Wednesday, February 18, 2009
AMS get USA approval for Liquiband
HEALTHCARE technology company Advanced Medical Solutions (AMS) has reached a key milestone in its evolution by securing permission to market its products in America.The £16.9m turnover business, based in Winsford, Cheshire, has been given clearance for one of its major ranges of skin healing products called LiquiBand. The announcement opens AMS to a US market which is worth an estimated £140m a year, and the news prompted its shares to rise by 4.5 per cent or 1.5p to 35p. They later settled at 34.75p, a rise of 3.37 per cent.The deal also prompted analysts to predict a future target share price of 45p.While the LiquiBand range reduces the need for surgical stitches by `gluing' wounds together, some of its other products contain a derivative of seaweed to promote healing or silver to fight the spread of diseases.AMS is still seeking clearance for its other products in America which will ultimately provide it with an even stronger foothold in both accident and emergency departments and operating rooms.AMS chief executive Dr Don Evans said: "I am delighted that we have received this initial clearance on the back of which we will be finalising commercial arrangements for the introduction of our tissue adhesive technology to this key strategic market during 2009."AMS has already established a leading position in Britain and Europe with its LiquiBand range.Elizabeth Klein, of analyst Teathers, said: "We continue to highlight AMS as one of our top picks due to its good cash position - with no debt, its robust end markets, good relationships with partners and an expectation that new product approvals could additionally drive growth."
Nycomed's Tachosil receives expanded indication
•Surgical patch TachoSil® – first and only dual action patch for general tissue sealing
ZURICH, Switzerland, Feb. 17, 2009--Today Nycomed received an expanded indication for TachoSil®, its innovative surgical patch, from the European Medicines Agency (EMEA). To date, TachoSil was approved for haemostasis (control of bleeding) in surgery. With the new expanded indication, it becomes the first and only dual action patch approved for haemostasis, tissue sealing as well as for suture support in vascular surgery.
TachoSil is the key product in Nycomed’s tissue management portfolio and effectively fulfils the market need for a ready-to-use surgical patch, developed to assist surgeons in achieving fast and reliable bleeding control. Now, with the new expanded indication, Nycomed can offer a dual action patch approved for haemostasis, tissue sealing as well as for suture support in vascular surgery.
“With the expansion of TachoSil’s indication, Nycomed will bring the benefits of this unique product to surgical teams and those patients undergoing lung or other types of surgery requiring rapid air or body fluid sealing,” said Lone Nørgaard Andersson, International Brand Manager at Nycomed.
The new indication was filed with the EMEA in 2008, based on international clinical trial results on lung and cardiovascular surgery. TachoSil is currently available in Europe and Russia/CIS. In the United States, the product will be marketed by Baxter International Inc., while Nycomed will manufacture it and be responsible for the US regulatory filing.
ZURICH, Switzerland, Feb. 17, 2009--Today Nycomed received an expanded indication for TachoSil®, its innovative surgical patch, from the European Medicines Agency (EMEA). To date, TachoSil was approved for haemostasis (control of bleeding) in surgery. With the new expanded indication, it becomes the first and only dual action patch approved for haemostasis, tissue sealing as well as for suture support in vascular surgery.
TachoSil is the key product in Nycomed’s tissue management portfolio and effectively fulfils the market need for a ready-to-use surgical patch, developed to assist surgeons in achieving fast and reliable bleeding control. Now, with the new expanded indication, Nycomed can offer a dual action patch approved for haemostasis, tissue sealing as well as for suture support in vascular surgery.
“With the expansion of TachoSil’s indication, Nycomed will bring the benefits of this unique product to surgical teams and those patients undergoing lung or other types of surgery requiring rapid air or body fluid sealing,” said Lone Nørgaard Andersson, International Brand Manager at Nycomed.
The new indication was filed with the EMEA in 2008, based on international clinical trial results on lung and cardiovascular surgery. TachoSil is currently available in Europe and Russia/CIS. In the United States, the product will be marketed by Baxter International Inc., while Nycomed will manufacture it and be responsible for the US regulatory filing.
Tuesday, February 17, 2009
First man dies after contracting 'mad cow disease' from clotting agent
The first case of a person dying after contracting the human form of mad cow disease from a blood clotting agent will be announced today.
The elderly man was one of thousands of haemophiliacs who received a blood plasma transfusion before strict rules were introduced to limit the spread of the deadly disease.
Up to 4,000 haemophilia sufferers have been warned that they could be at risk from the donations.
However, they were told that they had a low risk of contracting the variant Creutzfeldt-Jakob disease (vCJD) disease.
The Health Protection Agency will announce on Tuesday that the man, who died from other causes, did contract vCJD from the transfusion.
Prof Marc Turner, scientific director of the Scottish National Blood Transfusion Service, called for samples from vCJD patients to be released so that a test being developed by the company Amorfix to diagnose the disease before death could be perfected.
He told the BBC's Newsnight programme: "The two key things that need to be done are that the Amorfix test needs to be tested against the blood of patients with clinical vCJD in order to determine it can pick up positivity in that context and in parallel what we need to do is look at 10,000 blood samples from healthy individuals from both this country and America in order to determine the false positive rates and I would think that would take in the order of three to six months to carry out."
The blood test could be being used to screen Britain's blood supply within 18 months, he said.
To date 167 people have died from vCJD in Britain since it was first diagnosed in the mid-1990s.
But scientists warn that thousands of people could still go on to develop the disease because of the length of time it can remain in the body with no symptoms.
There have previously been three deaths following infection with vCJD linked to blood transfusions but this is the first of a patient who received plasma, which is used to clot blood and is crucial for people suffering from haemophilia.
All plasma is now sourced from America, where only a handful of cases of the disease have been identified.
Source: Telegraph.co.uk
The elderly man was one of thousands of haemophiliacs who received a blood plasma transfusion before strict rules were introduced to limit the spread of the deadly disease.
Up to 4,000 haemophilia sufferers have been warned that they could be at risk from the donations.
However, they were told that they had a low risk of contracting the variant Creutzfeldt-Jakob disease (vCJD) disease.
The Health Protection Agency will announce on Tuesday that the man, who died from other causes, did contract vCJD from the transfusion.
Prof Marc Turner, scientific director of the Scottish National Blood Transfusion Service, called for samples from vCJD patients to be released so that a test being developed by the company Amorfix to diagnose the disease before death could be perfected.
