Showing posts with label HaemoCer. Show all posts
Showing posts with label HaemoCer. Show all posts

Wednesday, October 8, 2014

HaemoCer approved for use in China and Canada

BioCer Entwicklungs GmbH (BCE), a German implantable biological medical device development and manufacturing company, announced today that it has achieved approval to commence sales of HaemoCer™, an Absorbable Polysaccharide Hemostat (APH), in the People's Republic of China.
"BioCer has now achieved near comprehensive Asia-Pacific regional representation, and the addition of the PRC approval of HaemoCer™ is a significant milestone," Dr Markus Heinlein, Managing Director stated. "The entry into China of our first product HaemoCer™ has been assisted by the early establishment of regional sales representation in the Asia-Pacific region. BCE are pleased Chinese surgeons and patients will now share the benefits of our technology. Our new Health Canada approval is also further evidence of strong international acceptance of our technology."
The PRC approval of HaemoCer™ expands an international sales network encompassing AustraliaHong KongIndia, Korea,MalaysiaNew ZealandSingapore and Thailand within the APEC region. BCE will be exhibiting at the EACTS, Milan, Italy, 11-15thOctober and the CMEF, Chongqing, China, 23-26th October 2014

Tuesday, November 19, 2013

Clinical Papers - Fibrin Sealants, BioGlue, Perclot, HaemoCer, Thrombin















Friday, October 11, 2013

BioCer Launch of HaemoCer Plus versus Arista, Perclot and unknown other as presented at EACTS in Vienna

Clearly demonstrated without question German technology continues to impress as "THE" device developer in the powdered plant based starch market. In the video you see from left to right Arista, Perclot, Unknown and the radical new polysaccharide agent HaemoCer Plus.

Tuesday, September 24, 2013

BioCer Present Newly EU Approved Super Rapid Plant-based Hemostat at EACTS

BAYREUTH, Germany, September 24, 2013 /PRNewswire via COMTEX/ -- BioCer Entwicklungs GmbH (BCE) a German implantable biological medical device development and manufacturing company announced today that it has achieved commercial approval to begin distribution in the EU, and international markets where CE mark is accepted of HaemoCer Plus. HaemoCer Plus is an Absorbable Polysaccharide Hemostat (APH) and an innovative powerful hemostatic technology that exhibits exceptional speed and ratio of absorbency.
"HaemoCer Plus follows 2 years of development and is a huge technological milestone with clear efficiency benefits. In comparative testing with our first agent HaemoCer the accelerated absorbent product nature is significant, and clearly evident to a far greater extreme with older plant-based powdered agents. As surgeons experience the rapid mode of action of HaemoCer Plus we expect they will convert, and this product will rapidly dominate this market segment," stated Dr. Markus Heinlein, Managing Director BCE. "As problematic bleeding in cardiac surgery is a constant challenge, BioCer are pleased to present and launch HaemoCer Plus at the EACTS."
Haemocer Plus APH is a plant-based hemostatic agent that utilizes the same raw material as BCE's flagship product HaemoCer. HaemoCer Plus APH technology is delivered in a powder format developed utilizing a new modification to Biocer's Polysacharide Ultra-hydrophilic Resorbable Engineering (PURE) manufacturing process. The new highly absorptive, biocompatible agent now performs at exceedingly fast absorptive speeds achieving results twice as fast and at double the capacity of HaemoCer.
HaemoCer Plus will be presented at the EACTS 5th-9th October 2013 in Vienna, Austria. Other meetings in 2013 include Medica (Germany) and Asia Pacific Hernia Society (Hong Kong) at BioCer's booth. BioCer also plan to attend Arab Health and welcome expressions of interest in distribution or licensing queries to please visit http://www.biocer-gmbh.de or email info@biocer-gmbh.de.

Tuesday, August 20, 2013

Medafor sells to Bard for $200 million, plus incentives that could add another $80 million.

