CryoLife (CRY) And Medafor In Fight Over Hemostase

CryoLife, Inc. and Medafor, Inc. are parties to an exclusive distribution agreement whereby CryoLife distributes Hemostase, an absorbable blood clotting agent manufactured and developed by Medafor.

On September 18, 2009, Medafor informed CryoLife of its belief that CryoLife has materially breached its duties and obligations under the Agreement and gave CryoLife notice of its intent to terminate the Agreement if the breach is not cured within 30 days. While Medafor contends that a material breach has occurred because CryoLife has pursued regulatory approval to distribute Hemostase in Hong Kong, CryoLife believes a court would find that a material breach of the Agreement has not occurred, and that, in the event a breach has occurred, that CryoLife would be able to cure it within 30 days of CryoLife’s receipt of notice. As such, CryoLife does not believe the Agreement will terminate on October 18, 2009.
The Agreement has a three-year term from its effective date of May 1, 2008 and will automatically renew for an additional three-year period if

CryoLife makes minimum purchases as designated under the Agreement; however,

there is no contractual obligation for CryoLife to make minimum purchases. Per the terms of the Agreement, CryoLife is the exclusive distributor of Hemostase in the U.S. for cardiac and vascular surgery (excluding Department of Defense hospitals) and the exclusive distributor internationally (excluding China and Japan) for cardiac, vascular, and general surgery, other than orthopaedic and ear, nose and throat surgery.

As previously discussed in the Company’s Forms 10-Q for the quarters ended March 31, 2009 and June 30, 2009, CryoLife has filed a lawsuit against Medafor alleging that Medafor has violated the Agreement by, among other things, entering into exclusive distribution agreements with other companies with respect to distribution territories reserved for CryoLife per the terms of the Agreement.

Legally embroiled Medafor's issue with SMI (manufacturer of PerClot) was recently dismissed pending review, the court commenting "As a result, the court dismissed Medafor's trade secret claims ...."

Lifebond - Israel has developed a new surgical sealant

Lifebond out of Caesarea Industrial Park, Israel has developed a new surgical sealant which is apparently stronger than the currently used blood-derived fibrin glues. The LifeSeal SLR staple line reinforcement sealant and LifeSeal Surgery sealant for general surgery are two main products from the company that are based on its proprietary hydrogel matrix technology, in which individual protein molecules tend to cross-link and form fibrin-like networks. The company plans to ask for US and European approval to market the material next year.

LifeBond's technology functions through the rapid and biocompatible in situ cross-linking of structural proteins. As they cross-link, proteins in the physiological environment undergo a process of gelation to form an adhesive hydrogel matrix. The properties of the cross-linking reaction and the hydrogel matrix can be controlled to fit a variety of applications.

LifeSeal GI is comprised of LifeBond sealant provided in a specialized two-component applicator syringe. The mixed sealant is applied to anastomosis staple-line junctures in the GI tract to fortify the attachment and prevent leakage until full function is restored. The applicator thoroughly mixes the two components as they are applied and evenly dispenses the sealant onto the staple-line juncture. The sealant can be applied manually or as a gas-assisted spray.

Application of LifeSeal GI onto the staple line moderates tension on the staple line because it stabilizes the tissue sections in relation to each other and adds adhesive strength to the junction. Furthermore, LifeSeal GI seals off the staple holes and narrows the spaces in between each staple. Thus, leakage, bleeding, and tearing at the staple line can be reduced, especially in diseased and fragile tissue.

LifeSeal Surgical sealant is provided in a variety of specialized two-component applicators. The mixed sealant is applied to a wound site or staple-line juncture to prevent fluid or blood leakage until full physiological function is restored. The applicator thoroughly mixes the two components as they are applied and evenly dispenses the sealant onto the wound site or staple-line juncture. The sealant can be applied manually or as a gas-assisted spray. The precise application method can be altered to optimize sealant use for specific applications.

