ProFibrix US Phase II Study with FibrocapsTM Meets All Primary and Secondary Endpoints

ProFibrix B.V., a leader in the development of innovative products for hemostasis, today announced that its U.S. multicenter Phase II clinical trial with Fibrocaps in spinal, peripheral vascular and general surgery resulted in a highly statistically significant reduction in mean time to hemostasis (TTH) and incidence of hemostasis at 3, 5 and 10 minutes, as compared to active control.

A total of 70 patients were enrolled in the company’s U.S., prospective, randomized, single-blind, controlled, multicenter Phase II study with lead product Fibrocaps for mild to moderate surgical bleeding. The US study results confirm the efficacy and safety results recently reported from the Dutch Phase II study in hepatic resection. Both studies demonstrate that Fibrocaps has a very good safety profile comparable to active control, along with rapid hemostatic activity across multiple surgical indications.

Dr. Neil Singla, one of the Principal Investigators of the US Phase II study, said: “The combined ease of use and efficacy of Fibrocaps in spinal and vascular surgery constitute a great leap forward in hemostasis in these surgical settings. These surgeries require optimal precision and thanks to the rapid time to hemostasis of Fibrocaps we can quickly and safely obtain a clear field of vision during these interventions.”

Jan Öhrström, CEO of ProFibrix said: “We are delighted that the positive results of the US Phase II study confirm the results from our European study reported in November 2011. In fact, the results of the two Phase II clinical trials have de-risked the Fibrocaps program substantially. We plan to initiate a pivotal Phase III trial in H1 2012, and target a BLA filing in 2013. Based on its strong and competitive properties, we believe that after launch Fibrocaps should be able to command a large share of the US$ 1 billion topical hemostat market.”

About Fibrocaps

Fibrocaps is a mixture of two essential blood clotting proteins, fibrinogen and thrombin, and is a unique dry powder topical fibrin sealant being developed to stop bleeding during or after surgery. Fibrocaps is clearly differentiated from existing liquid tissue sealants and hemostats: it is ready for immediate use, and is stable at room temperature.

About the Study

The Phase II clinical trial of Fibrocaps (FC-002 US) was a prospective, randomized (2:1), single-blind, controlled study in 70 subjects undergoing spinal (n=37), peripheral vascular (n=30) and general surgery (n=3). The study was conducted at 8 sites across the U.S. Fibrocaps was considered to have a very good safety profile, with no adverse events attributed to Fibrocaps, which is consistent with the previously conducted Phase II study. The primary efficacy endpoint of the study was a pooled intent-to-treat analysis of the mean TTH of Fibrocaps versus active control. The TTH means ± SD were 1.9 ± 1.3 min for Fibrocaps (n=47) and 4.8 ± 3.1 min for control (n=23) (p<0.001). The secondary endpoints of incidence of hemostasis at 10, 5 and 3 min were all statistically significant, with p-values of 0.003, 0.001 and <0.001, respectively.

ProFibrix conducted the Fibrocaps Phase II study in the U.S. under an open IND with the FDA. For more details on the study, please go to http://www.clinicaltrials.gov.

ProFibrix to present today at Biotech Showcase in San Francisco

ProFibrix will present at the Biotech Showcase 2012 in San Francisco, on Wednesday, Jan. 11, 2012. Jan Öhrström, CEO of ProFibrix, will make a formal presentation on the company at 9:45 a.m. in the Stockton Room. The Biotech Showcase runs parallel to the 30th Annual J.P. Morgan Healthcare Conference, and takes place at Parc 55 Wyndham San Francisco - Union Square.

About ProFibrix

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

Hemostat Market Research Indicates Strong Growth

Source: Mediligence Blog

Transfusion Guidelines in Children Reviewed

December 29, 2011 — Thresholds for transfusing children vary from those in adults, according to a 2-part review study published in the January 2012 issue of Anaesthesia & Intensive Care Medicine.

"The transfusion of a blood product into a child is associated with a greater risk of harm when compared to an adult," writes Rachel Hartrey, MBBCh, FRCA, a consultant pediatric anesthetist at Southampton University Hospital National Health Service Trust in the United Kingdom. "The younger the child, the greater these risks are: 18:100,000 in all paediatric age groups, increasing to 37:100,000 in those less than 1 year of age; this compares to 13:100,000 in adults. These calculations are based on red cell transfusion alone and do not take into account risks posed by other blood products, in particular fresh frozen plasma...and platelets."