Officials at Medafor Inc., a Brooklyn Center-based maker of a novel blood clotting product, said they’ve been looking for ways to enhance shareholder value — be it an initial public offering, new business relationships or just continuing organic growth. The one thing they weren’t looking for was a buyer, leaders said Monday.
Then the folks at C.R. Bard Inc., a New Jersey-based medical equipment maker, came calling.
Their offer — $200 million in cash now and up to $80 million more if revenue targets are hit in the next two years — proved too attractive to pass up, said Medafor CEO Gary Shope.

Medafor on Monday announced that it has an agreement to be purchased by C.R. Bard’s Davol Inc. division. The transaction has been approved by both companies’ boards of directors, but is subject to approval by Medafor’s shareholders and customary regulatory review.
“The premium price underscores what we have been building on,” Shope said in an interview Monday. “I think the shareholders are being rewarded with a great price.”
Medafor’s appeal has been its plant-based microporous polysaccharide hemospheres technology, which is used in its Arista MPH hemostat product. The product rapidly dehydrates blood and accelerates the body’s natural blood-­clotting process.
Sept. 24 is the target date for shareholder approval, Shope said. The deal values Medafor’s privately held shares at $6.37 per share. The revenue-based incentives are valued at up to $2.82 per share.
It’s a significantly better deal than the $2 per share that Atlanta-based CryoLife Inc. proposed in a takeover bid in 2010. At the time, the Medafor board called the bid “grossly inadequate.” CryoLife was an exclusive-rights distributor for Medafor’s blood-clotting technology in the United States and some international markets. It had also made offers for Medafor in 2008 and 2009, which Medafor also rebuffed.
C.R. Bard said Medafor will add approximately 1 percent to its 2014 revenue.
The company, a maker of vascular, oncology and surgical products, had revenue of about $3 billion last year. Scott Lowry, C.R. Bard vice president and treasurer, said he expects Medafor, which has 33 employees, to have annual revenue of $30 million to $40 million by the end of 2013. Medafor’s products will complement C.R. Bard’s hemostasis unit and broaden its product portfolio, he said.
“We look at this as a growth opportunity,” Lowry said. “Our plan is to grow this business.”
He says it is premature to comment on status of Medafor’s management and employees since the deal still needs Medafor shareholder approval and to pass other regulatory requirements. Shope, the Medafor CEO, said he believes that Bard is considering keeping the Medafor organization intact but that “going forward, they will be making their own decisions.”
John Houston, an attorney at Fredrikson & Byron who served as Medafor’s lead legal counsel for the transaction, said: “This really was an offer that came out of left field. It was not solicited and it was not anticipated.”
Officials from Bard had met with two of Medafor’s senior officers at a conference in Spain less than a year ago, he said.
According to C.R. Bard’s statement on the acquisition, the global market for surgical hemostats is over $1.4 billion. “The Arista hemostat provides a great alternative to other commercially available hemostats while providing strong synergy with our Progel Sealant technology and sales channel,” said Timothy Ring, C.R. Bard’s chairman and CEO.

Thursday, May 31, 2012

HaemoCer Instrumentation Advances Plant-sourced Hemostat Applications into Minimally Invasive Surgeries


