Saturday, October 4, 2008

Siemens Healthcare has signed a contract with the US Defense Advance Research Projects Agency

Siemens Healthcare has signed a contract with the US Defense Advance Research Projects Agency to develop a life-saving ultrasound device called the deep bleeder acoustic coagulation cuff (DBAC) that limits blood loss from the limbs of injured soldiers.
Partners at the University of Washington's Center for Industrial and Medical Ultrasound , the Texas A&M University's Institute for Preclinical Studies and Siemens Corporate Research will work together with Siemens Healthcare to achieve DARPA's goal of producing a prototype of the device in 18 months.
The DBAC is designed to limit blood loss from penetrating wounds to limbs, significantly reducing the risk of limb loss and death resulting from irreversible haemorrhagic shock.
Once applied to the limb, the cuff will be able to automatically detect the location and severity of the bleeding within it using ultrasound technology.
This will then trigger the cuff to emit and focus high-power energy towards the bleeding sites, speeding coagulation and halting bleeding.
The device is intended to be used by minimally-trained operators, curtailing bleeding in a minimal amount of time with automatic treatment and power shut-off.
The researchers will work in collaboration with the Combat Casualty Care Group at the US Army Medical Research and Material Command, surgeons from the Madigan Army Medical Center, and the US Army Institute for Surgical Research to develop the system.

Covidien Introduces the SprayShield TM Adhesion Barrier System to the European Marketplace

Covidien (NYSE: COV, BSX: COV), a leading global provider of healthcare products, today announced that its Surgical Devices business unit has introduced the SprayShield TM Adhesion Barrier System throughout Europe. The SprayShield Adhesion Barrier System offers surgeons a unique synthetic, sprayable hydrogel that provides a strong barrier between tissue and organ planes that helps reduce the development of post–surgical adhesions. The SprayShield Adhesion Barrier System, which has received CE–Mark, is indicated for use in both open and laparoscopic abdominopelvic surgical procedures as an adjunct to good surgical technique.
"The SprayShield Adhesion Barrier System represents yet another innovative solution delivered by our BioSurgery team," said Scott Flora, President, Surgical Devices, Covidien. "Like our other recent product introductions, including PleuraSeal TM lung sealant and VascuSeal TM vascular sealant, the SprayShield Adhesion Barrier System gives surgeons a new solution to help address an unmet clinical need," he added.
Adhesions frequently occur after surgery due to tissue trauma that forms connective tissue bridges, or internal bands in the body, that can connect internal structures and organs that normally are separated. Adhesions have been associated with post–operative complications such as pelvic pain, infertility and small bowel obstruction that may require additional surgery to resolve. A long–term comprehensive study of women who had prior pelvic surgery showed that approximately 35% were readmitted an average of 1.9 times over a 10–year period due to adhesion–related complications. Even during routine surgical procedures, the need to remove adhesions extends operating room time and can lead to increased blood loss and other complications.
The SprayShield Barrier technology is a synthetic, absorbable hydrogel delivered by an air–assisted sprayer. The device can be stored at room temperature and prepared in less than two minutes. The SprayShield Adhesion Barrier polymerizes within seconds when sprayed, enabling site–specific application, and is blue in color, allowing the surgeon to see the coverage and thickness of the material upon application. Post–operatively, the SprayShield Barrier continues to separate tissue and organ planes as healing progresses under the gel. After several days, the hydrogel breaks down into water–soluble molecules that are absorbed and cleared through the kidneys.
In addition to Europe, the SprayShield Adhesion Barrier System is available in certain Middle East markets and South Africa. It is not available in the United States at this time.

European co expresses interest in biotech co Omrix

Among the possible candidates to acquire Omrix is German giant Bayer.
Sources inform that a European company is interested in acquiring Israeli biosurgical and immunotherapy products maker Omrix Biopharmaceuticals Ltd. , and that it is offering a substantial premium on the company's $320 million market cap. The company is reportedly conducting due diligence.
Among the possible candidates to acquire Omrix is German pharmaceuticals giant Bayer AG (XETRA; BAY; LSE: BYR). Bayer markets products of Omrix competitor ZymoGenetics Inc. (Nasdaq: ZGEN) and is a partner of Omri, a company owned by Omrix CEO Robert Taub, who owns 15.7% of Omrix.

