It's Over...Medafor Terminates Disputed Drug Distribution Agreement With CryoLife

KENNESAW, Ga. -- CryoLife Inc. (NYSE: CRY) said it has received a notice from Medafor Inc. that terminates a contentious medical device distribution agreement between the two companies, the latest in a long-running dispute, according to an SEC filing.
CryoLife, the Kennesaw-based maker of medical products that enable heart and blood vessel reconstructive surgery, said it would challenge the validity of Medafor's termination of the agreement and pursue its rights and remedies in court.
CryoLife said Medafor's notice came after CryoLife challenged in court a determination in March by Medafor that it was "treating the agreement as terminated."
CryoLife had filed a case in the U.S. District Court for the Northern District of Georgia, Atlanta Division, to stop privately held Medafor, which develops drugs to help blood clotting during major surgeries, from proceeding with the termination of the agreement. The court agreed to hear the case but denied a preliminary injunction, last week.
CryoLife is the single largest shareholder in Minneapolis-based Medafor, with a 10.4 percent holding. CryoLife had sought to hold talks to buy the rest of the company but later withdrew the offer.
Medafor accuses CryoLife of violating an exclusive distribution deal by sellingHemostase, an absorbable blood-clotting agent manufactured by Medafor, in Spain for uses allegedly barred by the agreement. In a counter-suit, CryoLife accused Medafor of violating an agreement by allowing other companies to distribute the product in territories and medical fields reserved exclusively for CryoLife.
The termination of the deal will not materially alter CryoLife's guidance for Hemostase revenue of between $4 million and $4.5 million for the last two quarters of the year, the company said.

AccessClosure Announces Distribution Agreement for Radial Compression Band

MOUNTAIN VIEW, Calif., Sept. 29 /PRNewswire/ -- AccessClosure, Inc., the market leader in extravascular closure devices, announced today an exclusive agreement with Benrikal Services to distribute the Bengal Radial Compression Band in the United States.  The Bengal, uniquely designed for transradial procedures, will join the Mynx™ Vascular Closure Device in AccessClosure's portfolio of products.
"We felt that it was crucial to offer a solution for our customers who use the radial approach," said Gregory D. Casciaro, President and CEO of AccessClosure.   "As a customer-focused company, we are striving to provide technologies for all approaches to access site management.  The Bengal complements the key features of the Mynx, both of which were designed to minimize impact on the artery, to offer clinical versatility, and to deliver a comfortable experience for the patient.  Including the Bengal in our closure portfolio allows AccessClosure to offer the same level of service and education to an even broader base of interventionalists."
The Bengal was designed in partnership with radial pioneer Olivier F. Bertrand, MD, PhD, FSCAI, an Interventional Cardiologist at the Quebec Heart-Lung Institute and Associate-Professor, Faculty of Medicine, at Laval University.  "I designed this device to address unmet needs in radial closure.  I wanted a simple tool that achieves quick and effective hemostasis, while protecting the ulnar nerve and providing a comfortable experience for the patient," said Dr. Bertrand.  "I also wanted to simplify post-operative care for my nursing staff: in my practice, the Bengal requires less monitoring time as it can be removed immediately at the end of the hemostasis period."
Vascular closure devices help to close an artery after cardiovascular procedures.  Interventional cardiologists may choose to access the coronary arteries through the radial artery in the wrist instead of the traditional approach using the groin.  Use of the radial technique has increased in the United States in the past several years, due in part to the evolution of the technologies that enable the procedure.  
The Bengal design offers a new approach to radial artery closure, combining a compression pad that delivers a unique pattern of targeted pressure with a soft polymer gel that ensures patient comfort while the band is on the wrist.  "Our Canadian customers appreciate the simplicity and ease-of-use of this band," said Guy Bélanger, President of Benrikal Services.  "As transradialists grow increasingly focused on avoiding radial occlusion after procedures, we have observed a natural inclination to a device that is very easy to adjust and optimize."

CRYOLIFE ENTERS INTO WORLDWIDE DISTRIBUTION AND MANUFACTURING AGREEMENTS WITH STARCH MEDICAL

LATEST PERCLOT PATENT CLAIMS SHRINK - NEWS Please click HERE

ATLANTA, Sept. 28 /PRNewswire-FirstCall/ -- CryoLife, Inc. (NYSE: CRY), an implantable biological medical device and cardiovascular tissue processing company, announced today that it has entered into a worldwide distribution agreement and a manufacturing agreement with Starch Medical Inc. (SMI) of San Jose, California for Chinese manufactured PerClot®, a novel polysaccharide hemostatic agent used in surgery.  

Effects of an absorbable polysaccharide hemostat PerClot(r) on fracture healing of the cranial bone

