Schiller AG and BSP : agreement for the development of a new product line based on BSP's HyperQ™ technology

November 8, 2010 - SCHILLER AG, a leading international manufacturer and supplier of cardiopulmonary diagnostics and BSP Biological Signal Processing Ltd., a medical device company that develops and markets innovative solutions for noninvasive cardiac diagnosis and monitoring , announced on November 8th, 2010 the signing of an agreement to jointly develop a new product line based on BSP’s HyperQ™ technology. The project will be performed in collaboration with the University Hospital of Basel, one of the premier medical centers in Europe. The project is planned for 3 years with an overall estimated budget of 1.7 Million Euro and will be partly funded by the Swiss and Israeli governments within the prestigious EUROSTARS framework.

The new product line is intended for the lucrative market of resting electrocardiogram (ECG) applications for the early diagnosis and monitoring of myocardial ischemia in patients with suspected acute coronary syndrome, including myocardial infarction (MI). This collaboration comes in continuation to the successful implementation of BSP’s HyperQ™ Analyzer in Schiller's state of the art CS-200 Excellence machine, a system intended for the stress ECG market, which was launched in Medica 2009.

The HyperQ™ technology utilizes advanced signal processing to extract and analyze valuable clinical information from high-resolution ECG signals. Based on solid scientific foundations, and validated in numerous pre-clinical and clinical studies, HyperQ™ provides a novel diagnostic tool for the non-invasive diagnosis of ischemic heart disease, with superior accuracy, compared to conventional ECG... BSP's Press Release -

BLUE MEDICAL : EUROPEAN CE MARK APPROVALS FOR DRUG ELUTING BALLOON AND STENT ON DRUG ELUTING BALLOON COMBINATION DEVICE

Nov. 15, 2010 - BLUE MEDICAL RECEIVES EUROPEAN CE MARK APPROVALS FOR DRUG ELUTING BALLOON AND STENT ON DRUG ELUTING BALLOON COMBINATION DEVICE - First ever CE approved combination device is an attractive treatment for coronary artery diseases - Blue Medical announced that the company received CE Mark approval for Blue Medical science based Drug Eluting Balloon (DEB) and simultaneously for Blue Medical's coronary CoCr stent mounted on a Drug Eluting Balloon (CoCr Stent on DEB) in Europe for treatment of coronary diseases. DEB therapy delivers a controlled dose of Paclitaxel to the coronary artery during balloon angioplasty. A unique combination of a one-time short and precise drug delivery with DEB during placement of a coronary stent is now for the first time approved and available in Europe.

"Increased late stent thrombosis risk and the long term dual anti-platelet medication which are associated with the majority of current drug eluting stents is a concern in treating our patients today," said Primary Investigator of the PIONEER Study Peter Smits, M.D., head of Intervention Cardiology at the Maasstad Hospital, Rotterdam, The Netherlands. "DEB therapy in combination with bare metal coronary stents offers a potential solution for reducing late lumen loss without the need for long term dual-anti-platelet medication, improving patent comfort and reducing risks for bleeding and stent thrombosis."... Blue Medical's Press Release -

BioInvent : approval to start Phase II trial for its novel cardiovascular drug BI-204

10 November 2010 – BioInvent International AB (OMXS: BINV) announces IND clearance from the U.S. Food & Drug Administration (FDA) to initiate a Phase II study for BI-204. BI-204 is a human monoclonal antibody that specifically targets oxidized forms of a low-density lipoprotein (LDL) which has been linked to increased inflammatory processes leading to plaque formation in the blood vessel walls. BI-204 is being co-developed with Genentech for secondary prevention of cardiovascular events in patients with acute coronary syndrome (ACS).


The Phase II study is a multicenter, randomized, double-blind, placebo-controlled study of intravenous BI-204 in patients on standard-of-care therapy for stable atherosclerotic cardiovascular disease. Inflammation plays a critical role in the pathogenesis of atherosclerosis. The trial is designed to demonstrate a significant reduction in plaque inflammation following treatment with BI-204 as quantified by FDG-PET (18F 2‑deoxyglucose positron emission tomography). The trial will enrol 120 patients with stable coronary vascular disease in centers in the United States and Canada. The topline results of the study are expected to be reported in the first half of 2012. Additional trials are being contemplated in patients with ACS prior to commencing Phase III....BioInvent's Press Release -

Tryton Medical : First Patient Enrollment in E-Tryton Italy Registry of the Tryton Side Branch Stent System

Oct. 12, 2010 - Study To Assess Real-Life Clinical Results in 300 Patients With Bifurcation Disease in Italy - Tryton Medical, Inc., the leading developer of stents designed to definitively treat bifurcation lesions, announced that the first patient has been enrolled in E-Tryton Italy, a registry study of the company’s Tryton Side Branch Stent™ System. E-Tryton Italy is one of four registries in Europe evaluating the Tryton Side Branch Stent System in real-world clinical settings.
The Tryton Side Branch Stent System is designed to offer a dedicated strategy for treating atherosclerotic lesions in the side branch at the site of a bifurcation. Tryton’s highly deliverable cobalt chromium stent is deployed in the side branch artery using standard single-wire balloon expandable stent delivery system. A conventional drugeluting stent is then placed in the main vessel... [PDF] Tryton Medical's Press Release -