Tuesday, September 30, 2008

ProFibrix names new COO

ProFibrix, a Dutch biotech company focused on products to stop bleeding and initiate tissue repair, has appointed Jan Ohrstrom as its COO.
Dr Ohrstrom was previously part of the senior management team that took ZymoGenetics public, and played a key role in bringing recombinant human thrombin to the US market. Dr Ohrstrom will be based in Seattle, Washington, where ProFibrix has established a wholly owned subsidiary.
According to ProFibrix, its subsidiary ProFibrix Inc will facilitate the preparations of a global pivotal Phase II/III trial for the lead product Fibrocaps, to be conducted in 2009/2010. Additionally, it is expected to expand the company's reach to additional drug development expertise and at the same time provide easy access to US investors for the follow-up financing of ProFibrix.
Jaap Koopman, founder and CEO of ProFibrix, said: "We are delighted with the decision of Dr Ohrstrom to join ProFibrix. His extensive expertise in the management of drug development and business operations will be a tremendous asset to ProFibrix as we continue to move our products through clinical development towards commercialization and prepare for the next financing round early next year."

Wednesday, September 24, 2008

Beaumont Doctor Invents Device to Improve Blood Clot Treatment Outcomes

ROYAL OAK, Mich., Sept 23, 2008 /PRNewswire via COMTEX/ -- The Beaumont Commercialization Center, a medical device development company within Beaumont Hospitals, has a new surgical instrument available for licensing.
Paul J. Arpasi, M.D., a Beaumont radiologist, developed a device that will help reduce the risk for excessive bleeding and infection by allowing multiple catheters or other devices to be connected to a patient from a single puncture site.
When treating a patient, there is often a need to use more than one type of drug or medical device. This creates a need for more than one access site. Any time an access site is used, there is increased risk for excessive bleeding and infection, so it is ideal to keep the number of access sites to a minimum.
This new device has multiple access ports that allow thrombolytic catheters or other devices, such as wires, snares, and low-profile angioplasty balloons to be simultaneously connected to a patient through a single puncture site.
"The need to insert multiple devices or deliver more than one type of drug to a patient is very common and this invention helps to make that faster, easier, and less invasive," said Dr. Arpasi. "I'm grateful for the opportunity to improve this procedure and to help in reducing patient's risk of complications."
For licensing information, contact Mike Tanner, Director of Technology Development, at (248) 551-0567 or email him at michael.tanner@beaumonthospitals.com. For additional information on this and other licensing opportunities from the Beaumont Commercialization Center, please visit www.BeaumontCommercializationCenter.com

Tuesday, September 23, 2008

Hemostase MPH in Canada

Monday, CryoLife, Inc. a medical appliances and equipment provider, announced that it has begun distribution of Hemostase MPH in Canada, through Sorin Group Canada, Inc. Unique hemostatic powder is used to control bleeding in general, cardiac and vascular surgery, and is available in ready-to-use applicator.The Kennesaw, Georgia-based CryoLife stated that it began distributing Hemostase MPH in the U. S., the U.K., and Germany in the second quarter of 2008. Distribution will continue to expand to additional markets later in 2008 and in 2009, the company added.

