HemCon Patch

HemCon Medical Technologies offers a more flexible HemCon Patch designed for use for external, temporary control of bleeding during interventional and diagnostic cardiac catheterization, interventional radiology, electrophysiology and dialysis access procedures.

Offering diagnostic and interventional patients a quick, safe and comfortable post-procedural experience, the HemCon Patch delivers a flexible hemostatic solution where rapid arterial hemostasis is critically important to ensure quality care and safety. It stops bleeding and minimizes risk of artery damage. As one of the only hemostatic products to obtain an FDA antibacterial barrier claim, the HemCon Patch provides a barrier against a wide spectrum of micro-organisms, including methicillin-resistant Staphylococcus aureus (MRSA), Enterococcus faecalis (VRE) and Acinetobacter baumannii. This barrier may help to reduce the risk of hospital-acquired infections for both patients and providers. The HemCon Patch is also suited for patients that take anticoagulant medications or suffer from clotting or bleeding disorders.

US Congressional Sting Operation Exposes Gaps in Health System

Thousands of medical research groups that monitor clinical trials on behalf of the drug industry may face tougher regulations in the wake of a congressional sting operation that found gaps in the nation's oversight of experiments on humans.

The sting, detailed at a House Energy and Commerce Committee hearing Thursday, involved the creation of a fictitious company and a fake medical device, a surgical adhesive gel. The sham firm then applied to three for-profit oversight groups -- called institutional review boards, or IRBs -- for approval to begin a clinical trial using their adhesive on human subjects.

Drug and device makers along with hospitals and university research facilities must retain an independent IRB to oversee the methodology and safety issues for human studies. Corporations cannot get Food and Drug Administration approval for their products without an IRB certifying their clinical trials. About 6,350 IRBs are registered with the Department of Health and Human Services.

Lawmakers have raised concerns over whether IRBs routinely approve medical studies for paying clients. The committee leaders are considering whether to introduce a bill to strengthen IRB regulations.

Two IRBs contacted by the GAO's sting operators -- Argus IRB of Arizona and Fox IRB of Illinois -- rejected the Adhesiabloc proposal because of unanswered safety questions.

"We realized it was a terrible risk for the patient … It is the worst thing I have ever seen," an Argus IRB reviewer said, according to a slide shown at the hearing.

Coast IRB LLC of Colorado Springs, Colo., did approve a study for the fictitious adhesive gel, "Adhesiabloc." Five months after approving the study for abdominal surgery patients, Coast learned that neither Adhesiabloc nor its maker, Device Med-Systems of Virginia, existed.

Coast CEO Dan Dueber said in an interview that the congressional case was illegal entrapment. At the hearing, Mr. Dueber testified, "The GAO perpetrated an extensive fraud against my company. You pulled the wool over our eyes -- congratulations." Because the product was fake, it was never used.

As part of the sting, the committee also created a sham IRB to see whether the Department of Health and Human Services, which registers IRBs, would certify their fictitious group.

The committee, working with the Government Accountability Office, Congress's investigatory arm, named the CEO of the fake IRB Truper Dawg, after a staffer's three-legged dog, now deceased. Other fake names included "April Phuls" and "Timothy Wittless," which lawmakers said should have signaled irregularities to HHS. The department registered the IRB.

At Thursday's hearing, the toughest complaints were reserved for HHS. Rep. Joe Barton of Texas, the committee's ranking Republican, asked one HHS official: "Do you have any sense of outrage?" Referring to Coast, he continued, "What steps are being taken right now to decertify these charlatans?"

The director of HHS's office that registers review boards, Jerry Menikoff, said at the hearing that his bureau had only recently received the committee information about Coast, and would look into the matter.

Cryolife Release Hemostase Brochure

Cryolife have released brochures for their new product Hemostase MPH. Under their agreement Minneapolis based Medafor Inc. will sell their "Arista" FDA approved 2001 product under new labels with Cryolife to sell "Hemostase MPH" while Orthovita will sell "Vitasure".

