Cryolife Q3 - Edited...Offers Multiple Hemostatic Platform

Cryolife are offering a multi-Hemostatic platform which will challenge their competitors and offer surgical alternatives, please find below edited comments from Q3, for full info click the link at the bottom of this post. A visit to the CRY site is worthwhile HERE

Ashley Lee - EVP, CFO and COO

We saw evidence that the cardiac business continued to improve during the third quarter. Cardiac revenues for the third quarter of '09 increased 4% compared to the corresponding period in '08 and increased 13% compared to the second quarter of '09. The increase in the third quarter compared to the prior year was primarily due to a 7% increase in unit shipments partially offset by a decrease in average service fees. We believe factors contributing to the cardiac improvement include our efforts in physician training, including the Ross Summit and monthly aortic allograph workshops, the efforts of our new specialized cardiac technical representative sales force, anticipated seasonal increases with respect to the increase over the second quarter and increased shipments into international markets in particular, Germany and Austria. Also positively affecting the cardiac business during the quarter was our 510(k) clearance of CryoPatch SG used for cardiac reconstructive surgeries. We anticipate

that this will be a growing part of our cardiac business in the coming quarters. The vascular preservation service business continues to do well. Vascular revenues for the third quarter and first nine months of '09 increased 8% and 10% compared to the corresponding periods of '08. These increases resulted from an 8% and 10% increase in unit shipments for the third quarter and first nine months of '09 compared to the comparable periods of '08. Surgeons are seeing the benefits of using our preserved vascular tissues, especially for prevention of amputation of lower limbs and in actively infected surgical sites. We believe that this will continue to be a very attractive market for us and we believe that we have significant room for growth in this business. Product revenues which consist primarily of BioGlue and HemoStase increased 5% in the third quarter of '09, compared to the third quarter of '08 and increased 6% in the first nine months of '09 compared to the first nine months of '08. The increase year-over-year primarily reflects the growing usage of HemoStase in cardiac and vascular surgical indications. HemoStase revenues for the third quarter and first nine months of '09 were $1.6 million and $4.1 million.

Steve Anderson - President and CEO

On August 4, we announced that we had received a CE mark for BioFoam surgical matrix as an adjunct in the ceiling of abdominal parenchymal tissues, specifically liver and spleen when cessation of bleeding by ligature or other conventional methods is ineffective or impractical. The CE mark allows for unrestricted commercial distribution of BioFoam in the European community. BioFoam is based on the same protein hydrogel technology platform from which BioGlue Surgical Adhesive was developed, and becomes our second product from the company's protein hydrogel technology platform to receive a CE mark. The company has been developing BioFoam in conjunction with the United States Department of Defense which has provided the company with most of the funding for advancing this product. We continue to evaluate the potential for using BioFoam to seal penetrating wounds such as gunshot injuries as well as for other types of surgery. Today, the Department of Defense has granted about $5.4 million to CryoLife for the development of this surgical sealant. The controlled clinical launch of BioFoam began in Europe in early September with initial clinical uses occurring in Germany, the UK and France. Based on the number of liver and spleen procedures done annually in Europe, we estimate that this is a $30 million annual market opportunity with a worldwide annual market of about $100 million. As of yesterday, we had completed 21 BioFoam applications in 19 patients with the longest follow up now beyond 30 days in the controlled clinical launch. The product has worked well and provided homeostasis in all of the cases. All of these initial patients will have completed their 30 day follow-up by the 21st of November. We anticipate a full commercial launch in Europe to begin in January of 2010. Additionally, we have begun feasibility animal studies evaluating the use of BioFoam in cardiovascular procedures. One acute and two chronic animals were recently completed with BioFoam applied to the aorta, femoral veins and aortic jump graft. The BioFoam stop bleeding in all cases demonstrating the product's potential utility in these applications. The chronic animals will be evaluated at 30 days. We anticipate that BioFoam would be useful in cardiovascular procedures for external bleeding and suture line sealing. BioFoam is easily visualized in the surgical field and initial studies indicate that it biodegrades more quickly than BioGlue. We expect to conduct a pivotal animal study and file for a cardiovascular CE mark application towards the end of the first half of next year. If BioFoam proves to be valuable in controlling active bleeding in cardiovascular applications, we believe the market opportunity in Europe for BioFoam could be significantly larger than the market opportunity for BioGlue. Initial estimate suggests this expanded opportunity could approach $100 million annually. Earlier this week, we announced that the FDA had approved our Untied States IDE to conduct a human clinical trial for BioFoam for use in sealing liver parenchymal tissue on cessation of bleeding by ligature or other conventional methods, is ineffective or impractical. The approved IDE is for our perspective, multi-center randomized, feasibility study evaluating safety outcomes of BioFoam as compared to standard topical haemostatic agents. We will now seek approval from the United States Department of Defense which will be the final step necessary to begin this trial. Following DoD approval, the feasibility investigation will be conducted at two investigational sites and will enroll 20 eligible subjects with 10 subjects in each treatment group. Upon successful completion of the feasibility study and subsequent FDA and DoD approval, a follow-on perspective multi-center randomized controlled pivotal study will be conducted. It is currently anticipated, that the pivotal investigation will enroll a total of 164 eligible subjects. 82 subjects in each treatment group across a maximum of 10 investigational sites. The successful completion of the BioFoam US clinical trial which we anticipate will take about three years, would give the company a technology platform of three products to control surgical site bleeding that would in the aggregate, address active bleeding sites in vascular and cardiac reconstruction surgeries as well as the sealing of parenchymal tissues such as liver and spleen surgical procedures. Management believes that the total annual worldwide market for surgical adhesives and glues approaches $900 million.