St. Jude Medical to Showcase Complete Cardiovascular Access, Intervention and Hemostasis Management Solutions at Transcatheter Cardiovascular Therapeu

ST. PAUL, Minn.--(Business Wire)-- St. Jude Medical, Inc. (NYSE:STJ) today announced it will display products and technologies from the company`s portfolio of solutions for cardiovascular healthcare professionals at the 21st annual Transcatheter Cardiovascular Therapeutics meeting in San Francisco. The featured products reflect the company`s continued commitment to developing comprehensive, high-performance solutions which advance the practice of interventional cardiology by improving efficiencies and giving physicians more control. The company`s latest products and technologies for access, intervention, hemostasis management, cardiac rhythm management, and valve replacement will be demonstrated and on display on Sept. 23 and Sept. 24 from 9 a.m. to 5 p.m. and Sept. 25 from 9 a.m. to 2 p.m. at the St. Jude Medical booth (#1704) including:

Hemostasis Management:

From active vascular closure to compression-assist devices, St. Jude Medical has the most complete portfolio of products to aid physicians in achieving hemostasis following cardiovascular interventions. St. Jude Medical presents the eighth generation of the successful Angio-Seal product family with the most advanced design yet - the Angio-Seal Evolution. With the addition of two compression-assist devices following the acquisition of Radi Medical Systems, RadiStop Compression-Assist Device and FemoStop Gold Compression-Assist Device, the company can now offer physicians a full spectrum of closure technology to aid hemostasis. * Angio-Seal Evolution Vascular Closure Device: The new Angio-Seal Evolution device incorporates its repeatedly proven active closure system using a fully bioabsorbable anchor with a new, simpler system for deployment. This next-generation product from the industry-leading Angio-Seal product line was designed to reduce the number of necessary steps for closure and to assist physicians in overcoming procedural variables. The need to manually compact the collagen was eliminated, and only one suture cut is required. The Angio-Seal Evolution has received FDA and CE Mark approval. * Other Products on Display: Angio-Seal VIP, RadiStop Compression-Assist Device and FemoStop Gold Compression-Assist Device.

Irish Medical Tech Breakthrough

An Irish medical technology firm has developed a breakthrough device that will propel the company to tap into a US$1bn market. Its first product will launch in the European market in the first half of 2010.
Dublin-based Vasorum Ltd, which specialises in the interventional cardiology and radiology markets, will present the initial results of its First-in-Man clinical study for its flagship device AstraPlug at the world-renowned TCT (Transcatheter Cardiovascular Therapeutics) in San Francisco today.
The AstraPlug system delivers a miniature medical grade biocompatible stainless steel implant which allows immediate control of blood flow on removing a catheter from the groin following minimally invasive procedures such as angiogram, angioplasty or stent placement.
European market launch for AstraPlug is anticipated in the first half of 2010.
About 10 million patients undergo cardiac and peripheral catheterisation procedures annually. This involves the temporary insertion of the catheter into an artery through a vascular puncture.
While a variety of legacy methods cause significant discomfort and require several hours of bed rest, AstraPlug was able to achieve an excellent average time to haemostasis (30 seconds) in a painless manner in the trial group.
“Results from this First-in-Man study are very encouraging,” explained Dr Niall Mulvihill, Department of Cardiology, St James's Hospital, Dublin.
“AstraPlug achieved excellent results even in patients on anticoagulation and suffering from peripheral vascular disease. The rapid haemostasis, minimal training requirement, lack of necessity to exchange the procedure sheath and excellent patient comfort are clear advantages of using the AstraPlug device,” said Mulvihill.
CEO Dr James Coleman, R&D director Christopher Cummins and Dr Robert Perryman, CEO of AltaScience Limited, founded Vasorum Ltd in October 2005.
The trial included the AstraPlugTM device in both 5F and 6F sizes and comprised both diagnostic and interventional cases. The study has been carried out at St. James's Hospital Dublin, by Mulvihill, Dr Peter Crean, chief Dr med Eberhard Grube and colleagues at the Helios Heart Centre in Siegburg, Germany.
“Vasorum has endeavoured to develop the ideal percutaneous arterial puncture closure device,” explained Coleman.
“We believe that this innovative technology will impact very positively on the clinical management of patients undergoing percutaneous interventional vascular procedures.”
“With the market estimated to hit US$1 billion by 2010, the health-care industry in both the US and Europe is crying out for a device such as AstraPlug which will address both hospital’s need for cost effectiveness and patient needs for a speedy recovery,” Dr Coleman added.