Under the Cryolife agreement Medafor grants to Cryolife "exclusive right to promote, market, sell and distribute (collectively, “Distribute”) the Product throughout the Territory for all uses and applications" in all applications in cardiac surgery and vascular surgery in the United States; and in all general surgery applications outside the United States including cardiac and vascular surgeries, but excluding orthopedic and ear, nose, and throat surgeries. Neurosurgery and topical applications do not form part of the agreement.

Meanwhile Orthovita at the 29th Annual Health Care Conference, March '09,  in Boston  have predicted strong "horizontal" growth throughout hospitals. For the Vitasure IFU click HERE

Report predicts excess of 100 million procedures

The market potential for the future utilization of surgical sealants, glues, wound closure and anti-adhesion products is based on the progressive adoption of these products for multiple uses (sealing, hemostasis and even anti-adhesion) and their (more) routine use in surgical and other clinical practice, demographic forces influencing potential caseload and with the changing regulatory demands for this diverse set of products. According to the MedMarket Diligence report #S175, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2009-2013," from 2009 forward, the trends in product adoption and the demographic forces, combined with new product introductions are expected to accelerate market growth. There remains a growing potential for these products to be used in excess of 100 million procedures worldwide. Growth in utilization will exceed double-digit annual rates for new products and for established products in geographic markets that have yet to be fully tapped. 
A number of market leaders have consolidated their positions within the surgical closure and securement markets through successful internal development programs and through technology partnerships with innovative vendors of next-generation technologies. For example, Covidien and Ethicon (Johnson & Johnson) are major suppliers of cyanoacrylate products in the United States; with dominant sales resources to sell these products, these companies lead the market, although they face competition from the Canadian company Glustitch, the U.K.-based Medlogic and others. Synovis (formally Biovascular Inc.) has targeted cardiovascular and other procedures, and has a range of closure products; it has partnered with GEM to develop and exploit GEM’s internal high-strength glue product (Glubran) in the United States. 

Frost & Sullivan Commends Nycomed for Excellence in Product Differentiation Innovation

LONDON, March 23 /PRNewswire/ -- The "2008 European Tissue Sealants & Topical Hemostats Product Differentiation Innovation Award" is conferred on Nycomed in recognition of its revolutionary product - TachoSil. The innovative surgical patch, TachoSil is poised to be the future of the European tissue sealants and topical hemostats markets. At present, Nycomed, with TachoSil, is the sole company in the market with a ready-to-use dual action patch. TachoSil is unique: it does not fit into any of the standard market segments and constitutes a separate category on its own. "This pioneering product has both haemostatic and sealing properties and can be used to stop bleeding as well seal tissue," explains Frost & Sullivan Research Analyst Divya Belle. "TachoSil combines the bioactive mechanism of action of human coagulation factors fibrinogen and thrombin with a collagen patch for mechanical support."

Prospective randomized study evaluating an absorbable cyanoacrylate for use in vascular reconstructions

Lumsden AB, On Behalf of the Closure Medical Surgical Sealant Study Group 
J Vasc Surg, vol. 44, 1002 - 1009, 2006

Abstract

Background: 

An easy-to-use vascular sealant with good safety and efficacy is needed to prevent anastomotic bleeding in vascular surgery. This study evaluated the safety and efficacy of cyanoacrylate surgical sealant in establishing hemostasis of expanded polytetrafluoroethylene to arterial vascular anastomoses in arteriovenous (AV) grafts and femoral bypass grafts.

