HemCon Medical Technologies Introduces GuardIVa™

PORTLAND, Ore., and DUBLIN, Ohio, June 23, 2010 — HemCon Medical Technologies Inc. today announced the launch of the HemCon© GuardIVa™ Antimicrobial Hemostatic IV Dressing, the only antimicrobial dressing containing both a hemostatic compound and the antiseptic agent chlorhexidine gluconate (CHG). The company also announced a five-year sole-source distribution agreement with Cardinal Health to provide the new dressing to hospitals and surgery centers in single sterile units and within Cardinal Health Presource® procedure packs.

Because of its proprietary hemostatic compound, GuardIVa can be used in the first 24 hours after placement of IV devices to control bleeding and provide immediate antimicrobial protection to the IV site. GuardIVa is also able to absorb up to 11 times its own weight in fluid, reducing the need for frequent dressing changes.

GuardIVa’s CHG base also provides more effective and sustained antimicrobial activity over a seven-day span than the silver base used in other antimicrobial dressings.¹ The use of CHG-based dressings helps protect against micro-organisms such as Methicillin-resistant Staphylococcus aureus (MRSA) and Methicillin-Resistant Staphylococcus epidermidis (MRSE).

“GuardIVa’s superior hemostatic and antimicrobial qualities reduce the need for frequent dressing changes and provide a complete and cost-effective solution to help drive patient safety and IV site infection management,” said John W. Morgan, CEO of HemCon Medical Technologies, Inc. “We’re excited to be able to partner with Cardinal Health to extend this complete IV site care solution to its customer base of infection specialists and health care professionals leading the charge for infection control.”

Central Venous Catheters (CVCs) and Peripherally Inserted Central Catheters (PICCs) are among the ideal applications for GuardIVa.

“We know there is a heightened focus on infection prevention, especially as it relates to catheter-related bloodstream infections,” said Debra Schotz, senior vice president of Patient Care at Cardinal Health. “By including GuardIVa in our portfolio in addition to our full line of Presource standard and custom kits, we’re helping our customers comply with recommendations from the Institute for Healthcare Improvement calling for maximal barrier protection and a kit or central line bundle to improve compliance for catheter insertion and maintenance procedures.” ²

For product information, Cardinal Health customers should contact their nursing products or Presource sales representative. Information is also available through Cardinal Health by calling Jaime Simon at (614) 553-4663 for single sterile use or Crystal Humphreys at (614) 553-5263 for in-kit use.

Filtering donor blood cuts cardiac risk, lung complications

Washington, June 22 (ANI): Scientists have found another reason to filter the foreign white cells from donor blood-it dramatically reduces cardiopulmonary complications for patients who received a transfusion.
The study by researchers at the University of Rochester Medical Center (URMC), is the latest in a large body of work led by Dr. Neil Blumberg, who for 25 years has been investigating the benefits of filtering or washing blood to create safer, simpler approaches to transfusion therapy.
The observational study was conducted during the seven years before and after 2000, when the URMC introduced universal leukoreduction, a process that filters the white cells from blood to be used for transfusions.
Researchers looked at the number of reports of transfusion reactions during the 14-year period, and divided them by the total number of blood components transfused (778, 559).
Rates of acute, transfusion-related lung injury dropped 83 percent in the years after filtering took place, and transfusion-associated circulatory overload declined 49 percent, when compared to the rates prior to the year 2000.
Both conditions are rare, but are among the most common causes of death following a transfusion.
"These data are very exciting because we described two unexpected and unexplained associations between adverse reactions and leukoreduction. However, our observations do not prove cause and effect, and therefore require further investigation before we can say with certainty that leukoreduction is responsible for so many fewer cardiopulmonary complications," said Blumberg.
The Centers for Disease Control and Prevention is introducing a new blood surveillance system to track severe transfusion reactions, which should provide more detailed information to support or refute the study, said Blumberg.
Earlier, the researchers have shown that the odds of post-surgical infection and death are greatly reduced by leukoreduction.
White cells from donor blood can attack the immune system of the blood recipient; removing them diminishes the chances of an inflammatory response or infection, according to Blumberg's research.
The study is published online in the journal, Transfusion.

Investigators Perfect New Version of Blood-Regulator Thrombin

ST. LOUIS, June 18 /PRNewswire-USNewswire/ -- In research led by a Saint Louis University investigator, molecular biologists have discovered a way to harness the enzyme thrombin's anti-blood clotting properties. The finding opens the door to new medications that will treat diseases related to thrombosis, the presence of blood clots in blood vessels, which is responsible for nearly a third of all deaths in the U.S.

"Thrombosis is one of the most prevalent causes of fatal disease," said lead researcher Enrico Di Cera, M.D., chair of the department of biochemistry and molecular biology at Saint Louis University School of Medicine. "If we could develop an anti-thrombotic drug that didn't carry a risk of hemorrhage, it would revolutionize the treatment of cardiovascular disease, the leading cause of death in the U.S. and Western world.

"This research carries us closer to that goal."

Blood clotting has long ensured our survival, stopping blood loss after an injury. On the other hand, if triggered in the wrong conditions, clotting can lead to debilitating or fatal conditions like heart attack, stroke and deep vein thrombosis.

Funded by the National Institutes of Health, and published in the June 18, 2010 edition of The Journal of Biological Chemistry (Vol. 285. No. 25), researchers zeroed in on thrombin, a vitamin K-dependent enzyme key to blood coagulation.

An unusual enzyme, thrombin performs distinct and even opposing functions, acting as a pro-coagulant, pro-thrombotic but also as an anti-coagulant factor depending on which target protein - fibrinogen, PAR1 or protein C - becomes activated in the blood. Researchers studied thrombin to decipher the structure-function code that enables this protein to do so many different things.

Tackling this problem far below the level of tissue and organs, molecular biologists looked deep inside the structure, examining thrombin's amino acids to note how they behave and interact with each other.

Using protein engineering, researchers produced mutations in the enzyme's amino acid sequence, carefully taking out pieces and replacing them, a few at a time, to find the exact locations that influence the function of thrombin. Once they found these "hot spots," researchers went even further - trying each of the 20 natural amino acids to see which mutation would allow them to turn on and off the pro-coagulant, pro-thrombotic and anti-coagulant functions.