He told the BBC's Newsnight programme: "The two key things that need to be done are that the Amorfix test needs to be tested against the blood of patients with clinical vCJD in order to determine it can pick up positivity in that context and in parallel what we need to do is look at 10,000 blood samples from healthy individuals from both this country and America in order to determine the false positive rates and I would think that would take in the order of three to six months to carry out."
The blood test could be being used to screen Britain's blood supply within 18 months, he said.
To date 167 people have died from vCJD in Britain since it was first diagnosed in the mid-1990s.
But scientists warn that thousands of people could still go on to develop the disease because of the length of time it can remain in the body with no symptoms.
There have previously been three deaths following infection with vCJD linked to blood transfusions but this is the first of a patient who received plasma, which is used to clot blood and is crucial for people suffering from haemophilia.
All plasma is now sourced from America, where only a handful of cases of the disease have been identified.
Source: Telegraph.co.uk
Friday, February 13, 2009
Zymogenetics Q4-Edited
RECOTHROM net sales for the quarter were $4.7 million and this is 165% greater than net sales in the third quarter. We saw increased demand each month during the quarter. It’s important to point out though that there was an increase in the levels of wholesalers stocking during the quarter. We’ve estimated the increase at approximately $800,000, which could end up effecting first quarter 2009 revenues on one to two weeks of sales.
Half of the product sales for the quarter was $4.7 million, which included $3.8 million reserve for inventory projected to become obsolete. We now have a better visibility into our rate of market penetration and although we are planning to extend the shelf life of our finished product to 36 months. We won’t have the stability data until late 2009........
So for 2009 RECOTHROM sales, we expect to see a continued upward trend and we believe the net sales for the year will fall within the range of $25 million to $35 million...
Edward Tenthoff – Piper Jaffray
Great, thank you very much and congratulations on a much improved year-end. I know there has been a lot of work on for physicians, so congratulate them on the hard work in progress. If I made the starting with recoup sales in fourth quarter, the stocking issue and sort of the pricing update, you have given the guidance of $25 million to $35 million. Can you give us a little bit more color on that? Are you finding that you are converting bovine? Is it coming at the expense of other human thrombin? Give us a little bit more color on that fourth quarter success and sort of how the pricing is backing up currently?
Douglas Williams
Hi [Tenth], this is Doug. Thanks for the compliment at the beginning of your question. We do think that the quarter was certainly a good one for us, and moving us in the right direction. I think as far as the fourth quarter for RECOTHROM, certainly the pricing change that we took in October I think was a key reason for our accounts to convert. We have been seeing I think more activity in the marketplace in the fourth quarter in terms of sales activity, that has begun to translate into dollars and I think we are beginning to get a handle now on the run rate sort of based on that fourth quarter. And that’s what has sort of led us to project forward and give our guidance for 2009 with some sense of confidence. As far as the stocking issue is concerned I think again we sort of looked at the run rate and made an estimate based on what we have seen as the levels of wholesaler stock that were sort of consistent with previous levels of sales and made an estimate that approximately $800,000 of the fourth quarter reflected stocking sort of in anticipation at the beginning of the year. So we’ve sort of based that of comparing the sales curve with the previous stock in curves and really coming up with that gap and estimating that’s attributable to about $800,000 of that number.
Edward Tenthoff – Piper Jaffray
Right. And just then from the competitive [thought] can you say is the gain coming to the expense of bovine? Are you still seeing Omrix/J&J or has that transaction caused some disturbance there? Just give us a little bit of color on the market?
Douglas Williams
Yeah, I think in terms of the topical hemostat market, we’ve got information now on 2008, and how that market has played out. The IMS information would tell us that primarily what seems to happening in the marketplace is a displacement of bovine thrombin. I think that the majority of that change is attributable to us, taking market share away from Thrombin-JMI. I think the level of activity for Evithrom is still somewhat difficult as routine although certainly the numbers would lead you to believe that they haven’t been making significant inroads in terms of that particular product. Now again I think we’ve always said that we are not certain reporting around Evithrom as far as those numbers are concerned. And certainly the information that we have would suggest that in terms of our capturing market share from Thrombin-JMI that we are sort of leading the way versus the other plasma-based thrombins that are out there. And we don’t see any real discernible difference in terms of J&J’s acquisition of Omrix. We didn’t really expect that there would be given the J&J has always been responsible for the marketing and sales of the product all along.
Edward Tenthoff – Piper Jaffray
Great, that’s very helpful. I appreciate it.
Operator
The next question is from Marshal Urist with Morgan Stanley. Please state your question.
Marshal Urist – Morgan Stanley
Yeah, hey guys, good afternoon. So I just wondered if you go back and talk a little bit more about the RECOTHROM guidance, and I know you don’t want to talk about the formulary and patents and everything, but can you give us a sense of the extent to which the pace there is improving and, are you seeing any change in complete conversion versus sharing formularies? And then on the guidance for next year, when you got to that number, it’s still a pretty healthy improvement of the run rate from the quarter if you backout the inventory charges. I’m wondering what you guys are assuming in there in terms of how much of that is sort of follow through from account we’re already in and then how much would you be accounting on new accounts in formulary patents to get to that number?
Douglas Williams
I mean without giving you too much color around how we triangulated in on that range. I mean sufficed to say that we feel that though we have a much better handle on what's happening in the market right now than we did certainly earlier last year. We've looked at our current run rate then made a few assumptions about some of the accounts that we know have converted, but aren’t yet reflected in the sales. So, I think that we’ve taken sort of a data-oriented approach to generating that range that we've provide and we feel pretty comfortable right now with that range based on what we see today. So, I think we feel as though there are some accounts that obviously haven’t begun their ordering process. And I think overall what we are seeing in the market in terms of general activity trends, we are getting more P&T committee meetings. We are still successful at those P&T committee meetings. And again we are trying to move away from spending too much time on those softer metrics, which many of the people whose names I see are on the call have expressed some dismay at not really knowing how to utilize that information effectively, given all of the different variables that play into the time it takes or an account to convert, the time it takes for converted account to switch to actual steady state ordering patterns. It has been a complicated metric for people to understand. So, I think we feel pretty comfortable with the numbers we put out there based on fourth quarter run rate and what we see moving forward into market.
Han Li – Stanford Group Company
Yeah, good afternoon. Questions on RECOTHROM. Bayer filed European Marketing Application last August. Any update on the European Regulatory Discussion and Drug Vying approval and also can you give us some color on the European thrombin market and we know that J&J also filed for their human thrombin products in Europe too?