PerClot is a unique, absorbable powder hemostat that has CE Mark designation allowing commercial distribution into the European Community and other markets.  It is indicated for use in surgical procedures, including cardiac, vascular, orthopedic (no mention of OrthoClot was made in the release), spinal, neurological, gynecological, ENT and trauma surgery as an adjunct hemostat when control of bleeding from capillary, venous, or arteriolar vessels by pressure, ligature, and other conventional means is either ineffective or impractical.  CryoLife plans to file an Investigational Device Exemption (IDE) with the United States Food and Drug Administration (FDA) to begin clinical trials for the purpose of obtaining Pre-Market Approval (PMA) to distribute PerClot in the U.S.
"PerClot is an exciting technology platform that has already seen significant success in Europe.  Its unique formulation allows for full and rapid absorption, while showing excellent hemostatic capabilities.  We are very pleased to have secured the rights to this second generation hemostatic agent and its laparoscopic delivery devices via an agreement that will allow us to serve a broader range of medical specialties and leverage the continued opportunities in the large and growing hemostatic agent market," said Steven G. Anderson, president and chief executive officer.
The U.S. hemostatic market is estimated to be $732 million in 2010 growing to approximately $1.1 billion in 2014, while the European market is estimated to be $279 million in 2010 growing to approximately $430 million in 2014.(1)
CryoLife intends to distribute both PerClot and HemoStase® until CryoLife can no longer sell HemoStase as a result of Medafor's termination of the parties' distribution agreement for HemoStase.  Alternatively, CryoLife believes that in accordance with the terms of the agreement, at its sole discretion, CryoLife can return its inventory of HemoStase to Medafor for reimbursement.  CryoLife anticipates that it will commence distribution of PerClot in several international markets in the fourth quarter of 2010 and will obtain U.S. FDA approval by the end of 2013.  
"We were restricted by Medafor's continued attempts to terminate our agreement, including interruptions in product shipments.  In addition, our agreement with Medafor limited our ability to sell HemoStase in all surgical specialties.  Our international and largely unrestricted distribution agreement with SMI for PerClot addresses these issues and allows us to remain active in this important market," said Mr. Anderson.
Transaction Terms
Under the terms of the agreements, CryoLife receives the worldwide rights, excluding China, Taiwan, Hong Kong, Macau, North Korea, Iran and Syria, to commercialize PerClot for all approved surgical indications and a license to manufacture the PerClot product, exclusive of rights to sell PerClot with an endoscope.
As part of the transaction, CryoLife will pay SMI $6.75 million in cash and $1.25 million in restricted CryoLife stock, which includes $1.5 million in prepaid royalties.  CryoLife will pay an additional $2.75 million to SMI if certain FDA regulatory and other commercial milestones are achieved, and will also pay royalties on sales of PerClot manufactured by CryoLife.
The PerClot distribution agreement contains certain minimum purchase requirements and has a term of 15 years.  CryoLife may begin manufacturing PerClot from plant starch modified by SMI once the technology transfer from SMI has been completed, which is anticipated to occur sometime in 2011 or 2012.  Following the technology transfer and U.S. regulatory approval, CryoLife may terminate the distribution agreement.  In addition to allowing CryoLife to manufacture PerClot, the license agreement grants CryoLife a three-year option to purchase the remaining technology from SMI.
CryoLife estimates that the costs to develop PerClot and gain U.S. FDA approval will be between $5.0 million and $6.0 million, of which up to $750,000 is expected to be incurred in the fourth quarter of 2010 and the remainder over the next six to eight quarters.  Additionally, the Company estimates that it will incur up to $300,000 in product launch and other costs related to PerClot in the fourth quarter of 2010.  The Company will update its 2010 financial guidance and issue its initial 2011 financial guidance on its third quarter financial conference call.
About PerClot
PerClot is a medical device composed of absorbable modified polymer (AMP®) particles and delivery applicators.  AMP particles are derived from purified plant starch.  PerClot contains no human or animal components.  It is intended for use as an absorbable hemostatic system to control bleeding during surgical procedures or following traumatic injuries.
PerClot is ready to use, requiring no mixing and/or other components and does not need special handling or storage conditions.  Pre-clinical evaluations, clinical studies and surgical use have shown the efficacy of PerClot to be comparable to the current popular choice of surgical hemostatic materials while its unique formulation allows for rapid absorption.  PerClot particles are readily dissolved by saline irrigation and are degraded rapidly by human enzymes, primarily amylase, within several days.
About CryoLife
Founded in 1984, CryoLife, Inc. is a leader in the processing and distribution of implantable living human tissues for use in cardiac and vascular surgeries throughout the U.S. and Canada.  The Company's CryoValve® SG pulmonary heart valve, processed using CryoLife's proprietary SynerGraft® technology, has FDA 510(k) clearance for the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic pulmonary valves.  The Company's CryoPatch® SG pulmonary human cardiac patch has FDA 510(k) clearance for the repair or reconstruction of the right ventricular outflow tract (RVOT), which is a surgery commonly performed in children with congenital heart defects, such as Tetralogy of Fallot, Truncus Arteriosus, and Pulmonary Atresia.  CryoPatch SG is distributed in three anatomic configurations: pulmonary hemi-artery, pulmonary trunk, and pulmonary branch.  The Company's BioGlue® Surgical Adhesive is FDA approved as an adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels.  BioGlue is also CE marked in the European Community and approved in Canada and Australia for use in soft tissue repair.  The Company's BioFoam® Surgical Matrix is CE marked in the European Community for use as an adjunct in the sealing of abdominal parenchymal tissues (liver and spleen) when cessation of bleeding by ligature or other conventional methods is ineffective or impractical.  CryoLife currently distributes HemoStase®, a hemostatic agent, in much of the U.S. for use in cardiac and vascular surgery and in many international markets for cardiac, vascular, and general surgery, subject to certain exclusions, although CryoLife has received notice from Medafor that it has terminated its HemoStase distribution agreement with CryoLife.

TCT: Weighing the risks and benefits of vascular closures

WASHINGTON, D.C.–Vascular closure devices can be successfully deployed and off-label devices not approved by the FDA can be used when they are evaluated on a patient-by-patient basis weighing the risks, benefits and cost, said D. Christopher Metzger, MD, of the Wellmont Holston Valley Medical Center in Kingsport, Tenn., during a presentation Sept. 24 at the 2010 Transcatheter Cardiovascular Therapeutics (TCT)  annual scientific meeting.
“The truth is, while we all try to use FDA-approved techniques and products, in the art of medicine, there come situations where there is no FDA approval out there to guide,” said Metzger. “In those cases, we have to individualize and use our clinical judgment and available evidence for the best interest of our patients.”
Often during peripheral artery intervention, a unique, alternative closure site is necessary when the usual route becomes blocked, Metzger said, “We often need popliteal artery access, radial access, large venous sheaths and the occasional puncture of the subclavian artery.”
With what Metzger called these “unique” accesses, he said that patients may benefit even more from closure devices due to the fact that often nurses are not familiar with pulling sheaths from these locations and the difficult nature of closure of some access sites, including the small popliteal artery.