"We asked the question, what if we can take this enzyme and dissociate the functions, allowing only the function we want?" said Di Cera.

In earlier research, Di Cera's team did just that. They engineered thrombin to promote activity toward protein C - the anticoagulant target protein - and minimize activity toward fibrinogen and PAR1 - the procoagulant and prothrombotic targets.

"In 2000, we engineered a thrombin mutant with potent anticoagulant properties both in vitro and in vivo and we are moving this mutant to a phase I trial," said Di Cera. "In this study, however, we pressed further. We wanted to optimize this mutant to completely abrogate activity toward fibrinogen and PAR1."

"With this research we optimized the mutant so that there is no clotting at all. Furthermore, we generated a new mutant with exclusive prothrombotic activity, thereby demonstrating that the individual functions of thrombin can be dissociated by replacing a single amino acid in the protein."

Once clinical trials are performed, researchers hope to have developed an alternative to heparin, a blood thinner that is used to prevent blood clots and is often used before surgery, but which also causes allergic reactions, dosage challenges and bleeding.

"Heparin is a brute-force remedy that shuts down all thrombin functions, including its beneficial anti-coagulant role," said Di Cera. "Our approach is a new strategy that like a smart bomb only targets the functions we want to turn off."

Established in 1836, Saint Louis University School of Medicine has the distinction of awarding the first medical degree west of the Mississippi River. The school educates physicians and biomedical scientists, conducts medical research, and provides health care on a local, national and international level. Research at the school seeks new cures and treatments in five key areas: cancer, liver disease, heart/lung disease, aging and brain disease, and infectious disease.

No More Hemostase - Marriage from Hell ends

Under the headline "Medafor Shareholders Crush Cryolife" a new article, states ....." Medafor has decided to end its distribution relationship with CryoLife. Over the past 24 months Medafor has supplied CryoLife with its flagship product—a patented absorbable hemostasis powder which promotes rapid clotting. According to CryoLife CEO Anderson, losing the rights to distribute Medafor’s innovative hemostat will cost the company as much as $6 million in lost annual revenues.

It is probably worth noting that in 2009 CryoLife reported a precipitous decline in reported after-tax earnings from $32.9 million (2008) to $8.6 million (2009). CryoLife’s COO stated that losing the Medafor product would materially adversely affect CryoLife.

In retrospect, one has to ask the question: What were the guys at CryoLife thinking? Not only is roughly $6 million flushed away but now they will lose one of the strongest product lines."

The full article is available HERE

ProFibrix and CSL Behring Enter Into Fibrinogen and Thrombin Supply Agreement

LEIDEN, The Netherlands and SEATTLE, June 17, 2010 /PRNewswire/ -- ProFibrix B.V., a leader in the development of innovative products for hemostasis and regenerative medicine, today announced that it has entered into an agreement with CSL Behring for the clinical and commercial supply of plasma-based fibrinogen and thrombin, for the manufacturing of Fibrocaps(TM). CSL Behring is a leader in the plasma protein therapeutics industry and a subsidiary of CSL Limited (ASX: CSL), a global biopharmaceutical company headquartered in Melbourne, Australia.
Jaap Koopman, CEO of ProFibrix said: "We are extremely pleased with the supply agreement with CSL Behring. CSL Behring is one of the acknowledged global leaders in the plasma protein therapeutic industry. Importantly, the agreement will enable us to use CSL Behring's fibrinogen and thrombin, approved in markets around the world, as active components in our lead product Fibrocaps. This will offer us a tremendous advantage with regulatory authorities when seeking approval for Fibrocaps."

About Fibrocaps
Fibrocaps is based on a mixture of two essential blood clotting proteins, fibrinogen and thrombin, and is a unique dry powder topical tissue sealant in development to stop bleeding after or during surgery. Fibrocaps is clearly differentiated from existing liquid tissue sealants and hemostats: it is ready for immediate use, is stable at room temperature, and has shown to be safe and efficacious in the first Phase II study conducted in EU. ProFibrix is starting a global Phase II study in the summer of 2010.

Salient Surgical goes Dutch

ccccccccccccccccccccSalient Surgical Technologies Inc. is going Dutch, opening an office in Amsterdam to spearhead its international sales and marketing efforts.
The Portsmouth, N.H.-based company said it's had a presence in Europe since 2001, when it began marketing a line of surgical sealers, but wants to expand that footprint with its Aquamantys electrosurgical cautery system.
Citing positive results from clinical trials of the device in joint replacement and spine procedures, Salient Surgical said it's aiming to make the system the global standard of care for reducing bleeding during surgery.
Earlier this month Salient and Medtronic Inc. (NYSE:MDT) slapped Bovie Medical Corp. (NYSE:BVX) with a patent infringement lawsuit over the technology used in the Aquamantys system.
The lawsuit, filed in the U.S. District Court for Delaware, accuses Bovie Medical of violating a trio of patents licensed to Portsmouth, N.H.-based Salient with its SEER fluid-assisted electrosurgical system. It seeks a jury trial, a permanent injunction on further infringement, damages on lost royalties and legal fees.
Salient, founded as TissueLink Medical in 1999, banked $15 million from its seventh funding roundin January. Its backers include Medtronic — which owns a nearly 9 percent stake in the company — TLM Investors, QuestMark Advisors and the RiverVest Venture Fund.

Animal Products

Following on from the Bleeding Calf Syndrome posting available HERE and other postings available Here regarding risks of animal sourced products.

I have provided further info above provided by DEFRA. To the best of my knowledge only the UK and Scotland are acting to investigate?

You can follow this link for further details also 'This intriguing disease captures the imagination. The VLA will be working with others to help discover the cause.'

I expect manufacturers will focus efforts on recombinant, plant-based technologies.

While our industry battles achieving financial success in the market with the ideal of creating an agent that is:

• of minimized risk
• efficaious
• cost effective,
• easily deliverable
• and applicable to multiple surgeries

The removal of King Pharmaceuticals crown as leader in the multi- $million Thrombin market by Zymogenetics is

a sure indicator as to market preference and acceptance of these benefits. J&J have a human sourced Thrombin following theirpurchase of Omrix.

