Human Gelatin...

Gelatin is found in everything from Jell-O and marshmallows to cosmetics and candles. But the current method of taking gelatin from the skin and bones of cows and pigs has a number of drawbacks, including variation in quality from batch to batch, the potential for transmitting infectious diseases like Mad Cow and the possibility of triggering immune system responses in humans. We may not have to rely on pig bones for  gelatin forever, though the newest option--human derived gelatin--isn't too appetizing.
Beijing University of Chemical Technology researchers created the slightly creepy productby sticking human gelatin genes into a strain of yeast that can produce gelatin with reliable features--and a virtual guarantee that it won't be contaminated with pathogens or cause immune responses (because the gelatin molecules are based on human DNA sequences). No word on when the gelatin will be available for commercial use, but there are other companies working on similar products.

LifeBond, an Israeli maker of biosurgical products, raised over $20 million in a third round of financing led by Giza Venture Capital and Aurum Ventures, with Johnson & Johnson Development Corp joining the process

Johnson & Johnson (NYSE: JNJ) has invested in biological sealant developer Lifebond Ltd. as part of the company's $20 million third financing round. Giza Venture Capital and Aurum Ventures MKI Ltd. are leading the round alongside current investors Pitango Venture Capital, GlenRock Israel, the Zitelman Group, and Lifebond co-chairman Robert Taub.
Johnson & Johnson acquired Omrix Biopharmaceuticals, which Taub founded, for $425 million in 2006. It is interesting to see that Johnson & Johnson is investing in another company, which like Omrix, is developing a biological sealant.
Lifebond's flagship product is a surgical sealant for tissue after surgery to shorten the bowel. It partly competes with Omrix, and it seems that both Taub and Johnson & Johnson believe that Lifebond's products are as good as Omrix's products, but which Omrix's technology cannot produce.
Lifebond CEO Ishay Attar and COO Orahn Preiss-Bloom co-founded Lifebond in 2007, in the aftermath of the 2006 Second Lebanon War in order to develop next-generation would closure solutions for soldiers on the battlefield.
Lifebond will use proceeds from the financing round to complete preclinical trials of its LifeSeal sealant product to prevent life-threatening blood and fluid leakage from the intestine during surgery. Trials for LifeSeal for intestinal surgery under US Food and Drug Administration (FDA) will use premarket approval (PMA) protocols, the longer protocol for medical devices. Lifebond believes that it can bring the product to market within two years.
Lifebond is also developing hemostats that are in early clinical trials and a product to prevent hernias.

Late wound healing problems after use of BioGlue® for apical hemostasis during transapical aortic valve implantation

Wake Forest Researchers Discover Stored Blood Can Lead To Complications

Winston-Salem, NC -- People give the gift of life everyday and that blood is then stored properly and safely. And you may have even asked yourself or someone else, what happens to that stored blood used during transfusions?
Well, some researchers at Wake Forest University and the University of Pittsburgh School of Medicine looked into that issue.
Information released from the study states that depending on the amount and age of the stored blood used, there is evidence that transfusion can lead to complications including infection, organ failure and death.  They also found that these complications are likely due to red blood cell breakdown during storage, implying that transfused blood may need to be stored in a different way.
Their discovery could lead to changes in the way blood is stored. They believe that donated blood may need to be stored in a different manner.
Doctors have noted recently that blood stored for a long time may be associated with complications such as increased infection risk, kidney, lung, or multi-organ failure and death, particularly among medically vulnerable patients, according to study researchers Dr. Mark Gladwin of the University of Pittsburgh and Dr. Daniel Kim-Shapiro of Wake Forest.
According to Dr. Gladwyn, "When blood sits for a while, some of the cells break down and release their contents, which include molecules of hemoglobin and red blood cell microparticles."
Dr. Gladwyn further explains that these molecules accumulate in the bags the blood is stored in and are then transfused into the patient receiving the blood. This is called a storage lesion.
After they enter the bloodstream, the hemoglobin and microparticles bind to and destroy NO, a very important molecule that is used to ensure normal blood flow. This can then prevent tissues and organs from getting adequate oxygen, according to researchers.
They are working on other research projects to find approaches to correct the problem, and to assess the safety of blood, for transfusion that has been stored for longer than 14 days.
Currently, federal guidelines allow transfusion of blood that has been stored for up to 42 days.
Wake Forest University

Hemostasis Job Board.

Got what it takes to work in this sector?

Due to requests we have established a JOB board for employers and employee's to communicate directly. I am receiving more and more communications for Regulatory, Sales and Marketing opportunities and so please sign-up for the forum and post job offers or CV's. The Forum is located HERE.