Metzger explained that the antegrade popliteal artery or brachial arteries are harder to compress because of their smaller size. “If I open tiny arteries, I really don’t want you to sit there holding pressure for 15 to 20 minutes right after I finish it,” he said.
Metzger said that you must ensure that you are individualizing the risk/benefit ratio and costs prior to a procedure; use an angiogram to see whether or not you should use various devices; and individualize the closure devices to the particular patient artery.
Metzger offered that the Angio-Seal (St. Jude Medical) may not work best for smaller arteries like the brachial or popliteal arteries due to the size of the device left behind in the artery after closure. While he prefers using the Perclose ProGlide vascular closure system (Abbott Vascular), he said that you must be careful of the leading edge during peripheral work, particularly when maneuvering around a chronic total occlusion (CTO) or stent. He noted that the Perclose devices work best in the brachial arteries, popliteal arteries and sometimes even extravascular cases.
He also offered that the antegrade closure approaches are more complex compared with retrograde approaches because of the likelihood of puncturing the superficial femoral artery located in a higher position. However, Metzger noted that the Angio-Seal device may work best in these cases.
During popliteal artery access, Metzger said that a road-map approach is best  to puncture the artery in the right place. He and colleagues have used the procedure in almost 50 patient cases and have only had complications where a sheath needed replacement.
As for brachial access, he said that it is important to assess the artery and weigh the risks and benefit ratio of the procedure; however, he said that this procedure allows for the removal of larger sheaths while patients are fully anticoagulated, reducing the rates of thrombotic complications.
He noted that careful and accurate marking is most important when performing these closures so you ensure to not pinch a smaller artery closed and noted that the Perclose device may be best.
“Vascular closure devices can be used successfully in a large spectrum of  arterial and venous access sites off-label … the use of these devices has to be based on an individual assessment—the risks, benefits and costs, for each patient and their particular access site,” Metzger concluded.

Clinical trial establishes value of catheter-based aortic valve replacement

(HealthNewsDigest.com) - ATLANTA--A new way of replacing diseased aortic heart valves in patients too frail or sick to withstand the traditional open-heart surgical approach proved promising in a study published in the New England Journal of Medicine (NEJM).
Since October 2007, Emory University Hospital has been one of approximately 20 hospitals nationwide, and the only site in Georgia, studying the groundbreaking non-surgical treatment option for patients suffering from severe aortic stenosis. The life threatening heart condition affects tens of thousands of Americans each year when the aortic valve tightens or narrows, preventing blood from flowing through normally.
As part of the Phase II clinical trial, Emory Heart & Vascular Center cardiologists and cardiothoracic surgeons performed transcatheter aortic valve implantation (TAVI) comparing this procedure with traditional, open-heart surgery or medication therapy in high-risk patients with aortic stenosis.
The study followed 358 patients who received either catheter-delivered valves or standard non-surgical treatment. The findings showed that patients who had replacement heart valves delivered by catheter were more likely to survive a year than patients who were treated without replacing their original valves. According to the authors, catheter-delivered valves “should be the new standard of care” for patients who are not able to undergo surgery.
During the innovative TAVI procedure, doctors create a small incision in the groin or chest wall and then feed the new valve, mounted on a wire mesh on a catheter. Once the catheter is properly positioned in the opening of the aortic valve, the new valve is rapidly expanded. As it expands it pushes the diseased, native valve aside, allowing blood to flow normally through the implanted valve to the rest of the body.
“These results show great promise for patients with severe aortic stenosis and help us make a giant step forward in our battle against this common disease,” says Peter Block, MD, professor of medicine, Emory School of Medicine and principal investigator of the study at Emory. “They are especially important since the number of people with failing valves is expected to greatly increase as baby boomers continue to age.”
Aortic valve stenosis often occurs with age, most commonly among elderly patients over 70 years of age, but can surface earlier in life in those with rheumatic heart disease or congenital abnormalities of the valve. Patients often develop symptoms of chest pain, shortness of breath, fainting spells and heart failure.
Block and fellow interventional cardiologist Vasilis Babaliaros, MD, assistant professor of medicine at Emory University School of Medicine, led the Emory clinical trial along with their cardiac surgical colleagues Robert Guyton, MD, professor of surgery and chief, Division of Cardiothoracic Surgery, Department of Surgery, Emory University School of Medicine, and Vinod Thourani, MD, associate professor of surgery, Division of Cardiothoracic Surgery, Department of Surgery, Emory University School of Medicine.
Babaliaros spent several years abroad with French cardiologist Alain Cribier, MD, who successfully implanted the first catheter-delivered valve in 2002 in a seriously ill patient with aortic stenosis who had been refused for surgery. Babaliaros worked alongside Cribier to learn the new approach and bring it to the United States and to Emory.
Transcatheter aortic valve implantation is not yet approved by the U.S. Food and Drug Administration (FDA) and therefore is only available in a few centers throughout the country, including Emory, the first center in the Southeast and one of the five largest centers in the country. Approximately 90 patients have received new valves at Emory since the clinical trial started in 2007. It is anticipated that this valve will receive FDA approval in late 2011.

