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

CPC Appoints Medical Product Service GmbH as Authorized European Representative for MedClose

SARASOTA, Fla., Oct. 29 /PRNewswire-FirstCall/ -- CPC of America, Inc.(OTC Bulletin Board: CPCF), a company focused on the development of therapeutic devices for use in endovascular procedures, today announced that it is implementing a European strategy for the development and distribution of its MedClose(TM) investigational-stage medical device. In the roll out of its strategy, CPC announced an agreement with Medical Product Service GmbH (MPS) of Germany to act as authorized European representative for the Company in seeking European regulatory approval for MedClose(TM) Vascular Closure Device(VCD). MedClose(TM) is an extravascular puncture-closure device intended to be used with a biological sealant for diagnostic and interventional cardiovascular procedures. According to published third party research, European VCD market sales for2008 are projected to total approximately $160 million. Industry experts forecast that in Europe, the penetration of VCDs into minimally invasive cardiovascular procedures will experience a 9% compound annual growth rate and drive VCD sales and revenues."The European Union offers significant opportunities to broaden theMedClose(TM) market potential," said Rod Shipman, chairman and chief executive officer of CPC of America. "By aligning ourselves with MPS, we are setting a critical path to market in Europe. Our team will work closely with MPS inbuilding key partnerships and navigating the European regulatory regime and clinical trials. We recognize the need for a safe, reliable closure system that reduces time to hemostasis and allows for faster patient ambulation and,when necessary, wound re-access. With MedClose(TM), we aim to fill that need in the U.S. and Europe."As CPC's authorized representative in Europe, MPS will provide service under the respective CE marking requirements that apply in the European Union.MPS's role will include vigilance reporting, communicating with competent authorities in individual member states, assisting in securing international product registrations, and preparing and completing dossiers for clinical trials and CE markings."MPS knows that physicians operating in catheter laboratories across theEU demand precise instruments that help improve patient safety and outcomes,"said Gehard Fromel, Principal Regulatory Consultant of MPS. "We are eager to collaborate with CPC to bring to market a product that may help the European medical community and their patients."
About Medclose
The MedClose™ VCS is a medical device that is designed to seal femoral arterial puncture sites in patients who have undergone diagnostic or interventional catheterization procedures. It utilizes a proprietary catheter delivery vascular closure system that is designed to enhance manual compression by delivering a biologic sealant which creates an elastic coagulum that is fully resorbed within 10 to 14 days.

Falling apart over Omrix

When I added Omrix Biopharmaceuticals Ltd. (Nasdaq:OMRI) to my portfolio, tracked by "Globes", I noted that it was a profitable biotechnological company in a most interesting niche - biosurgical sealants for the prevention of hemostasis in surgery - and that it was not an all or nothing company, like Pharmos Corp. (Nasdaq: PARSD), for example, where one failed trial can wipe almost an entire investment. It now turns out that while Omrix may not be of the all or nothing genre, it is a real madhouse for investors like me, who were looking for an oasis of tranquility in the biotechnology sector, a sector that has traditionally been fraught with risk.
Since the beginning of the year, Omrix has managed to issue a severe warning (in March) for the fourth quarter of 2007, plunge heavily, and replace its CFO a second time. At the beginning of this month, on the eve of Yom Kippur of all times, it issued an announcement in which it reported positive interim results in the important trial of its advanced surgical sealant, following which the share rose strongly, just as the collapse on the markets was moving into high gear. The news made the fast a bit easier to handle, but the joy was short-lived.
By the next day, Yom Kippur itself, Omrix had already updated investors with the announcement that it was halting the trial due to the occurrence of a critical fault, just a day after declaring it a success. Investors like me switched on their computers after Yom Kippur ended, only to find that the share had plummeted for the second time in six months. Later on in the month, Omrix tried to put the fiasco of the failed trial behind it with a reassuring announcement to investors about a strong third quarter. But Omrix's weary investors found little cause for cheer, and the share barely moved at all.
The denouement came last Friday when Omrix joyfully announced the resumption of the trial, as if nothing had happened at all. "We got it wrong, there was no fault," was what the announcement amounted to, and the company's share regained just a small part of the ground it lost on Yom Kippur. One can imagine how investors, who abandoned the stock on Yom Kippur after it crashed 40% following the announcement of the fault, felt last Friday when Omrix revealed it never actually happened.
The analysts covering Omrix are also finding that their patience is wearing thin. In its latest review, Citigroup describes the company's astounding u-turn as "one step forward, three steps back, one step forward." It assumes that the fault occurred for one of two reasons - either a technical failure due to human error, or bleeding in another place not treated by the sealant. Until such time as they receive further clarification, which will most likely be forthcoming on November 6, when Omrix unveils its results, Citigroup's analysts are retaining the lukewarm "Hold" recommendation they issued following the company's stiff warning in March, with a target price of just $15.
On top of all this, the Omrix roller coaster has been dogged by sporadic rumors that it could be sold for around $25 a share. The identity of the possible buyers regularly changes. Among those rumored to be in the frame are Ofer Group, Johnson & Johnson Inc. (NYSE: JNJ), Omrix's partner in the marketing and development of the aforementioned sealant and, according to "Globes", also European pharmaceutical giant Bayer AG (LSE: BYR; XETRA: BAY).

Source: Globes

Omrix Biopharmaceuticals Announces Patient Enrollment Will Resume In Fibrin Pad U.S. Phase II Clinical Trial In Mild to Moderate Bleeding

Omrix Biopharmaceuticals, Inc. ("Omrix”) (NASDAQ: OMRI), a fully-integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products, announced today that the Fibrin Pad U.S. Phase II clinical trial in mild to moderate bleeding will resume patient enrollment and continue with no modifications.
On October 9, 2008, the Company announced that the U.S. Phase II clinical trial had been suspended in order to investigate an incident of post-operative bleeding. This event met the stopping rules, as outlined in the clinical trial protocol.
Per the clinical trial protocol, upon the suspension of the study, a Data Safety Monitoring Board, or DSMB, reviewed the data related to the event. The DSMB has concluded their investigation and authorized the trial to recommence.
About the Fibrin Pad
The Fibrin Pad builds on the Company's aprotinin-free fibrin sealant technology incorporated into EVICEL Fibrin Sealant (Human). The Fibrin Pad is designed for the management and rapid control of mild, moderate and severe bleeding. This next generation, fully absorbable biosurgical product candidate combines medical device and proprietary biological components which form an instant clot when they come in contact with blood.

Excerpt Vascular Solutions Inc. Q3 2008

.........Our highest sales product category in the third quarter was our hemostat products, with $5.8 million in net revenue in the third quarter, a decrease of 4% from the third quarter of 2007. The three causes for the decline were the continued reduction in sales of our Duett sealing device, which is our legacy product that we have chosen to not actively promote, the as-planned conversion from hospital pricing to distributor pricing in Germany as a result of the switch to a distributor sales model, and the decline in sales to King Pharmaceuticals.
In the third quarter of 2008, King purchased $90,000 of Thrombi-Gel and Thrombi-Pad, with an additional order planned but delayed by us until the fourth quarter due to our recently completed facility expansion. We recently -- we expect King purchases to continue at the current level until we receive FDA approval for the surgical indication for the Thrombi-Gel product, which we currently target for the end of 2009.
D-Stat Dry sales were essentially constant on a sequential quarter basis, as we have maintained our leading market share in the face of intense price competition from the non-thrombin patches.