Ashley Lee

As detailed in our press release this morning, we expect total revenues and preservation service revenues for the full year of '09 to be near the lower end of our previous range of guidance, BioGlue revenues to be slightly below our previous range of guidance and HemoStase revenues to be near the higher end of our previous range of guidance. We expect other revenues for '09 to be approximately $1 million primarily related to funding received from the DoD in connection with the development of BioFoam. The amount of other revenues is largely dependent upon actual expenses incurred related to the development of BioFoam. We currently plan to issue our initial 2010 financial guidance at the Piper Jaffray Health Care Conference in New York on either December 1 or 2. Although we are currently in the process of finalizing our 2010 plans, we will say that we certainly expect 2010 to be another record year in both revenues and operating income. There are a few items that we would like to comment on that we believe could be positive developments for the company in the future. As Steve mentioned earlier, we expect to begin enrolling patients in our BioFoam IVE either late this year or early next year under an FDA approved clinical trial. This will be the first step in getting a commercial approval to distribute BioFoam in the United States. We are still optimistic that we will get approval to sell BioGlue in Japan. Progress continues to be made on this matter. We are in the process of completing our second large animal study for the use of ProPatch our FDA cleared, SynerGraft processed tissue patch, for use in general surgery indications and specifically ventral hernia repair. If the studies are concluded successfully, we expect to ramp up our efforts to secure a commercialization partner in general surgery. We continue efforts on the business development front to find complementary products or companies that we can acquire to leverage our existing infrastructure and sales force to deliver more value to our shareholders.

Question-and-Answer Session

Matt Dolan - Roth Capital

First question on Bio, may be you can give us some detail there. We haven't seen a level quite as low for a year or two. What's happening there with pricing or competition or may be something at the hospital level? Just some more commentary would be appreciated.

Ashley Lee

Yeah Matt there are few factors that are playing into what we saw with BioGlue, First of all, we have seen some recent product approvals in recent meaning within the last couple of years. In areas where BioGlue had been used on an off-label basis, so we think that we've seen some of that business go away. We also continue to see hospitals challenge the use of products and surgical procedures, including seamless and haemostatic agents and we think that that's had a small effect on our business. We're also seeing some of our large competitors become very diligent in enforcing hospital purchasing requirements under their contracts. Again, that hadn't affected our business to a huge extent but again, it has had some effect. We've also seen hemostats actually be used in a small amount of procedures where BioGlue has currently been used. We don't think it's a significant issue for the BioGlue business going forward, but again, we did see we did see a little bit of that recently in the last couple of quarters. We still see a little bit of respect on pricing and for the nine months number, foreign currency exchange rates had an effect on the revenues year-to-date although to a lesser extent in the third quarter in this year. So, again there are several issues that we see there none of which I think, stands out anymore than the other. We hope that a lot of these issues are transient and that they will go away, especially factors relating to the economy. We think others will probably run their course in 2009 and going forward, we're still optimistic that we're going to be able to grow the business. Its a major focus of the sales force going into 2010 and if all goes according to plan and what we see, we still believe, that that long term, we're going to be able to grow this business at a rate consistent with growth in cardiac and vascular surgical procedures which is in the mid single digit range.

