Friday, May 30, 2008

Recothrom's April sales

Kevin DeGeeter, an analyst at Oppenheimer & Co., put out a report today saying that Recothrom, ZymoGenetics' treatment to stop bleeding during surgery, had $92,589 in April sales, substantially below his estimate of $750,000 for the month. He cited IMS, the market research firm.
By contrast, April sales of King Pharmaceuticals' Thrombin-JMI, which directly competes with Recothrom, jumped 11.5 percent to $23 million, according to IMS.
King has dominated the market for more than a decade and is now facing competition from both Recothrom (which was approved by the FDA in January) and Johnson & Johnson's Evithrom (which went on the market last year).
DeGeeter -- who has been bearish on Recothrom's prospects since its launch -- says:
"While we acknowledge the limitations of monthly sales data, the IMS numbers are not consistent with the upbeat comments from ZGEN management on the pace of product adoption.
ZymoGenetics has said that most of Recothrom's sales will take place during the second half of the year. Because Recothrom is bought by hospitals, committees at those institutions have to meet in order to decide whether to add the treatment to the selection of products that doctors can choose from to use. The process can take six months or more."
I e-mailed ZymoGenetics spokeswoman Susan Specht and asked whether the April sales numbers were in line with the company's expectations.
She said:
"The selling process is a long one and could take six months or more to work through with each hospital. We're making progress and expect that work to pay off in the second half of the year."
Source: The Life Sciences Blog

Thursday, May 29, 2008

Cryolife Presentation

Cryolife full presentation is available for 90 days scroll down this page to find the link.
KEY Slides CLICK TO IMAGE TO ENLARGE


Celox-A delivery system

Just recieved the Video of Celox-A delivery system I would like to share with you all below and the Pdf downloadable from Adrive and verified safe HERE


Wednesday, May 28, 2008

Polymer Technology Group (PTG) in-licenses bioresorbable polymers from Bezwada Biomedical

Ronald Trahan Associates Inc. Ronald Trahan, 508-359-4005, x108 APR The Polymer Technology Group, Inc. (www.polymertech.com), a preeminent biomaterials company, announced today that it has in-licensed a family of bioresorbable polymers from Hillsborough, N.J.-based Bezwada Biomedical L.L.C., whose founder and president, Rao Bezwada, Ph.D., will also serve as a consultant to PTG. Terms of the agreement
were not disclosed. Polymers specifically designed to degrade under physiological conditions are often referred to as "absorbable", "biodegradable" or "bioresorbable" polymers. With this in-licensing event, PTG will now be able to offer a wider range of new and generic bioresorbable polymers to the medtech industry for use in medical devices, drug delivery and tissue engineering. "We are very happy to be working with Dr. Bezwada, who has more than 25 years of research experience in the medical device industry, including 20 years of service at Ethicon (Johnson & Johnson) prior to establishing Bezwada Biomedical in 2003," said Bob Ward, CEO of PTG. "He has been a prolific inventor (72 issued U.S. patents), has published extensively and presented frequently at both national and international meetings, including the American Chemical Society and the Society for Biomaterials," added Ward. Ward and Dr. Bezwada will make a joint presentation--"A vertically integrated approach for tailoring bioresorbable polymers: from monomers to implantable devices"--at a "Corporate Lunch Forum" on Friday, May 30th, during the upcoming 8th World Biomaterials Congress (May 28-June 1) in Amsterdam.

The polymers will find applications in:

  • Minimally invasive surgery as absorbable tissue adhesive and sealant

  • Drug delivery and wound care

  • Medical devices
  • Tissue engineering

HemCon Medical Technologies Leverages Sangui Technology to Expand its Wound Care Products Line