Certainly reconstituted animal based technologies are facing severe threats currently as the link between zoonotic diseases (animal/human transfer) become more widely known. While BNP (Bleeding Calf Syndrome) transmission is far from clear it should be of concern. The lack of reporting and individual Government action highlight the inadequacies of public protection even with a cursory investigation.

While Bleeding Calf Syndrome may not pose infection risks via medical devices it exemplifies the public vulnerabilities to weak protection measures from their Governments. This is weak response and is exactly the response delivered that saw vCJD, and Prion borne infections escalate. Harvesting Bovine Materials HERE

New use for old drug could save thousands of lives

A cheap, common drug used to help women with heavy periods could save thousands of lives worldwide, by helping to prevent heavy bleeding after injuries caused in car crashes, shootings, or stabbings.

What do we know already?

Despite advances in surgery and medicine, millions of people die worldwide as a result of injuries caused by accidents and deliberate violence. These types of injuries are usually called 'trauma' by doctors. One of the main causes of death is heavy bleeding.
Heavy bleeding means there's not enough blood carrying oxygen around the body. Organs like the brain and heart stop working without a constant supply of oxygen.
The body's response to trauma injuries is to attempt to keep the blood vessels open, by breaking down blood clots in a process called fibrinolysis. Unfortunately, this can make it hard to stop the bleeding. The same thing happens after surgery, because the body reacts in the same way.
Doctors have used anti-fibrinolytic drugs after surgery for many years, to reduce blood loss. One anti-fibrinolytic drug, tranexamic acid, is cheap and known to be safe. It's also used to help reduce bleeding for women who have heavy periods.
Now researchers have tried using injections of tranexamic acid for people who have serious bleeding from trauma injuries. They carried out a very big study, in 40 countries worldwide, to see whether it would help to prevent deaths from bleeding. Half the people in the study were injected with the drug, and half with saline solution as a placebo.

What does the new study say?

People were less likely to die if they'd had tranexamic acid. In total, 16 percent of people died who'd had the placebo injection, compared with 14.5 percent of people who'd had tranexamic acid. The researchers calculated this could save 100,000 deaths each year worldwide. In the UK, about 1,800 people die each year from bleeding after injury, and the researchers calculate that routine use of tranexamic acid could save the lives of about 280 of these people.
The drug made no difference to the risk of either getting or dying from a complication such as a heart attack, stroke, or blood clot in the lung. That's important, because a drug that works to prevent bleeding might have increased the chances of getting a blood clot that caused this type of problem.
Interestingly, there was little difference in the numbers of patients who needed blood transfusions. About half of people had transfusions, whether or not they'd had tranexamic acid. This might suggest that the benefit of tranexamic acid wasn't purely down to a decrease in bleeding. However, it could also be because more people treated with tranexamic acid lived long enough to receive a transfusion, or simply that it can be hard to tell whether someone needs a transfusion or not.

How reliable are the findings?

The study was a randomised controlled trial, which is the best sort of study for finding out whether a treatment is helpful. The study looked at more than 20,000 patients, and found a clear result that those treated with tranexamic acid were more likely to survive. The results should be very reliable.

Where does the study come from?

The study was carried out by researchers from 40 countries around the world, including countries from Europe, South America, Asia, and Africa. It was published in The Lancet medical journal, owned by the publishing company Elsevier. It was paid for by the UK's Health Technology Assessment programme.

What does this mean for me?

The authors of the study recommend that doctors treating trauma patients should consider using tranexamic acid in cases of heavy bleeding, or where the patient is at risk of heavy bleeding. But writing in a separate article in the same journal, another doctor warns that very high doses of tranexamic acid have been linked to seizures after heart surgery. He says doctors should be cautious, especially if using other types of anti-fibrinolytic drugs.
The proportion of people in the study who died of their injuries may seem high. But that's because many of the injuries happened in parts of the world like rural Africa or India, where it may take longer for accident victims to get good-quality medical care. In a country like the UK, the death rate from injuries is likely to be much lower.

CryoSeal Fibrin Sealant System for Asahi

ThermoGenesis Corp. has made a deal to phase out its production of its CryoSeal wound care product line and license the product to a Japanese distributor.
Asahi Kasei Kurary Medical Co. Ltd. will pay ThermoGenesis $1 million this month so the Rancho Cordova med-tech company will continue to supply CryoSeal while Asahi ramps up production facilities and regulatory approvals in Japan. ThermoGenesis will provide the CryoSeal Fibrin Sealant System for Asahi to distribute in Japan and other Pacific Rim countries for 30 months, at which time Asahi will take over manufacturing.
ThermoGenesis will receive royalty payments on all CryoSeal products Asahi manufactures after the 30 months. Asahi has the option to acquire the CryoSeal line and patent rights any time in the next five years.
ThermoGenesis has enough CryoSeal inventory that it won’t need to engage in any “meaningful” manufacturing in the next 30 months, chief executive officer J. Melville Engle said in a news release.
“The divestiture of CryoSeal is part of our long-term strategy to focus on the development of enabling technologies for the stem cell regenerative medicine market,” Engle said. “This transaction frees up management and corporate resources to address these more strategic market opportunities.”

Spinal Sealant gets CE mark

HyperBranch Medical Technology, Inc. announced today that it has received a CE Mark for Adherus^TM Spinal Sealant. Adherus^TM Spinal Sealant is used in spinal surgeries where a water tight seal is required to prevent cerebrospinal fluid leakage from the dural repair. Prevention of cerebrospinal fluid leaks should benefit the patient in shorter hospital stays and fewer post-surgical complications such as reduced pain and fewer infections. Adherus Spinal Sealant also acts as an adhesion barrier, thereby simplifying subsequent surgeries should the need arise. The unique, single use device is terminally sterilized and can be applied in both Open and MIS procedures through either a 100mm or 150 mm tip. The CE Mark provides regulatory approval for the company to begin sales in Europe and other countries outside the U.S.

“Adherus^TM Spinal Sealant is an easy to use device that complements HyperBranch’s neurosurgical sealant product line. Adherus^TM Dural Sealant, which was first launched in 2009, is currently marketed outside the U.S. for cranial surgery. Adherus^TM Spinal Sealant has negligible swelling, degrades slowly not only provides a watertight seal but also acts as an adhesion barrier to limit scarring, a major advantage if subsequent surgery is required,” said John Conn, President and Chief Executive Officer.

