matrix and only 2 µm thick. The ultra-thin stent and coating combination delivers only 4 µg of the paclitaxel drug. The Synergy coating is bioabsorbed with all drug eluted from the stent within 6 months, with only the bare metal Cobra stent remaining thereafter. Cobra-P is expected to provide several benefits over the world’s top selling DES product that has a significantly thicker stent platform (97 µm struts), with a much thicker permanent polymer coating (17 µm) that carries significantly higher amounts of paclitaxel (112 µg).

The novel Synergy coating used on Cobra-P was co-developed by Medlogics in conjunction with Stanford University, and is considered especially beneficial for relatively low drug doses. Medlogics is also incorporating another bioerodible coating platform, exclusively licensed from CV Therapeutics, onto other products being evaluated that use higher doses of drug.
In addition to the compelling results observed so for under this trial for Cobra-P, Medlogics is also currently enrolling patients under three additional clinical trials related to other bare metal stent (BMS) and DES products. The company also expects to launch another DES trial before the end of the year utilizing another approved drug, but for which its application to DES products represents a new use proprietary to Medlogics.

About Medlogics Device Corporation

Medlogics, with headquarters in Santa Rosa, CA, is dedicated to providing safe and effective clinically superior devices to patients and their physicians worldwide. Medlogics was founded upon the principle of designing innovative, best-in-class solutions to endolumenal stents and local drug delivery devices. Medlogics is currently focused on developing improved next-generation stents and drug-eluting stents to treat coronary artery disease. To help accomplish this goal, Medlogics has vertically integrated research & development and manufacturing operations for drug-eluting coatings, stents, and catheters. Cobra™ is available for sale only under CE Mark territories outside of the United States, and is not available for sale within the United States. Cobra-P™ is an investigational product only and is not available for sale. Medlogics™, Cobra™, Cobra-P™, and Synergy™ are exclusive trademarks of Medlogics Device Corporation, all rights reserved. Cobra™, Cobra-P™, and Synergy™ are considered proprietary technologies of Medlogics, and are all patent pending.

CONTACT:

Kalei Hampson, Marketing Director, Medlogics Device Corporation; +1-707-545-5700

KHampson@MedlogicsDC.com