PORTLAND, Ore.--(BUSINESS WIRE)--HemCon Medical Technologies Inc. today announced it will use Witten, Germany-based SanguiBioTech GmbH’s ChitoSkin technology platform to help further innovations in hemostatic bandages and wound care dressings for the acute care market.
Under the terms of the agreement, HemCon will leverage Sangui’s technology platform to enhance and expand its product offerings for surgical and wound care. HemCon developed the chitosan-based hemostatic HemCon® Bandages and ChitoFlex® dressings that are used by military and medical first responders as well as health care professionals around the globe.
“We explored a wide variety of technology platforms to add to our new surgical and wound care offerings and feel that the Sangui chitosan platform offers great opportunities to enhance our solutions,” said John W. Morgan, president and CEO of HemCon. “We’re committed to continuing our investment to develop new choices for medical professionals and consumers. This agreement is an important step forward in realizing the full potential of chitosan-based products.”
SanguiBioTech GmbH is a wholly owned subsidiary of Sangui BioTech International, Inc. Sangui BioTech International focuses on vascular and hemostasis products. The firm specializes in developing oxygen-carrying agents to treat blocked arteries, anemia or acute blood loss through SanguiBioTech GmbH.
“We are proud to enter into an agreement with HemCon and offer our chitosan platform to help innovate new surgical and wound care products,” said Sangui Managing Director Hubertus Schmelz. “There is definitely a demand for products that can adapt to specific medical needs, especially as it relates to wound care.”
HemCon retains exclusive worldwide market and distributing rights for products developed under this structured financial agreement. HemCon will submit developed products for U.S. approvals to the FDA, while Sangui will prepare documentation for registration in the European Union.

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.

Monday, May 19, 2008

Hemostat Technologies

You can find a technology comparitive overview HERE . All downloads are verified safe via Adrive.

Celox


CELOX is an innovative new hemostat designed to bond with specific sites which are present on the surface of red blood cells and platelets to make a gel like clot /plug. This process is totally different from the body’s normal clotting mechanisms. CELOX is a proprietary blend of materials covered by 3 international patent applications.
CELOX contains a natural marine polymer, Chitosan.
Chitosan is a highly purified polysaccharide derivative of shrimp shells.
Chitosan is used widely and is in such products as bandages, medical devices diet aids and some cosmetics. It is an approved food ingredient.

Curamedical


CuraMedical BV is a medical device company operating in the wound management sector and based in the Netherlands. The key strategic goals of CuraMedical are the manufacture and marketing of haemostatic agents and cytological biopsy instruments. CuraMedical’s mission is “To become a leading medical device company specializing in the supply of value-added products in wound management and diagnostics, contributing to public healthcare and focussing on leading edge technology products which are manufactured at a competitive price”. CuraMedical entered the healthcare business in 1995 manufacturing and marketing Curaspon®, an absorbable haemostatic agent based on pharmaceutical gelatin. Nowadays Curaspon® is distributed to more than 60 countries world wide.
Curacel® is a sterile absorbable knitted fabric, prepared by the controlled oxidation of regenerated cellulose.

Sunday, May 18, 2008

PTV - Pharma TV a great resource for Companies

I am pleased to offer this link to PTV they are a wonderful resource especially for start-up companies. New companies will definitely appreciate these insights, I highly recommend for excellent insight from market leaders, and detail on financing pitfalls. There are interviews available online with firms in our industry such as Zymogenetics and a great resource for financing and acquisitions information. Please click HERE .