Irish Budget cuts mean no CJD screening of donated blood

Ireland - THE MINISTER FOR Health has been advised not to introduce a new technology to screen donated blood for Creutzfeldt-Jakob disease because it would not be cost effective to do so.
Variant Creutzfeldt-Jakob disease (vCJD) is one of a group of rare, progressive fatal non-inflammatory degenerative diseases of the brain affecting humans and animals.
Also known as prion diseases, they are thought to be caused by an abnormal form of a naturally occurring protein in the brain (the prion protein) that has been acquired through infection.
Following a detailed health technology assessment (HTA) carried out by the Health Information and Quality Authority (HIQA), Dr Patricia Harrington, head of assessment with the Authority’s Health Technology Assessment Directorate, said: “The Authority’s HTA found that to filter red cell concentrates as proposed by the blood service would initially cost €11 million per year. It was estimated that such a measure would, over a 10-year period, potentially prevent two deaths from vCJD.”
The origin of vCJD is linked to the outbreak of a bovine form of the disease, bovine spongiform encephalitis (BSE), which occurred in the UK in the 1980s and 1990s.
The incidence of BSE and vCJD peaked in the Britain in 1992-1993 and 2000, respectively, and has been declining since.
However, there is an ongoing risk of vCJD transmission from transfusion of blood or blood products due to donations from carriers of the disease.
Worldwide, there have been five documented cases of transfusion- related vCJD infection, resulting in three deaths from clinical vCJD.
Emphasising HIQA’s increasingly important role as health budgets dwindle, the report states: “Given the likely number of clinical cases and, in the context of a finite healthcare budget, consideration must be given to the existing technologies and services that may need to be displaced should a decision be made to introduce prion filtration, at a cost of up to €11 million per annum.”

Hemophilia drug trial shows hemostasis, controlled bleeding

Inspiration Biopharmaceuticals has released data from the trial evaluating OBI-1, an intravenous (IV) recombinant porcine factor VIII product (rpFVIII) as a treatment for bleeding in people with hemophilia A with inhibitors and in people with acquired hemophilia.
The trial involved three patients who had experienced severe bleeds not controlled with by-passing agents were treated with OBI-1.
The study confirmed that OBI-1 effectively resulted in hemostasis, and controlled all non-life/non-limb threatening bleeding episodes (minor bleeds) in those patients, even in the presence of high inhibitor levels against hFVIII.
Further data on hemostatic efficacy and safety are being collected as part of the Accur8 clinical trial program, designed to study OBI-1 in acquired hemophilia.
A second study in individuals with congenital hemophilia who have developed inhibitors against FVIII is set to commence later this year.
The drug is being co-developed by Inspiration and Ipsen.

BioCer Release Test Data on "PURE"-ity of Latest Hemostat Innovation HaemoCer Vs. Perclot

A year ago Cryolife CEO Steve Anderson was embroiled in the meltdown of the CRY/Medafor relationship as the distribution agreement for first generation polysaccharide hemostat Arista came to a very bitter and public disintergration.......more HERE. Following this debacle CRY have entered into an agreement with merchant Starch Medical a San Diego based company with manufacturing facilities for Perclot (generation 2 of the polysaccharide powders) based in Beijing, China.http://www.docstoc.com/docs/60831472/PerClot-Arista Our 2009 Poll indicates concern, results HERE.

Now it's Q2 one year later and newly released test reports commissioned by German based BioCer, manufacturers of HaemoCer (conducted by a third party laboratory) offer compelling information supporting the contention their PURE (Polysaccharide Ultra-Hydrophilic Resorbable Engineering) process is much more than marketing hype. The report comparing CRY's Chinese Perclot with German made HaemoCer is available HERE or by clicking the thumbnail below.

Meanwhile video of HaemoCer shows the latest polysaccharide plant based hemostats formation of a powerful adhesive gelled matrix in comparison to generation 1 product Arista by Medafor Inc.

CRY Q2 2011

Comment: Solid growth from CRY this Q2...Hemostasis portfolio buoyed by off-label use of Bioglue (Purified bovine serum albumin (BSA) and glutaraldehyde) in Japan and a suggested move of Perclot manufacturing to the USA from China. For Perclot this should be useful considering how many markets require a Free Trade Certificate (i.e. These certificates are required by governments in a growing number of countries that need assurance that products exported from the United States to their countries are the same as products sold in the United States , presumably meeting all state and federal laws and regulations, thus posing no threat to their subjects. Exports to these countries must be accompanied by a valid certificate, or the product will not be admitted.)


Steve Anderson 

...Japanese BioGlue sales in early July continue to be strong and demonstrate that the product is being well received. BioGlue is also doing very well in Brazil where our distributor is on track by a $1 million during calendar 2011. Sales of BioGlue in Brazil have increased from $150,000 for 2005 to about $1 million in 2011. BioGlue is projected to comprise 40% of company’s sales in 2011.As you will recollect, BioGlue’s gross margins are in excess of 80%.

