SAN JOSE, Calif.--(BUSINESS WIRE)--Starch Medical Inc. a privately held manufacturer and marketer of polysaccharide based hemostatic products for use in controlling bleeding in surgery and trauma applications has expanded its product portfolio with the launch of SuperClot® Hemostat in Europe.

Starch Medical received CE Approval earlier this year for SuperClot® and will utilize their existing network of distribution partners along with new strategic partners to bring this innovative new polymer hemostat solution to surgical teams and hospitals throughout Europe. Next week Starch Medical will exhibit and hold distributor meetings at MEDICA the world's leading trade fair for the medical industry held in Düsseldorf, Germany from November 13-16, 2017.

“The market for economical, safe and effective polysaccharide hemostats is growing rapidly worldwide and especially in Europe. Our exclusive agreement to market Starch Medical’s SuperClot® Hemostat in Italy provides us with the opportunity to better serve our hospitals and their patients,” said Giovanni Capello, Chief Executive Officer of Medix. “In addition to rapid and effective hemostasis, our surgeons are attracted by the wide variety of surgical applications where SuperClot® can be used. We believe that Starch Medical’s hemostat product line including SealFoam®, SealFoam® Sternal and now SuperClot® will become the standard to control the majority of surgical bleeding in the future.”

“Surgeons and hospitals around the world are rapidly adopting the benefits of our hemostatic platform technology to enhance their performance in addressing various bleeding scenarios,” stated Stephen Heniges, President at Starch Medical. “Since our products contain no human or animal components the safety profile is excellent. The ability of SuperClot® to rapidly penetrate blood and form an adhesive gel to help seal the wound will be greatly appreciated by our customers.”

Starch Medical will continue to expand its product portfolio and pursue strategic partners in key markets globally and expects to further penetrate Asia, Europe and The Middle East in the near future.

Medafor Injunction Holds Up US Perclot Topical

CryoLife, Inc. (NYSE: CRY), a leading medical device and tissue processing company focused on cardiac and vascular surgery, today provided an update on its ongoing litigation with C.R. Bard, Inc. and certain of its subsidiaries regarding PerClot. The U.S. District Court for the District of Delaware (the "Court") has allowed CryoLife's declaratory judgment lawsuit against C.R. Bard's Medafor, Inc. subsidiary ("Medafor") to proceed. The Court also granted Medafor's motion for a preliminary injunction with respect to CryoLife's marketing and sale of PerClot Topical in the U.S. CryoLife is currently awaiting the Court's order, which it expects will provide details regarding the scope of the injunction.

Pat Mackin, CryoLife President and Chief Executive Officer, said, "While we are disappointed with the District Court's ruling on the preliminary injunction motion, we continue to believe we have a strong case and remain focused on securing the best long-term outcome in the litigation for our shareholders. We remain on track to begin enrollment in our PerClot IDE clinical trial for surgical applications during the first half of 2015, which would position us for potential FDA approval in the second half of 2017."

In April 2014, CryoLife filed a declaratory judgment lawsuit against C.R. Bard and certain of its subsidiaries, including Medafor, requesting that the Court declare that CryoLife's manufacture, use, offer for sale, and sale of PerClot in the U.S. does not and would not infringe Medafor's U.S. Patent No. 6,060,461 (the "'461 Patent"). In addition CryoLife requested that the Court declare that the claims of the '461 Patent are invalid. In September 2014, Medafor filed a motion for a preliminary injunction against CryoLife.

The preliminary injunction applies to PerClot Topical, which is in the early stages of launch in the U.S. CryoLife included approximately$1.5 million in PerClot Topical sales in its previously announced 2015 financial guidance. At this low-volume level, the Company was anticipating the gross margin for PerClot Topical to be approximately breakeven. The Company's previously announced earnings per share guidance for 2015 included $3 million to $4 million in expense related to the litigation with C.R. Bard. The Company continues to expect that this represents the high end of potential litigation expenses for the year related to this matter, and it will re-assess its litigation strategy and provide appropriate updates to its financial guidance, if any, after receiving the Court's order.

See official papers below....

https://drive.google.com/file/d/0B6J8c60Kq5rVUVBka0ExTjdYaWc/view?usp=sharing
https://drive.google.com/file/d/0B6J8c60Kq5rVSmhSWXVFd1daNWM/view?usp=sharing

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 Australia, Hong Kong, India, Korea,Malaysia, New Zealand, Singapore 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. 