The first part of the review describes normal hematological ranges in infants and children, lower levels of hemoglobin that can be tolerated without undue risks, and how to evaluate blood loss to ensure that blood products are not transfused unnecessarily.

The second part of the review describes strategies to avoid transfusion of blood products, and which fluids to use instead, as well as recommendations regarding how much and which blood products to use when indicated to reduce adverse effects.

Normal hemoglobin values are highest at birth (14 - 24 g/dL), decreasing to 8 to 14 g/dL at 3 months, and then gradually increasing to 10 to 14 g/dL at age 6 months to 6 years, 11 to 16 g/dL at age 7 to 12 years, and 11.5 to 18 g/dL in adulthood.

Thresholds for Red Blood Cell Transfusions

For infants younger than 4 months, thresholds for red blood cell transfusions based on hemoglobin levels are 12 g/dL for preterm infants or term infants born anemic, 11 g/dL for chronic oxygen dependency, 12 to 14 g/dL for severe pulmonary disease, 7 g/dL for late anemia in a stable infant, and 12 g/dL for acute blood loss exceeding 10% of estimated blood volume.

For infants older than 4 months, thresholds for red blood cell transfusions based on hemoglobin levels are 7 g/dL in a stable infant, 7 to 8 g/dL in a critically unwell infant or child, 8 g/dL in an infant or child with perioperative bleeding, and 9 g/dL in an infant or child with cyanotic congenital heart disease (because of increased oxygen demand). To slow bone marrow stimulation in a child with thalassaemia major, the recommended threshold is 9 g/dL.

For a child with sickle cell disease (SCD), the recommended threshold is 7 to 9 g/dL, or more than 9 g/dL if the child has previously had a stroke. When a child with SCD undergoes major surgery, the threshold should be 9 to 11 g/dL, and sickle hemoglobin should be less than 30%, or less than 20% for thoracic or neurosurgery.

Strategies to Avoid Transfusion

Strategies to avoid perioperative transfusion of allogeneic blood include:

• maximizing preoperative hemoglobin;
• preoperative autologous donation, which is associated with risks including transfusing the wrong blood unit, wasting donated blood, bacterial contamination, and preoperative anemia;
• acute normovolemic hemodilution when major blood loss is expected;
• patient position to avoid increased venous pressure;
• use of tourniquets where appropriate;
• surgical technique to achieve hemostasis, using diathermy and tissue glues;
• deliberate hypotension (at a safe level);
• hypervolemic hemodilution, although infusing large volumes of fluid may dilute clotting factors and cause interstitial edema;
• use of tranexamic acid, although there is still uncertainty as to the most effective dose;
• and intraoperative cell salvage in operations in which major blood loss is anticipated. However, reactions to the retransfused blood have been reported, which may be caused by leukocyte stimulation or a reaction to the additives.

"Blood is not only involved in the carriage of oxygen, but has many other functions including haemostasis," Dr. Hartrey writes in the second part of the review. "Therefore it is little wonder that the development of a compound that deals with only one element of this (e.g. oxygen carriage) is compromised by side effects. Several of the proposed alternatives, including haemoglobin-based oxygen carriers...and fluorocarbon-based solutions, have been associated with significant clinical side effects such as abnormal clotting."

Dr. Hartrey has disclosed no relevant financial relationships.

Kenneth Mann named 'Distinguished Scientist'

A professor from the College of Medicine has recently been recognized by one of the top cardiovascular organizations in the world.

Professor of Biochemistry and Medicine Kenneth Mann, Ph.D was named a Distinguished Scientist by the American Heart Association (AHA), an honor reserved for those whose work has advanced understanding of cardiovascular disease, a University Communications article stated.

The award, created in 2003, progresses the AHA's goal of "building healthier lives, free of cardiovascular diseases and strokes," the article stated.

The research that propelled Mann to Distinguished Scientist status focused on blood coagulation. The National Institutes of Heath, the AHA and other areas in the pharmaceutical industry supported his publication, the article stated.

Mann's early career focused on the production of the protein thrombin and pharmaceuticals' influence on it, University Communications stated.