James Johnson
As it relates to Bayer’s filing in Europe there is no real update at this point to provide you with other than our assumptions haven't changed. We’re still operating under the joint assumptions that the existing package of data that we provided will be acceptable to garner registration in that territory. Again as you know the communication issues around contact with the EU authorities is something that we have to sort of follow the lead of our partner on and until they are ready to disclose any additional information, we sort of follow their lead in this regard. But at this point there is no change in the assumptions. We’re still operating under the assumption that the existing package will be acceptable to garner approval in the EU territory and beyond. And as far as the thrombin market, again I think this is a situation where there is no standalone thrombin in the EU market today. Bayer believes that provides a very significant opportunity to basically launch their product and build a new market, where there isn’t one. The current options for physicians in the EU territory are either cheap surgical sponges which really don’t have much in the way of hemostatic properties, or expensive fiber and sealants, which by definition are expensive and physicians sort of keep those in reserve. I think the price point for a standalone thrombin product in that market could be quite attractive and therefore it represents a good market opportunity for Bayer. That’s the way they have seen it obviously since they struck the deal with us and again we're optimistic that we’ll receive approval on schedule.
Han Li – Stanford Group Company
Okay. When you see on schedule and approval timeline, should we the earliest we expect or should be some time this summer?
Douglas Williams
And it’s usually about 12 to 14 months. I think is the average time in the EU.
Han Li – Stanford Group Company
So, they filed August, last August should be sometime August, September or it is?
Douglas Williams
Again I think that’s an estimate. I'm not sure that the EU follows quite as rigorous a calendar in that way. So, I would assume second half of 2009 sometime.
Han Li – Stanford Group Company
Quickly, roughly ballpark the European and other territories in terms of market size, can we think is equal size or bigger than the current U.S. market?
Douglas Williams
I think the way we've been thinking about the ex-U.S. market is that in the aggregate is probably a comparable size to the U.S. market.
Han Li – Stanford Group Company
Okay. And quickly a couple of housekeeping items, on the RECOTHROM, the U.S. sales, are you recording U.S. sales but you pay a royalty to Bayer, officially it’s commercial partner, so that will go into the express line going to SG&A I assume?
Douglas Williams
Yeah that’s correct.
Han Li – Stanford Group Company
And you disposed us up to 20% [virtually]?
Douglas Williams
The high end of the range is 20, but it starts in the mid teen.
David Miller – Biotech Stock Research
Okay. And then the last question is can you give us any kind of guidance there or just general kind of guidelines on when you might be including RECOTHROM in other products basing them in the sponges or other kinds of means to kind of extend the use of the product in the surgical suite?
Douglas Williams
I can’t give you specific guidance on that now other than to say that we have pre-clinical activities ongoing for a [flowable] version and the timeline associated with when that would be approved is largely based on the need to have discussions with regulatory agencies about what path that might take. So if we were to move forward that would be the first formulations just based on the level of activity that we've already completed. Preclinically there are other ideas and Steven Zaruby and his team will be exploring those and others as possible line extension strategies in the future, but for now I can’t give you a specific timeline given the lack of certainty around the regulatory path.
David Miller – Biotech Stock Research
Okay, and then I guess I have one other question on the guidance for cash use. Does that assume that any kind of in-licensing of products for the RECOTHROM sales force?
Douglas Williams
Yeah the answer is no on that. It did not assume any in-licensing activities.
Half of the product sales for the quarter was $4.7 million, which included $3.8 million reserve for inventory projected to become obsolete. We now have a better visibility into our rate of market penetration and although we are planning to extend the shelf life of our finished product to 36 months. We won’t have the stability data until late 2009........
So for 2009 RECOTHROM sales, we expect to see a continued upward trend and we believe the net sales for the year will fall within the range of $25 million to $35 million...
Edward Tenthoff – Piper Jaffray
Great, thank you very much and congratulations on a much improved year-end. I know there has been a lot of work on for physicians, so congratulate them on the hard work in progress. If I made the starting with recoup sales in fourth quarter, the stocking issue and sort of the pricing update, you have given the guidance of $25 million to $35 million. Can you give us a little bit more color on that? Are you finding that you are converting bovine? Is it coming at the expense of other human thrombin? Give us a little bit more color on that fourth quarter success and sort of how the pricing is backing up currently?
Douglas Williams
Hi [Tenth], this is Doug. Thanks for the compliment at the beginning of your question. We do think that the quarter was certainly a good one for us, and moving us in the right direction. I think as far as the fourth quarter for RECOTHROM, certainly the pricing change that we took in October I think was a key reason for our accounts to convert. We have been seeing I think more activity in the marketplace in the fourth quarter in terms of sales activity, that has begun to translate into dollars and I think we are beginning to get a handle now on the run rate sort of based on that fourth quarter. And that’s what has sort of led us to project forward and give our guidance for 2009 with some sense of confidence. As far as the stocking issue is concerned I think again we sort of looked at the run rate and made an estimate based on what we have seen as the levels of wholesaler stock that were sort of consistent with previous levels of sales and made an estimate that approximately $800,000 of the fourth quarter reflected stocking sort of in anticipation at the beginning of the year. So we’ve sort of based that of comparing the sales curve with the previous stock in curves and really coming up with that gap and estimating that’s attributable to about $800,000 of that number.
Edward Tenthoff – Piper Jaffray
Right. And just then from the competitive [thought] can you say is the gain coming to the expense of bovine? Are you still seeing Omrix/J&J or has that transaction caused some disturbance there? Just give us a little bit of color on the market?
Douglas Williams
Yeah, I think in terms of the topical hemostat market, we’ve got information now on 2008, and how that market has played out. The IMS information would tell us that primarily what seems to happening in the marketplace is a displacement of bovine thrombin. I think that the majority of that change is attributable to us, taking market share away from Thrombin-JMI. I think the level of activity for Evithrom is still somewhat difficult as routine although certainly the numbers would lead you to believe that they haven’t been making significant inroads in terms of that particular product. Now again I think we’ve always said that we are not certain reporting around Evithrom as far as those numbers are concerned. And certainly the information that we have would suggest that in terms of our capturing market share from Thrombin-JMI that we are sort of leading the way versus the other plasma-based thrombins that are out there. And we don’t see any real discernible difference in terms of J&J’s acquisition of Omrix. We didn’t really expect that there would be given the J&J has always been responsible for the marketing and sales of the product all along.
Edward Tenthoff – Piper Jaffray
Great, that’s very helpful. I appreciate it.