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

Chinese Starch Medicals Perclot Patent Claims Denied - Impact for Cryolife predicted

Recently denied claims for China based Perclot manufacturer Starch Medical have seen Starch re-file a dramatically reduced set of claims revised patent application published May 16, 2013 (see HERE). 
The original 2009 filing which includes "Inventors" Ji Xin (James Ji), previously Chinese Distributor of Medafor's Arista, has now dropped Jianping Chen (Jane Chen) as an "Inventor".

 Of more critical importance the patent has now shrunk in respect of claims made. Currently claims 1-53 have now been cancelled and it seems likely this patent is less than secure.

The EU search indicates denial regarding incorrect claims and scope of the claims regarding novelty, and inventive steps. Comments such as "the skilled person knows....this method does not support an inventive step" amongst others is available in the embedded document below.

  European Search Report Starch Medical PCT_US2009000227

In the meantime it will be interesting to see the reaction from Cryolife Shareholders who, having been subjected to the Medafor - Cryolife debacle, may now have serious due diligence queries of executives. The millions spent already on the CRY-Starch marriage may be a concern, but continued investments highlighted in the last quarterly report by executives such as Ashley Lee who announced Q1 2013 the intention of (after initial denial of the Perclot IDE) re-filing the IDE with the FDA in May. Ashley also stated further investment in Perclot with "a 320 patient study, randomized 1:1 with a 30-day follow up over across several medical specialties". CEO Steve Anderson commented when questioned about Perclot manufacturing "I think we’ve already spent the money that we’re going to spend to build out our manufacturing facility that frankly is up and ready to go".

It's Perclot AMP.......No, It's Endoclot AMP

Cryolife last month announced that finally they had some good news regarding the litigation with Medafor, and under terms of the settlement, Medafor has agreed to pay CryoLife $3.5 million in cash. However the Atlanta based CryoLife foray into the powdered Hemostat market segment may still prove "interesting". When making their arrangement with Chinese Starch Medical for rights to Perclot in all territories worldwide excluding China, Hong Kong, Macau, Taiwan, North Korea, Iran and Syria. They also included the following in the contract:

  1.5 Product Applicators, Etc. SMI agrees to promptly notify CryoLife of all improvements to applicators, tips and other accessories included within or used in connection with the Products, including all new applicators, tips and other accessories. All such improvements and any such new applicators, tips or accessories to the Products shall be included within the Products and the Parties shall adjust the catalog of Products to reflect these new products, with any transfer price to be negotiated in good faith, but based solely on costs to SMI for such improvements and/or new applicators, tips and accessories. The Parties agree that the Endoscopic applicator system used for powder delivery via gastrointestinal endoscope, as further described on Schedule 2.1 is not an improvement or new applicator and is not included in this Agreement.

2.   Distribution

    2.1  Limitations on SMI Activities. During the term of this Agreement SMI agrees (i) to sell the Products exclusively to CryoLife for use in Permitted Clinical Applications within the Territory, (ii) to refrain from selling or licensing any Products to any Existing Distributor or Third Party for sale or distribution in Permitted Clinical Applications within the Territory, (iii) to refrain from directly or indirectly marketing, promoting, or encouraging any Third Party to market, promote or Distribute the Products for any of the Permitted Clinical Applications within the Territory, (iv) to refrain from licensing or transferring any AMP™ Technology to any Third Party within the Territory for the purpose of manufacturing any Products upon terms or conditions that would enable or allow such Third Party to sell any Products for Permitted Clinical Applications within the Territory. In addition, SMI agrees that it shall refrain until January 1, 2015 from (A) directly, or indirectly selling, permitting to sell, market, promote or encouraging third parties to sell, permit to sell, market or promote any Competitive Product (defined below) for any Permitted Clinical Application within the Territory or (B) licensing or transferring to any Third Party technology that would enable or allow any Third Party to manufacture any Competitive Product within the Territory. The provisions of the foregoing sentence shall be deemed further modified so that SMI may only take the actions described therein if SMI complies with Section 1.4 (and therefore CryoLife does not match the right of first refusal set forth therein). As used herein, “Competitive Product” means any powdered absorbable surgical hemostat that is intended for or could be used for a Permitted Clinical Application. The foregoing limitations do not apply to sales by SMI of those products described on Schedule 2.1.

Read the full document HERE

.

Now Cryolife and their partners face the interesting prospect of Chinese made Perclot AMP particles meeting them in the EU re-branded as "Endoclot".  