Reporting Adverse Events to MedWatch

Chinese hospital compensates patients hurt by fake Roche drug 

Eight arrested in China over fake rabies vaccines 

Avastin officially hits Chinese market after fake drug incident

Austrian authorities destroy more than 22000 fake medications sold online

Air/Gas Embolisms with Pressurized Spray Devices for Hemostasis

New F.D.A.: Transparence and Flexibility

WASHINGTON — During the Bush administration, the Food and Drug Administration was mostly a place of black-and-white decisions. Drugs were approved for sale or they were not, and the agency’s staff was expected to publicly support those decisions.
But as Thursday’s landmark decision on the controversial diabetes medicineAvandia makes clear, things have changed under the Obama administration. Certainty, staff unanimity and even the approval status of big-selling medicines are no longer so black and white.
Presented with what seemed to be a choice between keeping Avandia on the market or withdrawing it, the Obama administration decided on an unusual middle path — allowing sales, but with tight restrictions. Even more unusually, the agency admitted that many of its top scientists disagreed, some passionately. Competing memorandums were posted immediately on the agency’s Web site.
And the agency’s three top officials co-wrote a highly unusual explanation of their action in The New England Journal of Medicine.
Some of these changes have been in the works for years, but they have accelerated under the Obama administration, driven by increasingly sophisticated measures of drug safety and growing skepticism about whether the F.D.A. is making the right decisions and making them appropriately.
“I think that F.D.A.’s credibility really depends on being able to explain its decisions well,” said Dr. Joshua Sharfstein, F.D.A.’s principal deputy commissioner. “We can’t expect people to think that F.D.A. has decided, therefore it’s the right answer.”
Some of the changes have been driven by people like Dr. Steven Nissen, a cardiologist at the Cleveland Clinic whose 2007 analysis of Avandia’s heart risks stunned doctors, patients and legislators, who asked why the F.D.A. had not done anything similar. When the agency revealed it had done an almost identical analysis a year earlier and found the same result, the controversy intensified.
“You have these third-party analysts setting the agenda for the agency in ways that never happened before,” said Daniel Carpenter, an F.D.A. historian at Harvard.
For the F.D.A., the Nissen analysis presented major challenges. It demonstrated that the agency no longer had a monopoly on the information needed to make drug and device safety decisions. Data from crucial clinical trials are increasingly being posted on public Web sites. And academics are using sophisticated techniques to test whether popular medicines are safe.
In March, for instance, a team of academics found that a children’s diarrhea vaccine contained harmless but apparently extraneous pieces of pig virus. Blindsided, the F.D.A. had no idea what effect the particles would have. While the agency studied the problem, the commissioner, Dr. Margaret Hamburg, asked its maker to stop selling — a request she had little power to enforce.
Two months later, the agency allowed sales to continue.
Like the vaccine finding, the Nissen analysis flummoxed the agency because the science behind it was controversial. Dr. Nissen combined the results of many clinical trials to suggest that Avandia substantially increased heart risks. Other studies suggested that there were higher risks.
None of these studies met the rigorous standards that the F.D.A. demands when approving new medicines, but they were among the only information available to explore whether popular medicines contribute to common problems like heart attacks.
The agency was torn about how to interpret the studies, a problem it rarely faced until recently. “In the past, we would approve the drug after a couple of efficacy trials and that was it,” Dr. Janet Woodcock, chief of the F.D.A.’s drug center, said in an interview. “We didn’t know too much more about the drug. It was simpler.”
Now, sophisticated analyses present the F.D.A. with a complex picture. “It’s good for public health that we’re learning more, but it creates a more complex environment in which to regulate,” Dr. Woodcock said.
It is an environment in which top agency officials are in some ways at sea. The agency has no systems or standards to follow in deciding which studies deserve their attention or should lead to changes in a drug’s status. And since new tests are being created constantly, creating such a standard would be an ever-evolving process.
Dr. Lynn Goldman, dean of the School of Public Health and Health Services at George Washington University, said the F.D.A. was being forced to become more comfortable with studies done in academic rather than regulatory settings. “They have to get used to a less controlled environment,” Dr. Goldman said.
And the agency’s decision to create a unique distribution program for Avandia is not one it can repeat often or doctors and pharmacists — who must learn a new system for each program — will give up.
“We have to get some standardization,” Dr. Woodcock said, “or we’ll burn out the system.”

ENTrigue sell Gell into ENT - with Hemcon help

SAN ANTONIO, Sept. 23 /PRNewswire/ -- ENTrigue Surgical, Inc. ("ENTrigue"), a San Antonio, Texas-based company that designs, develops, manufactures and distributes medical devices used for Ear, Nose and Throat surgical procedures, announced today the first clinical experience with its Ventera™ sinus dilation systems.  The Company also announced that it will launch its Synaero™ Hemostatic Gel at the American Academy of Otolaryngology Annual Symposium and Exhibition ("AAO Meeting") in Boston, Massachusetts, September 26-29, 2010 attended by ENT surgeons from around the world.
The Ventera™ sinus dilation systems include a single-use balloon delivered by one of several reusable instruments utilizing ENTrigue's proprietary SerpENT® articulating technology and does not require the use of a guide wire or cannula for delivering the balloon into various sinuses.  The initial clinical cases were performed by Dr. Amin Javer, a world renowned rhinologist and Director of the St. Paul's Sinus Center in Vancouver, Canada.  ENTrigue is in an early-launch phase with the Ventera™ systems in Canada and plans to launch the systems to various European markets over the next few months.  The Ventera™ technology is not presently available for sale in the United States.
Dr. Javer remarked, "The Ventera systems offer an elegant and intuitive approach to sinus dilation.  I am excited about the potential these systems offer as minimally invasive tools for managing sinus disease."  
The Company's new Synaero™ product is a hemostatic gel used to control mucosal bleeding related to sinus surgery and was co-developed with HemCon Medical Technologies Inc., a leading global developer and manufacturer of hemorrhage control products headquartered in Portland, Oregon.  The Synaero™ Hemostatic Gel, as well as the Ventera™ sinus dilation balloon and related instruments, will be on display at the ENTrigue booth at the AAO Meeting.  
ENTrigue also announced the addition of John T. Treace to its Board of Directors.  Treace is Sr. Vice President of Global Marketing and US Sales at Wright Medical Technology, Inc. in Arlington, Tennessee, and served as Director of Marketing for Medtronic ENT for several years prior to Wright.  He joins current Board members Fred Dinger, President & CEO; Donald Gonzales, M.D., Chief Medical Officer; Richard Emmitt of The Vertical Group; and Anthony Natale, M.D. of Prism VentureWorks

