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.
Monday, October 26, 2009
Thursday, October 22, 2009
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.
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
Friday, October 16, 2009
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.
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.
Wednesday, October 14, 2009
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.
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.
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.
Tuesday, October 13, 2009
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.
Monday, October 5, 2009
Thursday, October 1, 2009
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."
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."
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