Operator
The next question is from Marshal Urist with Morgan Stanley. Please state your question.
Marshal Urist – Morgan Stanley
Yeah, hey guys, good afternoon. So I just wondered if you go back and talk a little bit more about the RECOTHROM guidance, and I know you don’t want to talk about the formulary and patents and everything, but can you give us a sense of the extent to which the pace there is improving and, are you seeing any change in complete conversion versus sharing formularies? And then on the guidance for next year, when you got to that number, it’s still a pretty healthy improvement of the run rate from the quarter if you backout the inventory charges. I’m wondering what you guys are assuming in there in terms of how much of that is sort of follow through from account we’re already in and then how much would you be accounting on new accounts in formulary patents to get to that number?
Douglas Williams
I mean without giving you too much color around how we triangulated in on that range. I mean sufficed to say that we feel that though we have a much better handle on what's happening in the market right now than we did certainly earlier last year. We've looked at our current run rate then made a few assumptions about some of the accounts that we know have converted, but aren’t yet reflected in the sales. So, I think that we’ve taken sort of a data-oriented approach to generating that range that we've provide and we feel pretty comfortable right now with that range based on what we see today. So, I think we feel as though there are some accounts that obviously haven’t begun their ordering process. And I think overall what we are seeing in the market in terms of general activity trends, we are getting more P&T committee meetings. We are still successful at those P&T committee meetings. And again we are trying to move away from spending too much time on those softer metrics, which many of the people whose names I see are on the call have expressed some dismay at not really knowing how to utilize that information effectively, given all of the different variables that play into the time it takes or an account to convert, the time it takes for converted account to switch to actual steady state ordering patterns. It has been a complicated metric for people to understand. So, I think we feel pretty comfortable with the numbers we put out there based on fourth quarter run rate and what we see moving forward into market.
Han Li – Stanford Group Company
Yeah, good afternoon. Questions on RECOTHROM. Bayer filed European Marketing Application last August. Any update on the European Regulatory Discussion and Drug Vying approval and also can you give us some color on the European thrombin market and we know that J&J also filed for their human thrombin products in Europe too?
James Johnson
As it relates to Bayer’s filing in Europe there is no real update at this point to provide you with other than our assumptions haven't changed. We’re still operating under the joint assumptions that the existing package of data that we provided will be acceptable to garner registration in that territory. Again as you know the communication issues around contact with the EU authorities is something that we have to sort of follow the lead of our partner on and until they are ready to disclose any additional information, we sort of follow their lead in this regard. But at this point there is no change in the assumptions. We’re still operating under the assumption that the existing package will be acceptable to garner approval in the EU territory and beyond. And as far as the thrombin market, again I think this is a situation where there is no standalone thrombin in the EU market today. Bayer believes that provides a very significant opportunity to basically launch their product and build a new market, where there isn’t one. The current options for physicians in the EU territory are either cheap surgical sponges which really don’t have much in the way of hemostatic properties, or expensive fiber and sealants, which by definition are expensive and physicians sort of keep those in reserve. I think the price point for a standalone thrombin product in that market could be quite attractive and therefore it represents a good market opportunity for Bayer. That’s the way they have seen it obviously since they struck the deal with us and again we're optimistic that we’ll receive approval on schedule.
Han Li – Stanford Group Company
Okay. When you see on schedule and approval timeline, should we the earliest we expect or should be some time this summer?
Douglas Williams
And it’s usually about 12 to 14 months. I think is the average time in the EU.
Han Li – Stanford Group Company
So, they filed August, last August should be sometime August, September or it is?
Douglas Williams
Again I think that’s an estimate. I'm not sure that the EU follows quite as rigorous a calendar in that way. So, I would assume second half of 2009 sometime.
Han Li – Stanford Group Company
Quickly, roughly ballpark the European and other territories in terms of market size, can we think is equal size or bigger than the current U.S. market?
Douglas Williams
I think the way we've been thinking about the ex-U.S. market is that in the aggregate is probably a comparable size to the U.S. market.
Han Li – Stanford Group Company
Okay. And quickly a couple of housekeeping items, on the RECOTHROM, the U.S. sales, are you recording U.S. sales but you pay a royalty to Bayer, officially it’s commercial partner, so that will go into the express line going to SG&A I assume?
Douglas Williams
Yeah that’s correct.
Han Li – Stanford Group Company
And you disposed us up to 20% [virtually]?
Douglas Williams
The high end of the range is 20, but it starts in the mid teen.
David Miller – Biotech Stock Research
Okay. And then the last question is can you give us any kind of guidance there or just general kind of guidelines on when you might be including RECOTHROM in other products basing them in the sponges or other kinds of means to kind of extend the use of the product in the surgical suite?
Douglas Williams
I can’t give you specific guidance on that now other than to say that we have pre-clinical activities ongoing for a [flowable] version and the timeline associated with when that would be approved is largely based on the need to have discussions with regulatory agencies about what path that might take. So if we were to move forward that would be the first formulations just based on the level of activity that we've already completed. Preclinically there are other ideas and Steven Zaruby and his team will be exploring those and others as possible line extension strategies in the future, but for now I can’t give you a specific timeline given the lack of certainty around the regulatory path.
David Miller – Biotech Stock Research
Okay, and then I guess I have one other question on the guidance for cash use. Does that assume that any kind of in-licensing of products for the RECOTHROM sales force?
Douglas Williams
Yeah the answer is no on that. It did not assume any in-licensing activities.
Haemacure announces intention to restructure, sell company
MONTREAL — Biotechnology developer Haemacure Corp. (TSX:HAE) said Friday it is likely to run through its cash reserves without additional financing and announced its intention to merge or sell the company.
The Montreal-based firm said it would initiate a process meant to lead to a sale without specifying any potential buyers.
Haemacure implemented a series of cost-cutting measures intended to create a three-month window in which the company could either arrange a sale or secure bridge financing.
Those measures included placing 12 out of 18 employees on leave, restructuring obligations to suppliers and suspending major consulting agreements.
Haemacure said it was also postponing pre-clinical trials for its fibrin sealant, a potential skin-graft treatment that was due to enter the next phase of testing this summer.
The company said it would continue to prepare for the clinical trials in case financing becomes available.
Last month, Haemacure said its 2008 fiscal loss doubled to $8 million or five cents a share as revenue slipped to $96,500 from year-earlier levels of $119,700.
The Montreal-based firm said it would initiate a process meant to lead to a sale without specifying any potential buyers.
