Tuesday, May 27, 2008

CryoLife to Present at FBR Capital Markets Annual Spring Investor Conference


ATLANTA, May 27 /PRNewswire-FirstCall/ -- CryoLife, Inc. NYSE: CRY, a biomaterials, medical device and tissue processing company, announced today that it is scheduled to participate in the FBR Capital Markets Annual Spring Investor Conference, Thursday, May 29, 2008 at the Grand Hyatt Hotel in New York City.
Steven G. Anderson, president and chief executive officer of CryoLife, Inc., will present at 12:50 p.m. Eastern Time.
CryoLife's live presentation may be accessed through its Web site, HERE, on the Investor Relations page. An archived copy of the presentation will be available for 90 days on the same Web site.

ZymoGenetics Announces FDA Approval of RECOTHROMTM 20,000-IU Vial Size and Co-Packaging with Spray Kit

SEATTLE--(BUSINESS WIRE)--ZymoGenetics, Inc. (NASDAQ:ZGEN) announced today that the United States Food and Drug Administration (FDA) has approved a Prior Approval Supplement application for a 20,000 international unit (IU) vial of RECOTHROMTM Thrombin, topical (Recombinant) and also approved co-packaging of the 20,000-IU vial with the ZymoGenetics Spray Applicator Kit.
“RECOTHROM, the first and only recombinant thrombin, is now available in both 5,000 and 20,000-IU vial sizes,” said Bruce L.A. Carter, Chief Executive Officer of ZymoGenetics. “Within two weeks, we’ll be ready to ship the 20,000-IU vials, as well as spray kits co-packaged with the larger vial. This product introduction will provide our customers with flexibility to meet their needs while enhancing our ability to convert hospital thrombin usage to RECOTHROM. Additionally, we believe that our spray kit has design and convenience advantages, based on market research conducted with surgeons.”
RECOTHROM is a recombinant form of human thrombin that is structurally and functionally similar to human thrombin. It is not derived from animal or human blood.

Monday, May 26, 2008

Chitosan

There's an interesting research paper on Chitosan HERE its a 3.5Mb Pdf and verified safe download from adrive.

Sunday, May 25, 2008

Therus Corp.


Therus Corporation is developing the Therus® Acoustic Hemostasis System, a medical device designed for rapid, durable, noninvasive sealing of femoral artery access punctures following catheterization-laboratory procedures such as angiography and angioplasty.
While the Company is pursuing femoral artery sealing, there are numerous other potential clinical applications for therapeutic ultrasound. These applications are being evaluated by AcousTx Corporation, a spinoff company of Therus. The product launch is planned for 2008.

Clinical Trials



Interested to find out what hemostasis clinical trials are being conducted in the USA?
Click HERE

Tissue Welding


Thu, 22 May 2008
CSMG Technologies, Inc. (OTCBB: CTGI), a technology management company, announced that its Live Tissue Connect ("LTC") subsidiary has completed the onsite audit portion of the CE Mark registration in accordance with the European Medical Device Directive – 93/42/EEC. LTC announced it has already received their ISO 13485:2003 certification for the design and manufacture of Bipolar Forceps Systems. This Quality Management System certificate was issued by BSI Management Systems, one of the world's leading certification bodies.

Live Tissue Bonding Technology
Tissue Welding
The tissue bonding / welding device is a platform technology that bonds and reconnects living soft biological tissue through fusion without the use of foreign matters or conventional wound closing devices such as sutures, staples, sealant, or glues. The technology leaves little or no scar tissue visible to the naked eye after a few months. Unlike other tissue coagulation methods that tend to destroy tissue by charring, searing and necrosis, the tissue welding patented platform technology bonds and reconnects incised tissue and avoids charring, searing and necrosis, using a low heat delivery method aimed at restoration of the normal functions of the live organs and tissue. The smokeless capability of the tissue welding technology has a significant benefit to the medical professional health services provider because current technologies for R F frequency welding or bonding have significant smoke that the carcinogens have been found carry infectious microorganisms from high risk HIV and Hepatitis patients during surgery.


