BioSyntech

Established in 1995 and traded on the TSX Venture since 2004, BioSyntech has created and developed innovative biotherapeutic thermogels for regenerative medicine (tissue repair) and therapeutic delivery, which appeal to large unsatisfied markets.
BST-DermOn™ is a topical therapy, which conforms well to the wound and may help stimulate the natural healing process. It may maintain the wound’s moist environment while allowing gas exchange. The wound healing, as well as inherent hemostatic and bacterio-static properties of the chitosan component of BST-DermOn™ has well-documented in the scientific literature. Our animal studies have shown that it stimulates and supports the intrinsic healing process of slow or non-healing wounds.
Claude LeDuc President and CEO BioSyntech Inc. said "As part of the implementation of the streamlined business plan we will concentrate and focus our efforts and resources on advancing BST-CarGel® through the clinic. While we continue to believe strongly in the market opportunity of our other programs, given the current limited financial resources at BioSyntech, enrollment for the BST-DermOnTM clinical trial and development work on BST-InPodTM has been suspended at this time."

Researchers Use New Method to Control Bleeding in Hemophilia

MILWAUKEE, Nov 13, 2008 /PRNewswire via COMTEX/ -- Investigators at Children's Research Institute, BloodCenter of Wisconsin's Blood Research Institute and the Medical College of Wisconsin have discovered a new way to help the blood clot by having the missing clotting factor packaged in the patient's own platelets. In the October 2008 edition of Blood, investigators describe how a gene-modified bone marrow transplant can be used to initiate clotting in hemophilia. This type of approach may work in the 30 to 35 percent of hemophilia patients that have developed inhibitory antibodies against the missing clotting protein.
The bone marrow is removed from the patient and stem cells are treated with Factor VIII, a clotting factor, which is placed in the platelets. The marrow is given back to the patient, who then retains the essential clotting mechanisms to stop bleeding that otherwise would lead to complications.
For people suffering from hemophilia, this research means the potential relief of a constant, burdening disease. People who have hemophilia previously had to be treated every time they bled. Currently, they can receive treatments three times a week, but these are very costly and time consuming. The results from this study provide hope that people with hemophilia could potentially lead a disease-free life.
The scientific community once believed that hemophilia would be treated successfully by gene therapy. Research then showed that gene therapy typically resulted in the patient not retaining a substantial amount of clotting factor, which is integral in preventing serious bleeding.
This research was a collaborative effort that included investigators Qizen Shi, PhD, MD; David A. Wilcox, PhD; and Robert Montgomery, MD.

Vascular Solutions Ranked as One of the 500 Fastest Growing Technology Companies in North America

Vascular Solutions, Inc. today announced that it has once again been included on the 2008 Deloitte Technology Fast 500, a ranking of the 500 fastest growing technology companies in North America. Rankings are based on percentage revenue growth over five years, from 2003-2007.
Vascular Solutions' CEO, Howard Root, commented: "This is the fifth year that we have been ranked as one of the 500 fastest growing technology companies in North America, which is a testament to the continued dedication and hard work of our employees. It is especially pleasing to be able to achieve our 346% revenue growth over the past five years through advancing our mission of delivering excellence in vascular devices. We are honored to be one of just three Minnesota companies on the Deloitte's Technology Fast 500 list for 2008."

Natures Superglue

How does an aquatic bacterium that colonizes streams, rivers, and water pipes resist being swept away by a forceful current or running tap water? The answer lies in a bacterially-produced, secreted substance, consisting of polysaccharides (long chains of sugar molecules) along with other unidentified sticky molecules, on the "holdfast" at the tip of its long, slender, stalk-like appendage, with which it affixes itself to solid surfaces.

Professor Yves BrunThe common, hydrophilic bacterial strain Caulobacter crescentus (C. crescentus) is a gram-negative, rod-like bacterium that lives in all sorts of water sources, including lakes, streams, sea water, waste water, and even bottled spring water, attaching itself to solid substrates such as plants, other microorganisms, glass, stone, and metal. Evolution has enabled C. crescentus to live under nutrient-poor conditions, hence its ability to exist even in tap water. Producing no human toxins, its presence in drinking water is innocuous to humans.While studying developmental aspects of C. crescentus, Indiana University biologist Yves Brun and lab members discovered that the bacteria could not be removed with strong washing from plastic overhead transparencies. In contrast, they found that their genetically-manipulated C. crescentus mutants, which lacked these sugar molecules at the tip of the stalk, were no longer able to bind to surfaces. In collaboration, Brown University physicist Jay Tang (formerly of Indiana University) and colleagues determined that three times as much force had to be applied to remove a single C. crescentus bacterium from a glass pipette compared with a pipette containing a similar amount of commercial super glue. Furthermore, they measured the physical force required to remove C. crescentus from its affixed glass surface, determining it to be over an incredible 70 N/mm2 (newtons per square millimeter; about 5 tons/in2), equivalent to the downward force exerted by three cars balancing on a quarter.
This natural, non-toxic glue, which can be found in small quantities in drinking water, has the strongest adhesion force of any known natural material. Unlike commercial super glues, which are often toxic, it sticks well under water, even salt water, and, thus, has a wide range of potential applications, from biodegradable surgical or dental adhesives to repairing industrial surfaces that suffer rain or sea exposure.

