CryoLife Appoint D.P. Lang - VP Market Development

ATLANTA, Oct 04, 2010 /PRNewswire via COMTEX/ -- CryoLife, Inc. (CRY 6.17, +0.17, +2.83%), an implantable biological medical device and cardiovascular tissue processing company, announced today that it has appointed David P. Lang as vice president of market development for CryoLife International Inc. In this newly created position, Mr. Lang will have responsibility for coordinating and developing the international marketing and distribution strategies for PerClot, a novel hemostatic agent that the Company recently licensed from Starch Medical Inc. Mr. Lang will report to Gerald B. Seery, senior vice president sales and marketing and president, CryoLife International, Inc.
A graduate of Harvard University with a degree in economics, Mr. Lang began his career at Medtronic in 1970 and has held sales and marketing positions of increasing responsibility throughout his medical device marketing and management career. From 2008 to 2010, Mr. Lang served as the president and was a consultant to Starch Medical Inc. He served as vice president of international sales and marketing for Medafor, Inc. from 2001 to 2008, where he established their European, Latin American and Asian distribution networks.

Kraig Biocraft Laboratories Announces Application for Trademark of Spider Silk ...

LANSING, MI, Oct 05, 2010 (MARKETWIRE via COMTEX) -- Kraig Biocraft Laboratories, Inc.(KBLB 0.15, +0.03, +22.92%) announced today that that it has filed intent to use applications with the US Patent and Trademark office seeking registration of numerous marks for the purpose of branding recombinant silk fibers.
"The Company views branding of our recombinant silk to be just as important as it is with any other product line. It is anticipated that the proposed marks will enhance product marketability and distinguish our advanced technology from other fibers in the marketplace," said Kim Thompson, the Company's CEO and founder. "This is just the beginning of the Company's efforts to further distinguish itself in the market place as we move toward the commercialization of our technology."
The intent to use applications included seven separate proposed marks including Spiderpillar(TM) and Monster Silk(TM).
The Company recently announced the successful development of recombinant spider silk based fibers using genetic engineering. 
The Company will also hold a shareholder press conference on Friday, October 8, 2010 at 4:30 p.m. EDT and will issue a reminder press release the morning of the conference call, which will include the phone number and access code instructions.

Nordson Corporation Enters Agreement to Acquire Micromedics, Inc.

WESTLAKE, Ohio, Oct 05, 2010 (BUSINESS WIRE) -- Nordson Corporation (NDSN 75.00, +3.31, +4.62%) today announced it has entered into a definitive agreement to acquire St. Paul, Minnesota-based Micromedics Inc., a leader in applying and dispensing biomaterials for controlling bleeding, healing wounds and other related medical procedures. Terms of the deal, which is expected to close within approximately 30 days, were not disclosed.
"The Micromedics acquisition fits Nordson's growth strategy of purchasing high performing market leaders with differentiated technology and a significant recurring revenue stream," said Nordson President and CEO Michael F. Hilton. "Micromedics extends Nordson's expertise in precision dispensing technology and helps grow our existing position in the rapidly expanding medical device industry. The market for biomaterial applicators in particular is expected to continue growing due to an expanding range of applications, the continuing introduction of new types of biomaterials, and more widespread reimbursement for procedures using these products."
"The functionality, ease of use and recognized performance advantages of Micromedics products provides significant differentiation in the market and drives customer loyalty," said Micromedics President Curt Miller. "Nordson's global presence, technology leadership and ability to invest should enable Micromedics to build on these strengths, expand its position as a leading provider in the global medical device market, and provide its employees with multiple opportunities for growth."
Micromedics bioapplicator products are marketed under the name FibriJet and include single and dual syringe applicators modified with interchangeable tips for the particular needs of specific surgical procedures. The products enable the controlled dispense of a single material or simultaneous dispense of two materials to a localized treatment site with simple, one-handed operation. The products are sold to a wide variety of end customers, including distributors, surgeons, OEMs, hospitals and outpatient clinics.
The acquired business will be integrated into Nordson's Advanced Technology Systems segment. Additional Micromedics product lines related to ear, nose and throat applications and surgical instrument protection are not being acquired by Nordson and will be spun out prior to close as a new company called Summit Medical Inc.

The Mysterious Case of Kevin Xu - “businessman” Kevin Xu’s efforts to sell counterfeit pharmaceuticals including Plavix

Dan Rather and Pfizer expose a counterfeit drug dealer; IBM touts its technology in an anti-counterfeiting commercial.
Traditionally, fall ushers in a new season of television sitcoms and dramas. The ongoing drama of counterfeit drugs was again exposed in “Dan Rather Reports, The Mysterious Case of Kevin Xu,” an investigation into Chinese “businessman” Kevin Xu’s efforts to sell counterfeit pharmaceuticals including Plavix. PharmaManufacturing.com shows HDNet’s independent news organization’s video of the report, which credits Pfizer with exposing Xu.
A 34-page transcript of Rather’s 9/14/2010 report (Episode 528) is also available at HDNet. In it, John Clark, Pfizer’s global head of security, reports that China is often a source of counterfeit drugs and packaging.

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

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