The Adherus^TM products are synthetic hydrogels which polymerize in a moist field, flow optimally depending on the application, and are bio-degradable as the tissue re-establishes itself. The biocompatible composition is stored at room temperature and is delivered through a custom applicator to meet the specific needs of the procedure.HyperBranch Medical Technology, Inc. has now received CE Marks for ocular, cranial, and spinal sealants as well as a hernia mesh fixation product. The Company has completed a U.S. feasibility study and is starting the Pivotal portion of the study this month for the Adherus Dural Sealant. The Spinal product will follow the same approval path in the U.S. The company’s ophthalmic sealant is currently licensed to and marketed by BD Medical.

Scientist has succeeded in producing a replica of human collagen from tobacco plants

A scientist at the Hebrew University of Jerusalem's Robert H. Smith Faculty of Agriculture, Food and Environment has succeeded in producing a replica of human collagen from tobacco plants – an achievement with tremendous commercial implications for use in a variety of human medical procedures.

Natural human type I collagen is the most abundant protein in the human body and is the main protein found in all connective tissue. Commercially produced collagen (pro-collagen) is used in surgical implants and many wound healing devices in regenerative medicine. The current market for collagen-based medical devices in orthopedics and wound healing exceeds US $30 billion annually worldwide.

Currently, commercial collagen is produced from farm animals such as cows and pigs as well as from human cadavers. These materials are prone to harbor human pathogens such as viruses or prions (mad-cow disease). Human cadaver is scarce, and for certain indications possesses serious ethical issues.

Producing human recombinant type I pro-collagen requires the coordinated expression of five different genes. Prof. Oded Shoseyov of the Robert H. Smith Institute of Plant Sciences and Genetics in Agriculture has established the only laboratory in the world that has reported successful co-expression all the five essential genes in transgenic tobacco plants for the production of processed pro-collagen. For this work, Shoseyov was one of the recipients of a Kaye Innovation Award during the Hebrew University Board of Governors meeting in June.

Shoseyov's invention on has been patented, and the scientific findings behind it were published recently in the journal Biomacromolecules. A company, CollPlant Ltd ., has been established based on patents and technology that were developed in Shoseyov's laboratory. It has raised US$15 million to establish the first commercial molecular farming company in Israel and is already manufacturing collagen-based products that have attracted collaborative commercial interest from companies in the US, Japan Europe and Israel.

Yissum, the technology transfer company of the Hebrew University, is one of the shareholders of CollPlant.. CollPlant is a public company traded in "TASE", and the potential revenue for the Hebrew University from this invention is estimated to reach into the multi-million dollar range.

The Kaye Awards have been given annually since 1994. Isaac Kaye of England, a prominent industrialist in the pharmaceutical industry, established the awards to encourage faculty, staff, and students of the Hebrew University to develop innovative methods and inventions with good commercial potential which will benefit the university and society.

Cow Products - Why ?

Bovine Neonatal Pancytopaenia (BNP) is a newly emerging disease syndrome of calves less than one-month-old which has recently been reported in Britain and Europe.
It is often referred to as calf haemorrhagic disease, haemorrhagic diathesis, bleeding calf syndrome or blood sweating disease.
The first cases of the condition were reported in Germany in 2007.Since then, reports of confirmed cases have slowly risen in a number of European countries while the first confirmed case was recently diagnosed in Ireland and there have been four cases confirmed in Northern Ireland to date.

Typically, the clinical signs in young calves can include excessive bleeding from small abrasions of the skin, or even from injection sites, and the passing of large clots of blood in the dung.

Temperature

Calves affected with the condition normally have a high temperature and become rapidly depressed. In the majority of cases, death follows within 24 to 48 hours (mortality of about 90% is commonly reported), with aggressive veterinary treatment, including blood transfusions, normally providing only a temporary respite for the animal.

The disease syndrome tends to affect single calves in a herd although multiple calves have been affected in some herds in Britain and Germany.

Affected calves tend to be found in larger well-managed herds with a large proportion of affected farms also keeping sheep as well as cattle.

Within countries that have identified cases, a geographical pattern to the occurrence of the disease has not been identified nor has any breed or gender association been established.

On post mortem examination of affected calves, significant damage to the bone marrow has been consistently reported.

The bone marrow is responsible for producing the blood cells. Red blood cells are responsible for transporting oxygen, while white blood cells play a role protecting against infection. Platelets are responsible for blood clotting.

Of these three, the platelets are most severely affected, giving rise to the typical clinical signs of poor clotting and widespread bleeding in the calf.

While the cause of the condition is unknown, there is no evidence that the condition is infectious or that it gives rise to food safety concerns.

The fact that apparently normal calves at birth can develop clinical signs rapidly after consuming colostrum has focused the attention of researchers on colostrum. It is possible that colostrum acts as a vehicle for the introduction into the calf of the agent which damages the bone marrow.

During the 24 hours that follow the birth of an animal, the intestine allows antibodies (a form of defence against disease) which are contained in the colostrum to pass from the gut into the blood stream. This is an important step in the transfer of immunity from the mother to her offspring and plays a vital role in preventing disease in the newborn calf.

It is possible that, in a very small percentage of calves, some of these antibodies target the bone marrow cells, leading to the clinical signs of the disease. Indeed, a similar mechanism is known to cause destruction of blood cells in some newborn foals and piglets. Researchers wish to ascertain whether this is the case in affected calves and, if so, to determine what has changed in the cow or her environment which has led to the occurrence of the condition.

The Department of Agriculture, Fisheries and Food's regional veterinary laboratories are available to assist herdowners and veterinary practitioners with laboratory diagnosis and investigation of any suspicious cases.

The Department has offered to provide free post mortem examinations of any young calf with clinical signs typical of the condition.

While the condition is rare, with minimal losses to date, the Department is always vigilant to the occurrence of novel diseases or novel presentations of existing diseases. Herd owners are asked to notify their veterinary practitioner of any young calves with apparent clotting difficulties.

