A Medical Device Daily
CryoLife (Kennesaw, Georgia) said it has signed an exclusive 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 received CE-mark approval in 2003 and FDA pre-market approval in September 2006, will be distributed by CryoLife under the private-label name Hemostase MPH.
CryoLife expects to begin distributing Hemostase MPH in the U.S. in 2Q08, except to about 41 hospitals for which Medafor will retain distribution rights until no later than Dec. 31, 2008.
Outside of the U.S., CryoLife expects to begin distributing Hemostase MPH in Canada, the UK and Germany in 2Q08, with distribution in other markets beginning in 2009. Department of Defense hospitals are excluded from CryoLife's territory under the distribution agreement, but Veterans Affairs hospitals are included.
"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. "Hemostase MPH also allows us to compete in the surgical hemostat market, which we believe totaled approximately $380 million in the U.S. in 2007."
In other agreement news:
• Washington University School of Medicine (St. Louis) and AstraZeneca (London) reported a research collaboration that aims to develop improved ways to diagnose and treat Alzheimer's disease. The major focus of the alliance will be biomarkers, characteristic changes in the brain and spinal fluid, that physicians can use to diagnose Alzheimer's disease and track its response to treatment.
The new research projects created by the Washington University/AstraZeneca agreement will include an effort to better understand the connections between Alzheimer's disease and a class of central nervous system compounds called tau proteins, which help maintain the inner structures of nerve cells.
• Xceed Molecular (Wellesley, Massachusetts) reported that the University of Florida (Gainesville) has joined Xceed's Strategic Collaborator program. Xceed will work with primary researchers, Charles Joel Rosser, MD, of the department of urology, and Steve Goodison, MD, of the department of surgery, to perform initial verification and validation of an expression signature that has shown promise as a way to differentiate bladder cancer from other conditions using voided urine samples.
As part of the collaboration, Xceed and the university will test about 700 samples from patients previously identified to have either cancerous or non-cancerous bladder tumors to verify that the expression signature is useful in distinguishing the two populations.
If the signature is successfully validated, Xceed and the university will continue to work together to pursue subsequent clinical testing to validate the signature for use in patient management. Specific terms were not disclosed.
• Premier Purchasing Partners (Charlotte, North Carolina), a healthcare purchasing network, reported a new agreement for sharps disposal containers with device maker Covidien (Boulder, Colorado).
This 26-month agreement, effective May 1, is available to acute-care and continuum-of-care members of the Premier healthcare alliance.