Synthetic Blood Platelets Are Twice As Effective

Scientists working with small particles at the nanoscale have recently revealed that they have developed a new type of synthetic blood platelets, which have twice the clotting capabilities of the standard variety. In the experiments they conducted on lab mice, the science group, which are based at the Case Western University (CWU), in Cleveland, managed to obtain an increased efficiency using their innovation than they could squeeze out of traditional clotting methods.
Technology Review reports that the nanoparticles could be the next major innovation in this field, considering that the regular drugs were so significantly exceeded in terms of performance. “We're helping to form the clot,” CWU bioengineer Erin Lavik, who has also been the leader of the new investigation, explains briefly. The scientist reveals that plans are to create blood clotting particles that are so effective that they could be used by paramedics right at an accident site, or by doctors working on injured soldiers in battlefields around the globe.
Early safety tests turned out to be very promising, but the CWU team admits that there is still a lot of work to be done until the new nanoparticles are ready to be mass-produced, and administered to patients. Speaking about the challenges associated with the development of a good blood clotting method, University of Pennsylvania Medical School physician Mortimer Poncz said, “There's a balance between the two edges of the sword--bleeding too much and clotting too much. You don't want to stop bleeding in the leg but die of a heart attack or have stroke.” He has not been involved in the new study.
The new nanoparticles are about one third the size of normal platelets. They can run through the bloodstream without experiencing obstacles, but also have the same stickiness that makes their natural counterparts so effective at stopping bleeding. While existing drugs can indeed boost the immune system's proprietary response to injury, they can also be terribly expensive, so a cheaper, more effective method was very high up on researchers' priority lists.

Medafor publish commentary of Cryolife battle

Medafor have published a pdf document on their website detailing their current view of the on-going battle with Cryolife. In the document they accuse Cryolife (amongst a host of contractual and legal issues) of attempting to initiate a lawsuit to force a sale after the Board rejected a second offer by Cryolife to purchase Medafor. Medafor have also engaged in a lawsuit charging their previous CEO and Chairman, Dick Zerban and Cryolife CEO, Steven Anderson alleging the wrongful transfer of shares. The full document is available on the first page of the Medafor website.

Zymogenetics cuts back staff to focus on Recothrom

ZymoGenetics is cutting all of its immunology work along with 15 percent of its jobs, or 52 positions. That's in addition to the 161 jobs the developer cut in April when it decided to bow out of the cancer research business. All ongoing immunology discovery research programs will be discontinued; however, the company will keep the research capabilities necessary to support the ongoing development programs for current product candidates.
According to the regulatory filing, cutting new immunology research will allow the developer to focus on its sole marketed product, Recothrom Thrombin, a treatment for surgical bleeding. It will also give ZymoGenetics more resources for developing and commercializing its pipeline of clinical and preclinical product candidates. In a statement emailed to Xconomy, a spokesperson said that the company has abandoned the strategy of discovering and licensing out many early-stage candidates. Now it will focus on fewer programs that it will advance to later stages. The spokesperson added that the company is focusing on drug candidates that have the most potential over the next three to four years.
ZymoGenetics's reductions will result in an annual expense savings of $8 million to $10 million, in addition to the estimated $30 million in savings generated by the April restructuring. This round of layoffs leaves the developer with about 300 employees, according to Xconomy.

ProFibrix Initiates Phase II Clinical Trial of its Lead Topical Hemostat Product Fibrocaps(TM)

SEATTLE, Washington, and LEIDEN, The Netherlands - ProFibrix B.V. today announced the start of the company’s Phase II clinical trial for Fibrocaps(TM), the company’s lead topical Hemostat product, with the successful treatment of the first patients for mild to moderate bleeding during liver surgery. ProFibrix expects to complete the study before the end of 2009.
Fibrocaps is based on a mixture of two essential blood clotting proteins, fibrinogen and thrombin, and is a unique dry powder topical tissue sealant that rapidly stops bleeding after or during surgery. Fibrocaps has major advantages over existing liquid tissue sealants: it is ready for immediate use, is stable at room temperature, highly effective and fast acting.
ProFibrix expects to submit an Investigational New Drug Application (IND) for Fibrocaps to the U.S. Food and Drug Administration in the first half of 2010, and conduct a combined phase II/III pivotal study in various surgical indications.
Jaap Koopman, PhD, Chief Executive Officer, said: “The successful treatment of the first patients with our lead product Fibrocaps is an important milestone for the company. With focus and dedication we have made enormous progress over the past two years, and we are on track to bring Fibrocaps to the point of market approval.”

About ProFibrix
ProFibrix was founded in 2004 and is headquartered in Leiden, The Netherlands, with a subsidiary in Seattle, WA. The company leverages its expertise in fibrinogen technology to develop and market innovative products for the hemostasis and regenerative medicine markets. Human fibrinogen plays a pivotal role in blood clotting and tissue healing. ProFibrix is led by a team with extensive commercial, clinical and scientific experience in the hemostasis field.