Matt Dolan - Roth Capital

So, if I look at the guidance, what it implies for Q4, for pushing down towards the lower end of things, it's still a sequential increase but, not significant. I know last year, you saw a sequential decrease in Q4, but for the most part, it seems like Q4 is one of your bigger quarters of the year. Is that guidance related primarily to the BioGlue situation or maybe is there a more general comment you could provide on hospitals and destocking and some of the issues we saw earlier this year, what's the rationale there?

Ashley Lee

I'll comment on BioGlue specifically and we certainly expect to see fourth quarter be sequentially better than the third quarter. If you look at where we are in the month of October right now, October is on track to be better, provide good revenues than any particular month, any single month in the third quarter, and we expect that to continue into the fourth quarter. So, a couple of things there, we expect BioGlue to increase sequentially. We also think that that will have the effect of increasing gross margin sequentially in the fourth quarter compared to the third too, because it was a little bit lower than what we wanted it to be in third quarter and because BioGlue has such high gross margins, it effected margin in the third quarter and we fully expect gross margin in the fourth quarter to increase sequentially over the third.

Matt Dolan - Roth Capital

So may be just a general, I know you gave a kind of a synopsis of what's going to drive growth, but if we think of a base business growing in the mid-single digits, how are you going to provide growth or accelerate growth from what we've seen here in 2009, whether it be adding to the sales force or some of the initiatives you hit on. Are any of those something we should start to rely on?

Ashley Lee

Well, I am talking about tissue specifically, we continue to see year-over-year growth there, the cardiac business has certainly rebounded and we're seeing year-over-year growth in the vascular business. We expect that to continue into 2010. For BioGlue again, it's a major focus of the sales force right now. There are a few things that we are working on there from a marketing standpoint. We're really looking at marketing BioGlue in combination with HemoStase as a perfect partnership to really address like 90% of the needs that the operating room has to control blood loss. So, we're really focusing on marketing the two products together. We've always marketed their speed, simplicity and ease of use. We also are taking a different approach with product approval committees; especially as it relates to HemoStase and we are focusing on the economic story using BioGlue and the cost savings with the reduction in blood products. So, we fully expect to be able to grow BioGlue. And then HemoStase again, we're only getting into our second full year of the launch in 2010 and we expect that business to increase significantly.

Greg Brash - Sidoti & Company

And then just on the BioFoam expectations, you talked a little bit about potentially using in cardiac procedures, may be where you are using BioGlue. How long until those studies are completed. When can we realistically may be expect an indication [assumption] in that margin?

Ashley Lee

BioFoam will have a full launch in international markets at the beginning of next year. The initial work that we have been doing for sealing organs indicates that it is very effective. It can provide hemostasis and a liver reception under one minute, which is superb. And then the animal studies that we have recently been doing to evaluate the effectiveness for cardiovascular surgery would indicate that it can effectively hold cardiac pressure, which is extremely encouraging. And I am very encouraged about that because, there has been some criticism of BioGlue's long degradation time and the studies that we've been conducting, showed us that BioFoam pretty much is gone after six months in the body, and I think the doctors will find that very helpful to them. It's also very easily seen once it's applied in the body. You can see it more easily in the surgical field than you can see BioGlue and it isn't as runny. I think its going to be very user friendly, that's what I am leading up to there. But it's effectiveness as a haemostatic agent is very encouraging to us and that is going to end up being a significant product for us. That will give us three sealants adhesives, call them what you wish, had act in significantly different ways and have very different uses, whereas the HemoStase isn't very strong. BioGlue is very strong. And to refresh people's memory, BioGlue can withstand 500 millimeters of mercury blood pressure, within two minutes of being applied and BioFoam will fit right in the middle of those two products. It be very nice product, very versatile product and I am looking forward to that making a significant contribution in international growth next year.

Greg Brash - Sidoti & Company

And just one more on BioGlue, you mentioned several issues that have been impacting sales. Did you believe it's more a function of just hospitals cutting back on using sealants in a way to cut costs or a competitor out there just really taking on a share?

Ashley Lee

We really think it's just a conglomeration of all the factors that we mentioned Greg. We don't see any one of those factors contributing significantly more than the others. Just a lot of little things at this point, but we think that we're on our way to addressing several of those and again, we expect revenues to certainly increase sequentially in the fourth quarter and we expect the growth in 2010.

Ashley Lee

We have about 12 cardiac specialists throughout the United States and we're going to be adding to that in 2010 and we have between 40 and 45 sales representatives that handle vascular tissues. Vascular tissue sales reps handle vascular HemoStase and BioGlue and the cardiac specialists who focus primarily on cardiovascular surgeons would be handling the three products as well. That's how it's sorted out but, it takes a more sophisticated sales run to effectively interact with the cardiovascular surgeons. I think you have to know a lot more about cardiac reconstruction to be able to communicate effectively with them and that's why last year we took the top salesmen in the company and put them over into that new sales job and its turning out to be very effective.

