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.

Baxter Q2

Sales in regenerative medicine, which includes our BioSurgery products, totaled $147 million and increased 11%. Excluding foreign currency, sales increased 6%, driven by double-digit growth of surgical sealants and hemostats.....

Robert Parkinson

Yes, I would -- this is Bob Parkinson, David. A number of pieces to that. The reality is the European markets continue to be challenging, particularly the more developed Western markets. But having said that, we continue to benefit significantly by emerging developing markets, China, Brazil and so on. Also, generally speaking, the plasma proteins across the board, including developed Europe, were very strong in the second quarter. So it's tough to generalize regarding all markets outside the U.S. We are pleased by the overall strength and growth of our sales outside the U.S., but it is really -- the dynamics are very different between developed Europe, which continues, and we anticipate it's going to continue to be challenging versus our expanding investment and presence in emerging and developing markets, which consistently has been a growth priority for us...

Stryker Q2 2011

In addition, the company's biosurgery business manufactures hemostasis product such as the Vitagel, which are designed to control interoperative and postoperative bleeding. We believe the collective talent of our sizable sales forces across multiple franchises positions us to build on Orthovita's success and accelerate sales growth....Matthew O'Brien - William Blair & Company L.L.C.

Okay. And then the second question on the biologic side with the Orthovita acquisition. Can you just talk a little bit about where your utilization was with your biologic portfolio before the Orthovita deal in terms of all the spine cases, spinal fusion cases you were involved with? And then where you think that may go over the next 6 months or a couple of years even with that broad portfolio available to you now?

Katherine Owen

I would view that the acquisition is very similar in that if we're going to leverage the product offering that we got with the Orthovita deal through our much broader distribution channels in both inpatient and outpatient and across multiple divisions, Instruments, Spine, as was mentioned earlier. I wouldn't view this as leveraging the revenue that we were generating within our biotech specifically. This is where we're rounding out our product portfolio where there was a gap and, again, focusing on our core and leveraging the distribution capability that we have.

J and J, Q2 2011

We've been driving well above market growth in our biosurgicals platform through new products like the SURGIFLO Hemostatic Matrix Kit, one of the first product launches resulting from our 2008 acquisition of Omrix Biopharmaceuticals. We've also driven growth to the rapid globalization of the EVICEL Fibrin Sealant also acquired from Omrix. When we acquired Omrix, EVICEL is available in 1 country, Omrix's home country, Israel. But by the end of 2009, the product was available in 10 countries. And at present, we're at the 21 countries....

So let's start by taking a look at the overall MD&D market and what we're seeing. We continue to believe this market has solid long-term growth potential due to a number of tailwinds that you see on the left-hand side of this slide. I'll highlight each briefly. First, populations in the developed world are aging rapidly. In large countries like Japan, Germany and Italy, more than 20% of the total population is already over 65 years of age. That percentage is rising rapidly in other developed nations, including the U.S., with a first of approximately 77 million baby boomers began turning 65 this year at the astonishing rate of 1 person every 8 seconds. As most of us know from personal experience, we consume more healthcare as we grow older. In fact, those over the age of 65 consume an average of 7 times more healthcare per year than those under the age of 65.

A second tailwind is the growing demand for healthcare that we're seeing in emerging markets. China, for example, has lifted more than 400 million people out of poverty in the last 20 years. As standards of living rise, people increasingly expect and are able to afford better healthcare.

A third tailwind is the fact that significant unmet medical needs remain in both the developed and the developing world. The diseases that our products help treat, osteoarthritis, cardiovascular disease, diabetes, presbyopia, obesity, affect hundreds of millions of people today with prevalence rates that are on the rise globally.

Finally, we live in a time of tremendous scientific and technological progress. I was in Asia just a few weeks ago and had the pleasure of visiting with the number of high-tech companies outside of the healthcare industry. When you think about the advances that are being made in terms of our understanding of disease, and you couple that with some of the incredible new technologies that are being developed, it's a very exciting time to be in our space.