Orthovita to Present at the Piper Jaffray 21st Annual Health Care Conference

Orthovita, Inc. (NASDAQ:VITA), an orthobiologics and biosurgery company, announced today that it will present at the Piper Jaffray 21st Annual Health Care Conference in New York City. Antony Koblish, chief executive officer of Orthovita, is scheduled to present on Wednesday, December 2nd, at 3:00 p.m. Eastern Time, at the New York Palace Hotel, 455 Madison Avenue, New York, New York. A live webcast of the presentation will be available, and can be accessed for 30 days following the conference, by visiting http://www.corporate-ir.net/ireye/confLobby.zhtml?ticker=***VITA&item_id=2539636.

Covidien Introduces First FDA-Approved Spine Sealant

NORTH HAVEN, Conn.--(BUSINESS WIRE)-- Covidien (NYSE: COV), a leading global provider of healthcare products, today announced the launch of DuraSeal(TM) spine sealant, the first product approved by the U.S. Food and Drug Administration (FDA) for intra-operative sealing of the dural membrane during spine procedures. Nearly 1.5 million spine surgeries are performed in the U.S. every year, with an estimated 10% of these surgeries requiring dural repair and sealing. Tears in the dura the outermost membrane covering the brain and the spinal cord can result in cerebral spinal fluid (CSF) leaks after surgery, leading to possible medical complications and extended hospital stays. One recent study found that CSF leaks after spinal surgery are estimated to cost an average of $6,479 in additional expense, mainly due to longer hospital and intensive care unit stays.(1)
In a clinical study of more than 150 patients, DuraSeal spine sealant was shown to be superior at achieving an intra-operative watertight seal, compared with the control group, which consisted of conventional methods of dural closure such as sutures or fibrin sealants. DuraSeal spine sealant achieved an intra-operative watertight seal 100% of the time, compared with 64% of the time by the control group. The safety results between the two groups were similar, given the patients' medical conditions and the nature of the complex spinal procedures performed.(2)
The new sealant is a 100% synthetic hydrogel that provides excellent tissue adherence, is absorbed by the body and is easy to apply. Stored at room temperature, DuraSeal spine sealant takes only two minutes to prepare and three seconds to set, which enables surgeons to achieve an intra-operative dural seal quickly.
"DuraSeal is a great example of how we develop solutions at Covidien," said Dr. Michael Tarnoff, Chief Medical Affairs Officer, Surgical Devices, Covidien. "We observe the challenges that surgeons face in the operating room and work with the medical community to come up with innovative products that may optimize patient outcomes, can improve healthcare economics and are intuitive for surgeons and their teams to use."
The DuraSeal spine sealant system was introduced today at the North American Spine SocietyAnnual Meeting in San Francisco and last month at the Congress of Neurological Surgeons in New Orleans. For further information, please visit www.durasealspine.com.
ABOUT COVIDIEN
Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence.Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2008 revenue of$10 billion, Covidien has more than 41,000 employees worldwide in 59 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business.

Sometimes only the Lawyers win.......ZymoGenetics says restraining orders lifted

ZymoGenetics Inc. said Friday that a federal judge in Tennessee has removed three temporary restraining orders imposed on the company over marketing and promotion of its lead drug, Recothrom.
The Seattle biotechnology company (NASDAQ: ZGEN) on Wednesday disclosed that it had been slapped with the restraining orders as part of a lawsuit filed by four companies, including rival King Pharmaceuticals Inc. The lawsuit accuses ZymoGenetics of unfair competition, false advertising, trademark infringement and related claims, ZymoGenetics said.
In a filing Friday with the Securities and Exchange Commission, ZymoGenetics said the judge in Tennessee had vacated the restraining orders, which "have no further force or effect." The company did not elaborate, but said it disputes the lawsuit's allegations and intends to "vigorously defend" itself at a hearing in the case scheduled for Nov. 16.
ZymoGenetics on Thursday said third-quarter revenue increased 131 percent, to $8.5 million, from the same quarter a year ago, due to sales of Recothrom, a bleeding-control drug. The company narrowed its Q3 loss to $11.4 million, or 17 cents a share, from a loss of $28.8 million, or 42 cents a share, in the year-ago quarter.

King Pharmaceuticals Inc has sued ZymoGenetics Inc

Nov 4 (Reuters) - King Pharmaceuticals Inc has sued ZymoGenetics Inc seeking damages and injunctive relief, alleging trademark infringement among other things, and a U.S. court has temporarily restrained Zymogenetics from marketing a product, according to a regulatory filing.
ZymoGenetics said in the filing that the three temporary restraining orders (TROs), passed on Nov. 3 without hearing its side, were prohibiting it from engaging in certain marketing or promotional conducts related to Recothrom, its hemostasis aid.
ZymoGenetics said King, in the suit filed in a federal court in Tennessee, alleged Zymogenetics of engaging in unfair competition, false advertising, trademark infringement and other related claims.
"We are seeking immediate relief from the court to vacate the TROs, and we will seek an immediate hearing on this motion," ZymoGenetics said in the filing.
A hearing on King's motions for preliminary injunctive relief is scheduled for Nov. 16, and ZymoGenetics will oppose King's request for preliminary injunctive relief, it said.
"We currently believe that this litigation will not have a material adverse effect on our financial condition, our results of operation, or our cash flows," ZymoGenetics added.

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.