BAYREUTH, Germany, May 31, 2012 /PRNewswire/ --BioCer Entwicklungs GmbH (BCE), a German based medical device manufacturer, announces the CE approval of its advanced HaemoCer™ Universal Applicator (UA). HaemoCer™ UA is a delivery configuration for applications of the HaemoCer™ Absorbable Polysaccharide Hemostat (APH) system in minimally invasive surgical procedures.
The HaemoCer™ UA system is a unique instrumentation for laparoscopic, ENT, spinal and other MIS procedures where precise delivery of APH particles to the bleeding site is mandatory. The delivery instrument is easily attached to the HaemoCer™ bellows dispenser and enables hemostat delivery under direct vision to the wound site for the control of capillary, venous and arteriolar bleeding. The initial HaemoCer™ 5 gram product range has also expanded to include multiple size configurations meeting the strong international market demand for HaemoCer™ in multidisciplinary procedures.
Dr. Markus Heinlein, Managing Director of BioCer, commented, "The clinical introduction of HaemoCer™ UA offers surgeons a delivery option within the expanding practice of minimally invasive surgery. Collaborating with leading laparoscopic surgeons and German engineers, our system has been designed for the controlled release of hemostatic particles. HaemoCer™ UA encompasses 3 unique advances, including a press-and-release locking system facilitating UA tip placement without uncontrolled discharge. Secondly the system features a tip design which minimizes tip blockage, both common difficulties with current particle delivery devices. Finally the new instrumentation is sold separately and the push-on coupling sheath will accommodate other devices allowing medical professionals and patients to immediately benefit from this new instrumentation while converting stocks to HaemoCer™."
BioCer Entwicklungs-GmbH, HaemoCer APH particles are manufactured utilizing a Polysaccharide Ultra-hydrophilic Resorbable Engineering (PURE) process.  HaemoCer™ contains no human or animal components and is developed and manufactured in Germany. For information, distribution inquiries, and licensing options, please visit http://www.biocer-gmbh.de or email info@biocer-gmbh.de.

Thursday, October 27, 2011

CRY Q3 10Q, FDA Disapproves Perclot IDE.....Perclot China Trial underway......


10Q - PerClot and HemoStase
Revenues from the sale of hemostats, consisting of PerClot and HemoStase, decreased 71% for the three months ended September 30, 2011 as compared to the three months ended September 30, 2010. Revenues from the sale of PerClot and HemoStase decreased 40% for the nine months ended September 30, 2011 as compared to the nine months ended September 30, 2010. The revenue decreases in the three and nine months ended September 30, 2011 were primarily due to a decrease in hemostat sales volume in domestic markets, partially offset by an increase in sales volume in international markets. The revenue decrease in the nine months ended September 30, 2011 was also impacted by a decrease in average selling prices, which decreased revenues by 6%.
International hemostat revenues increased 24% for the three months ended September 30, 2011 and 55% for the nine months ended September 30, 2011 as compared to the three and nine months ended September 30, 2010, respectively. This increase is primarily due to an increase in international sales of PerClot in the 2011 periods over the international sales of HemoStase in the corresponding 2010 periods. Management believes that international PerClot revenues have been favorably impacted by the Company’s ability to market PerClot for all surgical specialties, expanding the direct European sales force into Austria, and PerClot’s product performance when compared to other hemostatic agents.
The decrease in domestic sales volume for the three and nine months ended September 30, 2011 was due to the Company’s planned discontinuation of sales of HemoStase in late March 2011. The Company recognized no domestic hemostat sales in the second or third quarters of 2011, subsequent to the discontinuance of HemoStase sales, as PerClot is not yet approved for commercial distribution in domestic markets. The Company anticipates this loss of domestic hemostat sales to result in a decrease in total hemostat sales for the remainder of 2011 when compared to the corresponding 2010 periods.


The Company will not be able to sell PerClot in the U.S. in future years until U.S. Food and Drug Administration (“FDA”) approval is granted. On March 31, 2011 CryoLife filed an Investigational Device Exemption (“IDE”) with the FDA seeking approval to begin clinical trials for the purpose of obtaining Premarket Approval to distribute PerClot in the U.S. On April 29, 2011 the FDA disapproved CryoLife’s IDE filing with numerous comments and questions. CryoLife is currently addressing those comments and questions and anticipates refiling its IDE for PerClot in the fourth quarter of 2011.


Q3 Report - Brackets have been added-
Ashley Lee...
We experienced some delays in getting PerClot approved in certain international markets and some competitive issues in the EU, which leaves us to slightly lower our guidance.