Focused on Latest Clinical and Diagnostic Advances in Coagulation

BEDFORD, Mass., Sept. 23 /PRNewswire/ -- Instrumentation Laboratory (IL), today announced it will host the 2nd IL Asia Pacific Hemostasis Forum on Wednesday, October 13, 2010 at the Grand Hyatt Nusa Dua, in Bali, Indonesia.  The event will run from 8:00 am to 12:00 pm, local time.  The forum will focus on the latest clinical and diagnostic advances and trends in hemostasis.  All healthcare professionals, practicing in the Asia Pacific region are welcome to attend.  
Professor Karmel Tambunan, MD, PhD, from the Division of Hematology and Medical Oncology at the University of Indonesia, Jakarta will serve as Scientific Chairman of the Forum.  In addition, several prominent experts in the field will present key information and lead discussions during the Forum, including Professor Ismail Elalamy, MD, a Hematologist at the Hopital Tenon, Paris France;  Associate Professor Tatsuya Atsumi, MD, PhD, from the Graduate School of Medicine at Hokkaido University, Sapporo, Japan;  and, Associate Professor Chris Ward, from the Department of Haemotology and Transfusion Medicine at the Royal North Shore Hospital, Sydney, Australia.
Topics will include new approaches and developments in the diagnosis of Heparin-Induced Thrombocytopenia (HIT), as well as new and emerging markers for Antiphospholipid Syndrome (APS) and associated clinical challenges.
"We are so honored to have some of the leading clinicians from around the world sharing their expertise on HIT and APS management and diagnostics," said Santiago Ramos, Regional Manager for North East Asia.  "The Forum will address many of the key issues facing clinicians today and will provide new information to help them deliver the very best patient care."
About HIT
HIT is a severe immune reaction to Heparin that can result in the paradoxical development of a thrombotic event.  One of the most common of all adverse drug effects, due to the sheer volume of patients receiving Heparin therapy (over 12 million patients annually in the US alone), it has a significant impact on anticoagulant management in hospitals worldwide.  If left untreated, patients with HIT may develop serious sequelae, including pulmonary embolism, myocardial infarction, or death.
Registering to Attend
Through October 1st, 2010, individuals can register to attend this Forum, by contacting Carol Lee, at wbj@werfen-china.com

Z-Medica Signs Distribution Agreement With Biomedica

Z-Medica Corporation, a medical device company developing innovative hemostatic agents, today announced that it has signed an exclusive distribution agreement with Biomedica, a leading Central European medical device distributor, for the hospital and Emergency Medical Services (EMS) markets in Austria, Hungary and Switzerland. Biomedica has strong relationships in the fields of cardiology, cardiac surgery, orthopedics and trauma and general surgery, among other specialties.
QuikClot® products received CE Mark from the European Union in November 2009 and the company has been negotiating distribution agreements with a series of best-of-breed medical device distributors such as Biomedica in European markets since then.
“We are very pleased that we have signed this distribution agreement with Biomedica because of their strong relationships, local sales presence and customer support in Austria, Hungary and Switzerland,” said Brian Herrman, Chief Executive Officer, Z-Medica. “Their focus on cardiology, orthopedics and trauma will be key to getting QuikClot into the hands of surgical practitioners and first responders for the first time in this region, so that they and their patients can benefit from QuikClot’s ability to achieve hemostasis safely and rapidly.”
QuikClot is a surgical gauze impregnated with kaolin, an inert mineral with no known contraindications, and can achieve hemostasis in severe bleeding situations in as little as three minutes. QuikClot is widely used throughout several clinical specialties, including cardiology, interventional radiology, critical care, dermatology, emergency medicine, orthopedics and OB/Gyn, and after months of testing against 12 other hemostatic products in the marketplace, the military version of the kaolin gauze (“Combat Gauze”) was chosen as the exclusive product for use by all US Military Forces in 2008. It continues to be the exclusive product used by all USA military forces for first line treatment of bleeding hemorrhage.
“We are very pleased to add QuikClot to our product portfolio,” said Dr. Stefan Marenzi, Managing Director of Biomedica. “We believe that the product will be well-received by our clients across several different specialties.”

St. Jude Says Data Reveals Excellent Sealing Performance Of Angio-Seal

(RTTNews) - Medical devices companySt. Jude Medical, Inc. (STJ: News ) Tuesday said subset data results for the Angio-Seal Evolution Vascular Closure Device Registry reaffirmed the excellent sealing performance of the Angio-Seal Evolution vascular closure device in patients undergoing routine diagnostic and interventional cardiac catheterization procedures.
The Angio-Seal Evolution device is designed to enable physicians to quickly and effectively seal femoral artery punctures made during minimally invasive catheter-based procedures.
The company noted that the results validated the exceptional performance of the device after being successfully deployed in 99.7% of procedures and with hemostasis achieved in 97.8% of these procedures by the device.
This new subset analysis strengthens those findings by demonstrating no significant difference in deployment success or hemostasis for patients with challenging conditions that might negatively impact device performance, such as obesity and scar tissue at the vascular access site, the company added.

Outsourced Big Pharma and Device Industry.......The Wild West of Blood, Yippee-I-aye!

The financial crisis of the past 18 months has put increasing pressure on drug and pharmaceutical companies to look more closely at their return on investment for R&D. This has led them to narrow the range of projects they believe will bring the best returns.
There has also been a change in the way these companies operate. About a third of the compounds they use now originate from outside the company, a figure that was previously close to zero.
"Within a few years, this could be as high as 70%," says Julian Remnant, director of life sciences for Deloitte. "They are finding the best science is coming from external laboratories."
In parallel, there is a huge push to look at the cost base of R&D. Pharma want these costs to be predictable, something that is hard to achieve when the research is carried out internally. Outsourcing, in contrast, can be done at a fixed cost.

Currently, blood products in China are totally divided into 9 categories from the type of product which is less than the developed countries. Besides, only several manufacturers can produce all the types at the same time. In recent years, the size of the market developed with an annual growth rate of 15%-20%. In 2007, the scale of China blood product market broke through 6 billion RMB Yuan mainly because of the annual growth of the human serum albumin market which takes 80% of China blood market. However, the demands of China blood product market can’t be well satisfied all along. An important reason is the short collection of the plasma raw materials caused by the policy factors. Domestic blood product manufacturers are small-scale enterprises basically, which has holdups including funds, technology, raw materials, and so on. Compared to the global blood product market, China has a very small proportion. However with the sustained economic development and the enormous population, China market has tremendous potential. 