Orthovita Q3 comments on Vitasure Intro

Michael Matson – Wachovia
Okay and then just one quick question. Can you give us the VitaSure sales for the quarter?
Anthony Koblish
The VitaSure sales were above $200,000 for the quarter. The product was launched in mid July.
Dale Provanik – Canaccord Adams
Okay and just a client of VitaSure told me that if you from the initial response you’ve seen a couple of hundred grand is pretty impressive considering what the revenue price plan is on that product. How can a contribution in this scale – do you think that you will get 50%, 60%, or 70% penetration relevant to using VitaGel and what does that 10%, what does that equate in annualized dollar rate and 20% just for above any out there?
Anthony Koblish
Well I think that you’ve got to remember that our (inaudible) for VitaGel is really around spine and orthopedics. So it is not the full Gem I [ph] hemostasis field. However, that said the combination of VitaGel and VitaSure is a very nice hemostasis to our surgery product portfolio. That is up quite well with our competitors. At the gen 1 and gen 2 products, it’s a mixed of price point approximately $200 versus upper $400 let’s say and that qualifies for VitaGel and we use them at different points in the procedure. Gen 1 products is typically used intraoperatively while the procedure is being done and the gen 2 product, VitaGel, is pretty much used at the end of procedure as you’re closing with airbrush. So it gives us a nice style of surgery portfolio. That said, I think the growth and expansion of VitaSure is going to look more like VitaGel in its early days than what the bone graft substitute platform looks like. So the nature of the biosurgery business is different.
The nature of that business is really based on getting the product into different surgery in an array of customers whereas the work of our logics in bone grafting business is more driving into a specific procedure and growing deeper and broader. So it’s a little bit of a different sales strategy and so I think with VitaGel we saw that grow a nice pace over time and really start to gain whole as it got broader and broader and broader and we expect VitaSure to do a similar type of penetration as well. But I think right now it’s too early for me to get as specific as what you ask. However, given our experience I think with VitaGel I do feel confident in the way these are rolling out and right now I’d say we’re in the learning mode and that learning is in the part where it is setback into the point where we probably got to go through a few more of the receipt back loops and cycles to see where we are and take a little bit more time. However, I agree with you. We started cold. We didn’t slip any business that was already out there, first 200K was all VITA new relationships. So I do see a great potential with that business and I do think that it will behave similarly with VitaGel over time.
Source: seekingalpha

ZymoGenetics rises following analyst upgrade

Shares of ZymoGenetics Inc. rose Friday after an Oppenheimer analyst upgraded the stock, saying Wall Street now has a more reasonable view of the stock, and more modest expectations for the company's blood clotting drug Recothrom.
With shares down 71 percent over the last year, Oppenheimer analyst Kevin DeGeeter upgraded ZymoGenetics stock to "Perform" from "Underperform." He said sales estimates for Recothrom have decreased over the last few months and noted that ZymoGenetics is reducing the price of the drug.
In afternoon trading, shares gained 21 cents, or 5.3 percent, to $4.20. Earlier they climbed as high as $4.93.
The company cut the price of Recothrom on Oct. 1, the first day of the fourth quarter. When ZymoGenetics reported its third-quarter results on Nov. 4, Chairman and Chief Executive Bruce Carter said the company was already seeing the results of the change: he expects Recothrom sales will rise to about $3 million in the fourth quarter, a 60 percent jump from the third-quarter total of $1.8 million.
In a telephone interview, ZymoGenetics Director of Corporate Communications Susan Specht said the change was made because doctors were "price sensitive" as a result of economic conditions.
Recothrom is derived from a synthetic process, while most clotting agents - products designed to reduce bleeding during surgery - are made from human or animal plasma. Specht said recombinant clotting products such as Recothrom are usually priced at a premium to plasma-derived drugs.
Some patients given cattle-derived anticoagulants develop antibodies that fight the drugs, which can cause increased bleeding.
Even with the change, she added, Recothrom still has a premium to animal-derived products.
Analyst DeGeeter said the cut is intended to make Recothrom more competitive with King Pharmaceuticals ' bovine-derived coagulant Thrombin-JMI. He said he had been concerned in the past that price pressures were going to hurt makers of all clotting drugs.