Worldwide BioGlue revenues were up 10% for the third quarter and up 5% for the nine month period. These increases were predominantly driven by volume increases, particularly in Japan, due to the recent launch of the product. This was the largest year-over-year quarterly increase for BioGlue revenues, since third quarter of 2008, and we continue to remain enthusiastic about the opportunity in Japan.
Total sales in the third quarter in Japan were $651,000 and year-to-date in Japan were approximately $1.2 million. To-date, approximately 250 surgeons have been trained and over 160 accounts have ordered product. We expect another large order from Japan before the end of the year.

PerClot sales for the third quarter were $620,000 and were $1.9 million year-to-date. We experienced some delays in getting PerClot approved in certain international markets and some competitive issues in the EU, which leaves us to slightly lower our guidance. However, despite these delays, our international revenues from the sale of powdered hemostats in the third quarter still increased 24% compared to the prior year, and 55% for the nine month period compared to the prior year.


Steve Anderson...As Ashley has discussed earlier in third quarter of 2010, we announced our first technology acquisition and that we have signed a worldwide manufacturing and distribution agreement for a unique powered hemostatic agent PerClot with Starch Medical of San Jose (Shanghai), California (China).
(Chinese) PerClot is an ideal replacement for the hemostatic powder that we had been distributing worldwide. The primary difference is that PerClot’s gross margin will be 80%.....we filed our IDE for PerClot with the FDA in March of this year. The FDA had questions about our submission that we have been addressing. We will be reaching our IDE to the FDA in mid November. We expect to begin the clinical trial for PerClot (Link to current trial Xijing Hospital of Digestive Diseases, Xi'an, Shaanxi, China) during the second quarter of next year. The clinical trial will probably involve about 300 patients, 150 PerClot patients and 150 control patients. We expect that with six months enrollment and three months follow-up of these patients that we will file our PMA in the second quarter of 2013.

  • In which circumstances does the FDA disapprove or withdraw an IDE?
    FDA may disapprove or withdraw approval of an IDE application if FDA finds that:
    1. The sponsor has not complied with applicable requirements of the IDE Regulation, any other applicable regulations or statutes, or any condition of approval imposed by an IRB or FDA.
    2. The application or a report contains untrue statements or omits required material information.
    3. The sponsor fails to respond to a request for additional information within the time prescribed by FDA.
    4. There is reason to believe that the risks to the human subjects are not outweighed by the anticipated benefits to the subjects or the importance of the knowledge to be gained, that informed consent is inadequate, that the investigation is scientifically unsound, or that the device as used is ineffective.
    5. It is unreasonable to begin or to continue the investigation due to the way in which the device is used or the inadequacy of:
      (i) the report of prior investigations or the investigational plan; (ii) the methods, facilities, and controls used for the manufacturing, processing, packaging, storage, and, where appropriate, installation of the device; or (iii) the monitoring and review of the investigation.
Q & A...
Matt Dolan - Roth Capital Partners
Great. First question on the guidance, just looking at the revenue at this point it implies maybe around 10% sequential uptick in Q4. So how far below $122 million should we expect or what gets you to that type of sequential uptick, meaning, is there a category that improves something on the macro level that rebounds?
Ashley Lee
We think that the upside is in the Cardiogenesis product line and the PerClot product line as well as potentially BioGlue in Japan.
Matt Dolan - Roth Capital Partners
Okay. But given your guidance on those categories it still requires a pretty big sequential uptick?
Ashley Lee
Yeah well the possibility exists again that we could do better and then we expect to do better in Cardiogenesis, PerClot, and BioGlue in Japan. And that -- we think that that’s, we have more upside in those three areas than the rest of the business.
Matt Dolan - Roth Capital Partners
Okay. And then on the earnings guidance just to clarify, I think the delta between adjusted and GAAP last quarter was $0.05 as supposed to an $0.08 differential at mid year. So I wanted to make sure that that’s the reason for the increase in the earnings guidance? And secondly the implied guidance for Q4 cuts EPS basically in half. So I’m just trying to understand why that would be?
Ashley Lee
The primary driver in non-GAAP, the increase in non-GAAP EPS as compared to the end of the second quarter is primarily due to the shifting of some R&D expenses due to some delays and getting some studies started, as those will be shifting out of 2011 into 2012. As it relates to the fourth quarter we provided for some additional expenses in the fourth quarter this year to account for the ongoing discovery and the acceleration of the discovery in our litigation with Medafor.
Raymond Myers - Benchmark
And that was going to be my next question. So let’s get right to that. Roughly how much Medafor litigation expense should we expect?
Ashley Lee
If you go through the end of the third quarter we had spent about $1.4 million and we’re expecting a similar amount in the fourth quarter of this year about $1.4 million.....

