Hemostase: Medafor says its off...CryoLife its on.......

NOT SO FAST, MY FRIEND!

The continued quagmire that is the CryoLife/Medafor relationship appears set to continue according to This latest Press Release from CryoLife.

Background

After a failed takeover bid by CryoLife they encouraged Medafor shareholder's to withhold their votes at a recent Medafor shareholder meeting. This was rejected by 95% of the 70% of attendee's and one disappointed shareholder will no doubt be Jim Karerchersuch who commented "I say get rid of CryoLife and let investors make some money,".

Expenses in the tussle continue to escalate for both companies with Medafor CEO Shope stating... "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, ."

and another online source stating ...."Anderson, who launched the hostile takeover attempt of Medafor in 2009 and chose several public venues to prosecute his case, spent approximately $6 million in the effort."

Conclusions

For those on the sidelines this extremely public battle has been an intriguing insight. Lately barely concealed personal attacks are now appearing in certain news articles relating to CryoLife CEO Steven Andersons, age and absence from the shareholder meeting despite his residence in MN. Meanwhile Medafor management were brought under the spotlight with the CryoLife claim "that Medafor's CEO and chief financial officer earned a combined $700,000 last year." Medafor management also denied any issues related to the fact that Medafor senior executives, and Pennsylvania residents Shope and Pasquale don't live in Minnesota, where the company's 21 employees are based. With Pasquale claiming it isn't necessary to live locally.

Investors and Distributors must be feeling unsettled by the lack of clarity in terms of supply, and without any public statement from Medafor or the courts (where both companies appear more comfortable communicating) the status quo appears confusing.

One positive indication from this mess is that plant-based hemostatic technology is certainly worth fighting for. Medafor partner Orthovita must have an eye on these occurences, as will other key China manufacturer Starch Medical.

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.”