Dangers of bleeding control in Kidney surgery

Interrupting the blood flow for more than 20 to 25 minutes during kidney cancer surgery leads to a greater risk for patients developing chronic kidney disease, Mayo Clinic researchers have found. The team’s study was published today in the journal European Urology.
Researchers analyzed outcomes of 362 patients with only one kidney who underwent surgery between 1990 and 2008 at Mayo Clinic and Cleveland Clinic for renal cortical tumors. Using a technique called warm ischemia, surgeons kept the patient’s kidneys body temperature during the partial nephrectomy. Ischemia involves cutting off the blood supply to the kidney with clamps in order to control bleeding and to keep blood from obscuring the surgeon’s view of the kidney. Ischemia can cause tissue damage from a lack of oxygen and nutrients.
Researchers found that each additional minute of warm ischemia is associated with a five-to-six-percent increase in the odds of developing acute renal failure or reduced kidney functioning and is associated with a six percent increased risk of new onset Stage IV chronic kidney disease during long-term follow-up.
“This is the largest evaluation of warm ischemia time in patients with a single kidney who are undergoing a partial nephrectomy,” says R. Houston Thompson, M.D., a urologist at Mayo Clinic and study primary investigator. “These results suggest that every minute counts when the renal arteries and veins are clamped. When planning for the surgery, surgeons should make efforts to minimize ischemia time, especially in situations where a person only has one kidney,” says Dr. Thompson.

Medafor's board gets a vote of confidence

Shareholders of Brooklyn Center-based Medafor Inc. on Thursday decisively rejected a suitor's proposal to withhold support from the company's board after it turned down a takeover bid.
The Atlanta biomedical firm CryoLife Inc., which is Medafor's top distributor and shareholder, abandoned its $2-a-share cash and stock bid for the privately held company in March. The Medafor board dismissed it as "grossly inadequate."
But the two companies continue to duke it out in federal court, most recently over Medafor's decision to sever the distribution agreement between the two. CryoLife had also proposed withholding support for the five-member board, on the grounds that it "has overseen the destruction of Medafor's business, its technology and the value of its shares."
Shareholders who control roughly 70 percent of the company's shares voted by a 95 percent margin to re-elect the board.
At the center of the dispute is Medafor's unique blood-clotting powder, called HemoStase, which CryoLife distributes in the United States and in some markets abroad. But the legal status of that agreement is now unclear: A ruling by a federal district judge on the matter is expected soon. (While sales have temporarily lapsed in those markets as a result of the dispute, Medafor says customers will continue to be served after the ruling.)
At Thursday's meeting, held at the Northland Inn in Minneapolis, Medafor's CEO Gary Shope said the company's revenue in 2009 grew 40 percent to $13.8 million. He said trends in the business are strong through the first quarter of this year.
"The Medafor of today is a revitalized company," Shope said. "We've had a few bumps in the road, but we'll get through it."
The real problem for Medafor is the distraction and expense stemming from CryoLife's takeover bid and continuing litigation, Shope said. Had it not been for the $1.2 million the company shelled out for legal expenses last year, Medafor would have been profitable, he said.
The meeting was attended by about 175 shareholders, who listened as Shope and Chairman Michael Pasquale tag-teamed a series of questions.
Many shareholders appeared frustrated that they haven't been able to cash out their long-held stock at a profit. "I say get rid of CryoLife and let investors make some money," said Jim Karercher, a longtime investor from Ortonville, Minn.
Some asked for salary figures for the two executives, a request that was denied. CryoLife claims the company's CEO and chief financial officer earned a combined $700,000 last year.
Another shareholder asked why Pennsylvania residents Shope and Pasquale don't live in Minnesota, where the company's 21 employees are based. Pasquale said the company is global, and it isn't necessary to live locally.
One noticeable absence from the meeting was Steven Anderson, CryoLife's CEO, who is a Minnesota native and a former Medtronic Inc. executive. Anderson had planned to attend the meeting, but was waylaid by a family emergency, according to CryoLife spokeswoman Nina Devlin.

CryoLife to Submit Bond After Seeking Preliminary Injunction Against Medafor

KENNESAW -- CryoLife Inc. (NYSE: CRY ) likely will be ordered to submit a bond for up to $500,000 after filing an emergency motion for preliminary injunction in a drug distribution dispute with Medafor Inc., according to an SEC filing.
CryoLife, an Atlanta-based maker of medical products that enable heart and blood vessel reconstructive surgery, said it opposed Medafor's demand for a bond in the range of $14 million to $40 million because any injunction would not harm the defendant.
The U.S. District Court in Atlanta said it requires a bond before issuing a preliminary injunction, and ordered the two litigants to submit proposed bond amounts by June 11. The filing states the court is considering a bond in the range of $100,000 to $500,000.
CryoLife accuses Minneapolis-based Medafor of violating a drug distribution agreement by allowing other companies to distribute Hemostase, an absorbable blood-clotting agent manufactured by Medafor, in territories and medical fields reserved exclusively for CryoLife.
Under the agreement, CryoLife said it is the exclusive U.S. distributor of the drug used in cardiac and vascular surgery, excluding those performed at Department of Defense hospitals; and the exclusive distributor internationally, except China and Japan , for all surgeries other than orthopedic and ear, nose and throat surgery.
Medafor, in turn, accuses CryoLife of violating their exclusive distribution deal by selling Hemostase in Spain for uses allegedly barred by the agreement.

Grifols to Acquire Talecris Biotherapeutics Creating a World Leading Provider of Life-Saving Plasma Protein Therapies

BARCELONA, Spain and RESEARCH TRIANGLE PARK, N.C., June 7, 2010 /PRNewswire via COMTEX/ -- Grifols (GRF.MC) a global healthcare company and leading producer of plasma protein therapies, and Talecris(TLCR 19.97, +4.06, +25.48%) a U.S.-based biotherapeutics products company, today announced that they have signed a definitive agreement through which Grifols will acquire Talecris for a combination of cash and newly-issued Grifols non-voting shares having an aggregate value today of approximately $3.4 billion (euro 2.8 billion), creating a global leader of life-saving and life enhancing plasma protein therapeutics.