Saturday, July 30, 2011

BioCer Release Test Data on "PURE"-ity of Latest Hemostat Innovation HaemoCer Vs. Perclot

A year ago Cryolife CEO Steve Anderson was embroiled in the meltdown of the CRY/Medafor relationship as the distribution agreement for first generation polysaccharide hemostat Arista came to a very bitter and public disintergration.......more HERE. Following this debacle CRY have entered into an agreement with merchant Starch Medical a San Diego based company with manufacturing facilities for Perclot (generation 2 of the polysaccharide powders) based in Beijing, China.http://www.docstoc.com/docs/60831472/PerClot-Arista Our 2009 Poll indicates concern, results HERE.

Now it's Q2 one year later and newly released test reports commissioned by German based BioCer, manufacturers of HaemoCer (conducted by a third party laboratory) offer compelling information supporting the contention their PURE (Polysaccharide Ultra-Hydrophilic Resorbable Engineering) process is much more than marketing hype. The report comparing CRY's Chinese Perclot with German made HaemoCer is available HERE or by clicking the thumbnail below.

Meanwhile video of HaemoCer shows the latest polysaccharide plant based hemostats formation of a powerful adhesive gelled matrix in comparison to generation 1 product Arista by Medafor Inc.

Thursday, June 2, 2011

Tuesday, March 22, 2011

BioCer Introduce Latest Plant-based Hemostasis and Coated Hernia Repair Technologies to China

BAYREUTH, GermanyMarch 21, 2011 /PRNewswire/ -- BioCer Entwicklungs GmbH, a Bayreuth, Germanybased medical device manufacturer, are pleased to announce their attendance at the China Medical Equipment Fair (CMEF) Shenzhen, China 15th-19th April 2011. HaemoCer(TM) an Absorbable Polysaccharide Hemostat (APH) and Ti0(2)Mesh(TM) Hernia repair system will be on exhibit at the BioCer booth.
HaemoCer(TM) APH technology is delivered in a powder format developed to meet the challenges of problematic bleeding in surgery. Utilizing Biocer's Polysacharide Ultra-hydrophilic Resorbable Engineering (PURE) process modifies plant-based polymers to create a highly absorptive, biocompatible agent which enhances and accelerates the natural clotting cascade. The PURE technology format of HaemoCer(TM) APH contains no thrombin, collagen, or other human or animal components, and is resorbed within days.
TiO(2)Mesh(TM) is an implant utilizing a biocompatible coating for surgical Hernia repair. Ti0(2)Mesh(TM) combines multiple requirements, specifically addressing the needs of the laparoscopic surgeon. TiO(2)Mesh(TM) offers a complete solution to the laparoscopic surgeon and coincides with the advance and rapid growth of minimally invasive surgery in China.
Heinz-Josef Schmies, Managing Director of BioCer Entwicklungs Gmbh commented, "The introduction at the CMEF of HaemoCer(TM) APH and its proprietary, integrated PURE technology offers Asian-Pacific medical professionals an opportunity to examine directly the latest advance in polysaccharide hemostats. TiO(2)Mesh(TM) which encompasses a cutting edge coating technology combined with all the requirements of the ideal Hernia repair mesh offers a complete solution to unmet needs. We anticipate surgeons and patients in China and Asia-Pacific will benefit from these advanced technological innovations in Hernia repair and Hemostasis."
BioCer Entwicklungs GmbH is a privately-held medical device company and welcomes CMEF visitors to their booth H26, hall 2. For further information, distribution inquiries, and licensing options, please visithttp://www.biocer-gmbh.de/en/.

