• CryoLife (Kennesaw, Georgia) reported signing a three-year agreement with Medafor (Minneapolis) for CryoLife to distribute Medafor's microporous polysaccharide hemostatic agent for use in cardiac and vascular surgery in the U.S. The deal also covers cardiac, vascular and general surgery, other than orthopedic and ear, nose and throat surgery, outside the U.S. (excluding Japan and China). The absorbable powder hemostat, which has CE mark approval and FDA pre-market approval, will be distributed by CryoLife under the private-label name Hemostase MPH. CryoLife expects to begin distributing Hemostase MPH in the U.S. this quarter, except to about 41 hospitals for which Medafor will retain distribution rights until no later than Dec. 31. CryoLife said it expects to begin distributing Hemostase MPH in Canada, the UK and Germany in 2Q08, with distribution in other markets beginning in 2009. "Hemostase MPH gives surgeons the ability to quickly control active surgical bleeding, making it the perfect complement to CryoLife's BioGlue product line, which is much stronger and provides both tissue reinforcement and sealant capabilities," said Steven Anderson, president/CEO.
• diaDexus (South San Francisco, California) said it has appointed Fisher HealthCare (Waltham, Massachusetts) as the exclusive customer channel for its new automated PLAC test for the Hitachi, Hitachi Roche P-Modular and Olympus chemistry analyzers to U.S. hospital clinical laboratories. FDA recently cleared the automated format, diaDexus said. diaDexus says the PLAC test is the only blood test FDA-cleared to assess risk for both coronary heart disease and ischemic stroke associated with atherosclerosis. The test measures lipoprotein-associated phospholipase, a vascular-specific inflammatory enzyme implicated in the formation of rupture-prone plaque.
• Micrus Endovascular (San Jose, California) and Chemence Medical Products (Alpharetta, Georgia) reported an agreement to jointly develop liquid embolic products for neurovascular indications using Chemence's cyanoacrylate technology and intellectual property. Micrus will oversee the regulatory and clinical process and be exclusive worldwide distributor for neurovascular products developed based on the agreement. Micrus has made an upfront payment to Chemence and will make additional developmental milestone payments. "We see significant potential for a liquid embolic to be used either in conjunction with embolic coils or by itself for the treatment of aneurysms. The unique properties of Chemence's cyanoacrylate technologies may prove capable of providing complete occlusion and treatment of cerebral aneurysms within a matter of minutes," said John Kilcoyne, CEO and chairman of Micrus. Micrus products are used to treat both cerebral aneurysms responsible for hemorrhagic stroke and intracranial atherosclerosis, which may lead to ischemic stroke.
• The U.S. Naval Medical Research Center (NMRC; Silver Spring, Maryland) reported receiving about $3.4 million from the Department of Defense to develop Hemopure, a blood substitute product made by Biopure (Cambridge, Massachusetts), as a potential treatment of combat casualties with brain injury and concomitant hemorrhagic shock. Biopure is collaborating with NMRC to develop HBOC-201 as a platform for what it says would be the first multifunction blood substitute for trauma patients. The NMRC will conduct the preclinical work towards a multi-functional product for traumatic brain injury as part of the Post Traumatic Stress Disorder/Traumatic Brain Injury Research Program of the Office of the Congressionally Directed Medical Research Programs, the company said. Biopure said it is supporting NMRC's efforts to lift the clinical hold on the NMRC's investigational new drug application to conduct the pending clinical trial in trauma patients, Restore Effective SUrvival in Shock (RESUS).
• St. Jude Medical (St. Paul Minnesota) reported a partnership with the Microsoft Health Solutions Group (Redmond, Washington) to research the integration of data from implantable devices with patient-controlled, personal health records. St. Jude and Microsoft will work with physicians to determine the optimal level of integration between the Merlin.net Patient Care Network and Microsoft HealthVault that will allow physicians to share device information with their patients. Merlin.net PCN is a secure Internet-based system that collects and displays information from implantable devices, such as implantable cardioverter-defibrillators (ICDs). It stores data that is captured during implant procedures, in-office follow-up visits with physicians and remote follow-up transmissions in patients' homes. Transmitted data includes reports of irregular heart rhythms and real-time electrograms (EGM) which show patients' heartbeats at the time of transmission. Microsoft HealthVault is an Internet-based consumer health record system that allows individuals to collect, store and share their health information privately and securely.