Wednesday, September 29, 2010

It's Over...Medafor Terminates Disputed Drug Distribution Agreement With CryoLife

KENNESAW, Ga. -- CryoLife Inc. (NYSE: CRY) said it has received a notice from Medafor Inc. that terminates a contentious medical device distribution agreement between the two companies, the latest in a long-running dispute, according to an SEC filing.
CryoLife, the Kennesaw-based maker of medical products that enable heart and blood vessel reconstructive surgery, said it would challenge the validity of Medafor's termination of the agreement and pursue its rights and remedies in court.
CryoLife said Medafor's notice came after CryoLife challenged in court a determination in March by Medafor that it was "treating the agreement as terminated."
CryoLife had filed a case in the U.S. District Court for the Northern District of Georgia, Atlanta Division, to stop privately held Medafor, which develops drugs to help blood clotting during major surgeries, from proceeding with the termination of the agreement. The court agreed to hear the case but denied a preliminary injunction, last week.
CryoLife is the single largest shareholder in Minneapolis-based Medafor, with a 10.4 percent holding. CryoLife had sought to hold talks to buy the rest of the company but later withdrew the offer.
Medafor accuses CryoLife of violating an exclusive distribution deal by sellingHemostase, an absorbable blood-clotting agent manufactured by Medafor, in Spain for uses allegedly barred by the agreement. In a counter-suit, CryoLife accused Medafor of violating an agreement by allowing other companies to distribute the product in territories and medical fields reserved exclusively for CryoLife.
The termination of the deal will not materially alter CryoLife's guidance for Hemostase revenue of between $4 million and $4.5 million for the last two quarters of the year, the company said.

AccessClosure Announces Distribution Agreement for Radial Compression Band

MOUNTAIN VIEW, Calif., Sept. 29 /PRNewswire/ -- AccessClosure, Inc., the market leader in extravascular closure devices, announced today an exclusive agreement with Benrikal Services to distribute the Bengal Radial Compression Band in the United States.  The Bengal, uniquely designed for transradial procedures, will join the Mynx™ Vascular Closure Device in AccessClosure's portfolio of products.
"We felt that it was crucial to offer a solution for our customers who use the radial approach," said Gregory D. Casciaro, President and CEO of AccessClosure.   "As a customer-focused company, we are striving to provide technologies for all approaches to access site management.  The Bengal complements the key features of the Mynx, both of which were designed to minimize impact on the artery, to offer clinical versatility, and to deliver a comfortable experience for the patient.  Including the Bengal in our closure portfolio allows AccessClosure to offer the same level of service and education to an even broader base of interventionalists."
The Bengal was designed in partnership with radial pioneer Olivier F. Bertrand, MD, PhD, FSCAI, an Interventional Cardiologist at the Quebec Heart-Lung Institute and Associate-Professor, Faculty of Medicine, at Laval University.  "I designed this device to address unmet needs in radial closure.  I wanted a simple tool that achieves quick and effective hemostasis, while protecting the ulnar nerve and providing a comfortable experience for the patient," said Dr. Bertrand.  "I also wanted to simplify post-operative care for my nursing staff: in my practice, the Bengal requires less monitoring time as it can be removed immediately at the end of the hemostasis period."
Vascular closure devices help to close an artery after cardiovascular procedures.  Interventional cardiologists may choose to access the coronary arteries through the radial artery in the wrist instead of the traditional approach using the groin.  Use of the radial technique has increased in the United States in the past several years, due in part to the evolution of the technologies that enable the procedure.  
The Bengal design offers a new approach to radial artery closure, combining a compression pad that delivers a unique pattern of targeted pressure with a soft polymer gel that ensures patient comfort while the band is on the wrist.  "Our Canadian customers appreciate the simplicity and ease-of-use of this band," said Guy BĂ©langer, President of Benrikal Services.  "As transradialists grow increasingly focused on avoiding radial occlusion after procedures, we have observed a natural inclination to a device that is very easy to adjust and optimize."