Wednesday, July 7, 2010

Department of Defense Funding Shows Continued and Bi-Partisan Support for STB® Lifesaving Technologies' Products

ROCKVILLE, Md., July 7 /PRNewswire/ -- For the third consecutive year the Department of Defense demonstrated its commitment to help save the lives of our troops by providing STB Lifesaving Technologies® with $2.85 million of funding.
The award is to further advance the development of STB®'s Fibrin Adhesive STat (FAST®) dressing, designed to be effective against the full spectrum of blood loss, including severe arterial and venous bleeding. Fifty percent or more combat-related deaths are attributable to uncontrolled hemorrhaging, and with products such as this, thousands of military and civilian lives could be saved.
"We are most appreciative of the support we have continued to receive from the Department of Defense and members of both the Senate and House. This funding is not only invaluable; it serves as a strong statement of their belief in our Fibrin Adhesive STat (FAST®) dressing and their commitment to help us bring our products to the battlefield, emergency responders and operating rooms," said STB® CEO, Richard Moscarello.
Funding for the grant was included in the FY2009 U.S. Department of Defense appropriations bill and received bipartisan support from Senators Richard Burr (R-NC), Ben Cardin (D-MD), Barbara Mikulski (D-MD), Charles Schumer (D-NY) and former Senator Elizabeth Dole (R-NC) and Representatives Bob Etheridge (D-NC), David Price (D-NC) and Chris Van Hollen (D-MD).
"We've all been encouraged by the pre-clinical studies, but it's particularly gratifying that support for our science is backed with significant monetary commitments as well," said STB®'s Moscarello.

About STB®

Founded in 2005, STB Lifesaving Technologies® (STB®) is a privately held, pre-clinical stage, biotechnology development company located in Rockville, Maryland. STB® which stands for "stop the bleeding", is focused on developing a comprehensive suite of products to stop serious and life threatening bleeding in trauma and surgical settings. With a strong proprietary position using its all-natural protein technology with five patents and one provisional patent pending, STB®'s products will be indispensable to both the military and civilian medical markets.

Ethicon, Inc. Expands Hemostasis Product Portfolio with Approval of the Company's First Synthetic Internal Use Sealant

SOMERVILLE, N.J., July 7, 2010 /PRNewswire via COMTEX/ -- Ethicon, Inc., a worldwide leader in surgical care, announced today the introduction of ETHICON(TM) OMNEX(TM) Surgical Sealant, ETHICON(TM) Biosurgery's first synthetic sealant designed to achieve adjunctive hemostasis (stoppage of bleeding) in vascular reconstructions by mechanically sealing areas of leakage. The US Food and Drug Administration (FDA) recently granted approval of the Premarket Approval Application (PMA) for ETHICON(TM) OMNEX(TM) Surgical Sealant.

ETHICON(TM) OMNEX(TM) creates a strong, flexible physical seal independent of the body's clotting mechanisms. It is proven in an ex-vivo model to be two-to-four times as strong as other surgical sealants, is ready for use in less than 30 seconds, and proven to seal to ePTFE grafts and bond securely to friable vessels.(1)

"A basic rule of patient safety and excellent outcomes is to prevent unnecessary bleeding during and immediately after surgery," said Alan B. Lumsden MD, Medical Director of the Methodist DeBakey Heart & Vascular Center and the Chairman of the Department of Cardiovascular Surgery at The Methodist Hospital in Houston.* "The availability of an effective surgical sealant such as ETHICON(TM) OMNEX(TM) provides surgeons with a valuable new tool that is clinically proven to decrease the time it takes to seal the surgical site, including ePTFE grafts, and prevent leakage from occurring."ETHICON(TM) OMNEX(TM) is clinically proven to significantly decrease time to hemostasis based on clinical trials conducted to support its safety and effectiveness. Specifically, results from a pivotal, randomized, controlled, open-label, multi-center trial of 151 patients at 13 centers in the United States and European Union demonstrated that ETHICON(TM) OMNEX(TM) provided hemostasis three times faster than oxidized regenerated cellulose at a rate of 1.99 minutes vs 6.73 minutes, with 54 percent of the ETHICON(TM) OMNEX(TM) patients receiving immediate hemostasis.(2) There were no significant differences in adverse events compared to oxidized regenerated cellulose during the study time period and 4+ year follow-up analysis.(2)

ETHICON(TM) OMNEX(TM) Surgical Sealant has proven efficacy in a broad spectrum of vascular reconstructive procedures including arteriovenous access, aortobifemoral bypass, femoral popliteal bypass, endarterectomy, abdominal aortic aneurysm and aortotomies.(1)

ETHICON(TM) OMNEX(TM) Surgical Sealant is contraindicated in patients with known hypersensitivity to cyanoacrylate or formaldehyde. The device is not for intravascular use. ETHICON(TM) OMNEX(TM) Surgical Sealant is intended for use as an adjunctive sealant and is not to be used in place of sutures, staples, or mechanical closure.