The full transcript is available at Seekingalpha

ZymoGenetics’ Former Medical Boss Leads Rival Startup, ProFibrix

One of the key people who transformed ZymoGenetics from a basic research institute into a more balanced biotech company with both R and D, has set up shop in a rival startup just a few blocks away on Seattle’s Eastlake Avenue. If he plays his cards right, this little company will surpass his former employer, with what he hopes will be an even better treatment to control bleeding.

His name is Jan Öhrström (pronounced Yahn Oar-strum), and he’s the former chief medical officer of Seattle-based ZymoGenetics (NASDAQ:ZGEN), and now the chief operating officer of a company calledProFibrix. The newer company is headquartered in the Netherlands, and when it went looking to establish a U.S. presence a year ago, it hooked up with Öhrström to build that in Seattle. The company picked up some momentum in August when it raised $11 million in a Series B venture round, and it has some intriguing technology, so it was time to catch up with Öhrström over lunch to find out what’s up.

ProFibrix sees itself carving out a niche in the market for drugs and sealants that are used to stop excess bleeding, both in the surgical operating room and among paramedics—or on the military battlefield. The company is creating a dry powder that is ready to be used at a moment’s notice, can be sprinkled on a wound, remains stable at room temperature, and can be packaged in a spray or a bandage. It sees its potential edge in convenience when going up against standard treatments that need to be thawed, mixed with another solution, or kept in a fridge. If this new product can be proven effective in clinical trials, ProFibrix will tap into a couple different market segments worth about $600 million a year combined in the U.S.

“There’s no doubt about it, we can make significant inroads in the market,” Öhrström says.

Jan Ohrstrom

When we met over lunch near his home on Mercer Island, Öhrström was excited about getting ProFibrix set up in a new office on Eastlake, complete with all the usual mundane aspects of a startup—getting the lease signed, phones working, and the office furniture assembled (I could relate this part to when Greg and I got the Xconomy Seattle office up and running in June 2008.)

ZymoGenetics is well known for its blood coagulation expertise, although its Recothrom drug has gotten off to a slow start in sales. ProFibrix CEO Jaap Koopman, it turns out, had been cultivating a relationship with Öhrström for years, dating back to when Ohrstrom oversaw the development of recombinant thrombin (Recothrom). The vision was that if ProFibrix could get Ohrstrom on board—somebody who had technical knowledge of coagulation, expertise in leading drug development, and the experience of doing the IPO roadshow for ZymoGenetics back in 2002—then ProFibrix would have somebody who could help it attract more U.S. scientific talent, and get on the radar of U.S.-based investors.

What attracted Öhrström to the new company was ProFibrix’s lead drug candidate, which it calls Fibrocaps. It’s a tissue sealant that is derived from a pair of clotting proteins found in human blood—fibrinogen and thrombin. ProFibrix gathers those proteins from human blood, and spray dries them through a proprietary manufacturing process. That makes them into microparticles in a dry powder, which is stable at room temperature, and just needs a little liquid added (like what is found at a bleeding site) for it to spring into action and start clotting.

This sort of thing could be used by surgeons to control excess bleeding, like the ZymoGenetics drug, and could also be used by paramedics or Army medics who need something quick and convenient to stop bleeding fast, Öhrström says. It would offer a convenient alternative to fibrin sealants made by Baxter Healthcare and Johnson & Johnson, which require thawing or heating, or some kind of mixing or application device, he says.

Convenience is a big part of the story, but Öhrström got more animated talking about the science. Liquid coagulants sometimes have the disadvantage of being applied to a highly viscous bleeding site on the body, and they can run off. When these types of liquid tissue sealants are made into a spray applicator, they also sometimes clog up on the tip and don’t spray very well, Öhrström says.

The ProFibrix microparticles have the physical advantage of being able to embed themselves in any number of difficult situations that doctors and paramedics might face. “When you have a bleeding surface, it’s rarely flat. It’s got crevices,” Ohrstrom says. “A dry powder can conform to any surface.”

OK, so what kind of evidence does ProFibrix have to prove this concept? Not a lot yet. It started enrolling the first of about 20 patients in a clinical trial in June, and hopes to have results in hand by the end of this year. If it can stick to what Öhrström calls “an ambitious timeline,” then it will start a mid-stage trial in 2010 that can roll over into a pivotal study. That trial could form the basis for a new drug application to the FDA by late 2011 or early 2012, he says.