We are also very pleased with the early European market acceptance of PerClot. During the second quarter of 2011, sales of PerClot in Europe increased by 76% over the sales of HemoStase, a product we formally distributed for the same timeframe a year earlier. Sales of PerClot for the first six months of 2011 in Europe were $1,271,000 versus $721,000 of HemoStase for the same period in 2010.

In our opinion, PerClot is a more effective product than HemoStase [Arista, Medafor Inc.]. We believe that PerClot is a second generation powdered hemostatic agent and the doctors are genuinely pleased with what it does on the surgical setting. Sales in Australia have also been excellent.

During the first quarter conference call we stated that we had filed our US IDE for PerClot with FDA. The FDA had a number of questions and comments regarding our initial IDE submission. We have been addressing the FDA’s issue and are working on our responses. It’s important to note that HemoStase’s gross margin were 55%, and that when approved in the United States we will replace that product with PerClot whose gross margin will be an excess of 80%. I believe that PerClot sales will be a revenue and earnings growth engine for CryoLife going forward....

Ashley Lee

..Once we get PerClot, the manufacturing process transferred here [from current Starch Medicals Chinese manufacturing site] and approved in the US, that’s going to be an 80 plus percent gross margin product...

Steve Anderson

In addition to that, we’re working hard on getting third quarter approved in Brazil and in Canada, and we’re making good progress on that, its just a matter of working our way through the bureaucracy that is involved in approval in those countries. And so they should come on here in the next six to nine month and that products then would be looking at significant sales increases as a result of that. And the success we’re having in Brazil was of course with BioGlue it is sort of piggyback on that. And so, I would expect with the larger volumes late this year and next year with PerClot that those margins probably will continue to increase...

Raymond Myers - Benchmark

On the last call I asked you about this and you were a little more cautious at that time about Japan BioGlue sales, because that market is small you said that you thought you would have to do an additional clinical study to enter the $150 million general surgical sealant market in Japan. And I wonder are we being more optimistic now that we can broaden the use before having to do that study?

Steve Anderson

I think it’s evident that the Japanese physicians are using it off label for other uses. I think it’s too early. I don’t happen to know where they are using it at this time, but it’s obvious from the volume that they are using it an addition to and other places in addition to aortic dissections. We are going to do an additional clinical study, but we have the same exact approval from the FDA initially when we marketed that product in the States and of course and it ended up being used a lot for certain neurological indication and maybe that’s where it’s being used in Japan. I would have to ask our distributor we happen to know that I don’t at this early stage.

Joe Mondillo - Sidoti & Company

With the growth that you guys are seeing in BioGlue and PerClot, we assume to see an increase in CapEx going forward to support the growth that you are seeing?

Ashley Lee

Not necessarily. That’s one of the parts of our business that we think is very leverageable. We have got the infrastructure here currently at our facility to ramp production for BioGlue. We do not perceive any significant spend on CapEx for PerClot and getting that manufacturing process migrated [from Beijing, China] to our US facility....

Blood Stored Too Long May Threaten Patient Safety

THURSDAY, July 21 (HealthDay News) -- New research links medical problems caused by blood transfusion to the breakdown of red blood cells during blood storage. The findings suggest that a better way to store blood is needed.
When transfused, older blood or high amounts of blood can lead to complications, including infection, kidney and lung failure and death, said study co-author Dr. Mark T. Gladwin in a news release from Wake Forest University, which led the study.
The study examines the interaction between nitric oxide (NO) and the byproducts created as red blood cells break down over time. The researchers found that the interaction in older blood can reduce blood flow and perhaps damage tissues in the body.
"When blood sits for a while, some of the cells break down and release their contents, which include molecules of hemoglobin and red blood cell microparticles," said Gladwin, chief of the division of pulmonary, allergy and critical care medicine at the University of Pittsburgh School of Medicine. "These accumulate in the stored bag of blood and are transfused into the patient with the blood. In the bloodstream, the hemoglobin and microparticles bind to and destroy [nitric oxide], a very important molecule that is used by the body to keep blood vessels dilated for normal blood flow."
"Transfusion of stored blood is one of the most common medical therapies," said study senior author Daniel B. Kim-Shapiro, professor of physics and director of the Translational Science Center at Wake Forest University, in the news release. "For example, perhaps we can restore nitric oxide activity that is lost upon transfusion, use preservation solutions that better limit the degradation of blood cells, or develop agents that scavenge free hemoglobin."
Future studies will examine the safety of blood stored more than 14 days. Under current federal guidelines, blood can be stored for up to 42 days.
Each year in the United States more than 5 million people receive blood transfusions, according to the study.
The study is published in the journal Circulation.