Delivery of certain drugs in a fibrin sealant

ZURICH, Switzerland & WOBURN, Mass., Sep 23, 2008 (BUSINESS WIRE) -- Kuros Biosurgery AG and Aeris Therapeutics, Inc., both privately held biotech companies, announced today that Kuros has granted Aeris an exclusive license in the field of lung volume reduction to certain patent rights Kuros exclusively licensed from the American Red Cross that cover the delivery of certain drugs in a fibrin sealant. In return for the license, Kuros will receive upfronts, milestones and royalties on the sale of Aeris' lead product, the AeriSeal(TM) Biologic Lung Volume Reduction (BLVR) System, a novel investigational emphysema treatment. Aeris is currently preparing for the initiation of Phase 3 clinical trials for the AeriSeal BLVR system.
Commenting on the license, Dr. David Dove, CEO of Aeris, said: "The licensing of this IP from Kuros is an important step in the continued development of our unique Biologic Lung Volume Reduction System. We believe that BLVR has the potential to offer patients suffering from emphysema a treatment option that can alleviate their symptoms of shortness of breath and improve quality of life."
The AeriSeal Biologic Lung Volume Reduction System is a non-surgical treatment in which a bronchoscope is used to deliver a proprietary mixture of drugs and biologics that form a bio-absorbable gel to diseased areas of the lungs. The gel is composed of a mixture of a fibrin sealant as a drug delivery system, an antibiotic to prevent infection and drugs designed to cause a reaction in targeted areas of the lungs. A unique element of the BLVR System is its use of the body's natural scar formation response to permanently collapse diseased areas of the lungs. This reduction in lung volume allows the less diseased parts of the lungs to function more effectively and thereby improves the breathing of patients with emphysema.

Omrix Biopharmaceuticals Completes Enrollment of Initial 90 Patients Needed to Conduct Interim Analysis in Fibrin Pad U.S.


Omrix Biopharmaceuticals, Inc. ("Omrix") (NASDAQ: OMRI), a fully-integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products, announced today that it has completed enrollment of the first 90 patients in its Phase II clinical trial for the Fibrin Pad in mild to moderate bleeding. The Company expects to release 90 patient interim efficacy analysis by the end of October 2008.
The Fibrin Pad is a breakthrough convergence product being developed by Omrix in collaboration with ETHICON, INC., a Johnson & Johnson company. The Phase II clinical trial is a randomized, controlled clinical study in soft tissue to evaluate the superiority of the Fibrin Pad when compared to SURGICEL. The primary endpoint will measure time to hemostasis at four minutes after randomization and if any re-bleeding occurs during a subsequent six minute observation period. The first 90 patients were randomized 2 to 1 so that 60 patients have been treated with the Fibrin Pad and 30 patients have been treated with SURGICEL.
The interim efficacy analysis is being conducted to assess the superiority of the Fibrin Pad when compared to SURGICEL. If the interim analysis demonstrates superiority, the study will continue as an open label study and will enroll an additional 40 patients. Of the 130 total patients enrolled in the study, 100 will be treated with the Fibrin Pad as required by the study protocol. All 130 patients are expected to be enrolled by the end of 2008 or early 2009.
About the Fibrin Pad
The Fibrin Pad is being developed in collaboration with ETHICON, Inc., a Johnson & Johnson company, and builds on the Company's aprotinin-free fibrin sealant technology incorporated into EVICEL* Fibrin Sealant (Human). The Fibrin Pad is designed for the management and rapid control of mild, moderate and severe bleeding. This next generation, fully absorbable biosurgical product candidate combines medical device and proprietary biological components which form an instant clot when they come in contact with blood.

TraumaCure Receives CE Mark Clearance to Sell WoundStat in Europe

TraumaCure Inc. announced today that its ground-breaking hemostatic agent, WoundStat™, has received CE Mark approval, clearing the way for sales in the European Union and all countries recognizing the CE Mark. CE Mark approval from the European Union certifies WoundStat has met health, safety and environmental requirements for consumer safety.

Thursday, September 18, 2008

Neose selling out to Novo Nordisk, BioGenerix


Neose Technologies Inc. reached agreements Thursday to sell its assets to two foreign drug company collaboration partners for about $43 million.
The struggling Horsham, Pa., biopharmaceutical company stock was trading at 23 cents a share when the deals with Novo Nordisk of Denmark and BioGenerix of Germany were signed.
The asset sales are the initial step in a contemplated liquidation of Neose.
Neose (NASDAQ:NTEC), which specializies in using its enzyme pegylation technology to remodel molecules and develop next-generation therapeutic proteins, has been working with BioGenerix on a treatment for chemotherapy-induced neutropenia (which causes a drop in infection-fighting white blood cells), and with Novo Nordisk on an improved hemostasis compound to inhibit bleeding.
Under the terms of the deal, Neose is retaining certain intellectual property rights, including those related to producing glycolipids, for “future disposition.”