Haemacure implemented a series of cost-cutting measures intended to create a three-month window in which the company could either arrange a sale or secure bridge financing.
Those measures included placing 12 out of 18 employees on leave, restructuring obligations to suppliers and suspending major consulting agreements.
Haemacure said it was also postponing pre-clinical trials for its fibrin sealant, a potential skin-graft treatment that was due to enter the next phase of testing this summer.
The company said it would continue to prepare for the clinical trials in case financing becomes available.
Last month, Haemacure said its 2008 fiscal loss doubled to $8 million or five cents a share as revenue slipped to $96,500 from year-earlier levels of $119,700.
Thursday, February 12, 2009
StarFoam Pad from SMI
Starch Medical Inc. have released new footage of their StarFoam plant based hemostatic pad.
SMI came to market with a second generation of plant-based hemostatic solutions which contain no animal or human components in Q4 '08. Their first product, PerClot which has similarities to Medafor's manufactured Arista A.K.A. Hemostase MPH (Cryolife) and Vitasure (Orthovita), is currently sold in European and OUS Markets. The Starfoam product is a wafer-like pad which may be trimmed to suit the surgical procedure. StarFoam utilizes the same AMP technologies as all SMI products and is indicated for a wide range of applications, including but not limited to sternal edge bleeding and unique wound contours. CE mark for StarFoam was awarded in December, 2008.
Company President Mr David Lang comments "I encourage your cost-free evaluation of our innovative hemostatic and woundcare systems. A simple request at info@starchmedical.com will fulfill your product delivery and assure the presence of a Starch Medical representative."
Friday, February 6, 2009
Vascular Solutions - Edited 10k
Thrombin qualification project expenses were $-0- for the year ended December 31, 2008 compared to $147,000 for the year ended December 31, 2007. On October 18, 2004, we entered into a supply agreement with Sigma-Aldrich Fine Chemicals, an operating division of Sigma-Aldrich, Inc. (Sigma) for the supply of thrombin to us. Pursuant to the terms of the agreement, we have paid for certain development costs of Sigma to allow Sigma to produce thrombin for our use. The initial contract term ends after 10 years and is automatically extended for up to five additional successive one year terms unless one party delivers notice of termination at least one year prior to the scheduled termination of the agreement. During the term of the agreement, Sigma has agreed not to sell thrombin of the type developed for us under the agreement in or as a component of a hemostatic product for medical use. We do not have any minimum purchase requirements under the agreement; however, if we purchase less than three lots of thrombin in any year then (1) Sigma will be released from its agreement not to sell thrombin in or as a component of a hemostatic product for medical use, and (2) Sigma will have the right to terminate the agreement upon 30 days notice.
The Sigma contract was part of our plan to fully qualify a second source of thrombin (in addition to the Thrombin-JMI(R) Supply Agreement discussed in "Agreements with King Pharmaceuticals, Inc." above) and to bring the new thrombin through the regulatory process to be used in our hemostatic products. We have purchased $2.7 million of thrombin from Sigma, of which we have expensed approximately $0.4 million in our development work and used approximately $0.3 million in product manufacturing. We received regulatory approval in the first quarter of 2008 allowing us to use the Sigma thrombin in our international hemostat products. A $0.7 million expense was incurred in the fourth quarter of 2008 relating to a reserve recorded against our existing supply of Sigma thrombin due to the uncertainty of whether this amount of thrombin will be utilized prior to expiration of its shelf life. The remaining Sigma thrombin balance of $1.3 million at December 31, 2008 is expected to be used in our hemostat products sold in international markets before expiration of its shelf life.
As described in "Agreements with King Pharmaceuticals, Inc." above, in January 2007 we entered into the Thrombin-JMI(R) Supply Agreement in the United States with King with a price fixed throughout the 10 year term, adjusted for a producer price index tied to pharmaceuticals. The thrombin price under the agreement is confidential information; however, the price reflects a 25% discount to the price we paid in the last year of our previous thrombin supply agreement with King. The Thrombin-JMI(R) Supply Agreement does not terminate or affect our ability to complete the qualification of our own second thrombin source; however, with the near-term economic need to qualify a second source eliminated, we will be able to evaluate and plan our continuing expenses and steps on this project. We do not expect to incur any significant thrombin qualification expenses in 2009.
The Sigma contract was part of our plan to fully qualify a second source of thrombin (in addition to the Thrombin-JMI(R) Supply Agreement discussed in "Agreements with King Pharmaceuticals, Inc." above) and to bring the new thrombin through the regulatory process to be used in our hemostatic products. We have purchased $2.7 million of thrombin from Sigma, of which we have expensed approximately $0.4 million in our development work and used approximately $0.3 million in product manufacturing. We received regulatory approval in the first quarter of 2008 allowing us to use the Sigma thrombin in our international hemostat products. A $0.7 million expense was incurred in the fourth quarter of 2008 relating to a reserve recorded against our existing supply of Sigma thrombin due to the uncertainty of whether this amount of thrombin will be utilized prior to expiration of its shelf life. The remaining Sigma thrombin balance of $1.3 million at December 31, 2008 is expected to be used in our hemostat products sold in international markets before expiration of its shelf life.
As described in "Agreements with King Pharmaceuticals, Inc." above, in January 2007 we entered into the Thrombin-JMI(R) Supply Agreement in the United States with King with a price fixed throughout the 10 year term, adjusted for a producer price index tied to pharmaceuticals. The thrombin price under the agreement is confidential information; however, the price reflects a 25% discount to the price we paid in the last year of our previous thrombin supply agreement with King. The Thrombin-JMI(R) Supply Agreement does not terminate or affect our ability to complete the qualification of our own second thrombin source; however, with the near-term economic need to qualify a second source eliminated, we will be able to evaluate and plan our continuing expenses and steps on this project. We do not expect to incur any significant thrombin qualification expenses in 2009.
Tuesday, February 3, 2009
Haemonetics Corporation F3Q09 - Edited
Christopher Lindop
The core business remains strong with 12% growth, excluding currency and the TEG acquisition and year-to-date reported revenue growth for the entire business including TEG is 18%. Revenue growth in the quarter came from plasma, diagnostics, and blood banks. Year-to-date all product lines are contributing with solid growth. As we have said many times, we have multiple growth drivers, so let me share more insight.
