Cryolife may have problems beyond continued supply of Hemostase

A new non-clinical video comparing Hemostase (AKA Arista) with PerClot indicates Cryolife may have problems beyond continued supply of Hemostase. The video indicates a much stronger absorptive capacity for PerClot manufactured by SMI. The non-clinical video available HERE on Youtube appears to be an internal SMI validation of their product. Meanwhile the Medafor rejected proposal and (what appears to be imminent divorce) of the Medafor-Cryolife marriage is being thrashed out publicly in a curiously tabloid fashion.

Recently Medafor CEO Gary Shope stated "we no longer believe that CryoLife can be viewed as a trustworthy partner" and on March 18, 2010 after notifying CryoLife that it was treating the EDA as terminated, Medafor notified CryoLife that it would not fulfill their order.

Gary Shope, CEO of Medafor, has also stated, "Over the past six months, CryoLife has repeatedly breached our contract in China, Europe, Brazil and the U.S. CryoLife has also continued to insist that it is entitled to distribute HemoStase in China and Japan, despite the clear terms of the EDA to the contrary . As such, we were highly concerned about whether CryoLife was going to honor our agreement in the future, and had no choice but to insist it provide us assurance, as required by law. CryoLife ignored our request, effectively repudiating the contract and allowing us to cease all performance under the agreement.” Under the agreement, CryoLife had the exclusive right to sell the MPH product into cardiac and vascular surgeries in the United States (excluding Department of Defense facilities) and into cardiac, vascular and general surgeries in the rest of the World (except China and Japan ) excluding ENT, orthopedic, neurosurgery and topical applications.

Both Cryolife and Medafor have made no secret of their mutual dissatisfaction with each other, Cryolife has created a site dedicated to public laundering of their difficulties HERE and includes the following:

Frequently Asked Questions

Why did CryoLife acquire a stake in Medafor? How much of Medafor does CryoLife now own? What were the terms of the proposal CryoLife made most recently to Medafor? What was the breakdown between cash and stock? What has been the reaction of Medafor’s board to the recent CryoLife proposal? Why has CryoLife chosen to make its communications with Medafor’s board public? Is the proposal that CryoLife made to the Medafor board and that it has now withdrawn available to Medafor shareholders? What can Medafor shareholders who wish to sell their shares to CryoLife do? Why did CryoLife purchase additional shares from some investors but not make its proposal available to all? How has Medafor failed to help HemoStase reach its full potential? What will CryoLife do differently? How did CryoLife arrive at its most recent proposed acquisition price? Does CryoLife’s Medafor stake give CryoLife any additional powers outside those of a normal shareholder? Why did CryoLife withdraw its offer? What are CryoLife’s next steps? When does CryoLife plan to communicate with Medafor shareholders? Why did CryoLife file a lawsuit against Medafor? Why is Medafor claiming that CryoLife repudiated its distribution agreement and what is CryoLife’s response? Why would Medafor continually attempt to put revenues at risk and expose itself to additional litigation with this fourth attempt to terminate the agreement? Why would Medafor decline to ship product for additional revenue? Who can shareholders contact if they have questions? While Medafor respond on their website HERE

Sorin Group Sells Angel(TM) Whole Blood Separation System and activAT(R) Autologous Thrombin Processing Kit to Cytomedix

MILAN, Italy, Apr 12, 2010 (BUSINESS WIRE) -- Sorin Group, (MIL:SRN), a global company and a leader in the treatment of cardiovascular diseases, announced today that it has completed the sale, for $7 million (EUR5.25 million) in cash paid in installments over two and a half years, of the Angel(R) Whole Blood Separation System ("Angel(TM)") and activAT(R) Autologous Thrombin Processing Kit ("activAT(R)") product lines to Cytomedix, Inc. (GTF 0.90, -0.05, -5.26%), a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis. Together these products had sales of approximately $5 million (EUR3.75 million) in 2009.

Angel(TM) consists of a blood processing device and disposable products used for separation of whole blood into red cells, platelet poor plasma and platelet rich plasma ("PRP"); activAT(R) is designed to produce autologous thrombin serum from platelet poor plasma, providing a completely autologous, safe alternative to bovine-derived products.

"We are pleased to enter into an agreement to sell these non-core assets to Cytomedix, and we count on Cytomedix to maintain the same high level of customer service, support and product excellence that our customers have come to expect from Sorin", said Michel Darnaud, President, Cardiopulmonary Business Unit.

Baxter International Inc. Q1 2010

Sales in the regenerative medicine business which includes our bio surgery products totaled $119 million and increased 20%. Sales excluding foreign currency grew 14% and continue to reflect robust growth of Floseal, Coseal and Tisseel....... we expect the regenerative medicine to have sales growth exceeding 25% reflecting the ApaTech acquisition and continued double digit growth in the base business.........

Besides the existing growth vehicles of hemophilia and bio surgery and the various product categories of medication delivery like [hemostasia] and nutritionals, if you just look at kind of near-term new product launches in the various businesses, not to get off of IVIG. Let’s start with that. We have a 30 gram IVIG product we hope to get approved this year and hopefully launch in the U.S. by the end of this year. We have a 10% sub-q product without Enhance, without the Hylenex technology that we will be submitting shortly and hope to have on the market in 2011. Then of course HYQ which incorporates the Hylenex technology we are very excited about. Then new indications like MMN and the whole Alzheimer’s thing which we don’t need to get into.

So even within the antibody therapy area we have a very nice lineup of near-term and longer term things that can really I think change the game. The rest of bio science of course we just got approval for TachoSil in our bio surgery business which we will be launching. We continue to make good progress with our seasonal influenza vaccine targeting EU approval this year and hopefully approval and launch in the U.S. before too long.

I guess where we are completing a trial right now for a broader hemostasis claim which could be very helpful for the growth of that product. I mentioned in renal but Enterprise which is the next generation PD cycler we will be launching hopefully by sometime in early 2011. Our hemo next generation infusion pump platform. Then in the short-term a number of market expansion opportunities with existing products. ADVATE launches in big markets this year like Brazil and then next year Russia. Following year China. Supreme launch in Japan. I will stop there. I am getting pretty granular. We have a fairly nice array and continuous array in all of our businesses of new product launches both near-term and obviously some bigger things longer term. In addition to the existing growth platforms whether it is hemophilia or recombinant and bio surgery and so on. I covered a lot.

St. Jude Medical Inc. Q1 2010

..........Total sales of cardiovascular products for the first quarter of 2010 were $256 million, up 7% over the first quarter of 2009, including $10 million of favorable foreign currency translation. On a constant currency basis, first quarter cardiovascular products sales increased 3% versus last year. Within this category of products, sales of vascular closure products in the first quarter of 2010 were $98 million consistent with the first quarter of 2009.........