Department of Defense Awards CryoLife $1.7 million to Develop BioFoam Hemostatic Technology

CryoLife, Inc., (NYSE: CRY) an implantable biological medical device and tissue processing company, today announced it has been awarded approximately $1.7 million under the Department of Defense (DoD) Appropriations Bill to continue further development of CryoLife's protein hydrogel technology. Preclinical studies of CryoLife's BioFoam(R) Surgical Matrix, a protein hydrogel product under development for organ sealing, are nearing completion. This grant will help fund upcoming clinical studies of BioFoam in the United States. In December 2008, CryoLife received conditional approval from the FDA to conduct the feasibility phase of the Company's BioFoam IDE submission for liver parenchyma sealing. Before beginning the feasibility study, the Company must receive final approval of the study protocol and related documents from the FDA and an additional approval of the same from the U.S. Department of Defense. The Company is in the final review process with the Department of Defense. The Company also filed a CE Mark submission with its Notified Body in December 2008 for BioFoam's use as an adjunct in the sealing of abdominal parenchymal tissues (liver and spleen) when cessation of bleeding by ligature or other conventional methods is ineffective or impractical. The Company also continues to conduct preclinical research with BioFoam for use in wound sealing in trauma surgery. "Over the past four fiscal years the DoD has allocated a total of approximately $5.4 million to CryoLife for the development of protein hydrogel products," said Steven G. Anderson, CryoLife president and chief executive officer. "We are excited about advancing this product through the clinical process.BioFoam, a protein hydrogel biomaterial under development by CryoLife, contains an expansion agent which generates a mixed-cell foam. The foam creates a mechanical barrier to decrease blood flow and minimize pores for the blood to enter, leading to cellular aggregation and enhanced hemostasis. It is easily applied and could potentially be used intraoperatively to control internal organ hemorrhage, limit blood loss, and reduce the need for future operations in liver resections. BioFoam is based on the same technology as BioGlue(R), a CryoLife product approved by the U. S. Food and Drug Administration to control bleeding as an adjunct to sutures and staples in open surgical repair of large vessels. BioGlue is also CE marked in the European Community and approved in Canada and Australia for use in soft tissue repair.

JnJ release Q1 results - edited

We completed our acquisition of Mentor Corporation at the end of January and we are moving full speed ahead on integration of Mentor and Omrix Biopharmaceuticals within our Ethicon Surgical business. We are making progress with the integration of health media and human performance institute as we advance our new wellness and prevention platform. This business is now being reported as part of the Consumer segments financial results. These and our other acquisitions like Dabao Cosmetics and SurgRX are adding important sales and growth opportunities to our business but I would remind you that this quarter and the years results will also reflect the divestiture of our professional wound care business which was sold in the fourth quarter of 2008. Ethicon worldwide sales grew operationally by 9.1% with the US up 18.8% and sales outside the US up 3.7% operationally. The acquisitions of Mentor and Omrix offset by the divestiture of the professional wound care business added approximately two points to the worldwide growth. Sales in the US on a pro-forma basis for our newly acquired aesthetics products from Mentor although lower then 2008 performed better then the estimated market. Strong double digit growth was achieved in meshes and bio-surgical.

Angiotech Pharmaceuticals, Inc. announces License Agreement with Baxter International Inc.

Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP) today announced it has completed an Amended and Restated Distribution and License Agreement with its partner Baxter International Inc. (Baxter). As consideration for the Amended and Restated Distribution and License Agreement, Angiotech will receive $25 million. Angiotech and Baxter initially entered into a Distribution and License Agreement in 2003 relating to certain intellectual property for Angiotech's COSEAL(R) surgical sealant. The Distribution and License Agreement entitled Baxter to market and sell COSEAL worldwide (excluding Japan), from which Angiotech has derived royalty revenue from Baxter. The Distribution and License Agreement also gave Baxter an option for distribution rights in Japan. As a result of this transaction, Baxter will obtain worldwide rights to COSEAL and certain additional fields of use for COSEAL, and expanded worldwide rights to COSEAL derivatives. Baxter will owe no further royalty or milestone obligations to Angiotech relating to the existing formulation of COSEAL or any future products under the terms of the Amended and Restated Distribution and License Agreement.