First I will discuss plasma, our largest business with year-to-date revenues of $150 million. Plasma disposables continue to grow exceptionally well at 30% in the quarter and 31% year-to-date. This growth is driven by market expansion and new contracts. We saw increases in all geographies including Japan as demand for IPIG and albumin outpaced global supplies of plasma. In the US Haemonetics also benefited from a new contract with Octapharma which we announced in Q1 of fiscal ’09. In Japan we saw stronger unit growth combined with a year-over-year price improvement related to a plasma safety enhancement released in Q1 of this year.
It is important to note that plasma-derived drugs are not considered elective treatments and as such are not impacted by current economic trends. Fractionators continue to make investments in their business and industry analysts report that collections are expected to grow about 12% over the next year to meet ongoing drug demands. So as we have shared previously, while we expect plasma growth to moderate from the current extremely high growth rates, we currently expect double-digit revenue growth in the plasma business for the next 24 months.
Blood banks, which are mainly platelet collection disposables, are our second biggest business with $108 million in revenues year-to-date. Blood bank disposables grew 10% in the quarter and 8% year-to-date. The platelet market is growing nominally in developed markets, but we have identified areas for growth in emerging markets, specifically Eastern Europe and parts of Asia. In addition, as you may recall, this year we are benefiting from the market share gains through a contract with Canadian Blood Services. We saw the comparative benefit of the CBS contract through our past quarter. We are pleased that our blood bank business continues to contribute to overall revenue growth as we continue to gain market share in the developed markets and expand markets globally.
Moving to red cells, the red cell disposables business, which has revenues of $37 million year-to-date, grew 5% in the quarter and 7% year-to-date. While more than our original expectations for growth in this product line, our outlook has us growing it between 8% to 10% for the full year.
First I will discuss plasma, our largest business with year-to-date revenues of $150 million. Plasma disposables continue to grow exceptionally well at 30% in the quarter and 31% year-to-date. This growth is driven by market expansion and new contracts. We saw increases in all geographies including Japan as demand for IPIG and albumin outpaced global supplies of plasma. In the US Haemonetics also benefited from a new contract with Octapharma which we announced in Q1 of fiscal ’09. In Japan we saw stronger unit growth combined with a year-over-year price improvement related to a plasma safety enhancement released in Q1 of this year.
It is important to note that plasma-derived drugs are not considered elective treatments and as such are not impacted by current economic trends. Fractionators continue to make investments in their business and industry analysts report that collections are expected to grow about 12% over the next year to meet ongoing drug demands. So as we have shared previously, while we expect plasma growth to moderate from the current extremely high growth rates, we currently expect double-digit revenue growth in the plasma business for the next 24 months.
Blood banks, which are mainly platelet collection disposables, are our second biggest business with $108 million in revenues year-to-date. Blood bank disposables grew 10% in the quarter and 8% year-to-date. The platelet market is growing nominally in developed markets, but we have identified areas for growth in emerging markets, specifically Eastern Europe and parts of Asia. In addition, as you may recall, this year we are benefiting from the market share gains through a contract with Canadian Blood Services. We saw the comparative benefit of the CBS contract through our past quarter. We are pleased that our blood bank business continues to contribute to overall revenue growth as we continue to gain market share in the developed markets and expand markets globally.
Moving to red cells, the red cell disposables business, which has revenues of $37 million year-to-date, grew 5% in the quarter and 7% year-to-date. While more than our original expectations for growth in this product line, our outlook has us growing it between 8% to 10% for the full year.
Brian Concannon
Thanks Chris and good morning everyone. Chris just mentioned two key points: global economic factors and market extremes. Some of you are asking how Haemonetics will be impacted by the turmoil in the global economy, the predicted downturn in elective surgeries and lower capital spending at hospitals. So, let me try to address these questions, but first, let me give you the bottom line.
We expect any negative impact in fiscal ’10 to be modest. Haemonetics is the global leader in blood management solutions, so at the heart of our business is blood and transfusions are a critical part of every health system around the world. Try to run a hospital without blood. It is impossible. Let me share one example.
Recently a leading hospital network, which accounts for about 5% of inpatient admissions in the US, released some key statistics. The company said that for the nine months ended September 2008 blood costs represented 6% of its total expenses. In this period, while its inpatient census grew at about 2% blood costs were rising at nearly 18% year-over-year. This statistic was compared to pharmaceutical costs, which rose at about 1% per year, and med-surg supplies which grew roughly at 5%.
So we know that there are large for profit organizations incurring significant blood costs affecting their income statements. Inevitably, healthcare providers will have to better manage blood costs and they have only two choices, stop surgeries or control the costs of blood. Which is a better financial decision?
Thanks Chris and good morning everyone. Chris just mentioned two key points: global economic factors and market extremes. Some of you are asking how Haemonetics will be impacted by the turmoil in the global economy, the predicted downturn in elective surgeries and lower capital spending at hospitals. So, let me try to address these questions, but first, let me give you the bottom line.
We expect any negative impact in fiscal ’10 to be modest. Haemonetics is the global leader in blood management solutions, so at the heart of our business is blood and transfusions are a critical part of every health system around the world. Try to run a hospital without blood. It is impossible. Let me share one example.
Recently a leading hospital network, which accounts for about 5% of inpatient admissions in the US, released some key statistics. The company said that for the nine months ended September 2008 blood costs represented 6% of its total expenses. In this period, while its inpatient census grew at about 2% blood costs were rising at nearly 18% year-over-year. This statistic was compared to pharmaceutical costs, which rose at about 1% per year, and med-surg supplies which grew roughly at 5%.
So we know that there are large for profit organizations incurring significant blood costs affecting their income statements. Inevitably, healthcare providers will have to better manage blood costs and they have only two choices, stop surgeries or control the costs of blood. Which is a better financial decision?
Now let me cut this another way. More than 30% of our business is plasma collections and as Chris shared earlier this is a growing market with ongoing demand for plasma derived drugs. Industry analysts see that demand continuing. 35% of our business is platelets and red cell collections and 15% of our business is cardiovascular surgical blood salvage and diagnostics. The fact is, if you need a transfusion as part of you cancer treatment, or if you need heart surgery these are not elective procedures.
The one area where we could have exposure in the changing economic climate is elective surgeries and specifically orthopedic surgical blood salvage. But here our total exposure is just around $35 million annually. Less than 6% of total corporate sales come from our OrthoPAT. The OrthoPAT device can save the hospital costs and the orthopedic surgical blood salvage market is less than 10% penetrated. Downward pressure on large joint procedure reimbursement, a 25% decline in 10 years, combined with increased implant prices is putting pressure on healthcare provider’s profitability. What does all of this mean?
