Wednesday, May 14, 2008

HemCon completes acquisition of Alltracel Pharmaceuticals

HemCon Medical Technologies Inc. said Wednesday it has completed the acquisition of Dublin, Ireland-based Alltracel Pharmaceuticals in a cash-for-stock deal.
The purchase occurred through Castlerise Investments Ltd., a newly formed wholly owned subsidiary of HemCon. Alltracel will operate as a wholly owned subsidiary of HemCon and maintain its headquarters in Dublin. Combined revenue is expected to exceed $100 million.
Alltracel licenses their proprietary technologies across a wide spectrum of industries in the wound care markets. In addition, Alltracel offers private-label oral care products licensed in Europe through the Butler and GUM brands. The acquisition expands distribution opportunities for HemCon's KytoStat Bandage and other products in Europe while also expanding Alltracel's oral care products and medical technologies in the United States.
"We look forward to combining our resources and continuing to innovate," said John W. Morgan, CEO of Portland-based HemCon, in a statement. "The acquisition further strengthens HemCon's ability to develop health care breakthroughs and life-saving technologies on a global scale."
HemCon develops and makes products that control bleeding and infection resulting from trauma or surgery.
The company's signature product is a bandage -- made from material extracted from shrimp shells called chitosan -- that bonds to severe wounds within minutes of being applied.
Source Portland Business Journal

Turkish Hemostat - Ankaferd Bloodstopper

Ankaferd Bloodstopper is a stable and sterile medical product of standard vegetable content which serves as a hemostasis regulator and displays fast haemostatic effect when applied to control minor or major hemorrhages due to exterior wounds, traumatic cuts, dental operations, spontaneous or surgical procedures.
The product appears to be registered in Turkey only currently.

U.S. Department of Defense Picks New QuikClot(R) Combat Gauze(TM) as First-Line Hemostatic Treatment for All Military Services




WALLINGFORD, Conn., May 14 /PRNewswire/ -- Z-Medica Corporation (Z-Medica), a medical products company focused on innovative blood clotting nano-technologies, announced that the United States Department of Defense has selected the company's newest hemostatic product, QuikClot(R) Combat Gauze(TM) brand, for all military services as the first-line hemostatic treatment for life-threatening hemorrhage that is not amenable to tourniquet placement. Bleeding is the number one cause of death for soldiers injured in battle and QuikClot(R) products offer the most effective solution to severe blood loss outside the operating room setting. They have been proven in battlefield use and, with more than one million units deployed, are the leading hemostatic agents in the field.
The Committee on Tactical Combat Casualty Care (CoTCCC) made the decision to recommend QuikClot(R) Combat Gauze(TM) after reviewing test reports on a number of hemostatic products. QuikClot(R) Combat Gauze(TM) was the only one of these products tested by both the Naval Medical Research Center and the U.S. Army Institute for Surgical Research. In addition to test efficacy, the committee sited a number of other factors in according QuikClot(R) Combat Gauze(TM) the number one position: -- Preference for the gauze delivery format, which is familiar to combat
medical personnel.
-- Ability of QuikClot(R) Combat Gauze(TM) to be shaped to any wound and
to reach bleeding vessels in penetrating wounds.
-- Ease of removal once hemostasis has been achieved.
"Z-Medica's approach to product innovation has always been to listen to the voice of our customer and to focus our research & development efforts on delivering life-saving products that meet their needs," said Z-Medica CEO Raymond J. Huey. "With QuikClot(R) Combat Gauze(TM) we have provided a product that is virtually 100% effective in a very intuitive format that can be applied quickly and simply by anyone."
QuikClot(R) Combat Gauze(TM) combines surgical gauze with a proprietary inorganic material that stops arterial and venous bleeding in seconds -- even more rapidly in this format than earlier Z-Medica products. Based on a different mineral than zeolite-based QuikClot(R) products, it generates no heat. It shares the benefit of being inert and non-allergenic. QuikClot(R) Combat Gauze(TM) comes in rolls four yards long by three inches wide.
In addition to the military testing, the new product was tested in pre-clinical trials at the University of California, Santa Barbara, the University of Massachusetts Medical School and at various field facilities. It has 510(k) clearance from the U.S. Food & Drug Administration. The United States Department of Defense has awarded Z-Medica a $3.2 million grant for large-scale testing of the product on penetrating wounds. These multi-center clinical trials will take place during 2008.
Earlier QuikClot(R) products are in use by all branches of the U.S. Military, by first responders and security agencies across the U.S. and in 36 countries worldwide, with more than a million units in distribution. Z-Medica recently launched its first products for consumers.

Tuesday, May 13, 2008

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.

Friday, May 9, 2008

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.

Wednesday, May 7, 2008

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