Thursday, May 15, 2008

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

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

ZymoGenetics says first product is meeting expectations

ZymoGenetics says first product is meeting expectations
ZymoGenetics' executives said Tuesday that the company's first commercial product, a synthetic protein to control bleeding during surgery, has brought in nearly a million dollars in sales since its launch in mid-January ?an amount they said met their expectations.
However, analysts cautioned that it was too early to tell how much market share ZymoGenetics' product, Recothrom, would ultimately capture from King Pharmaceuticals, which has dominated the market for treatments to control bleeding during surgery for more than a decade.
ZymoGenetics claims that Recothrom avoids complications associated with King's animal-derived product, which is sold with a warning regarding the potential for abnormalities, including severe bleeding.
Although the Recothrom sales numbers were below several analyst's estimates, analysts said that the early figure was largely inconsequential.
Because Recothrom is bought by hospitals, committees at those institutions have to meet in order to decide whether to add the treatment to the selection of products that doctors can choose from to use. The process can take six months or more.
"Everybody wants to read a lot of information into the first data point you get. But it's the first one you get," said Kevin DeGeeter, an analyst at Oppenheimer & Co., who has repeatedly questioned Recothrom's prospects because ZymoGenetics has priced Recothrom at a 20 percent premium to King's product. "My concern ultimately remains the same."
DeGeeter had estimated that Recothrom would bring in $3.3 million during the first quarter. "There's nothing here to suggest this is jumping off the shelves," he said.
Hanzhong Li, an analyst at Stanford Group, expected Recothrom to bring in $2 million but said the figure was largely a "placeholder," noting that ZymoGenetics had long said that most of Recothrom's sales would take place during the second half of this year. He estimates that Recothrom sales will reach $35 million for the year.
Of the 60 hospital committees that have reviewed Recothrom so far, 22 have decided to buy the product exclusively, while another 27 more have added it, in addition to the King product, said ZymoGenetics CEO Bruce Carter during a conference call. The other committees have not yet made decisions. An additional 100 committee meetings will take place this month alone.
Carter said that ZymoGenetics has enlisted the support of more than 2,000 surgeons and 1,000 pharmacists to ask that their institutions add Recothrom to the selection of products that they could use.
"It will take time for our efforts to bear fruit," he said during the conference call, which was held to report the company's first-quarter earnings. "We do expect that work to pay off in the second half of the year."
For the quarter, ZymoGenetics said that its total revenue increased to $13.5 million, compared to $5.2 million during the same period a year earlier, due in part to milestone payments associated with treatments in its pipeline. The company also posted a net loss of $40.9 million, or 60 cents per share, compared with a net loss of $33.3 million, or 49 cents a share, during the first quarter of 2007.
As of March 31, ZymoGenetics had $155 million in cash and short-term investments.
During the conference call, ZymoGenetics CFO James Johnson said that the company was working on a "financing transaction" to raise additional funds this year. He said the company could potentially use its inventory of Recothrom in order to raise money.
DeGeeter of Oppenheimer & Co. said Johnson's remarks probably meant that the company would issue debt, backed in part by its inventory. But he said the company would probably eventually also have to issue more stock to raise funds.
"You have a company that in the first quarter that lost $41 million," he said. "How quickly can they grow sales to get that number down to something more manageable? Because $41 million is not manageable. We'll see."
May 6, 2008 3:26 p.m. View more HERE

Tuesday, May 6, 2008

Gecko-Inspired Bandage May Heal Surgical Incisions

Elizabeth Dougherty, Harvard-MIT Division of Health Sciences and TechnologyFebruary 18, 2008
MIT researchers and colleagues have created a waterproof adhesive bandage inspired by gecko lizards that may soon join sutures and staples as a basic operating room tool for patching up surgical wounds or internal injuries.
Drawing on some of the principles that make gecko feet unique, the surface of the bandage has the same kind of nanoscale hills and valleys that allow the lizards to cling to walls and ceilings. Layered over this landscape is a thin coating of glue that helps the bandage stick in wet environments, such as to heart, bladder or lung tissue. And because the bandage is biodegradable, it dissolves over time and does not have to be removed.
The team is led by MIT Institute Professor Robert Langer and Jeff Karp, an instructor of medicine at Brigham and Women's Hospital and Harvard Medical School. Both are also faculty members at the Harvard-MIT Division of Health Sciences and Technology (HST). Their colleagues include several other researchers from MIT, as well as from the University of Basel, Switzerland. In addition, Dr. Jeff Borenstein and David J. D. Carter from Draper Laboratory fabricated the nanomolds involved in the work, and Jay Vacanti and Cathryn Sundback performed all animal experiments with colleagues at Massachusetts General Hospital.
The work is described in the Feb. 11 online issue of the Proceedings of the National Academy of Sciences.
"There is a big need for a tape-based medical adhesive," said Karp. For instance, a surgical adhesive tape made from this new material could wrap around and reseal the intestine after the removal of a diseased segment or after a gastric bypass procedure. It could also patch a hole caused by an ulcer. Because it can be folded and unfolded, it has a potential application in minimally invasive surgical procedures that are particularly difficult to suture because they are performed through a very small incision.
Gecko-like dry adhesives have been around since about 2001 but there have been significant challenges to adapt this technology for medical applications given the strict design criteria required. For use in the body, they must be adapted to stick in a wet environment and be constructed from materials customized for medical applications. Such materials must be biocompatible, meaning they do not cause inflammation; biodegradable, meaning they dissolve over time without producing toxins; and elastic, so that they can conform to and stretch with the body's tissues.
The MIT researchers met these requirements by building their medical adhesive with a "biorubber" invented by Karp, Langer and others. Using micropatterning technology--the same technology used to create computer chips--the researchers shaped the biorubber into different hill and valley profiles at nanoscale dimensions. After testing them on intestinal tissue taken from pigs, they selected the stickiest profile, one with pillars spaced just wide enough to grip and interlock with the underlying tissue.
Karp then added a very thin layer of a sugar-based glue, to create a strong bond even to a wet surface. The resulting bandage "is something we never expect to remove," said Karp. Because of that difference, he continued, "we're not mimicking the gecko"--which has sticky feet but can still lift them up to walk--"we are inspired by the gecko to create a patterned interface to enhance the surface area of contact and thus the overall strength of adhesion."
When tested against the intestinal tissue samples from pigs, the nanopatterned adhesive bonds were twice as strong as unpatterned adhesives. In tests of the new adhesive in living rats, the glue-coated nanopatterned adhesive showed over a 100 percent increase in adhesive strength compared to the same material without the glue. Moreover, the rats showed only a mild inflammatory response to the adhesive, a minor reaction that does not need to be overcome for clinical use.
Among other advantages, the adhesive could be infused with drugs designed to release as the biorubber degrades. Further, the elasticity and degradation rate of the biorubber are tunable, as is the pillared landscape. This means that the new adhesives can be customized to have the right elasticity, resilience and grip for different medical applications.
"This is an exciting example of how nanostructures can be controlled, and in so doing, used to create a new family of adhesives," said Langer.