Robert D. Tucker PhD, MD. Dr. Tucker is with the University of Iowa, Department of Pathology and the Department of Biomedical Engineering. He will be presenting his teams' comparative results with the LTC bipolar sealing system at the 17th annual Congress of the International Society for Gynecologic Endoscopy, the World Congress of Gynecologic Endoscopy and SEGI Annual meeting which will be held in Bari, Italy from June 4th to 7th 2008

Friday, May 23, 2008

FDA still awaiting OK to open China offices


WASHINGTON (AP) — Chinese bureaucracy is slowing U.S. efforts to increase safety monitoring of food and medicine destined for the United States, a top health official said Friday.
The Food and Drug Administration wants to establish foreign offices in three Chinese locations — Beijing, Shanghai and Guangzhou. Thirteen employees would be assigned to work there.
Leavitt said Chinese health officials support the concept of an FDA presence, but the Ministry of Foreign Affairs has yet to give its formal approval. Once it does, the ministry will begin the process of approving diplomatic visas.
"Bureaucracies in their country and in ours never move fast enough for me," Leavitt said. Still, he said he believed that approval for the offices would happen soon.
"This is about giving them better capacity to reach their most important consumer market," he said. "I think they can see that."
Safety issues involving the blood thinner heparin, food and other products imported from China has put pressure on the FDA to boost its international presence. In the heparin case, a Chinese-made component contained a contaminant linked to as many as 81 deaths and hundreds of allergic reactions.
Leavitt envisions an FDA presence around the globe. After China, he said his next priority is an office in India.
"There are 90 to 100 FDA-inspected facilities there producing mostly drugs and medical devices," Leavitt said. "I expect that number to grow. The connection between the U.S. pharmaceutical industry and India is real and expanding. We just need to be there."
Source Associated Press

Haemacure announces webcast of presentation at Rodman & Renshaw 5th Annual Global Healthcare Conference




Haemacure Corporation (TSX:HAE), aspecialty bio-therapeutics company developing high-value human proteins forcommercialization, announced today that its Chairman of the Board and ChiefExecutive Officer, Joseph Galli, will present at the upcoming Rodman & Renshaw5th Annual Global Healthcare Conference on Tuesday, May 20, 2008.
To access the broadcast via internet inlisten-only mode, or the subsequently archived recording, simply cut and pastethe following link directly into your web browser:
http://www.wsw.com/webcast/rrshq13/hae.cn

Thursday, May 22, 2008

Vascular Solutions to Present At FBR 12th Annual Spring Investor Conference

MINNEAPOLIS, May 14, 2008 (PRIME NEWSWIRE) -- Vascular Solutions, Inc. (Nasdaq:VASC) today announced that the Company is scheduled to present at FBR Capital Markets' 12th Annual Spring Investor Conference on Wednesday, May 28, 2008 at 1:35pm (EDT).
Howard Root, Chief Executive Officer of Vascular Solutions, will deliver the Company's presentation. To hear the live audio webcast and view the slides of the Vascular Solutions' presentation, go to the investor relations page of the Company's web site http://www.vascularsolutions.com and click on the "IR Conferences" icon a few minutes prior to start time to download any necessary software.

Wednesday, May 21, 2008

Archive - Baxter gets rights to TachoSil


DEERFIELD, Ill., January 7, 2008 — Baxter Healthcare Corporation today announced an agreement with Nycomed that grants Baxter exclusive rights to market and distribute the company’s TachoSil® patch in the United States. TachoSil is a patented Nycomed product, which is currently available in more than 50 markets outside of the United States including Europe and Japan. The product is a fixed combination of a collagen patch coated with human thrombin and fibrinogen. It is used in a variety of surgical procedures to seal tissue and control bleeding, requires little preparation and can be stored at room temperature. The currently approved indication in Europe is “for supportive treatment in surgery for improvement of hemostasis where standard techniques are insufficient.” TachoSil is not yet an approved product in the United States.

TachoSil® is a ready-to-use surgical patch that allows haemostasis to be achieved quickly and easily. TachoSil® is the only ready-to-use fixed combination of a collagen sponge coated with a dry layer of the human coagulation factors fibrinogen and thrombin. TachoSil® achieves haemostasis in 3-5 minutes and has several distinct advantages compared with current supportive techniques.