The ProFibrix group in Seattle will likely remain small, Öhrström says. The company has already recruited Linda Zuckerman from ZymoGenetics to head all preclinical development, and it will look to assemble a small team of maybe six to eight people with expertise in drug development, regulatory affairs, and business development. It doesn’t expect to have labs here. “We want to keep the payroll lean,” Öhrström says.

I had to ask Öhrström how he manages in a trans-Atlantic company, with headquarters that operate nine hours ahead of him. Ohrstrom, who is from Denmark, is used to it from his days working with Denmark-based Novo Nordisk before he joined ZymoGenetics. The new job requires that he travel a fair bit to the Netherlands, but he says he doesn’t mind, and it is actually not too much of a strain on his family life.

“My wife is Dutch, and she has family in Holland, so she’s very supportive,” Öhrström says with a laugh.

Vascular Solutions - Q3 Edited

Our highest sales product category in the third quarter was our hemostat products with $6.4 million in net revenue, a 10% increase from the third quarter of 2008. With the second quarter exit of one of our competitors in the hemostatic patch market, in the third quarter we were able to drive continued growth of our D-Stat Dry and Thrombix patches.
We also increased sales of our new Wrap version of the Dry, which is configured to be placed around, in-dwelling lines of catheters. In the third quarter, we recorded $153,000 in sales of ThrombiGel and Thrombi-Pad to King Pharmaceuticals under our distribution agreement, a quarterly level that we expect roughly to continue until we receive approval for the surgical indication for the ThrombiGel product.
In July, we completed the enrollment of the final patient in our ThrombiGel surgical clinical study and we have now completed the necessary 60 day follow up and expect to analyze the data and submit our PMA to the FDA by the end of December. We believe that this surgical indication will greatly expand King’s ability to sell our ThrombiGel into their targeted surgical markets, which based on current FDA review times. We are projecting to receive by the end of 2010.
In the fourth quarter, we also expect to launch the new Rad-Band, a low cost compression device for use following radial artery catheterizations, which has already received FDA clearance and also an improved version of our original D-Stat Radial. We are completing the build of launch quantities of our new Hunter biopsy marker device.
However, due to an FDA comment letter on our 510(k) submission in the third quarter, we will now need to submit additional information, which will push the launch of this device, the Hunter product, into 2010. Related to our hemostat products, we continue to await the appellate decision on our $4.5 million jury verdict for defamation against Marine Polymer Technologies, which has now been increased with interest to $5.2 million.
The oral argument was heard by the first circuit of the US Court of Appeals in Boston on February 4. Once the appeals court issues its decision, the only remaining steps would be a possible petition for rehearing by the entire panel of the first circuit and a potential writ of appeal to the U.S. Supreme Court. Only after all the appeals are exhausted will we record any resulting gain in our projections of net income or cash flow.
We continue to be highly confident in a favorable decision on the entire award, including interest, but given the delay by the appeals court, we do not expect to receive the judgment, if affirmed, until 2010.
In the third quarter, we also increased sales of Zerusa’s Guardian hemostatic valve by 15% sequentially over the second quarter. In October, the FDA cleared Zerusa’s 510(k) application for the new Guardian II version that we expect to launch next week. We believe that this new Guardian II version, particularly when combined with the Flamingo inflation device that we distribute for Pursue Medical, will substantially increase sales of access products in 2010.

Chris Cooley - FTN Equity Capital Markets
Just two quick follow-ups, James, maybe could you remind us what you kind of view the maintenance CapEx run rate going forward, as we think about 2010 and beyond? Then, secondly, when you just look at your hemostatic products, we’ve seen some of the larger coronary players report softness in that market in terms of PCI volumes, and also seen some pricing. Kind of can you walk us through, maybe either Howard or James, what’s baked into your assumptions for the market and pricing, as we think about the hemostatic space between now and calendar year end?

James Hennen
I’ll start with the CapEx question. We’ve been running the last three years at about $1 million a year in CapEx, but going into 2010, we may in which making some margin improvements and bringing some things in-house as far as more manufacturing capabilities. So we haven’t given guidance on 2010, but it may be more than that general $1 million, maybe $1.5 million type range, so nothing a substantially increase over $1 million run rate. So that’s where we expect it to be.