The combination of Grifols and Talecris will create a vertically integrated and diversified international plasma protein therapies company, bringing together complementary geographic footprints and products, as well as increased manufacturing scale. Grifols' leading global footprint will benefit from Talecris' strong presence in the United States and Canada. Grifols' available manufacturing capacity will enable Talecris to increase production in the near term. As a result, the combined company will be better able to meet the needs of more patients with under-diagnosed disease states around the world.

In addition, upon completion of the transaction, the combined company will have:

• the ability to derive more protein therapies from every liter of plasma, enhancing access and availability for patients, and optimizing use of collected plasma;
• an established plasma collection operation capable of meeting the combined company's needs to address increasing patient demand and an accelerated path to improving the cost efficiency of the Talecris plasma platform;
• a broad range of key products addressing a variety of therapeutic areas such as neurology, immunology, pulmonology and hematology, among others;
• an enhanced R&D pipeline of complementary products and new recombinant projects that will drive sustainable growth;
• a well established clinical research program in the U.S.

Grifols Chairman and CEO Victor Grifols commented, "The acquisition of Talecris furthers our vision to better serve patients and health care professionals with innovative products, a strong clinical research capability and new research into recombinant therapies. We look forward to combining the strengths of both companies to improve the quality of the lives of patients around the world, while positioning the enlarged group for long term profitable growth."

Talecris Chairman and CEO Lawrence D. Stern commented, "We believe that Grifols' well-established reputation, know-how and expertise will enable the combined entity to meet the needs of more patients. Our employees will benefit from the opportunities available to them as part of a larger, global organization committed to the expansion of Talecris' existing business, the development of our pipeline products, and the maintenance of our culture of compliance and quality. Importantly, our stockholders will realize a compelling premium and benefit from the ability of the combined business to accelerate key gross margin improvement opportunities within Talecris."

CryoLife purchases recombinant human serum albumin and gluteraldehyde formula

ATLANTA, June 7 /PRNewswire-FirstCall/ -- CryoLife, Inc. (NYSE: CRY), an implantable biological medical device and cardiovascular tissue processing company whose products include BioGlue Surgical Adhesive, announced today that it has completed the purchase of U.S. patent # 6,329,337. The patent involves the formulation and use of recombinant human serum albumin and gluteraldehyde, and now becomes part of CryoLife's protein hydrogel patent portfolio, which includes BioGlue.

"CryoLife will continue to invest in emerging and adjacent intellectual property and tools that will complement our portfolio of surgical adhesives and glues for surgeons," said CryoLife president and CEO Steven G. Anderson. "With our acquisition of this technology, we have an additional opportunity to expand and strengthen our surgical adhesive portfolio," Anderson added.

CryoLife's BioGlue Surgical Adhesive is the leading surgical adhesive used in cardiovascular surgery around the world and is used in a wide range of reconstruction procedures. Composed of purified bovine serum albumin (BSA) and gluteraldehyde, BioGlue has been used in more than 550,000 surgical procedures and has been published in more than 250 preclinical and clinical papers discussing safety, efficacy, and application techniques since its launch in 1998.

"The strength of BioGlue assures the surgeon that delicate tissues are well reinforced and assists in controlling bleeding in complex surgery. We believe that these and other properties of BioGlue Surgical Adhesive make it a leading sealant used in complex cardiac and vascular surgery," Anderson said.

Surgical Complications of bleeding, infection dehiscence and necrosis are interelated

Miami — Keeping good closures from going bad requires not only thorough patient education and surgical planning by the physician, but also patient adherence to pre- and post-surgical instructions, according to an expert who spoke at the 68th annual meeting of the American Academy of Dermatology.

Common surgical complications include bleeding, infection, dehiscence and necrosis, all of which are usually interrelated, says Emily J. Fisher, M.D., chief of cosmetic and laser dermatology, Lahey Clinic, Burlington, Mass. "It's very unlikely to have one of these without a second, third or fourth complication occurring," she says.

Typical examples include lower-leg complications, where lack of skin laxity and excess wound tension can lead to tissue ischemia and necrosis, as well as infection and dehiscence.
Bleeding risks

Bleeding and infections represent the most common types of postsurgical complications, Dr. Fisher says. "Minor hemorrhagic complications include increased intraoperative bleeding, which can be a challenge. But if you get it under control, it doesn't usually cause long-term problems," she says.

However, intraoperative bleeding also can increase the length of procedures and drive surgeons to choose less-than-optimal closures. "If the patient is having significant bleeding, performing a complicated flap or graft can be challenging and poses an increased risk of bleeding due to the amount of undermining necessary," Dr. Fisher says. "As a result, a surgeon may opt to perform a simpler closure to decrease this risk, but that may not be the best from a cosmetic standpoint.

"More worrisome complications include postoperative bleeding," she says. "That may require flap takedown and additional hemostasis." Often, Dr. Fisher's patients who experience postoperative bleeding will seek treatment at emergency rooms — even though she warns them not to — where ER physicians may make unwise or unnecessary alterations to the flap or graft. Fortunately, she says, although studies show postoperative bleeding is the most common dermatosurgical complication, it only impacts about 2 percent of patients (Cook JL, Perone JB.Arch Dermatol. 2003 Feb;139(2):143-152).

Full Article HERE

J&J comment on EU market and the US release of Fibrin Pad

Johnson & Johnson's (JNJ) big medical devices and diagnostics unit anticipates that pressure on product prices in Europe will rise over the long term but not immediately, the unit's top official said Thursday.
J&J also said it expects the portion of the $350 billion devices and diagnostics market it competes in to grow at a faster rate than the overall market.
Additionally, the company anticipates that unit will make about 80 "significant" regulatory filings between 2010 and 2010.
J&J, which is dealing with fallout from the recent recall of children's medicines, is holding an all-day review Thursday for the devices and diagnostics unit. That unit grew sales by 2% to $23.6 billion last year and became J&J's largest segment, eclipsing a pharmaceutical business that has been pressured by competition from generic drugs.
The segment derived more than half of its sales last year from outside the U.S. A big question for device and drug companies these days is how the European debt crisis will affect product prices as governments try to rein in health spending.
"I think longer term we clearly see there being increased pricing pressure," Alex Gorsky, worldwide chairman for J&J's devices and diagnostics unit, said during the meeting. But there are reasons to believe it won't be an "immediate" issue, and doesn't mirror the situation with drug prices, he said.
These reasons include the tendering systems used to purchase devices and the dynamics between hospitals and governments, he said.
Pricing in Europe remained a top issue when analysts asked questions. Gorsky told them the pricing issue is difficult to forecast. He also said J&J hasn't seen a slowdown in procedure volumes that could also impact sales, but added "we'll have to watch closely."

