U.S. Army Selects HemCon Medical Technologies as Sole Source Partner to Develop Lyophilized Human Plasma

The U.S. Army has selected HemCon Medical Technologies Inc. as the sole source to develop, test and secure FDA approval for a lyophilized (freeze-dried) human plasma (LHP) product and delivery system. The $15.4 million multi-year cooperative agreement will support the research and development of the new process. The project is expected to be complete in 2010.
The use of plasma as a resuscitation fluid, according to early U.S. Army studies, has shown to significantly reduce battlefield mortality. In many situations, use of fresh frozen human plasma is limited by storage requirements and the short shelf-life for thawed plasma. As a life-saving measure for coagulopathy, the US Army Medical Research and Materiel Command has identified the LHP initiative as a high priority. The new LHP product and delivery system will offer individual units of single source donor plasma that are safe and easy to carry, reconstitute and administer.
HemCon previously partnered with the U.S. Army to develop the HemCon® Bandage. Since 2003, HemCon has produced and distributed the HemCon Bandage and ChitoFlex® dressings for the U.S. Army and other military and civilian medical professionals. The chitosan-based hemostatic dressings, manufactured using a proprietary process, are currently included in every U.S. soldier’s battlefield first-aid kit. The success of the HemCon Bandage led to improved civilian patient care when the bandage moved to acute care facilities in 2007.
Leveraging a core competency in lyophilization, HemCon plans to do the same with its LHP initiative – improve battlefield and civilian care. Success of the LHP process on the battlefield could mean improved care for civilians. Responsible for more than 160,000 deaths annually, the National Trauma Institute reports that trauma is the leading cause of death in the U.S. for individuals ages one to 44. An LHP product and delivery system that is readily available at the point of care could significantly decrease mortality for these patients. Another advantage of LHP is the ability to reconstitute in less than 2 minutes; where waiting 20 minutes for fresh frozen plasma to thaw – may be the difference between life and death.
“This is a crucial initiative, and HemCon is honored to be the choice of the U.S. Army,” said John W. Morgan, president and CEO of HemCon. “Developing a lyophilized human plasma product and delivery system will be a significant evolution for battlefield and civilian trauma care. It’s also an important evolution for HemCon as we expand our presence in global health care markets. As the use of LHP carries into the civilian medical space, I believe we will see increased survival rates in patients treated at smaller hospitals and numerous trauma centers where currently, fresh frozen plasma is not readily available.”
Source BusinessWire

Haemacure Announces Webcast of Presentation at the Biotech/Pharma/Healthcare Investor Forum

Haemacure Corporation (TSX:HAE), a Montreal based specialty bio-therapeutics company developing high-value human proteins for commercialization, announced today that its Chairman of the Board and Chief Executive Officer, Joseph Galli, will present at the upcoming Biotech/Pharma/Healthcare Investor Forum on Thursday, May 15th, 2008 at 12:30 Eastern Daylight Time.The Investor Forum will webcast the audio portion of the presentation and post the associated slides via its website at www.investorcalendar.com/ClientPage.asp?ID=129757, hosted by PrecisionIR. To access the live broadcast via internet in listen-only mode, or the subsequently archived recording, simply cut and paste the abovementioned link or http://www.investorcalendar.com/ directly into your web browser.
Source marketwire.

Johnson & Johnson Video Library

Access J&J video for Evicel and Surgiflo HERE

FDA Approves New Formulation of Coagulation Therapy

WASHINGTON (Reuters) - Denmark's Novo Nordisk won U.S. approval to sell a new formulation of a genetically engineered protein therapy that helps the blood clot, regulators said on Friday.
The product, NovoSeven RT, can be stored at room temperature for up to two years, the Food and Drug Administration said. An older formulation had to be refrigerated.
NovoSeven RT is a genetically engineered version of Factor VIIa, a protein found in plasma that is essential for the clotting of blood.
Approved uses of NovoSeven RT include treatment of bleeding, and prevention of surgical bleeding, in certain patients with hemophilia.

Read FDA News HERE

Omrix Biopharmaceuticals Announces First Quarter 2008 Financial Results

Omrix Biopharmaceuticals, Inc. (“Omrix” or the “Company”) (NASDAQ: OMRI), a fully-integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products, today announced financial results for the first quarter ended March 31, 2008: Read more HERE

In 2003 and 2004, Omrix entered into development, distribution and supply agreements with Ethicon Inc., a Johnson and Johnson company. The partnership agreement between OMRIX and Ethicon allows each company to do what it does best: OMRIX will manufacture products and hold regulatory licenses; Ethicon will retain exclusive sales and marketing rights in the U.S. and EU to OMRIX biosurgical products in the field of hemostasis and sealing only.