Changing processes
Alongside this trend, the pharmaceutical industry is also in a state of flux as it shifts its base from chemical molecule-based products to biological ones, bringing with it different manufacturing techniques, a lot more clinical trials and an increase in costs that an industry already facing pressure to reduce prices is finding hard to sustain.
"There is a huge push to look at the cost base of R&D. Pharma want these costs to be predictable, hard to achieve when research is carried out internally."
This combination has led some companies to look at the option of outsourcing key functions to more cost-effective parts of the world, notably India, Southeast Asia and Latin America.
"The processes for biological trials are a lot more stringent," says Swetha Shantikumar, an analyst with Frost & Sullivan. "A lot more data needs to be gathered, and the costs of this are high in Europe or the USA. Yet there is cheaper manpower and similar facilities in some of the emerging markets."
On top of this, many common drugs will soon be reaching the end of their 20-year patent protection, and companies are hoping to jump in on this and start manufacturing them cheaply, a task that may prove too expensive in western countries. Add to that a desire for cheaper generic drugs and it is clear why some companies have looked to outsourcing.
"Healthcare costs are hitting the roof," says Shantikumar. "They want more generic drugs cheaper, so there is more pressure to outsource."
Patient pools
The governments of China and India are aware of this and are setting up facilities that are compliant to western standards to attract western drug companies, while the government in Brazil is setting up similar infrastructure so it too can get a share of the pie.
"India has the advantage that the gene pool of patients is very similar to the West, so clinical trial results will be similar," says Shantikumar. "This makes the approval process quicker."
The patient profile in some of these countries is wider than in the West, which can be an advantage for clinical trials. For example, China has a massive population and, particularly in rural areas, a lower standard of healthcare. This results in a large number of ill people and thus a ready audience for clinical trials.
It's a process that also benefits the Chinese people as the government is keen to set up more rural hospitals. Setting up combined facilities that can carry out clinical trials and act as local hospitals is seen as a way to let the West partly fund their creation.
"The financial crisis in the West has led to a lot of people heading back to their own countries."
"Western companies want to participate in the growth in healthcare in these markets," says Remnant. "There is also a lot of scientific talent in these markets."
The cost per patient for conducting clinical trials in these countries is significantly less than in the West. It is also seen as a long-term investment to be in growing markets for healthcare. Having facilities in these countries makes it easier for launching and selling products to their markets and in some cases regulations insist that the trials of drugs have to be carried out locally for the drug to be made available.
Developing countries are also able to capitalise on what is becoming known as the brain gain. Over the years, many of their top scientists and medical staff have been lured away from these countries by the higher earning potential of the West. Setting up research laboratories and more medical facilities on home soil is encouraging some to return to their countries.
"They are coming back and bringing knowledge with them," says Shantikumar. "Also, the financial crisis in the West has led to a lot of people heading back to their own countries."
IP and compliance
One big drawback for international companies, notably China, has been IP protection. Counterfeiting of almost every product has been a major problem in many Southeast Asian countries and has put off international companies from investing in these areas. But the situation is improving and the Chinese government in particular is making big strides to tackle this issue.
"The government wants to improve the situation so foreigners will be comfortable in investing," says Shantikumar. "Previously, there were a lot of security issues. The Indian IP system is stronger than China's but both are trying to improve."
"China has a massive population and a lower standard of healthcare. This results in a ready audience for clinical trials."
India has a language advantage over China when it comes to attracting western companies because far more of its population speak English.
A disadvantage for all these emerging outsourcing locations is that physicians are not as familiar with the clinical trial process as they are in the West, but that situation is improving.
"There are also disadvantages because of lax regulations," says Aparna Krishnan, senior research analyst at IHS Global Insight. "If they work with local industry, there is a danger of supplies being contaminated because standards are not adopted. This is the main worry. It makes more sense for them to set up their own facilities so they can maintain standards."
Remnant agrees: "There are quality issues. The level of compliance is not as high as in the West."

EU Lacks Transparency In Adverse Event Reports

The regulatory considerations for the US are often cited as so rigorous that they delay valued technologies reaching the market. However weak EU vigilance and a systemic vision for EUDAMED lacking transparency earmarks all EU individuals as easy victims for massive medical device testing and product failure.
In todays world of outsourcing of Medical Device production to manufacturing wild west territories such as India and China concerns should be creating a greater need for vigilance and freedom of public access. And yet Eudamed state:

Who can access Eudamed?

Eudamed is a secure web-based portal acting as a central repository for information exchange between national competent authorities and the Commission and is not publicly accessible. Eudamed is currently being used by a number of Member States on a voluntary basis and will be obligatory as from May 2011.

However the public are not to be informed, it would seem reasonable for a patient or physician to have available adverse event reports (proven or not). It seems EU citizens will not have this visibility.......WHY???
Fundamentally the EU lacks transparency for both patients and physicians in terms of adverse event reports, it also lacks clearly defined regulation of notified bodies and along with this does not indicate clear packaging notification of origin of country production. A company registered anywhere in the world may not be required to specify their product is produced, packaged and sent from India, China or Timbuktu. 

All of this also begs the question of "What events happen in Mexico, Yemen and beyond?". The case for Global Harmonisation is an issue often discussed but will ultimately be driven by a disaster.

The following Belgian Document (French initially, but English follows) highlights major concerns.