Howard Root
In terms of the market, in PCI volumes I mean I’ve been aware of the big companies in our space, with Saint Jude and Boston Scientific yesterday and their comments. The nice thing about our business strategy is we’re not dependent on market growth in order for us to be successful.
So, playing in the clinical niches, which sometimes we got abused for saying that we’re a small product company, now it’s really a plus, because we can go out there and develop new things, which aren’t material increases and most of the times actually decreases in the budget and even if the number of procedures don’t go up, they just shift to the next technology and being a clinically differentiated company plays well there.
In terms of pricing, we always focus on that being flat, but we don’t have price increases. In the patch market, I think we have bought a couple of new product launches a year or two ago or new product free samples a year ago and I think we’ve won that game. We’ve got the clinical data on our side.
We can show the benefit of our product and we’ve got approved indications, which a lot of these patches just don’t have. So I think you’ve seen in the last two quarters resumption on that area and I think keeping a steady price, not falling victim to the low cost patches that don’t have the data, has done us well.
In terms of long-term market, I am still optimistic about our strategy and I’m optimistic about the healthcare system. I need to get a little bit of certainty in terms of the healthcare reform and what’s going to go on as a general matter, a global matter, but as far as it affects Vascular Solutions that really like this space we are in because in a turbulent world, certainly start ups are going to have a hard time with it, anyone trying to replicate what we’re doing is going to have a hard time doing it and the big companies are having a hard time to find growth.
So we are in the perfect middle ground where we can still grow double digits with products that don’t demand an increase in the market and we have a wide-ranging international market open to us that we can expand into 2010 and beyond as well. I pay attention to what’s going on in the market, but it doesn’t affect us day-to-day, and I’m glad we are in that space because it’s not all roses out there for the overall healthcare system in the U.S.

source: seekingalpha

Baxter Q3 - Edited

.... in our regenerative medicine business, we initiated a Phase III study evaluating the use of ARTISS in facial surgery in the United States. This is the second of three pivotal studies required by the FDA to obtain a broad adherence label.
As you know, ARTISS is the first and only slow-setting fibrin sealant indicated for use in adhering skin grafts in adult and pediatric burn patients. And is the newest agent in our expanding biosurgery portfolio.
...Sales in regenerative medicine, which includes our BioSurgery products, totaled $109 million and increased 5%. Sales excluding foreign currency grew 10% reflecting robust growth for FLOSEAL. And finally revenues in the other category, totaled $81 million versus $89 million last year.

J 'n J Q3 - Edited

Ethicon worldwide sales grew operationally by 9.4% with US up 18% and sales outside the US up 3.8% operationally. The acquisitions of Mentor and Omrix partially offset by the divestiture of the professional wound care business added approximately 3.5 points to the worldwide operational growth. Sales for our newly acquired aesthetics products for Mentor were in line with 2008. On a worldwide basis double digit operational growth was achieved in biosurgicals and meshes.
Johnson & Johnson leads the industry in developing and next generation of advanced hemostats to address the persistent clinical problems associated with bleeding in surgical settings. A truly unique example of convergence three Johnson & Johnson companies; Ethicon, [Senacore], and the recently acquired Omrix Biopharmaceuticals have been working together to develop one such hemostat that we call the Fibrin pad.
With our heman plasma based biologics embedded directly into proprietary matrix the fibrin pad has the potential to uniquely and effectively dress bleeding challenges that are currently unmet by traditional hemostats. It’s designed to combine the functions of mechanical sealing and biological hemostatis. Upon contact with blood the biodegradable device causes a clot to form rapidly and stop bleeding without any other action. A BLA for the fibron pad is targeted for submission by the end of 2009.

Patch Uses Stem Cells To Plug Holes in The Heart

They say only time heals a broken heart, but Duke University researchers think they can do better. Using embryonic stem cells from mice and their own novel molding technique, a team of researchers at Duke has developed a three-dimensional heart cell “patch” that conducts electrical impulses and contracts, two all important characteristics of heart tissue.