In order for hospitals to make money on a procedure the cost of the surgeon, the nurses, the OR, and yes, the blood products have to be managed. If we can save hospitals money on blood costs in our under penetrated market than some elective surgery issues can be resolved.
Now when you consider that a recent study by the Englewood Hospital in New Jersey estimates the total cost of delivering a unit of blood for transfusion is approximately $1,100.00, the value of avoiding or minimizing transfusion becomes clear. Even in the declining procedure market there is significant opportunity for OrthoPAT growth for market penetration by helping hospitals to control total blood costs.
Let me remind you of Atlantic Health, the health system we spoke about last quarter. Atlantic Health implemented Haemonetics blood management systems and saved about $1 million in blood related costs.
My final point is we place devices and generate revenues from the sale of disposables that save the hospital money every time they are used. With this business model, we avoid the inevitable pressures of tightening capital budgets. We are not in the capital equipment business.
In closing, nearly all of Haemonetics revenue comes from products, systems, and services that healthcare providers need despite a downturn in the economy and pressures on healthcare systems. Our strategy addresses a growing need. We believe we are uniquely positioned in these troubled times as the blood management company. We are the only company which can help customers control blood costs throughout the total blood supply chain from the donor to the patient.
The one area where we could have exposure in the changing economic climate is elective surgeries and specifically orthopedic surgical blood salvage. But here our total exposure is just around $35 million annually. Less than 6% of total corporate sales come from our OrthoPAT. The OrthoPAT device can save the hospital costs and the orthopedic surgical blood salvage market is less than 10% penetrated. Downward pressure on large joint procedure reimbursement, a 25% decline in 10 years, combined with increased implant prices is putting pressure on healthcare provider’s profitability. What does all of this mean?
In order for hospitals to make money on a procedure the cost of the surgeon, the nurses, the OR, and yes, the blood products have to be managed. If we can save hospitals money on blood costs in our under penetrated market than some elective surgery issues can be resolved.
Now when you consider that a recent study by the Englewood Hospital in New Jersey estimates the total cost of delivering a unit of blood for transfusion is approximately $1,100.00, the value of avoiding or minimizing transfusion becomes clear. Even in the declining procedure market there is significant opportunity for OrthoPAT growth for market penetration by helping hospitals to control total blood costs.
Let me remind you of Atlantic Health, the health system we spoke about last quarter. Atlantic Health implemented Haemonetics blood management systems and saved about $1 million in blood related costs.
My final point is we place devices and generate revenues from the sale of disposables that save the hospital money every time they are used. With this business model, we avoid the inevitable pressures of tightening capital budgets. We are not in the capital equipment business.
In closing, nearly all of Haemonetics revenue comes from products, systems, and services that healthcare providers need despite a downturn in the economy and pressures on healthcare systems. Our strategy addresses a growing need. We believe we are uniquely positioned in these troubled times as the blood management company. We are the only company which can help customers control blood costs throughout the total blood supply chain from the donor to the patient.
Brad Nutter
I would also mention Dan, that we have seen great balanced growth in all geographies. North America is up 21%, Asia is up 21%, Europe is up 17%, Japan 11%, although we, as Chris indicated, some of that currency. The fact is, this is the first time in a long time that we have seen all of our geographies all growing double digits, so that is a tremendously strong aspect of our business when you consider that more than 50% of our sales are outside of the United States. We like that balanced growth. North America has done that for four years in a row, but it is nice to see both Asia and Europe do it two years in a row.
I would also mention Dan, that we have seen great balanced growth in all geographies. North America is up 21%, Asia is up 21%, Europe is up 17%, Japan 11%, although we, as Chris indicated, some of that currency. The fact is, this is the first time in a long time that we have seen all of our geographies all growing double digits, so that is a tremendously strong aspect of our business when you consider that more than 50% of our sales are outside of the United States. We like that balanced growth. North America has done that for four years in a row, but it is nice to see both Asia and Europe do it two years in a row.
Source: seekingalpha
Adhesion Barrier Market to Skyrocket to Over $550 Million by 2013
WALTHAM, Mass., Feb 02, 2009 /PRNewswire via COMTEX/ -- Growing interest and innovation will drive adhesion barrier market, according to Millennium Research Group
According to Millennium Research Group's (MRG's) US Markets for Surgical Hemostats, Internal Tissue Sealants, and Adhesion Barriers 2009 report, growing surgeon interest in adhesion barriers, combined with numerous upcoming product launches, will fuel revenues in the US adhesion barrier market. Exceeding $550 million by 2013, the adhesion barrier market will experience a compound annual growth rate of almost 25% over the next five years.
It is estimated that the cost of treating adhesiolysis (the surgical removal of adhesions) in the US is over $2 billion annually. Due in part to the narrow range of approved indications for currently available products, the US adhesion barrier market remains underpenetrated; however, interest in these products is expanding rapidly as hospitals and surgeons realize the many benefits of using an adhesion barrier in surgical procedures. This interest will prompt a growing number of competitors to enter the US adhesion barrier market in the coming years.
The arrival of new adhesion barriers will expand indications, and the associated favorable clinical data that supplement product approvals, will boost surgeon awareness and drive adoption. Improved awareness will further be bolstered by continuing innovation and intensifying competition from market competitors, contributing to unit growth and adhesion barrier market expansion over the next five years.
"Following the removal of Gliatech's ADCON-L, FzioMed's Oxiplex/SP adhesion barrier was slated to be the first such product approved for spinal applications in the US," says Kevin Flewwelling, Manager of Orthopedics at MRG. "But, due to the product's unfavorable approval vote from the FDA's Orthopaedic & Rehabilitative Devices Panel in July of 2008, several companies have demonstrated renewed interest in developing an adhesion barrier approved for use in the lucrative US spine market."
MRG's US Markets for Surgical Hemostats, Internal Tissue Sealants, and Adhesion Barriers 2009 report provides in-depth coverage of the surgical hemostat, internal tissue sealant, and adhesion barrier markets. Competitors covered include Baxter BioSurgery, Covidien, CryoLife, Davol (a subsidiary of C.R. Bard), Ethicon (a Johnson & Johnson company), Genzyme Biosurgery, King Pharmaceuticals, MAST Biosurgery, Orthovita, Pfizer, and many more.
According to Millennium Research Group's (MRG's) US Markets for Surgical Hemostats, Internal Tissue Sealants, and Adhesion Barriers 2009 report, growing surgeon interest in adhesion barriers, combined with numerous upcoming product launches, will fuel revenues in the US adhesion barrier market. Exceeding $550 million by 2013, the adhesion barrier market will experience a compound annual growth rate of almost 25% over the next five years.