HemCon Patch

HemCon Medical Technologies offers a more flexible HemCon Patch designed for use for external, temporary control of bleeding during interventional and diagnostic cardiac catheterization, interventional radiology, electrophysiology and dialysis access procedures.

Offering diagnostic and interventional patients a quick, safe and comfortable post-procedural experience, the HemCon Patch delivers a flexible hemostatic solution where rapid arterial hemostasis is critically important to ensure quality care and safety. It stops bleeding and minimizes risk of artery damage. As one of the only hemostatic products to obtain an FDA antibacterial barrier claim, the HemCon Patch provides a barrier against a wide spectrum of micro-organisms, including methicillin-resistant Staphylococcus aureus (MRSA), Enterococcus faecalis (VRE) and Acinetobacter baumannii. This barrier may help to reduce the risk of hospital-acquired infections for both patients and providers. The HemCon Patch is also suited for patients that take anticoagulant medications or suffer from clotting or bleeding disorders.

US Congressional Sting Operation Exposes Gaps in Health System

Thousands of medical research groups that monitor clinical trials on behalf of the drug industry may face tougher regulations in the wake of a congressional sting operation that found gaps in the nation's oversight of experiments on humans.

The sting, detailed at a House Energy and Commerce Committee hearing Thursday, involved the creation of a fictitious company and a fake medical device, a surgical adhesive gel. The sham firm then applied to three for-profit oversight groups -- called institutional review boards, or IRBs -- for approval to begin a clinical trial using their adhesive on human subjects.

Drug and device makers along with hospitals and university research facilities must retain an independent IRB to oversee the methodology and safety issues for human studies. Corporations cannot get Food and Drug Administration approval for their products without an IRB certifying their clinical trials. About 6,350 IRBs are registered with the Department of Health and Human Services.

Lawmakers have raised concerns over whether IRBs routinely approve medical studies for paying clients. The committee leaders are considering whether to introduce a bill to strengthen IRB regulations.

Two IRBs contacted by the GAO's sting operators -- Argus IRB of Arizona and Fox IRB of Illinois -- rejected the Adhesiabloc proposal because of unanswered safety questions.

"We realized it was a terrible risk for the patient … It is the worst thing I have ever seen," an Argus IRB reviewer said, according to a slide shown at the hearing.

Coast IRB LLC of Colorado Springs, Colo., did approve a study for the fictitious adhesive gel, "Adhesiabloc." Five months after approving the study for abdominal surgery patients, Coast learned that neither Adhesiabloc nor its maker, Device Med-Systems of Virginia, existed.

Coast CEO Dan Dueber said in an interview that the congressional case was illegal entrapment. At the hearing, Mr. Dueber testified, "The GAO perpetrated an extensive fraud against my company. You pulled the wool over our eyes -- congratulations." Because the product was fake, it was never used.

As part of the sting, the committee also created a sham IRB to see whether the Department of Health and Human Services, which registers IRBs, would certify their fictitious group.

The committee, working with the Government Accountability Office, Congress's investigatory arm, named the CEO of the fake IRB Truper Dawg, after a staffer's three-legged dog, now deceased. Other fake names included "April Phuls" and "Timothy Wittless," which lawmakers said should have signaled irregularities to HHS. The department registered the IRB.

At Thursday's hearing, the toughest complaints were reserved for HHS. Rep. Joe Barton of Texas, the committee's ranking Republican, asked one HHS official: "Do you have any sense of outrage?" Referring to Coast, he continued, "What steps are being taken right now to decertify these charlatans?"

The director of HHS's office that registers review boards, Jerry Menikoff, said at the hearing that his bureau had only recently received the committee information about Coast, and would look into the matter.