Healthcare company Johnson & Johnson (JNJ), Thursday revealed growth strategies and product pipeline information for its Medical Devices & Diagnostics Segment. The company said the segment was its largest, and that new products and acquisitions would help sustain its market-leading position in the $350 billion, worldwide medical device and diagnostics market.
The New Brunswick, New Jersey-based company provided information on products that have been launched already or are on the anvil for the current fiscal, from its seven global franchises.
Ethicon Endo-Surgery, a maker of surgical device solutions for minimally invasive and open surgery; and Advanced Sterilization Products is rolling out a host of new products, J&J said. They include new energy instruments as part of its HARMONIC family of technology that delivers precise ultrasonic energy to minimize thermal tissue damage to the patient, while providing surgical efficiency.
Further, Ethicon continued to focus on patient comfort and surgeon ease-of-use as it built its portfolio of hernia repair products with ETHICON PHYSIOMESH Flexible Composite Mesh and its first entry into the hernia mesh fixation market with ETHICON SECURESTRAP 5mm Strap Fixation Device.
Ethicon Endo-Surgery would make a BLA filing in the U.S for its Fibrin Pad in the fourth quarter. The product combines two biomaterials and two biologics to stop bleeding during surgical procedures.

Cytomedix to Present at Sixth Annual Noble Financial Equity Conference

ROCKVILLE, Md., June 1, 2010 (GLOBE NEWSWIRE) -- Cytomedix, Inc. (NYSE Amex:GTF) (the "Company"), a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, today announced that the Company will participate in the Sixth Annual Noble Financial Equity Conference taking place June 7-8, 2010 at the Seminole Hard Rock Hotel in Hollywood, Florida.

Martin Rosendale, President and CEO of Cytomedix, will present a corporate update on Tuesday, June 8, 2010 at 1:30 p.m. ET in which he will provide an overview of Cytomedix, including an update on the integration of its recent acquisition of the Angel® Whole Blood Separation System and the activAT® Autologous Thrombin Processing Kit from the Sorin Group.

Company management will be available for one-on-one meetings with investors participating in the Noble Financial Equity Conference. For those who would like to schedule an appointment with Cytomedix's management, please contact Anne Marie Fields, Lippert/Heilshorn & Associates, Inc., at 212-838-3777 or at afields@lhai.com or contact your Noble Financial representative.

The presentation will be video webcast live at www.cytomedix.com where it will also be archived for 90 days.

About Cytomedix

Cytomedix is a biotechnology company that develops, sells, and licenses regenerative biological therapies, to primarily address the areas of wound care, inflammation, and angiogenesis. The Company currently markets the AutoloGel™ System, a device for the production of platelet rich plasma ("PRP") gel derived from the patient's own blood for use on a variety of exuding wounds; the Angel® Whole Blood Separation System, a blood processing device and disposable products used for separation of whole blood into red cells, platelet poor plasma and platelet rich plasma ("PRP") in surgical settings; and the activAT® Autologous Thrombin Processing Kit, which produces autologous thrombin serum from platelet poor plasma. The activAT® kit is sold exclusively in Europe and Canada, where it provides a completely autologous, safe alternative to bovine-derived products. The Company is currently pursuing a multi-faceted strategy to penetrate the chronic wound market with its products. Cytomedix is also pursuing opportunities for the application of AutoloGel™ and PRP technology into other markets such as hair transplantation and orthopedics, as well as actively seeking complementary products for the wound care market. The Company also seeks to monetize other product candidates in its pipeline through strategic partnerships, out-licensing, or sale. Most notably is its anti-inflammatory peptide (designated "CT-112") that has shown promise in pre-clinical testing. Additional information regarding Cytomedix is available at www.cytomedix.com.

Minimallly invasive option to partial nephrectomy and the 5 % to 10 % risk of bleeding and need for transfusion

DALLAS – June 4, 2010 – A minimally invasive technique used to destroy kidney tumors with an electrically controlled heating probe showed similar effectiveness as surgical removal of tumors in curbing cancer recurrence rates for up to five years after treatment.
In an article available online in the journal Cancer, Dr. Jeffrey Cadeddu, professor of urology and radiology at UT Southwestern Medical Center, reported the outcomes of more than 200 patients who were treated with radiofrequency ablation (RFA).
Once the diagnosis of tumor is confirmed and the RFA technique is agreed upon, a needle-like probe is placed inside the tumor. The radiofrequency electricity waves passing through the probe heat up tumor tissue and destroy it. Surgeons view the RFA procedure with the aid of imaging devices such as computed tomography (CT scan).
Of the 208 patients who underwent the RFA procedure, 160 were diagnosed with renal cell carcinoma, a type of kidney cancer that is slow-growing but malignant and able to spread easily to other organs. Those patients had three- and five-year survival rates of more than 95 percent.
"These types of cancers aren't typically fast-growing, but there are between 40,000 and 50,000 cases of kidney cancers diagnosed each year in the United States," Dr. Cadeddu said. "The fact that cancer survival rates were comparable to surgical interventions is very encouraging."
Currently, many patients who are diagnosed with primary tumors that originate inside the kidney are treated surgically.
"The standard treatment is usually a partial nephrectomy, where the surgeon removes the tumor and some surrounding tissue via open or laparascopic surgery," said Dr. Cadeddu. "With surgery, there is a 5 percent to 10 percent risk of bleeding and an associated need for transfusion, as well as an increased chance of readmission for the patient. Of course, the recovery time is longer as well."
With open surgery, surgeons go in through a patient's abdomen or flank to remove the kidney tumor. A laparascopic partial nephrectomy involves doctors accessing the organ through several small incisions in a patient's abdomen. The recovery time for open surgery is about six to eight weeks and three to four weeks for laparascopic procedures.
With RFA, 90 percent of the patients are able to go home the same day, said Dr. Cadeddu, but the real advantage to RFA is its superior preservation of kidney tissue.
"Preserving kidney function has been clearly demonstrated to maximize quality of life and length of life for patients with kidney tumors," Dr. Cadeddu said. "Whenever possible, we try to save as much of the kidney as we can."