Cohera Medical, Inc. Announces Closing of Insider Round of Financing for Over $7.6 Million

PITTSBURGH, May 7 /PRNewswire/ -- Cohera Medical, Inc., a rapidly growing medical device company developing a suite of wound management systems and surgical adhesives, announced today that it has closed an insider round of financing for over $7.6 Million. The proceeds of this transaction will support the growth of the company through pilot clinical trials for its lead product, TissuGlu(R), a strong, resorbable surgical adhesive, as well as pre-clinical development of Cohera's product pipeline.
"Cohera has generated significant value since our last financing and this is reflected in the strong support from our shareholders," said Patrick Daly, President and CEO of Cohera Medical. "The team at Cohera is focused on developing world class products that improve patient care and we are excited about the future of the Company."
"As Cohera's largest investor through our affiliate Kern Medical, LLC, we are delighted to once again lead its investment round," said Jay Kern, Founder and General Partner of Kern Whelan Capital, LLC, and Manager of Kern Medical II. "Strong participation by existing investors in this financing reflects the significant accomplishments that Patrick and his team have made in developing Cohera's revolutionary line of adhesive products."

TissuGlu - Unlike “Superglue” products, TissuGlu® is biocompatible and biodegradable, making it safe for internal use. Unlike “fibrin glue” products, it is strong, easy to use, and contains no human or animal product derivatives. Studies in the laboratory have demonstrated that the bond created with TissuGlu® is as strong after one hour as a normal wound is after a week of healing. It works well on planar surfaces, binding tissue layers to eliminate the potential space between recently separated tissues in which fluid accumulates (potentially reducing the need for fluid drains).

ThermoGenesis, GE Deal

RANCHO CORDOVA, Calif., May 7 --ThermoGenesis Corp. , a leading supplier of innovative products and services that process and store adult stem cells, said today that in partnership with GE Healthcare it has restructured its existing International Distribution Agreement to maximize the AXP product value utilizing each parties' respective strengths and focusing on long-term strategic goals.........more HERE

Global Blood Resources LLC

.....The UConn Health Center in Farmington began using the Hemobag more than a year ago.One of the first institutions to use the device was Salem Hospital in Salem, Ore."We've used over 800 Hemobags," said Scott Beckmann, one of the hospital's perfusionists. "We're using less blood bank products. That's been a cost savings for the hospital."Before Salem Hospital began using the device, "We used cell washers that would wash away significant and beneficial blood elements and would only give back red blood cells — red blood cells are important, but that's not all there is to it," Beckmann said. "Ethically, we would look at this waste bag full of viable elements — proteins, platelets that help plug that hole in the artery — and it was being thrown out."When the Hemobag was finally made available, we sat down with the surgeons and said, 'This looks like a helpful device.' We said 'Let's try it for two weeks,' and before the two weeks were up, we decided to use it during every surgery."...................read more HERE

Orthovita and ThermoGenesis financial reports

Orthovita Reports 2008 First Quarter Financial Results - HERE
ThermoGenesis Corp. Announces Third Quarter Fiscal 2008 Results - HERE

FDA asks ZymoGenetics to revise new product's press release

FDA Letter HERE
The U.S. Food and Drug Administration says ZymoGenetics omitted important facts when announcing the launch of its first commercial product, Recothrom, and it asked the company to revise the press release.
The Seattle company's product is a genetically engineered form of thrombin, a protein that helps control surgical bleeding. In a Jan. 17 press release, ZymoGenetics said its product was shown to be as effective as a competitor derived from bovine blood, and had a "lower incidence of antibody formation."
In a letter posted on the FDA's website Wednesday, the agency called that statement "false or misleading," because it suggested that bovine thrombin's antibodies are less safe than Recothrom. In clinical trials, the agency noted, the antibodies did not lead to adverse events in patients treated with the bovine product. Both products had similar instances of adverse events, the FDA said.
In response to the FDA letter, ZymoGenetics added a three-sentence footnote with the missing information. The information is already present in the company's promotional materials, said spokeswoman Susan Specht. "This will not change the sales materials," she said.
The FDA action underscores the fierce competitiveness of the medical market — and how closely federal regulators watch over it. ZymoGenetics has asserted that genetically engineered products, also called recombinant, are less risky than those derived from bovine or human blood, which could contain impurities.
The company said Tuesday that its Recothrom sales had reached $1 million in the first quarter of its launch.
"We believe the launch is going well, and we're seeing strong interest in the marketplace, reflecting an appreciation for the advantages of a recombinant topical hemostat," said Chief Executive Bruce Carter.
Kevin DeGeeter, an analyst with Oppenheimer & Co, said in a note that Recothrom adoption is "taking longer than previously thought," and called the launch "soft."
Many hospitals targeted by ZymoGenetics are stocking both Recothrom and its bovine competitor made by King Pharmaceuticals.
McAdams Wright Ragen analyst Paul Latta cut his 2008 sales outlook to $18 million from $30 million, but said the product's long term potential remained unchanged.
"We're still seeing a $300 million to $400 million product in three to five years," Latta said. "But clearly it will take a while to get there."
Source:Seattletimes.com