As can be seen HERE the original Chinese Xijing Hospital trial changes for the use of AMP show the changes from perclot to "endoclot", but the endoclot webpage discusses AMP particles....see HERE. 

The CRY Q2 Earnings Conference Call is scheduled for 7/31/2012. 
Click the images below to enlarge

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.....

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.

CRY Q2 2011

Comment: Solid growth from CRY this Q2...Hemostasis portfolio buoyed by off-label use of Bioglue (Purified bovine serum albumin (BSA) and glutaraldehyde) in Japan and a suggested move of Perclot manufacturing to the USA from China. For Perclot this should be useful considering how many markets require a Free Trade Certificate (i.e. These certificates are required by governments in a growing number of countries that need assurance that products exported from the United States to their countries are the same as products sold in the United States , presumably meeting all state and federal laws and regulations, thus posing no threat to their subjects. Exports to these countries must be accompanied by a valid certificate, or the product will not be admitted.)


Steve Anderson 

...Japanese BioGlue sales in early July continue to be strong and demonstrate that the product is being well received. BioGlue is also doing very well in Brazil where our distributor is on track by a $1 million during calendar 2011. Sales of BioGlue in Brazil have increased from $150,000 for 2005 to about $1 million in 2011. BioGlue is projected to comprise 40% of company’s sales in 2011.As you will recollect, BioGlue’s gross margins are in excess of 80%.

We are also very pleased with the early European market acceptance of PerClot. During the second quarter of 2011, sales of PerClot in Europe increased by 76% over the sales of HemoStase, a product we formally distributed for the same timeframe a year earlier. Sales of PerClot for the first six months of 2011 in Europe were $1,271,000 versus $721,000 of HemoStase for the same period in 2010.

In our opinion, PerClot is a more effective product than HemoStase [Arista, Medafor Inc.]. We believe that PerClot is a second generation powdered hemostatic agent and the doctors are genuinely pleased with what it does on the surgical setting. Sales in Australia have also been excellent.

During the first quarter conference call we stated that we had filed our US IDE for PerClot with FDA. The FDA had a number of questions and comments regarding our initial IDE submission. We have been addressing the FDA’s issue and are working on our responses. It’s important to note that HemoStase’s gross margin were 55%, and that when approved in the United States we will replace that product with PerClot whose gross margin will be an excess of 80%. I believe that PerClot sales will be a revenue and earnings growth engine for CryoLife going forward....

Ashley Lee

..Once we get PerClot, the manufacturing process transferred here [from current Starch Medicals Chinese manufacturing site] and approved in the US, that’s going to be an 80 plus percent gross margin product...

Steve Anderson

In addition to that, we’re working hard on getting third quarter approved in Brazil and in Canada, and we’re making good progress on that, its just a matter of working our way through the bureaucracy that is involved in approval in those countries. And so they should come on here in the next six to nine month and that products then would be looking at significant sales increases as a result of that. And the success we’re having in Brazil was of course with BioGlue it is sort of piggyback on that. And so, I would expect with the larger volumes late this year and next year with PerClot that those margins probably will continue to increase...

Raymond Myers - Benchmark

On the last call I asked you about this and you were a little more cautious at that time about Japan BioGlue sales, because that market is small you said that you thought you would have to do an additional clinical study to enter the $150 million general surgical sealant market in Japan. And I wonder are we being more optimistic now that we can broaden the use before having to do that study?

Steve Anderson

I think it’s evident that the Japanese physicians are using it off label for other uses. I think it’s too early. I don’t happen to know where they are using it at this time, but it’s obvious from the volume that they are using it an addition to and other places in addition to aortic dissections. We are going to do an additional clinical study, but we have the same exact approval from the FDA initially when we marketed that product in the States and of course and it ended up being used a lot for certain neurological indication and maybe that’s where it’s being used in Japan. I would have to ask our distributor we happen to know that I don’t at this early stage.

Joe Mondillo - Sidoti & Company

With the growth that you guys are seeing in BioGlue and PerClot, we assume to see an increase in CapEx going forward to support the growth that you are seeing?

Ashley Lee

Not necessarily. That’s one of the parts of our business that we think is very leverageable. We have got the infrastructure here currently at our facility to ramp production for BioGlue. We do not perceive any significant spend on CapEx for PerClot and getting that manufacturing process migrated [from Beijing, China] to our US facility....

Perclot Vs. Haemocer

Small wonder! 

BioCer release video of HaemoCer the latest technology in powdered Plant based Hemostats from Germany using the DAPI application.

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.

  BioGlue Incidents