Blood Banking & Blood Products Market to Reach US$36 Billion by 2015

San Jose, CA (Vocus) September 7, 2010
The global market for blood banking and blood products is exhibiting a healthy trend. New infections continue to take a toll on the population across the world, fueling the demand for blood banking and blood products. Regulatory, and healthcare bodies across the world are adopting stringent policies relating to blood safety. As an extension to this, manufacturers are working on developing improved, safer, and advanced blood-banking technologies for the collection, processing and delivery of blood products, further adding fuel to market growth.
The US constitutes the largest regional market for blood banking and blood products, as stated by the new market research report on Blood Banking & Blood Products. In the United States, while 2% of the population receives transfusions annually, another 15% undergo transfusion at least once in their lifetime. On an average, around 50-70 million units of blood, and blood components are transfused in developed countries every year. The developed markets are characterized by increased levels of public awareness, sophistication of blood collection technologies, and governmental support. While developed countries bank blood resources to suffice about 80% of their needs, blood supplies in the developing countries just suffice 40% of the requirements.
Increasing population in developing countries such as India and China, puts pressure on demand for blood on the blood bank segment. Governments of these countries are focused on enhancing healthcare delivery, which includes the blood bank segment. Resultantly, Asia-Pacific is projected to emerge as the fastest growing regional market over the analysis period.
Though blood and blood products provided by blood banks are free from viruses, bacteria, and other disease causing microorganisms, safety has become the main issue the world over. Risks involved in blood transfusion have also become a major issue in the blood banks, and blood products industry. Many companies are now visualizing blood decontamination as a step towards blood safety and availability. Though the process does not do away with the traditional blood screening, and donor exclusion programs, it is expected to prevent infected transmission. New processes are being developed to make blood supply safer. Areas such as blood filtration, and pathogen passivation methods are witnessing development. The need for safe, and suitable blood has been the driving force behind the blood banking, and blood products industry.
The global Blood Banking & Blood Products market is dominated by Blood Components and Plasma Products. The market for blood components and plasma products comprise of whole blood & cellular components, and plasma fractions. Equipment, blood tests, and other consumables are forecast to witness a compounded annual growth rate of more than 4.0% during the analysis period.
Leading blood banks profiled in the report include AABB, America’s Blood Centers, American Red Cross, Canadian Blood Services, Japan Red Cross Society, Lifebank Corp., New England Cord Blood Bank Inc., New York Blood Center, National Blood Foundation, among others. Major players profiled in blood bank technology and supplies space include Beckman Coulter Inc., Becton, Dickinson and Company, CSL Behring LLC, Daxor Corp., Fenwal Inc., Haemonetics Corp., Talecris Biotherapeutics, and ThermoGenesis Corp. Key players in plasma fractionation includes Baxter International, Bio Products Laboratory, CSL Ltd., Grifols, Kedrion, Octapharma, Sanquin, and others.
The report titled “Blood Banking & Blood Products: A Global Strategic Business Report” announced by Global Industry Analysts Inc., provides a comprehensive review of the blood banking and blood products market, current market trends, growth drivers, impact of recession on the industry, segment market analysis and potential, new product introductions/innovations, recent industry activity, and focus on major and niche global as well as regional market participants. The study analyzes market data and analytics in terms of value sales for global as well as regional markets including the US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World. Product segments analyzed include Blood Components and Plasma Products (Whole Blood & Cellular Components, and Plasma Fractions), and Whole Blood & Cellular Components.
For more details about this comprehensive market research report, please visit –http://www.strategyr.com/Blood_Banking_and_Blood_Products_Market_Report.asp

HemCon Medical Technologies Will Appeal Patent Judgment

PORTLAND, Ore.--(BUSINESS WIRE)--HemCon Medical Technologies, Inc., announced today that it will appeal a permanent injunction entered by a US District Court in New Hampshire based on a patent held by Marine Polymer Technologies, Inc. The injunction enjoins further manufacture, use and sale of HemCon’s HEMCON® BANDAGE, CHITOFLEX® DRESSINGS, HEMCON® DENTAL DRESSINGS and any other products which are no more than colorably different from those products. HemCon intends to file a motion for an emergency stay of the injunction during the pendency of the appeal."HemCon will urge on appeal that the Marine Polymer patent is not infringed and/or is invalid, and ask the appellate court to overturn or vacate the judgment. We firmly believe that the lower court made the wrong decision and we are hopeful that the Court of Appeals will correct this and find that HemCon’s products do not infringe the patent or that the patent is invalid,” said John W. Morgan, HemCon's President and Chief Executive Officer.
Marine Polymer sued HemCon in 2006, alleging that HemCon had violated its patent covering a biocompatible chitosan compound. Marine Polymer’s patent describes a chitosan compound that is derived from the sterile culturing of marine micro algae.
HemCon uses a chitosan compound to manufacture highly effective bandages that have been used in battlefield conditions by the U.S. military, among others. HemCon does not use chitosan that is derived from sterile culturing of micro algae, as described in the Marine Polymer patent.
HemCon has separately initiated a proceeding to reexamine the validity of the patent through the US Patent & Trademark Office. In 2009, HemCon filed a request with the Patent Office to reexamine, and possibly invalidate or limit, Marine Polymer’s patent in light of prior publications about chitosan. The Patent Office granted the Request for Reexamination in November 2009. On April 1, 2010, the Patent Office issued a first office action, rejecting all claims of Marine Polymer’s patent. Marine Polymer has filed a response canceling some patent claims and arguing that the remaining claims are valid as originally issued.

Interventional Therapies receives CE mark on Quick-Close® II

(I-Newswire) September 17, 2010 - WESTPORT, CT: Interventional Therapies announced today that it received CE mark for its advanced second generation Quick-Close II.

The Quick-Close® II is the second generation of the FDA approved and CE marked Quick-Close® vascular closure device. It features ergonomic enhancements, increased ease of use, reduced learning curve and increased adoption rates. 
Quick-Close® is approved for use in femoral arteriotomy closure in both diagnostic and interventional endovascular procedures using 5F to 8F sheaths. Quick-Close®, by design, allows for simple, verifiable, and consistently safe vascular closure with the additional safety of a monfiloment suture closure. The device allows the user to have a safety check at each step, ensuring proper percutaneous placement and function. Quick-Close® requires less deployment steps and user dexterity than existing devices. 
Quick-Close® has proven to significantly reduce time-to-hemostasis and time-to-ambulation. In the Quick-Close® pivotal trial involving 367 patients, median time-to-hemostasis was one minute. 
“We are pleased with the continued progress of the vascular closure product line,” said Bob Knarr, President and CEO of Interventional Therapies. “The second generation VCD forms the foundation for the Quick-Close® Multi-Close™ device, uniquely designed for percutaneous large bore closures of arteriotomies up to 24F.” 