Tuesday, February 22, 2011

Cryolife Q4 - Upbeat news for shareholders 10 people in the EU until 2013 to carry Medafor Divorce, Perclot-China marriage and Bioglue EU IP

Product revenues which consists primarily of BioGlue and HemoStase increased 4% in the fourth quarter and full year of 2010 compared to the corresponding periods in 2009. For the three month and full year periods HemoStase revenue increased partially offset by a slight decrease in BioGlue revenues. Fourth quarter of 2010 also included $264,000 of PerClot revenue as we began to roll out PerClot in international markets.
Total gross margins were 60% for the fourth quarter of 2010 compared to 61% for the fourth quarter of 2009. Total gross margins excluding the write off of $1.6 million for the HemoStase inventory were 60% for the full year of 2010 compared to 62% in the full year of 2009. Preservation services gross margins for the fourth quarters of 2010 and 2009 were 39% for each period and 40% in the full year of 2010 compared to 42% in the full year of 2009.
Product gross margins for the fourth quarter of 2010 were 80% compared to 82% in the corresponding period in 2009. Product gross margins excluding the write down of $1.6 million of HemoStase inventory were 81% in the full year of 2010 compared to 83% in the full year of 2009. General administrative and marketing expenses for the fourth quarter of 2010 were $12.2 million compared to $12.6 million for the fourth quarter of 2009. These expenses for the fourth quarter of 2010 included approximately $474,000 in costs related to business development activities and $268,000 in costs related to our litigation with Medafor.
General administrative and marketing expenses for the full year of 2010 were $49.1 million compared to $50 million for the full year of 2009. The full year of 2010 included a charge of approximately $1.4 million in costs related to our litigation with Medafor $1 million related to business development activities and $729,000 related to the write off of capitalized legal expenses associated with our BioGlue intellectual property rights in Germany.....
Raymond Myers – The Benchmark Company
Okay. Good. When were you targeting PerClot approval and launch?
Product revenues which consists primarily of BioGlue and HemoStase increased 4% in the fourth quarter and full year of 2010 compared to the corresponding periods in 2009. For the three month and full year periods HemoStase revenue increased partially offset by a slight decrease in BioGlue revenues. Fourth quarter of 2010 also included $264,000 of PerClot revenue as we began to roll out PerClot in international markets.
Total gross margins were 60% for the fourth quarter of 2010 compared to 61% for the fourth quarter of 2009. Total gross margins excluding the write off of $1.6 million for the HemoStase inventory were 60% for the full year of 2010 compared to 62% in the full year of 2009. Preservation services gross margins for the fourth quarters of 2010 and 2009 were 39% for each period and 40% in the full year of 2010 compared to 42% in the full year of 2009.
Product gross margins for the fourth quarter of 2010 were 80% compared to 82% in the corresponding period in 2009. Product gross margins excluding the write down of $1.6 million of HemoStase inventory were 81% in the full year of 2010 compared to 83% in the full year of 2009. General administrative and marketing expenses for the fourth quarter of 2010 were $12.2 million compared to $12.6 million for the fourth quarter of 2009. These expenses for the fourth quarter of 2010 included approximately $474,000 in costs related to business development activities and $268,000 in costs related to our litigation with Medafor.
General administrative and marketing expenses for the full year of 2010 were $49.1 million compared to $50 million for the full year of 2009. The full year of 2010 included a charge of approximately $1.4 million in costs related to our litigation with Medafor $1 million related to business development activities and $729,000 related to the write off of capitalized legal expenses associated with our BioGlue intellectual property rights in Germany.....
Raymond Myers – The Benchmark Company
Okay. Good. When were you targeting PerClot approval and launch?
Steve Anderson