Devices, Drug Cut Bleeding Risk in PCI

Combining the direct thrombin inhibitor bivalirudin (Angiomax) with vascular closure devices was associated with the lowest rate of bleeding complications in patients undergoing percutaneous coronary intervention (PCI), a large database analysis showed.

Among more than 1.5 million PCI patients in the National Cardiovascular Data Registry (NCDR), 0.9% suffered bleeding complications when both bivalirudin and vascular closure devices were used, according to Steven P. Marso, MD, of the University of Missouri in Kansas City, and colleagues.

The highest rate, 2.8%, was seen in patients for whom manual compression was the sole means of bleeding control, the researchers reported in the June 2 issue of the Journal of the American Medical Association.

Rates associated with vascular closure devices and bivalirudin alone were 2.1% and 1.6%, respectively (P<0.001>for differences):

6.1%, manual compression
4.6%, vascular closure devices
3.8%, bivalirudin
2.3%, vascular closure devices plus bivalirudin

But Marso and colleagues also found that the combination approach was used more often in low-risk patients. Only 14.4% of high-risk patients had both bivalirudin and closure devices for bleeding control, compared with 21.0% of low-risk patients.

By the same token, 40.3% of high-risk patients had manual compression versus 30.8% of low-risk patients.

"This apparent risk-treatment paradox highlights an opportunity for routine preprocedural risk stratification as a means to identify patients ideally suited for individualized bleeding avoidance strategies with the goal of increasing the safety of PCI," Marso and colleagues wrote.

"Targeting bleeding complications as a quality-improvement goal holds great potential for improving the safety and cost-effectiveness of PCI," they added.

The study examined outcomes in 1,522,935 patients undergoing PCI at 935 hospitals participating in the data registry from 2004 to 2008.

Among them, 30,654 had inhospital bleeding complications. These were defined in three ways: serious enough to warrant transfusion or a prolonged hospital stay for management, or leading to a decrease of more than 3 g/dL in blood hemoglobin content.

Bleeding risks were predicted on the basis of age, gender, peripheral vascular disease, renal function, previous congestive heart failure, previous PCI, and whether patients had myocardial infarction with ST-segment elevation. The risk prediction model had been developed previously from NCDR data.

Marso and colleagues suggested several potential explanations for the lower use of the drug-plus-device strategy in high-risk patients.

One is that assessing patients for bleeding risk is neither easy nor common, they indicated. Another is that familiarity with bivalirudin and/or closure devices outside the elective PCI setting may be limited.

"The results of this study suggest the need for additional research to better understand why higher-risk patients are least likely to receive bleeding avoidance strategies," Marso and colleagues wrote, adding that interventions to encourage pre-PCI risk assessment should be tested.

In a statement, Ralph Brindis, MD, MPH, president of the American College of Cardiology, said the study's findings would themselves help reverse the paradox.

"Assessing a patient's risk of bleeding prior to PCI can help improve its safety by utilizing proven bleeding avoidance strategies for patients most likely to benefit from the procedure," he said. "This study identifies how we can adapt our practices to focus on individual comorbidities and provide even greater high-quality, patient-centered care."

Kirk Garratt, MD, clinical director of interventional cardiovascular research at Lenox Hill Hospital in New York City, commented in a statement that the data do suggest "a synergy between drug and device."

"My only concern is that we don't know how many patients were considered for a closure device but didn't get one," he said.

"We always take a picture of the artery after we put the sheath in, to see if a closure device will work. Sometimes we learn that the artery has been punctured in a way that increases bleeding and prevents use of closure devices," he observed.

The authors noted several limitations of the study. "First, this was not a randomized trial; thus, a causal relationship between bleeding avoidance and evaluated strategies cannot be concluded. Second, potential unmeasured confounding is a limitation of all observational studies."

Kuros Completes Patient Recruitment

Zurich, Switzerland, 2nd June 2010 - Kuros Biosurgery AG, a biotechnology company focused on the development of novel biomaterials and bioactive-biomaterial combination products for trauma, wound and spinal indications, announced today that it has completed recruitment in a 200 patient Phase IIb clinical trial designed to assess the efficacy and safety of KUR-113 (Viz.I-040202) in open tibial shaft fractures.
This study is a randomized, controlled, open-label (dose-blinded) dose finding study of the safety and efficacy of KUR-113 in the treatment of patients with acute open tibial shaft fractures. The aim of the trial is to assess the safety and efficacy of KUR-113 in combination with standard of care (SOC) vs SOC alone. The use of KUR-113 is designed to improve bone healing by reducing the time needed to achieve bone healing as well as the incidence of secondary interventions.
KUR-113 utilizes Kuros’ “TG-hook” technology for binding proprietary biologics into a fibrin sealant. The product candidate is composed of a variant of parathyroid hormone (vPTH) and fibrin sealant and is applied directly to the fracture site in the form of a paste. KUR-113 has been designed to deliver vPTH locally at the fracture site and to maintain this via the slow controlled release of vPTH over time from the fibrin matrix. The fibrin matrix also plays a further important role in the bone healing process by providing a physical scaffold for cell ingrowth. The trial will assess whether this approach is safe and efficacious.
A total of 200 patients have been randomized and treated in over 31 centers across Europe. The primary endpoint of this study is the proportion of patients healed at 6 months after surgery when compared to SOC alone. Kuros is expecting to report the outcome of this study in the first half of 2011.
Dr. Virginia Jamieson, Chief Medical Officer of Kuros, commented: “We are very pleased to have completed recruitment for this study with KUR-113 and we look forward to reporting the results of this novel approach to the treatment of open tibial shaft fractures in the first half of 2011.”
KUR-113 is licensed to Baxter International Inc. under a collaboration and license agreement which was signed in 2005. Following the successful completion of this study, Baxter will take over responsibility for the further development of KUR-113.
Didier Cowling, Chief Executive Officer of Kuros, commented: “Completion of patient recruitment in this large Phase IIb study is another significant step for Kuros. We look forward to broadening the application of this technology to additional orthopedic settings”