Mann and his research team have focused on computer simulation and clinical trials to determine the effects of various pharmaceuticals on blood clotting and thrombin production, Mann said.

"Because our work flows in through all areas, we cover everything from cardiology to vascular surgery and trauma," he said. "We've even written a lot of current textbooks on blood clotting and hematology."

Mann's contributions have been recognized by various medical associations and have received awards such as the E. Donnall Thomas prize and the Stratton Medal of the American Society of Hematology, according to University Communications.

"I got involved in blood clotting for a lot of reasons, and was mentored and tutored by very nice people over my career," Mann said.

His research career and training of graduate and medical students has produced scientists in the blood coagulation field. Mann attributes his success to his students, collaborators and his wife, Jeanette, the article stated. 

Z-Medica Donates $1.5 Million in QuikClot

WALLINGFORD, Conn., Dec 08, 2011 (BUSINESS WIRE) -- Z-Medica Corporation, a medical device company which develops and distributes innovative hemostatic agents, announced that it has donated $1.5 million in QuikClot(R) the company's life-saving hemostatic agents, to AmeriCares, a nonprofit global health and disaster relief organization. The QuikClot products will be used by AmeriCares for disaster relief efforts as well as its ongoing health programs around the globe, helping to prevent loss of life and limb. Z-Medica had previously donated $150,000 of its QuikClot products to AmeriCares for use in Haiti following the earthquake there in 2010.

"We had great success providing QuikClot for use in Haiti following the earthquake and for other relief efforts and we are grateful that Z-Medica has responded to our request for an additional donation of this life-saving tool," said Dr. Frank J. Bia, AmeriCares Medical Director. "QuikClot is now a standard part of our response efforts and we make sure it is part of our aid deliveries for disasters and our ongoing partnerships."

QuikClot is an ideal product for use in the field, including disaster relief areas or by first responders, due to its ease-of-use and ability to achieve hemostasis in as little as three minutes. The United States Department of Defense currently uses QuickClot Combat Gauze(TM) as the official first-line hemostatic treatment for traumatic bleeding in all branches of the United States military. QuikClot is also regularly used by first-responders and medical professionals in the field and in hospital clinical environments such as the cardiac catheterization laboratory, interventional radiology, the emergency room and virtually anywhere else where bleeding needs to be controlled.

"AmeriCares is an extremely professional and efficient organization and we have the highest confidence that they will save many lives with this donation," said Brian Herrman, Chief Executive Officer, Z-Medica. "Every US soldier, marine, and airman carries QuikClot at all times, which has saved many lives. Our mission at Z-Medica, therefore, is to ensure that all medical professionals and first responders everywhere have access to QuikClot, in both disaster areas, as well as in day-to-day situations such as hospital trauma units, emergency rooms and the cardiac catheterization labs."

Woman's face catches on fire during surgery

A woman's face caught on fire during routine surgery in the US.
Kim Grice, 29, was undergoing surgery to have cysts removed from her brain when her face erupted in flames.
Grice was airlifted to a Burn Unit with burns to her face and neck.
Grice's father, Ted Grice, told a local newspaper his daughter's face had "caught on fire" during surgery.
"The doctors and the hospital are not telling us what happened," he said. "They said they had never seen anything like it before and they are terribly sorry that it happened."
Grice's mother said she was in shock.
"This is not what happens with a routine outpatient surgery."
According to ABC News, however, "flash fires"are not uncommon.
Between 550 and 650 surgical fires occur each year in the US alone. More than half of surgical fires happen inside a patient's airway or on the patient's upper body, while a quarter of surgical fires happen on other parts of the body.
About 70 per cent of "flash fires" are ignited by electrosurgical tools commonly known as Bovies, devices that use a high-frequency electric current to cut tissue or stop bleeding, reported MSNBC.
Twenty per cent of fires are sparked by hot wires, light sources, burrs or defibrillators while about 10 per cent are sparked by lasers.