It is estimated that the cost of treating adhesiolysis (the surgical removal of adhesions) in the US is over $2 billion annually. Due in part to the narrow range of approved indications for currently available products, the US adhesion barrier market remains underpenetrated; however, interest in these products is expanding rapidly as hospitals and surgeons realize the many benefits of using an adhesion barrier in surgical procedures. This interest will prompt a growing number of competitors to enter the US adhesion barrier market in the coming years.
The arrival of new adhesion barriers will expand indications, and the associated favorable clinical data that supplement product approvals, will boost surgeon awareness and drive adoption. Improved awareness will further be bolstered by continuing innovation and intensifying competition from market competitors, contributing to unit growth and adhesion barrier market expansion over the next five years.
"Following the removal of Gliatech's ADCON-L, FzioMed's Oxiplex/SP adhesion barrier was slated to be the first such product approved for spinal applications in the US," says Kevin Flewwelling, Manager of Orthopedics at MRG. "But, due to the product's unfavorable approval vote from the FDA's Orthopaedic & Rehabilitative Devices Panel in July of 2008, several companies have demonstrated renewed interest in developing an adhesion barrier approved for use in the lucrative US spine market."
MRG's US Markets for Surgical Hemostats, Internal Tissue Sealants, and Adhesion Barriers 2009 report provides in-depth coverage of the surgical hemostat, internal tissue sealant, and adhesion barrier markets. Competitors covered include Baxter BioSurgery, Covidien, CryoLife, Davol (a subsidiary of C.R. Bard), Ethicon (a Johnson & Johnson company), Genzyme Biosurgery, King Pharmaceuticals, MAST Biosurgery, Orthovita, Pfizer, and many more.
Monday, February 2, 2009
Woundstat halted by US army
WASHINGTON — Until more testing can be done, Army medics are being told to stop using a new product just sent to the war front to help control bleeding among wounded troops.
Officials were in the process of distributing some 17,000 packets of WoundStat, granules that are poured into wounds when special bandages, tourniquets or other efforts won't work. But a recent study showed that, if used directly on injured blood vessels, the granules may lead to harmful blood clots, officials said Tuesday.
The Army Medical Command will continue its research and work with the manufacturer in hopes of figuring out in the next few months whether to resume use of WoundStat, said Col. Paul Cordts, head of Army health policy and services.
WoundStat manufacturer TraumaCure, Inc., of Bethesda, Md., had no immediate comment.
The product had been approved by the U.S. Food and Drug Administration. It was one of the latest in a series of Army efforts to improve survival rates on the battlefield.
Today, 90 percent of injured troops survive their wounds, the highest rate of any war, Cordts said in an interview. He credited better training of combat medics, better body armor the troops wear and better tactics they use on the battlefield, as well improved bandages, tourniquets and so on.
Defense Department figures show that as of this month, more than 4,800 troops have been killed in Iraq and the global war on terror. The latter category counts casualties mostly from Afghanistan. Some 34,000 troops have been wounded in the wars, where insurgents have made wide use of roadside bombs and other explosives.
Excessive blood loss is the number one killer on the battlefield, and the Army announced in October that it was sending two potential lifesavers ‹ the WoundStat packets and a bandage called Combat Gauze to replace older other products that had been in use at the time.
A committee of Army medics, Navy corpsmen, surgeons and others recommended the Combat Gauze bandage which has an agent that triggers blood clotting should be the first-line treatment for life-threatening hemorrhaging in cases where a tourniquet could not be placed, such as the armpit or groin area.
The WoundStat granules were to be used if the bandage failed to work.
Cordts said the Army put out a message on Dec. 18, directing the temporary halt in use of WoundStat. Though it has arrived at the war zones, officials are unclear on how widely it has been distributed so far. They¹re working to identify any soldiers who got the treatment, study their cases and examine them for any problems with blood clotting, Cordts said.
He said he didn't know whether it had been used on any soldiers and thus had no reports back from the field positive or negative on how effective it might have been.
Cordts said that after an additional few months of study, officials will likely determine whether they should discontinue its use altogether or perhaps redistribute it with warnings for how it is to be used.
Officials were in the process of distributing some 17,000 packets of WoundStat, granules that are poured into wounds when special bandages, tourniquets or other efforts won't work. But a recent study showed that, if used directly on injured blood vessels, the granules may lead to harmful blood clots, officials said Tuesday.
The Army Medical Command will continue its research and work with the manufacturer in hopes of figuring out in the next few months whether to resume use of WoundStat, said Col. Paul Cordts, head of Army health policy and services.
WoundStat manufacturer TraumaCure, Inc., of Bethesda, Md., had no immediate comment.
The product had been approved by the U.S. Food and Drug Administration. It was one of the latest in a series of Army efforts to improve survival rates on the battlefield.
Today, 90 percent of injured troops survive their wounds, the highest rate of any war, Cordts said in an interview. He credited better training of combat medics, better body armor the troops wear and better tactics they use on the battlefield, as well improved bandages, tourniquets and so on.
Defense Department figures show that as of this month, more than 4,800 troops have been killed in Iraq and the global war on terror. The latter category counts casualties mostly from Afghanistan. Some 34,000 troops have been wounded in the wars, where insurgents have made wide use of roadside bombs and other explosives.
Excessive blood loss is the number one killer on the battlefield, and the Army announced in October that it was sending two potential lifesavers ‹ the WoundStat packets and a bandage called Combat Gauze to replace older other products that had been in use at the time.
A committee of Army medics, Navy corpsmen, surgeons and others recommended the Combat Gauze bandage which has an agent that triggers blood clotting should be the first-line treatment for life-threatening hemorrhaging in cases where a tourniquet could not be placed, such as the armpit or groin area.
The WoundStat granules were to be used if the bandage failed to work.
Cordts said the Army put out a message on Dec. 18, directing the temporary halt in use of WoundStat. Though it has arrived at the war zones, officials are unclear on how widely it has been distributed so far. They¹re working to identify any soldiers who got the treatment, study their cases and examine them for any problems with blood clotting, Cordts said.
He said he didn't know whether it had been used on any soldiers and thus had no reports back from the field positive or negative on how effective it might have been.
Cordts said that after an additional few months of study, officials will likely determine whether they should discontinue its use altogether or perhaps redistribute it with warnings for how it is to be used.
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