Sunday, May 4, 2008

Iran invents extremely sticky nanoglue


Iranian scientists have employed nanoparticles in an innovative way, inventing a new generation of tension-resistant tissue glue.
The 'nanoglue' made of branched biopolymer is characterized by its high adhesive and tension-resistant quality. Its effect becomes apparent in less than a minute.
Scientists say because it is rich in fibrinogen, extracted from the patients own blood, allergic reactions are rarely reported when used.
The glue also contains high amounts of fibronectin, which facilitates the conjunction of biological agents to a cellular scaffold, improving the tissue repair process.
Shahid Beheshti University scientists claim the glue has been successfully tested in repairing intestines, trachea, fallopian tubes and brachial plexus on dogs.
They add that the intestinal repair process, considered as one of the most sophisticated operations, can be simplified using the new glue.
According to the scientists, the glue has also shown promising results in repairing fallopian tubes, helping the treatment of infertile couples.
source: presstv

Saturday, May 3, 2008

ANNOUNCEMENT - Medical Hemostat Forum

I have added a new forum for readers HERE the aim is providing a place where those with an interest may share ideas, discuss technology, network and ask questions. The forums are anonymous and you are able to communicate with others freely (within the boundaries of "good taste"). I hope it maybe a useful meeting point for manufacturers, distributors and medical professionals. Currently the forums will be somewhat of a testing ground based on use, so if you feel it maybe a useful resource I encourage you to REGISTER and have your say!

Thursday, May 1, 2008

Covidien Introduces the VascuSeal


Covidien (NYSE: COV, BSX: COV), a leading global provider of healthcare products, today announced that its Surgical Devices business unit has introduced the VascuSeal™ Vascular Sealant System throughout Europe and in select Middle East markets. VascuSeal™ offers surgeons a unique advanced hydrogel that provides an immediate, blood-tight seal that is effective intraoperatively and throughout the critical healing period. VascuSeal™, which is CE-Marked, is intended for use as a surgical sealant during arterial and venous reconstructions to seal suture lines.
Unlike a hemostatic agent, a vascular sealant can seal blood leaks and does not depend on either the time for the blood to clot or the strength of the blood clot to perform successfully. The VascuSeal™ Sealant System offers surgeons a valuable tool to reduce bleeding from the suture line in vascular bypass procedures, and reduces post-operative complications associated with suture line bleeding.
The VascuSeal™ sealant technology is a patented synthetic, absorbable hydrogel delivered by a dual syringe applicator. The device can be stored at room temperature and prepared in less than two minutes. VascuSeal™ sealant polymerizes within seconds when sprayed on the suture line and is blue in color which provides the vascular surgeon visualization of coverage and thickness of the material upon application. Postoperatively, VascuSeal™ sealant continues to seal the suture line 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.
“The VascuSeal™ Vascular Sealant System represents another innovative product in the BioSurgery marketplace,” said Scott Flora, President, Surgical Devices, Covidien. “We expect VascuSeal™ to be well-received by surgeons looking to improve patient outcomes, save time and reduce blood loss during surgical procedures,” added Flora.