Methods: 

This multicenter, randomized, controlled, open-label study was conducted in a hospital setting at 12 sites: 10 in the United States and 2 in Europe. A total of 151 patients undergoing femoral bypass procedures or AV shunt procedures for hemodialysis access using expanded polytetrafluoroethylene grafts were randomized 2:1 to receive cyanoacrylate surgical sealant or the control (oxidized cellulose) between April 26, 2004, and January 18, 2005. Randomization was stratified by clinical site and type of procedure. After the anastomosis, cyanoacrylate surgical sealant or the control was applied to all anastomosis sites for patients undergoing femoral bypass procedures and to only the arterial anastomosis sites for patients undergoing AV shunt procedures. The primary end point was the elapsed time from clamp release to hemostasis. Secondary end points were the proportion of patients achieving hemostasis at t=0 (immediate), 1, 5, or 10 minutes after clamp release, use of additional adjunctive measures to achieve hemostasis, and occurrence of adverse events.

Results: 

Baseline demographics and clinical characteristics showed that the two treatment groups were similar at baseline. The mean time from clamp release to hemostasis was 119.3 seconds with cyanoacrylate surgical sealant vs 403.8 seconds with the control (P<.001). Immediate hemostasis was achieved in 54.5% of patients receiving cyanoacrylate surgical sealant and in 10% of those receiving the control. The proportion of patients requiring additional adjunctive measures was lower with cyanoacrylate surgical sealant, and the occurrence of adverse events was similar in both groups.

Conclusions: 

This study demonstrates that cyanoacrylate surgical sealant is effective at reducing the time to hemostasis and achieving immediate hemostasis in AV shunt and femoral bypass procedures and that it is safe for internal use. Cyanoacrylate surgical sealant is an easy-to-use vascular sealant with good safety and efficacy that significantly decreases anastomotic bleeding in vascular surgery.

Camp HemoVon to Host Kids With Blood Disorders

Morgantown, WV (BNN) – Children with blood disorders will have the opportunity to forget their health problems and have fun with kids just like them when Camp HemoVon kicks off on July 26. 
Formerly known as West Virginia Hemophilia Camp, Camp HemoVon is a weeklong camp for children ages 7 to 16 who have a bleeding disorder such as hemophilia or von Willebrand disease. The camp is sponsored by West Virginia University Health Sciences, West Virginia Bleeding Disorder Association, Camp Happy Valley and various pharmaceutical companies. 
“Camp HemoVon is a way for kids to engage in normal activities they might not otherwise be able to do,” said Anita Graham, camp coordinator. 
According to the Centers for Disease Control and Prevention, hemophilia is an inherited disorder that affects 18,000 people in the United States, most of whom are male. The condition results from deficiencies in blood clotting factors and can lead to spontaneous internal bleeding and bleeding following injuries or surgery. 
The most common bleeding disorder is von Willebrand disease, found in approximately 1 to 2 percent of the U.S. population, according to the CDC. It results from a deficiency or defect in the body’s ability to make von Willebrand factor, which is a protein that helps blood clot. While the disorder occurs equally in both genders, females are more likely to recognize the symptoms of the disease because of heavy or abnormal menstrual periods and bleeding after giving birth. 
In its 13th year, Camp HemoVon usually hosts campers from West Virginia, Maryland and Pennsylvania, as well as doctors and counselors. Campers are patients who have been treated in Morgantown, Charleston and Pittsburgh. 
This marks the first year the camp will be held at Camp Happy Valley in Scott Depot, W.Va. Previously, the camp was held at Camp Horseshoe in Tucker County, W.Va. The camp is held in conjunction with Camp WINACA (Children WIN Against CAncer), a camp for children with cancer. 
 Campers have the opportunity to participate in a variety of activities including swimming, archery, hiking, fishing, boating, ropes course, climbing wall, zip line, basketball, tetherball, field activities and campfires. 
There is no cost for campers to attend. The WVU Hemophilia Center secures funding, runs the infirmary and provides on-site 24-hour medical coverage with help from a licensed physician and registered nurses from around the state. The infirmary is under the direction of Elizabeth Kurczynski, M.D. The Hemophilia Center of Western Pennsylvania also provides care. 
Initial registration for Camp HemoVon is due by April 30. For more information on attending the camp or on providing financial support to the camp, contact Anita Graham by phone at 304-293-1205 or by e-mail at agraham@hsc.wvu.edu.