Cardiomyocytes, the heart muscle cells that keep the blood pumping, are difficult to grow effectively because left to their own devices, they will simply develop into a disorganized clump of cells. To get around this, the team coaxed embryonic stem cells to develop into cardiomyocytes by placing them in an environment much like the one in which they develop naturally. By encapsulating the cells in a gel made of fibrin, a blood-clotting protein, the researchers provided the mechanical support for the cells to form an organized, three-dimensional structure.
But the key ingredient for the researchers were helper cells called cardiac fibroblasts. These cells make up as much as 60 percent of the cells present in the heart, and when introduced to the mold they caused the cardiomyocytes to pull together as if they were growing in a developing human heart. The alignment of the cells in the correct direction allows them to contract and carry electrical signals as though they are native tissue, allowing them to function fairly seamlessly alongside existing heart tissue.
After being cast in the fibrin mold, the patches can be placed on the heart where the tissue is thin or compromised and injected with cells that would then generate new heart tissue. But obstacles remain; aside from the many regulatory hurdles a procedure like the heart patch must leap, engineering a blood vessel supply to sustain the patch also presents substantial challenges. The use of embryonic stem cells also invites controversy, so the Duke team also plans to test their patch using non-embryonic stem cells. Ethical and regulatory issues aside, the proof of concept is an important breakthrough for cardiac researchers who have a limited arsenal with which to battle heart disease, the leading cause of death in many developed countries. An effective non-embyronic stem cell heart patch would not only circumvent the problem of immune system reactions, but sidestep sensitive ethical land mines, clearing the way to put broken hearts on the mend.

HyperBranch Medical Technology, Inc. Receives CE Mark for its NuSeal 30 Hernia Mesh Fixation Sealant Product

HyperBranch Medical Technology, Inc. announced today that it has received a CE Mark for its NuSeal 30 hernia mesh fixation sealant product. NuSeal 30 is used in hernia procedures to adhere the mesh. NuSeal 30 provides for secure mesh placement, minimizes pain caused by other fixation devices and gradually degrades as the body heals. The CE Mark for NuSeal 30 provides regulatory approval for the company to begin the registration process in countries outside the U.S. The unique, single use device is terminally sterilized and sets on contact after a spray application. The synthetic, biocompatible composition is stored at room temperature and is delivered through a custom applicator to meet the specific needs of the procedure. The intended users of NuSeal 30 are General Surgeons in a surgical environment. John Conn, President and CEO, said, "NuSeal 30 is a follow on product to the platform technology developed at Hyperbranch. NuSeal 30 is a major improvement to mesh fixation eliminating the need for staples and tacks while providing secure fixation, reducing pain and creating an anti-microbial environment. The Company will continue to introduce this technology in other indications." The Durham, N.C. medical device company recently announced the CE Mark approval of its NuSeal 100 for dural closure and the licensing of OcuSeal ophthalmic bandage to BD Medical. The company is currently conducting US clinical evaluations for the dural closure product and is in various stages of development for other indications of the platform technology. About HyperBranch Medical Technology, Inc. HyperBranch Medical Technology, a privately-held company based in Durham, N.C., is developing innovative medical devices for the ophthalmology, general, and specialty surgery markets. The company is focused on the development of unique products based on its novel hydrogel technology. Development work on HyperBranch`s surgical sealant platform has led to the recognition of several novel hydrogel properties that suggest significant utility in a variety of additional clinical applications. For more information visit www.hyperbranch.com.

Curasan Ag To Invest Approximately 1 Million Euros In Future Growth

Oct 12, 2009 – Kleinostheim, Germany – curasan AG, which is listed on the General Standard of the German Stock Exchange (ISIN: DE 000 549 453 8), is to invest in its future growth by implementing a technological investment programme amounting to approximately 1 million euros, despite the current crisis in the financial markets.
The aim of the investment package is to significantly strengthen and expand the company’s research, development and production capacities and to integrate modern technologies. Part of this strategy will involve relocating the Frankfurt production and development centre to larger premises in the immediate vicinity of the current location. The relocation will take place step by step and is scheduled to be completed by mid-2010.
“We have a wide range of products that will be ready for market launch in the near future and this investment is therefore necessary in order to be able to provide sufficient supplies to future sales partners”, explains Hans Dieter Rössler, Chairman of the Management Board.
Two of the new products will be ready for the market later this year: towards the end of 2009, curasan AG will enter into negotiations regarding the award of a sales licence for a product that helps to retrieve autologous (patient’s own) growth factors (ATR®). A further product, Osbone®, will be ready for licensing this year. This is a synthetically manufactured, non-resorbant bone replacement material.
The development of a paste version of Cerasorb® could also be pushed forwards during 2009. For physicians, this pharmaceutical form is easier to handle than granulates when used in places that are difficult to access (“bone out of a syringe”). The production of pilot batches, as well as the creation of all the documentation required for approval, is planned for 2010.
The focus of curasan AG medical products currently on the market is the area of biomaterials. This includes products for bone replacement (Cerasorb®), osteoarthritis (Curavisc®) and haemostasis (stypro®). In the pharmaceutical sector, curasan AG supplies a medication for the treatment of superficial bladder carcinomas (Mitem®), which is marketed and sold by Schwarz Pharma AG / UCB-Group.
“We are forecasting continued growth in the future”, states Hans Dieter Rössler, Chairman of the curasan AG Management Board.