U.S. FDA advisory meeting - TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES ADVISORY COMMITTEE

On Oct. 28, the committee will discuss FDA's risk assessment for potential exposure to the variant Creutzfeldt-Jakob disease(vCJD) agent in U.S.-licensed plasma-derived Factor VIII and labeling of blood and blood components and plasma-derived products, including plasma-derived albumin and products containing plasma-derived albumin, to address the possible risk of transmission of vCJD.
On Oct. 29, the committee will hear informational presentations related to FDA's geographic donor deferral policy to reduce the possible risk of transmission of CJD and vCJD by blood and blood products and human cells, and tissue and cellular and tissue based products. The committee also will hear updates on the development of devices to remove transmissible spongiform encephalopathy agents from blood components and chronic wasting disease.

DATE: Oct 28-29, 0830/1230

LOCATION: Holiday Inn, 2 Montgomery Village Ave., Gaithersburg, Md.

CONTACT: Bryan Emery or Rosanna Harvey, 301-827-0314

Z-Medica launches new trauma kit

WALLINGFORD, Conn., Sept. 15 (UPI) -- A new hemostatic trauma kit to quickly stop bleeding is now available to law enforcement agencies around the United States.
Z-Medica, which has headquarters in Connecticut, this week launched its QuikClot Belt Trauma Kit designed for law enforcement agencies and said it can achieve hemostasis in severe bleeding situations in as little as three minutes.
"We understand that law enforcement officers often face situations that involve traumatic bleeding where emergency medical care is not available, so we designed a practical tool to help them almost immediately stop uncontrolled bleeding," said Z-Medica Chief Executive Officer Brian Herrman. "The new QuikClot Belt Trauma Kit includes the QuikClot product that every U.S. soldier carries, and which many law enforcement officers are already carrying, combined with all of the tools needed to stop traumatic bleeding in a lightweight pack."
The 5.75-inch-by-4-inch kit includes either QuikClot First Response or QuikClot Combat Gauze, plus SWAT-Tourniquet, a cardiopulmonary resuscitation shield and gloves. The kit is designed to be worn on an officer's duty belt along with other gear, taking up little space.

Global market for surgical hemostats gets bloody!

By showing the pie chart below, with all of its overlapping labels and clutter, we do so not out of any lack of graphing skills but as a blunt reflection of how competitive the global market for surgical hemostats has become.

The number of competitors in this field has rapidly multiplied, driven by the relatively low barriers to market entry and the recent market success of a range of different hemostat product types that are being steadily adopted in clinical practice.  Hemostats have become accepted tools in the armamentaria of surgeons, both as stand alone products for stopping bleeding of traumatic and surgical wounds and as adjuncts to other wound sealing and closure technologies.
The natural course of proliferation inevitably leads to market consolidation and this is the short term prospect for products in hemostasis as well established players seek to literally buy greater market share and broaden their product portfolios.

Source: MedMarket Diligence, LLC; Report #S180 (pending publication).

Society For the Advancement of Blood Management - 2010 AGM

Powder Hemostatic Medical Devices Segment

To date there are many types of Hemostatic Medical Devices on the market, there are also a plethora of formats utilized e.g. gauze, liquid, pastes and powders. Today I will introduce a list of powders, and while not comprehensive it is indicative of current technologies available to the surgeon. Initially Oxi Cell, Gelatin and Avitene powders were the main products. However now Chitin, and Starch/polysacharides have increased in visibility originally, and now with a very large program of out-licensing of the same technologies under different names. Powders face application and procedural technique issues, as do all formats. Over the following weeks I would like to explore needs, demands and evaluate these systems. Repetitive technology re-branding is also something I hope Blog followers will offer further thoughts on, another item to be considered is sourcing, manufacturing source such as China and due diligence of some of these companies. If you wish to contribute experience or thoughts please feel free to contact me at hemostatguy@gmail.com. We will also explore geographic factors, manufacturing,. distribution and due diligence

Pro Fibrix - Fibrocaps thrombin fibrinogen
 A dry powder based on a mixture of fibrinogen and thrombin, Fibrocaps is a ready-to-use preparation designed to be stable at room temperature and applied in different formats. This is a product and company that shows innovation! Pro Fibrix feel free to contact me.....hemostatguy@gmail.com

HemostasisLLC - Starch

BioCer Entwicklungs-GmbH is a Bayreuth, Germany based company which commercializes innovative technologies developed in conjunction with leading German Research Institutes and Universities.
Biocer have the most powerful of the plant based Starch products with HaemoCer Plus which was commercialized in Q3 2013. The video shows HaemoCer Pl;us compared to the other powdered polysaccharides with double speed and double absorbency. 

Starch Medical - PerClot Starch (AKA OrthoClot)
Absorbable Modified Polymer (AMP™) Chinese technology is a proprietary engineering process that modifies plant starch into ultra-hydrophilic, adhesive forming hemostatic polymers. AMP™ materials are biocompatible, absorbable polysaccharides containing no animal or human components. 

ClotPlus - OrthoClot Starch (AKA PerClot)
OrthoClot™ China made Polysaccharide Haemostatic System Administrator (PHS) is a natural plant-based haemostatic system composed of Absorbable Modified Polymer (AMP™). OrthoClot™ is intended as an absorbable haemostatic system

Medafor - Arista Starch (Outlicensed as Hemostase and Vitasure)
Arista™AH is an absorbable hemostat, based on Medafor's patented MPH® (Microporous Polysaccharide Hemospheres) Technology that is used in the control of profuse bleeding in general surgery when conventional procedures are ineffective or impractical.

CryoLife - Hemostase starch (AKA Arista and Vitasure) 
HemoStase is a plant-based powder that rapidly dehydrates blood and promotes clotting on contact.

Orthovita - Vitasure Starch (AKA Arista, Hemostase)
Vitasure Absorbable Hemostat is comprised of many powerful polysaccharide spheres packaged within a bellows applicator.






Celox - Chitin
Celox™ is made with chitosan, a natural polysaccharide. Chitosan has a known metabolic pathway. That means any left in the body is broken down by the bodies normal enzymes and converted into materials normally present in the body.

Hemcon (Alltracel) - Oxi Cell

Davol - Avitene

Ethicon - Gelatin Powder