Researchers hope to take a lesson from mussels

The bandages of the future may come from oceanic tidal zones, where creatures who want to stay in one place have developed sophisticated ways of sticking to things. Frustrated by the inadequacies of human-engineered medical adhesives, researchers hope to take a lesson from mussels, barnacles, tubeworms and other animals that can resist the ocean's buffeting currents. "The interface between ocean and land has been an important zone in evolutionary history," said University of Utah biochemist Russell Stewart. "Marine organisms exploit multiple bonding mechanisms. By using multiple chemical bonds, they're able to bond to multiple substrates" — a fancy way of saying they can stick to anything. Chemists recently made prototype bandages with an inkjet printer filled with adhesive proteins taken from mussels, whose remarkable "feet" — a tangle of fibers that anchor them to rocks — have made them the most widely-studied specialist in marine clinging. Mussels can also attach themselves to wood, iron, steel, each other, and even Teflon. The shortcomings of modern medical adhesives are manifold. As anyone who's ever put a Band-Aid on an elbow knows, off-the-shelf medical glues aren't suitable for moving joints. Sutures — which can be thought of as a form of mechanical adhesion — can leave scars and leave bodies open to infection. Sealants made from blood-coagulating compounds are promising, but still prone to contamination. And surgical-grade glues are essentially Krazy Glue with different brand names. As the instructions on Krazy Glue packets make clear, it's a toxic substance not meant to be put inside a body, even if it could seal a tissue under repair by a surgeon — which, often, it can't. The inside of a body, however, poses many of the same challenges as an intertidal zone. Marine glues need to stick to wet surfaces. They do so by employing a variety of chemical bonds to displace the water, right down to the last  molecule. Then they need to keep their glue from dissolving in water. "There are chemical changes and cellular changes within the body, and all sorts of causes" that can dissolve a medical adhesive, said University of North Carolina bioengineer Roger Narayan, coauthor of the inkjet adhesive study in the Journal of Biomedical Materials Research Tuesday. Earlier research by co-author Jonathan Wilker, a chemist at Purdue University, showed that mussels strengthen their glue with molecules of iron, though the mechanical details of this process remain unclear. So do the molecular details of mussel adhesive itself. The glue is made from a mix of proteins that can be harvested and even synthesized — but much of its adhesive power comes from the proteins' structural arrangement. That's lost during harvesting, and can't yet be artificially replicated. "There's a gradient of proteins in that structure," said Stewart. "The proteins have different functions: varnishes, primers, the parts that connect the adhesive" to the threads that compose the mussel's foot. The difficulty in recreating mussel protein structures could explain why mussel-based medical adhesives are not yet on the market, despite nearly two decades of research. Stewart has chosen a less-complicated source of inspiration: the polycheate, a surf-dwelling worm that glues together grains of sand to make a tubular home for itself. "The mussel has to glue a string to a wet rock, whereas a polycheate just has to glue two similar materials together. That's a much simpler bonding problem," said Stewart.  At the point of contact between surface and adhesive, said Stewart, polycheate and mussel glues — though composed of similar proteins — likely rely on a different mix of  molecular bonds. Among them are the van der Waal forces of gecko foot fame, hydrogen bonds, covalent bonds, and salt bridges — a smorgasbord of molecular stickiness. The bonds have been identified, said Stewart, but not their configuration, or their relationship to individual proteins. Researchers need to determine "the proportion of different bonds, and how those might work in some cooperative and unexpected manner."  Meanwhile, barnacles — the least-understood marine adhesive — don't use dopa, a protein central essential for mussel and polycheate glues. The lack of dopa, said Stewart, shows just how many ways nature has found to solve the problem of adherence in the surf. "A lot of these things are not well-understood," said Narayan. "These sorts of studies are the first steps to better understanding these materials."

