FDA - Dangers of Intravascular Thrombin

Specialty Medical Products Company Enters $10 Billion Orthopedic Biomaterials Market with Patented Technologies

FORT WORTH, Texas, Oct. 1 /PRNewswire-FirstCall/ -- Wound Management Technologies, Inc., (OTC Bulletin Board: WNDM) a rapidly growing provider of specialty medical products, announced today it has closed on its acquisition of Resorbable Orthopedics LLC, a private company with patented technologies including a resorbable bone wax and a delivery system for orthopedic bone void fillers, among others.Under the terms of the agreement, Resorbable Orthopedics has become a wholly owned subsidiary of Wound Management Technologies in a stock transaction.
Scott Haire, CEO of Wound Management Technologies, said, "This highly significant acquisition adds complementary orthopedic biomaterials products to our existing CellerateRx wound care products. Wound Management Technologies, through two subsidiaries, is participating in one of the fastest growing medical markets worldwide. The total global biomaterial market is currently $28 billion and is expected to exceed $58 billion in the next five years. The orthopedic biomaterials market is approximately $10 billion alone, driven by improved patient benefits, a shorter FDA approval cycle and an aging population ever more aware of biomaterial benefits."
"Wound Management Technologies is executing our strategy for rapid growth. The building blocks are coming together and the acquisition of Resorbable Orthopedics is another accomplishment for Wound Management Technologies. We are executing on our strategy to broaden our platform technologies that target a growing patient population. Diabetes and orthopedic disorders are expanding internationally and we are responding by establishing global distribution channels," said Haire.
Barry Constantine, founder of Resorbable Orthopedics LLC, said, "The patents offer innovative, safe and effective resorbable orthopedic products. The bone wax and delivery system address issues such as 'bone wax granuloma' and the delivery of materials that manage bone wound healing in a cost effective manner. At a time when there is a great need for safer and more affordable health care products, these are well timed solutions."

$16.8 million grant awarded to develop platelet recovery treatments

SEATTLE – The National Heart, Lung and Blood Institute of the National Institutes of Health has awarded a $16.8 million, seven-year grant to launch a bicoastal research partnership between

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium and Children's Hospital of Philadelphia.
The collaboration, led by scientists at the Hutchinson Center, will develop molecular- and cell-based therapies for a range of blood diseases, with an initial focus on a life-threatening complication of stem-cell transplantation called thrombocytopenia. The condition, which is sometimes associated with abnormal bleeding, is caused by a delayed recovery of blood-clotting cells called platelets.
The problem is that some stem cell transplant patients, particularly those receiving stem cells from cord blood, often do not produce enough platelets in a timely fashion which puts them at risk for life-threatening bleeding. Platelet production can be delayed by several months in persons who receive a stem cell transplant to treat certain cancers. Transfusions can help, but the number of platelet donors is limited, transfusions carry a risk of blood-borne diseases, and patients who receive multiple transfusions can develop antibodies that destroy the platelets.
According to principal investigator Beverly Torok-Storb, Ph.D., a member of the Hutchinson Center's Clinical Research Division, the goal is to control the process of blood cell production so that all types of blood cells - red cells to carry oxygen, white cells to fight infection and platelets to prevent bleeding - recover together within a few days.
The partner institutions will focus on two complementary strategies to address delayed platelet production. Scientists at the Hutchinson Center and the UW will develop reagents that can be administered to patients to stimulate the differentiation and proliferation of precursor cells into platelets. The Philadelphia group will work to generate "ex vivo," or outside the body, platelets and their precursors from embryonic stem cells for use as cell therapy. The principal investigator in Philadelphia is Mortimer Poncz, M.D., chief of the Division of Hematology at Children's Hospital of Philadelphia.
The Hutchinson Center/UW group will receive a total of $8.2 million during the seven-year grant; the Philadelphia research group will receive $8.6 million.
"This coast-to-coast collaborative effort will take advantage of complementary skills and interests in these two institutions to develop new therapies for all patients needing platelet transfusions," Poncz said.
At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of world-renowned scientists and humanitarians work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Our researchers, including three Nobel laureates, bring a relentless pursuit and passion for health, knowledge and hope to their work and to the world. For more information, please visit HERE.