King Pharmaceuticals Inc. Q3 2008

Commenting on the Thrombin market Joseph Squicciarino - Chief Financial Officer, King Pharmaceuticals said "......with Thrombin the update on the competitive landscape is we're doing very well. Price continues to erode due to competition. We're going to be as competitive as we need to be to keep the business and the market is pretty much going as we predicted because there is no huge unmet medical need for a recombinant product that has no safety advantage."

ZymoGenetics pushes to increase lackluster sales of only drug

ZymoGenetics said Tuesday that quarterly sales for its only commercial product increased by 27 percent but still fell short of expectations, spurring a new strategy to ramp up sales.
"Sales are still low, and our focus is and must be to grow sales as quickly as possible," said Chief Executive Bruce Carter in a conference call to discuss its quarterly financial results.
The product, Recothrom, is a genetically engineered form of thrombin, a blood factor used to control surgical bleeding. Net sales of the product amounted to $1.8 million in the third quarter, versus $1.4 million in the preceding quarter.
The Seattle company reduced prices at the beginning of October and is undertaking a more aggressive campaign highlighting the risks of Recothrom's competitor, a similar product derived from bovine blood. Sales are being held down by hospital concerns about prices and limited awareness among doctors about the compound.
ZymoGenetics posted a third quarter net loss of $28.8 million, or 42 cents per share, down from $39 million, or 57 cents per share, in the same period last year.
ZymoGenetics launched Recothrom in January amid great expectations, but the market has been skeptical about the company's ability to achieve higher sales. Its stock price has suffered accordingly.
Last year ZymoGenetics was the region's largest independent biotech by market capitalization, and its share price peaked at $15. On Tuesday, shares traded at $3.85, up 3 percent; the company's market cap now ranks third among local biotechs.
In May, McAdams Wright Ragen analyst Paul Latta cut his 2008 sales outlook to $18 million from $30 million; other analysts more recently reduced that estimate to about $12 million.
On Tuesday, ZymoGenetics issued its first official guidance for Recothrom, predicting 2008 sales of $7 million. In the long term the company expects to lead the market for thrombin, said spokeswoman Susan Specht.
Some analysts have estimated that eventually Recothrom sales could reach $300 million to $400 million.

The Clotting Cascade and Blood

Highlights Cryolife Q3

BioGlue revenues were a record $36.5 million for the first nine months of 2008, compared to $32.4 million in the first nine months of 2007, an increase of 13%. This increase was primarily due to the aggregate impact of a favorable product mix, and a 4% increase in the number of BioGlue milliliters shipped, which increased revenues by 10%, and an increase in average selling prices, which increased revenues by 3%..........

Other medical device revenues in the third quarter and nine months of 2008 included $549,000 and $726,000 in sales of Hemostase MPH, which we began distributing in May of this year.........

During the quarter we were awarded another grant of $848,000, of which $212,000 has been received from the Department of Defense for our continued development of our BioFoam surgical matrix product. Our CE mark application for BioFoam is targeted to be submitted to our European notified body in December. We would expect that we would receive approval for the BioFoam CE mark in April of ’09.
Our plans are to launch this product throughout Europe beginning in the second quarter of 2009. After CE approval, we plan to conduct several post-approval studies to evaluate BioFoam in liver resections. These will be conducted at three European clinics, with approximately 15 patients per clinic.
For approval in the United States, we will need to submit an IDE application and conduct a clinical trial. We are currently targeting a December submission for the BioFoam IDE. The U.S. human study indication will be as an adjunct to control bleeding following liver resection surgery. We will initially be requesting a pilot clinical study at one or two centers, in 10 to 20 patients. We would expect our follow on pivotal U.S. study to include up to 200 patients. We estimate that it will take about two years to complete the pilot and pivotal studies in the United States.........

Other medical device revenues, which consist primarily of sales of Hemostase MPH, are expected to be between $4.5 and $5.5 million in 2009. Product and tissue processing revenues could be affected by several factors, including but not limited to, the general economic environment, and its effect on demand for the company’s products and processed tissues, and changes in foreign currency exchange rates, and their effects on revenues generated in international markets. Again, this guidance assumes foreign currency exchange rates stay near current levels...............

And from the Q & A.

Greg Brash - Sidoti & Company
Okay, and is the -- just one last question, is the Hemostase MPH, is that tracking your expectations? Are you pleased with how the product is selling and the physician feedback?
Ashley Lee
Yes, we are, we’re getting a lot of attraction with that product, and we think it’s also very complimentary to BioGlue, and we think that it’s had some impact on the BioGlue sales increases.
Greg Brash - Sidoti & Company
Okay, I mean do you think doctors are pretty brand-loyal on this market? Obviously, you’re doing pretty well, and you’re still initial launch year, but are they pretty open to trying the product?
Ashley Lee
They are open to trying the product. When you see it work, it’s a very impressive visual reaction, because it works instantaneously so I think from that stand and it’s effective, so I think that it will continue to grow.
Greg Brash - Sidoti & Company
Okay, thanks guys.

Source: seekingalpha