Haemacure Reports First Quarter 2009 Results and Hires Advisor for the Sale or Merger of the Company

MONTREAL, March 12 /PRNewswire-FirstCall/ - Haemacure Corporation (TSX : HAE) released today the results of its first quarter ended January 31, 2009.

Results

Revenues amounted to $19,226, as compared to $24,674 for the same quarter last year. Revenues were exclusively derived from the sale of legacy fibrin sealant application devices. Operating expenses amounted to $2.7 million, up from $1.2 million for the same quarter last year. The increase was mainly related to the purchase of supplies and materials associated with the validation of the Company's manufacturing facility, and the pivotal phase II/III clinical trials of its lead product candidate (which had been planned to start by mid-2009), as well as the hiring of personnel and legal and consulting fees. The consolidated net loss for the quarter amounted to $2.6 million, or $0.01 per share, as compared to $1.2 million, or $0.01 per share, for the same quarter last year.

Financial Position

Cash, cash equivalents and temporary investments amounted to $1.4 million as of January 31, 2009, as compared to $4.6 million as at October 31, 2008.

On February 13, 2009, Haemacure, having failed to obtain adequate financing to maintain the level of its operations, implemented major cost cutting measures intended to provide the Company with a window of approximately 90 days in which to either arrange a bridge loan, obtain new financing, or sell or merge the Company. The Company has since retained PricewaterhouseCoopers Corporate Finance, Inc. to assist with the sale or merger of the Company.

"We have taken the necessary steps to lengthen our runway in these unprecedented financial and economic times. While these measures are difficult for all involved we have had tremendous support from our directors, employees, suppliers and business partners. I am encouraged by the number of industry members that have come forward and demonstrated an interest in exploring some form of relationship that could lead to a sale, merger or financing", saidJoseph Galli Chairman & CEO of Haemacure.

CPC Pursues Development of Proprietary Synthetic Sealants as part of MedClose(TM)

CPC of America, Inc. (OTC Bulletin Board: CPCF.OB), a company focused on the development of therapeutic devices that enhance the quality of patient care in endovascular procedures, announced today that it is actively pursuing the development of proprietary polyethylene glycol (PEG) synthetic sealants as part of its global commercialization strategy for MedClose(TM). MedClose(TM) is an investigational-stage vascular closure system that is intended to seal arterial puncture sites following diagnostic or interventional catheterization procedures.

CPC will develop synthetic PEG sealants as platform technologies for the MedClose(TM) vascular closure system using ultra-pure functionalized, biocompatible and biodegradable polymers. The sealants will have adjustable physical properties, making it possible to 'fine tune' the gel time and strength for varied clinical applications. The proprietary compounds will be sourced from multiple suppliers, providing flexibility and accessibly for global commercialization and cost savings.

"PEG sealants have been found to have notable advantages to other surgical sealants," notes Dr. Olexander Hnojewyj, a medical advisor to CPC who has conducted extensive research and secured multiple patents and patent applications related to vascular closure sealants. Because PEG sealants are purely synthetic, they carry no risk of transmission of viral pathogens or prions. They are also shown to result in less swelling and inflammation than fibrin sealants, are easy to apply, and report consistently good hemostatic results(1).

"With our synthetic sealant strategy and the combined expertise and experience of our medical, technical and research team, we are well positioned to secure global commercialization of the MedClose(TM)," says Rod Shipman, President and CEO of CPC of America. "We anticipate clinical investigation for multiple indications, which may include sealing of femoral arteriotomy closures, biopsies and vertebral bodies following transpedicular interventions. They may also include the sealing of difficult-to-control bleeding sites during surgery - such as cardiac, lung, liver, pancreas, and OB/GYN procedures."

About CPC

CPC of America develops therapeutic devices for use in endovascular procedures. CPC's current focus is the completion of development and testing of the MedClose(TM) vascular closure system, an internal puncture-closing system for use in catheter laboratories.