Old red blood cells may double mortality in trauma patients

Severe trauma patients requiring a major transfusion are twice as likely to die if they receive red blood cells stored for a month or longer, according to research published in BioMed Central's open access journal Critical Care. The increased rate of death was measured up to six months post transfusion which is consistent with previous reports in cardiac surgery patients.
Philip Spinella and Christopher Carroll, both paediatric intensivists from Connecticut Children's Medical Centre, Hartford, Connecticut, USA and their team studied 202 severe trauma patients treated at Hartford Hospital following a critical injury with five or more units of red blood cells. They found that even one unit of red blood cells stored more than 28 days doubled the incidence of deep vein thrombosis and increased death secondary to multiple organ failure. Though medical experts had long suspected that older red blood cells caused complications, this is one of the first studies to strongly support this dramatic link. This study differs from previous studies since the amount of RBC units transfused to the fresh and old RBC study groups were equal. As a result, this eliminated the major criticism of previous studies that it is the amount of RBCs transfused not the storage age that was affecting outcomes.
Over 29 million units of blood were transfused in the United States in 2004, and this is a routine and reliable part of trauma care treatment around the world. However, red blood cell transfusion continues to be associated with adverse complications. This study provides evidence that allows doctors to reduce these risks by giving fresher red blood cells to severe trauma patients who need these major transfusions for life-saving procedures.
According to Spinella, 'The preferential use of younger RBCs to critically ill patients has the potential to increase waste due to outdating. Since blood is often a scarce resource this is important and methods need to be developed to minimise waste while providing the most efficacious and safe blood product for a given patient.
The authors speculate, 'These important findings should encourage research into the effects of old blood and coagulation in critically ill patients. With the widespread of use of red blood cell transfusion for critically injured patients, this study has the potential to cut deaths in hospitals around the world.'

Vascular Solutions - UBS Global Life Sciences Conference

Cryolife - UBS Global Life Sciences Conference

Orthovita - UBS Global Life Sciences Conference

Z-Medica QuikClot Interventional Hemostatic Bandages Now Available for Use During Catheterization Procedures

SAN FRANCISCO--(BUSINESS WIRE)--Z-Medica Corporation, a medical device company developing innovative hemostatic agents, today announced the availability of the QuikClot® Interventional™ hemostatic bandage, on display at booth #1338 at the 21st annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation. One of the primary applications for the new QuikClot® Interventional™ hemostatic bandage is to control arterial and venous bleeding following cardiac catheterization or other vascular access procedures that traditionally have required considerable manual compression time or clamping which can be painful for the patient.
QuikClot® Interventional™ is a non-invasive, easy to use hemostatic bandage indicated for use in the local management and control of external bleeding from vascular access sites and percutaneous catheters or tubes utilizing sheaths of up to 12 Fr. It is safe to use and proven effective for use on femoral and other arterial and venous bleeds. It contains an inert and inorganic mineral that has no known contraindications and accelerates the body’s natural hemostatic process. For ease of use, the product does not require any advance preparation and is double-packaged in a blister package and a foil pouch for aseptic technique. It includes a 3M® Tegaderm® adhesive bandage for easy application.
QuikClot® Interventional™ is applied in three simple steps and requires no special training. The health care professional removes the hemostatic pad from the packaging and places it into the sterile field using sterile technique. The hemostatic pad is then placed on the puncture site and manual pressure is applied for at least five minutes or until bleeding stops. Finally, without moving or lifting the pad, the 3M® Tegaderm® adhesive bandage is applied over the pad and secured to the skin, while manual compression is maintained. The QuikClot® hemostatic pad may be left in place for up to 24 hours and can be removed by gently peeling away the Tegaderm® bandage and removing the pad. QuikClot® Interventional™ is currently being used in several interventional cardiology and radiology laboratories across the U.S. Recently, Z-Medica Corporation has gathered over 300 documented reports of human use of this product with an overall success rate of 98.2%, meaning that this novel device was able to achieve hemostasis in virtually all cases following arterial and venous catheterization.

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.