Vascular Solutions and Zerusa Limited Announce FDA Market Clearance for the Next Generation Guardian II Hemostasis Valve

MINNEAPOLIS and GALWAY, Ireland, Oct. 12, 2009 (GLOBE NEWSWIRE) -- Vascular Solutions, Inc. (Nasdaq:VASC) and Zerusa Limited today announced that they have received 510(k) clearance with the FDA for the sale of the Guardian(r) II Next Generation hemostasis valve in the United States. Under the terms of an agreement between the two companies from July 2007, Vascular Solutions is the exclusive distributor of the Guardian device in the United States. Zerusa recently began the rollout of its CE marked Guardian II launch through its distribution network in Europe, the Middle East and other markets. Howard Root, Chief Executive Officer of Vascular Solutions, commented: "We're delighted to be able to offer this next generation of the Guardian hemostasis valve to our customers through our 85+ employee direct U.S. sales force. The device enhancements contained in this new device are well suited to our U.S. customers, and we're looking forward to making an expanded impact with this product in the marketplace." Liam Mulloy, Chief Executive Officer of Zerusa Limited, commented: "We appreciate all the market feedback both from Vascular Solutions and our other partners to date. This has directly led to device enhancements on our Guardian II hemostasis valve - while maintaining the key benefits appreciated by our customers worldwide such as blood loss minimization, management of multiple devices and ease of use. We look forward to building on our relationship with Vascular Solutions to further develop the U.S. market opportunity."

Guardian II - Unique Seal Technology (Click image to enlarge).

Provides a cleaner procedural field protecting physicians, staff and patients by reducing the amount of blood in the field.
Allows separation of guidewires and other devices during complex procedures.
Click-open and Click-close Design
Allows single handed operation
Unique proximal cap is easily depressed for both opening and closing the lumen.
Distinctive wide “bulls eye” opening in the proximal cap allows for easy insertion of devices along with the ability to separate multiple guidewires and other devices during complex cases.

Ergonomic Design

Practical design allows the Guardian to fit comfortably in a physician’s hand.
Subtle finger tabs have been added for improved handling characteristics.
Actual device length 92mm.
8 French Lumen
Allows multiple or large therapeutic devices to be inserted during procedures.
Secure Device Lock
Rotating lock-nut has been designed to provide an additional mechanism for securing device position. Lock-nut functions similar to a tuohy borst™ style valve.

FDA - Dangers of Intravascular Thrombin

Specialty Medical Products Company Enters $10 Billion Orthopedic Biomaterials Market with Patented Technologies

FORT WORTH, Texas, Oct. 1 /PRNewswire-FirstCall/ -- Wound Management Technologies, Inc., (OTC Bulletin Board: WNDM) a rapidly growing provider of specialty medical products, announced today it has closed on its acquisition of Resorbable Orthopedics LLC, a private company with patented technologies including a resorbable bone wax and a delivery system for orthopedic bone void fillers, among others.Under the terms of the agreement, Resorbable Orthopedics has become a wholly owned subsidiary of Wound Management Technologies in a stock transaction.
Scott Haire, CEO of Wound Management Technologies, said, "This highly significant acquisition adds complementary orthopedic biomaterials products to our existing CellerateRx wound care products. Wound Management Technologies, through two subsidiaries, is participating in one of the fastest growing medical markets worldwide. The total global biomaterial market is currently $28 billion and is expected to exceed $58 billion in the next five years. The orthopedic biomaterials market is approximately $10 billion alone, driven by improved patient benefits, a shorter FDA approval cycle and an aging population ever more aware of biomaterial benefits."
"Wound Management Technologies is executing our strategy for rapid growth. The building blocks are coming together and the acquisition of Resorbable Orthopedics is another accomplishment for Wound Management Technologies. We are executing on our strategy to broaden our platform technologies that target a growing patient population. Diabetes and orthopedic disorders are expanding internationally and we are responding by establishing global distribution channels," said Haire.
Barry Constantine, founder of Resorbable Orthopedics LLC, said, "The patents offer innovative, safe and effective resorbable orthopedic products. The bone wax and delivery system address issues such as 'bone wax granuloma' and the delivery of materials that manage bone wound healing in a cost effective manner. At a time when there is a great need for safer and more affordable health care products, these are well timed solutions."