Cryolife Release Hemostase Brochure

Cryolife have released brochures for their new product Hemostase MPH. Under their agreement Minneapolis based Medafor Inc. will sell their "Arista" FDA approved 2001 product under new labels with Cryolife to sell "Hemostase MPH" while Orthovita will sell "Vitasure".

Under the Cryolife agreement Medafor grants to Cryolife "exclusive right to promote, market, sell and distribute (collectively, “Distribute”) the Product throughout the Territory for all uses and applications" in all applications in cardiac surgery and vascular surgery in the United States; and in all general surgery applications outside the United States including cardiac and vascular surgeries, but excluding orthopedic and ear, nose, and throat surgeries. Neurosurgery and topical applications do not form part of the agreement.

Meanwhile Orthovita at the 29th Annual Health Care Conference, March '09,  in Boston  have predicted strong "horizontal" growth throughout hospitals. For the Vitasure IFU click HERE

Report predicts excess of 100 million procedures

The market potential for the future utilization of surgical sealants, glues, wound closure and anti-adhesion products is based on the progressive adoption of these products for multiple uses (sealing, hemostasis and even anti-adhesion) and their (more) routine use in surgical and other clinical practice, demographic forces influencing potential caseload and with the changing regulatory demands for this diverse set of products. According to the MedMarket Diligence report #S175, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2009-2013," from 2009 forward, the trends in product adoption and the demographic forces, combined with new product introductions are expected to accelerate market growth. There remains a growing potential for these products to be used in excess of 100 million procedures worldwide. Growth in utilization will exceed double-digit annual rates for new products and for established products in geographic markets that have yet to be fully tapped. 
A number of market leaders have consolidated their positions within the surgical closure and securement markets through successful internal development programs and through technology partnerships with innovative vendors of next-generation technologies. For example, Covidien and Ethicon (Johnson & Johnson) are major suppliers of cyanoacrylate products in the United States; with dominant sales resources to sell these products, these companies lead the market, although they face competition from the Canadian company Glustitch, the U.K.-based Medlogic and others. Synovis (formally Biovascular Inc.) has targeted cardiovascular and other procedures, and has a range of closure products; it has partnered with GEM to develop and exploit GEM’s internal high-strength glue product (Glubran) in the United States. 

Frost & Sullivan Commends Nycomed for Excellence in Product Differentiation Innovation

LONDON, March 23 /PRNewswire/ -- The "2008 European Tissue Sealants & Topical Hemostats Product Differentiation Innovation Award" is conferred on Nycomed in recognition of its revolutionary product - TachoSil. The innovative surgical patch, TachoSil is poised to be the future of the European tissue sealants and topical hemostats markets. At present, Nycomed, with TachoSil, is the sole company in the market with a ready-to-use dual action patch. TachoSil is unique: it does not fit into any of the standard market segments and constitutes a separate category on its own. "This pioneering product has both haemostatic and sealing properties and can be used to stop bleeding as well seal tissue," explains Frost & Sullivan Research Analyst Divya Belle. "TachoSil combines the bioactive mechanism of action of human coagulation factors fibrinogen and thrombin with a collagen patch for mechanical support."

Prospective randomized study evaluating an absorbable cyanoacrylate for use in vascular reconstructions

Lumsden AB, On Behalf of the Closure Medical Surgical Sealant Study Group 
J Vasc Surg, vol. 44, 1002 - 1009, 2006

Abstract

Background: 

An easy-to-use vascular sealant with good safety and efficacy is needed to prevent anastomotic bleeding in vascular surgery. This study evaluated the safety and efficacy of cyanoacrylate surgical sealant in establishing hemostasis of expanded polytetrafluoroethylene to arterial vascular anastomoses in arteriovenous (AV) grafts and femoral bypass grafts.