I think that PerClot’s approval will be sometime towards the end of 2012 or early 2013 the clinical study that we are going to run is includes about 300 patients and will be across a number of different specialties for a number of different indications. But I would say the soonest we could get it done at the end of 2012 probably a more timely expectation is early 2013.
Raymond Myers – The Benchmark Company
And that’s for approval or for finishing this study.
Steve Anderson
That’s approval.
Raymond Myers – The Benchmark Company
And so well let’s start with the study through this to finish the 300 patient study if you would follow your IDE at the end of March when do you think you can finish the study.
Steve Anderson
It will go pretty quickly but I don’t think that we would be finished with the 300 patient enrollment until fourth quarter of 2011.
Raymond Myers – The Benchmark Company
And that leaves about a year for FDA is that your thought?
Steve Anderson
Yeah.
Raymond Myers – The Benchmark Company
Great, your HemoStase revenue was quite strong in the fourth quarter is that related to winding down the sales and a desirable push out the last of your inventory before you can’t sell it anymore or does that more represent underlying strength in the market.
Ashley Lee
I think it represents both you know I mean you know this full area of powdered hemostatic agents is rolling and that’s why we’ve made the commitment to be in it long-term with the acquisition of the PerClot distribution rights and at the same time you know as you mentioned we do have some inventory that we are trying to sell prior to our discontinuing distributing HemoStase which is going to be in late March so it’s a combination of both.
Raymond Myers – The Benchmark Company
So should we expect similar sales on Q1 as if we saw in Q4.
Ashley Lee
For HemoStase.
Raymond Myers – The Benchmark Company
Yeah.
Ashley Lee
No.
Raymond Myers – The Benchmark Company
Lower, higher?
Ashley Lee
That would be lower than the fourth quarter of 2010 and I think that our guidance for again for the full year for all powdered hemostats is between $4 million and $6 million.
Raymond Myers – The Benchmark Company
Okay, and is some of the HemoStase that you might be selling in Q1 product that is already written off?
Ashley Lee
Potentially.
Raymond Myers – The Benchmark Company
So there could be a potential of a reversal of the prior charges?
Ashley Lee
I wouldn’t say a reversal of the prior charges we could be recognizing some revenue for which there is no associated – costs associated with the revenues so not by that finish in reversal but we could have some revenue with very high gross margin on it.
Raymond Myers – The Benchmark Company
Do you expect that to be potentially meaningful to earnings in the quarter.
Ashley Lee
I wouldn’t expect it to be meaningful to earnings in the quarter.
Raymond Myers – The Benchmark Company
Okay well.
Ashley Lee
It might be meaningful to cash flow though.
Raymond Myers – The Benchmark Company
Nice your cash flow is already very good. You’ve had a share buyback consistently through 2010 do you intend to continue that in 2011?
Ashley Lee
The buyback has continued into the first couple of months of 2011 and just to give you an idea of where we are we have purchased roughly about 1.3 million to 1.4 million stock in the first two months 2011 at an average price of you know somewhere around 5.25 [ph] that’s a guess.
Raymond Myers – The Benchmark Company
So you’ve purchased $1.3 million or shares?
Ashley Lee
Dollars.
Raymond Myers – The Benchmark Company
Dollars.....
Raymond Myers – The Benchmark Company
Yeah, thank you I’m here. Ashley and Steve could you maybe start with reminding us how many sales people do you have now and what are your plans to expand that.
Steve Anderson
In round numbers we have about 50 in the field in United States and we are direct in the UK, Germany and Austria with approximately 10 people in the field over there.


Steve Anderson
I think that PerClot’s approval will be sometime towards the end of 2012 or early 2013 the clinical study that we are going to run is includes about 300 patients and will be across a number of different specialties for a number of different indications. But I would say the soonest we could get it done at the end of 2012 probably a more timely expectation is early 2013.

FYI BioGlue paper, click on thumbnail.