Zymo webcast

ZymoGenetics, Inc. (NASDAQ:ZGEN), announced today that Douglas E. Williams, Ph.D., Chief Executive Officer, will provide an update on company activities at the Invest Northwest 2009 Conference in Seattle on Wednesday, March 18, 2009, at 10:30 a.m. Pacific Time.

A live webcast of the presentation can be accessed by going to: www.zymogenetics.com. The webcast will be archived for 30 days.

VOTE NOW !!!! Will the Feb. '09 vCJD scare in the UK affect your consideration of using a human or bovine sourced hemostat or sealant?

Currently I am offering 3 polls for open voting, if you are interested in offering an opinion I Thankyou! I will publish results later in the year, upon poll closure.

All Polls are located in the "side-bar". 

Thankyou and..............

As always I am available at hemostatguy@gmail.com

Thanks, HG

Irish Create Helpline Over Mad Cow fears

IRELAND - THE DISCOVERY that a haemophiliac who died in Britain last year had evidence of variant CJD or vCJD infection has led to just over 30 people ringing a helpline specifically set up to respond to the issue. The helpline was aimed at people who had received UK-derived plasma products or had concerns about blood products they received. Two information meetings were held in Dublin and Cork at the weekend to further allay concerns and were attended by a handful of people. It emerged two weeks ago that the elderly man, who did not die from vCJD, was infected from a UK plasma-derived product known as Factor VIII. Haemophilia and related bleeding disorders are caused by a lack of clotting factors and are treated by products containing clotting factor concentrate such as Factor VIII. Since the late 1990s, Ireland has been using a synthetic clotting concentrate. On hearing the details of the man’s death, the National Haemophilia director Dr Barry White and the Irish Haemophilia Society’s Brian O’Mahony wrote to the 50 Irish patients who had received UK plasma-derived products to inform them of developments. Only two of those had received a product that was subsequently identified as being at risk of vCJD. Thousands of people in the UK have received products where some of the donors developed vCJD, but none of the recipients have developed symptoms. There have been 167 cases of vCJD in the UK and four in Ireland since the link between eating infected meat and a new variant of CJD was made in the mid-1990s. Some nine people who died of vCJD in the UK had donated blood for the manufacture of clotting factor concentrates.

Orthovita Board of Directors Elects William Tidmore Chairman of the Board

The Board of Directors of Orthovita, Inc. (NASDAQ: VITA) has named William Tidmore Chairman of the Board of the Company effective March 3, 2009, following the resignation on March 1, 2009 of David Fitzgerald as Chairman of the Board and a director of Orthovita.

Mr. Tidmore has served as a member of Orthovita’s Board of Directors since 2007 and has over 20 years of experience in the spine and orthopedic industry. He was formerly President and Chairman of DePuy Acromed, as well as President of DePuy, which was acquired by Johnson & Johnson in 1999. Mr. Tidmore held various senior management positions during his tenure of over 14 years with Depuy, including leadership roles for international businesses with direct operational responsibilities across Europe, Latin America, Japan and Canada. Prior to that, Mr. Tidmore held several management positions at Ethicon, Inc., including Vice President of Sales and Marketing in Canada.

Mr. Fitzgerald, who had served since 2003 as Orthovita’s Chairman of the Board and as a member of the Board of Directors of ArthroCare Corp. (OTC:ARTC.PK), submitted his resignation to the Company due to his recent appointment as Acting President and Chief Executive Officer of ArthroCare. His decision to resign from Orthovita’s Board was based on the change in his role at ArthroCare to a senior executive, in recognition of the time commitment and possible business conflicts associated with this position.

“Dave has been an outstanding Chairman at Orthovita who has played an important role in the Company’s success throughout the years,” said Antony Koblish, President and Chief Executive Officer of Orthovita. “Under his guidance, Orthovita significantly increased sales, completed several key equity and debt financings, acquired marketing rights for two hemostasis products and made substantial progress in product development. We appreciate Dave’s contributions and he will be missed. We look forward to solid leadership from Bill Tidmore and the contributions that his extensive experience in the orthopedic and spine industry will bring.”