Methods: 

This multicenter, randomized, controlled, open-label study was conducted in a hospital setting at 12 sites: 10 in the United States and 2 in Europe. A total of 151 patients undergoing femoral bypass procedures or AV shunt procedures for hemodialysis access using expanded polytetrafluoroethylene grafts were randomized 2:1 to receive cyanoacrylate surgical sealant or the control (oxidized cellulose) between April 26, 2004, and January 18, 2005. Randomization was stratified by clinical site and type of procedure. After the anastomosis, cyanoacrylate surgical sealant or the control was applied to all anastomosis sites for patients undergoing femoral bypass procedures and to only the arterial anastomosis sites for patients undergoing AV shunt procedures. The primary end point was the elapsed time from clamp release to hemostasis. Secondary end points were the proportion of patients achieving hemostasis at t=0 (immediate), 1, 5, or 10 minutes after clamp release, use of additional adjunctive measures to achieve hemostasis, and occurrence of adverse events.

Results: 

Baseline demographics and clinical characteristics showed that the two treatment groups were similar at baseline. The mean time from clamp release to hemostasis was 119.3 seconds with cyanoacrylate surgical sealant vs 403.8 seconds with the control (P<.001). Immediate hemostasis was achieved in 54.5% of patients receiving cyanoacrylate surgical sealant and in 10% of those receiving the control. The proportion of patients requiring additional adjunctive measures was lower with cyanoacrylate surgical sealant, and the occurrence of adverse events was similar in both groups.

Conclusions: 

This study demonstrates that cyanoacrylate surgical sealant is effective at reducing the time to hemostasis and achieving immediate hemostasis in AV shunt and femoral bypass procedures and that it is safe for internal use. Cyanoacrylate surgical sealant is an easy-to-use vascular sealant with good safety and efficacy that significantly decreases anastomotic bleeding in vascular surgery.

Camp HemoVon to Host Kids With Blood Disorders

Morgantown, WV (BNN) – Children with blood disorders will have the opportunity to forget their health problems and have fun with kids just like them when Camp HemoVon kicks off on July 26. 
Formerly known as West Virginia Hemophilia Camp, Camp HemoVon is a weeklong camp for children ages 7 to 16 who have a bleeding disorder such as hemophilia or von Willebrand disease. The camp is sponsored by West Virginia University Health Sciences, West Virginia Bleeding Disorder Association, Camp Happy Valley and various pharmaceutical companies. 
“Camp HemoVon is a way for kids to engage in normal activities they might not otherwise be able to do,” said Anita Graham, camp coordinator. 
According to the Centers for Disease Control and Prevention, hemophilia is an inherited disorder that affects 18,000 people in the United States, most of whom are male. The condition results from deficiencies in blood clotting factors and can lead to spontaneous internal bleeding and bleeding following injuries or surgery. 
The most common bleeding disorder is von Willebrand disease, found in approximately 1 to 2 percent of the U.S. population, according to the CDC. It results from a deficiency or defect in the body’s ability to make von Willebrand factor, which is a protein that helps blood clot. While the disorder occurs equally in both genders, females are more likely to recognize the symptoms of the disease because of heavy or abnormal menstrual periods and bleeding after giving birth. 
In its 13th year, Camp HemoVon usually hosts campers from West Virginia, Maryland and Pennsylvania, as well as doctors and counselors. Campers are patients who have been treated in Morgantown, Charleston and Pittsburgh. 
This marks the first year the camp will be held at Camp Happy Valley in Scott Depot, W.Va. Previously, the camp was held at Camp Horseshoe in Tucker County, W.Va. The camp is held in conjunction with Camp WINACA (Children WIN Against CAncer), a camp for children with cancer. 
 Campers have the opportunity to participate in a variety of activities including swimming, archery, hiking, fishing, boating, ropes course, climbing wall, zip line, basketball, tetherball, field activities and campfires. 
There is no cost for campers to attend. The WVU Hemophilia Center secures funding, runs the infirmary and provides on-site 24-hour medical coverage with help from a licensed physician and registered nurses from around the state. The infirmary is under the direction of Elizabeth Kurczynski, M.D. The Hemophilia Center of Western Pennsylvania also provides care. 
Initial registration for Camp HemoVon is due by April 30. For more information on attending the camp or on providing financial support to the camp, contact Anita Graham by phone at 304-293-1205 or by e-mail at agraham@hsc.wvu.edu.