ProFibrix Phase II with FibrocapsTM Meets Primary Endpoint – On Track for Phase III in 2012

LEIDEN, The Netherlands & SEATTLE--(BUSINESS WIRE)-- ProFibrix B.V., a leader in the development of innovative products for hemostasis, today announced that its multicenter Phase II clinical trial with Fibrocaps in liver resection surgery resulted in a highly statistically significant 50% reduction in mean time to hemostasis (TTH) compared to active control.
A total of 56 patients were enrolled in the company’s Dutch prospective, randomized, controlled, multi-center Phase II study with lead product Fibrocaps for mild to moderate surgical bleeding. The study results show that Fibrocaps has a very good safety profile along with rapid hemostatic activity that succeeds in significantly reducing mean time to hemostasis, the primary end point of the Phase II trial.
Professor dr. R.J. Porte from the University Medical Center Groningen, the Lead Investigator of the study, said: “We’re very pleased with the excellent performance of Fibrocaps in this Phase II study. I have no doubt that the substantial reduction in mean time to hemostasis we report for Fibrocaps is clinically very meaningful, and demonstrates the strength of this unique dry powder formulation of fibrinogen and thrombin.”
Jan Öhrström, CEO of ProFibrix said: “Our clinical data constitute the strongest result ever reported for fibrin sealants in a Phase II study in this indication. These positive results ensure that we remain on track to initiate a pivotal Phase III trial in H1 2012, and target a BLA filing in 2013. In the coming months we expect to report on the results of the Phase II trial we are running in parallel in the U.S. Altogether we believe that the positive outcome of the European and U.S studies should allow us to generate strong support from investors as we continue developing Fibrocaps and its line extensions.”

BAX Q3 2011

In terms of individual business performance and beginning with BioScience, global BioScience sales of $1.5 billion increased 9% in the third quarter. Excluding foreign currency, BioScience sales increased 4%. Within the product categories, recombinant sales of $552 million grew 5%. Excluding foreign currency, sales declined 1% as growth of 4% in the U.S. was offset by the expected impact from recent tenders and somewhat slower demand across Europe, given strong performance in the previous quarter. On a year-to-date basis, excluding the impact of tenders we discussed, global recombinant sales growth, excluding currency, is in mid single digits consistent with global market demand.

Moving on to Plasma Proteins. Sales in the quarter were $372 million and advanced 8%. Excluding the impact of foreign currency, sales grew 4%. Growth across the various Plasma Proteins was significantly offset by lower albumin sales as a result of temporary supply constraints and delays in the clearance of shipments in China as a result of new testing guidelines that were implemented there late last year. Combined, these 2 items impacted sales in the quarter by approximately $20 million.

Sales in the U.S. improved sequentially across multiple products in the portfolio, including FEIBA, PD Factor VIII and ARALAST, but were down 8% year-over-year driven primarily by the supply constraints of albumin, whereas, international sales climbed 10% driven by strong demand for FEIBA and PD Factor VIII despite certain tender delays in Eastern Europe.

In Antibody Therapy, sales of $380 million increased 13%. Excluding foreign currency, sales were up 11%, driven by a robust demand for GAMMAGARD LIQUID and the launch of SubQ. Growth in this category of 11% also reflects some ongoing benefits related to Octapharma of at least $20 million in the third quarter.

Sales in regenerative medicine, which includes our BioSurgery products, totaled $143 million and increased 10%. Excluding foreign currency, sales increased 5% driven by high single-digit growth of Fibrin Sealants. This performance was offset by lower ACTIFUSE revenues triggered by the temporary disruption in the U.S. channel resulting from the planned transition to a direct sales model from ApaTech's former distributor model that we mentioned last quarter....

JnJ Q3 2011

I will now review the Medical Devices & Diagnostics segment results.

Worldwide Medical Devices & Diagnostics segment sales of $6.3 billion grew 1.7% operationally as compared to the same period in 2010. Currency had a positive impact of 4.4 points, resulting in a total sales increase of 6.1%.

Sales in the U.S. were down 0.7%, while sales outside the U.S. increased on an operational basis by 3.9%. Excluding drug-eluting stent, worldwide sales increased over 3% on an operational basis.....
During the quarter, Ethicon received a complete response letter from the U.S. Food and Drug Administration regarding its Biologics License Application or BLA for the Fibrin Pad. The Fibrin Pad is a novel product candidate that combines Ethicon to biomaterials and plasma-derived Biologics to aid in stopping bleeding during surgery. This BLA marks the first of multiple submissions and approvals the company will pursue to deliver this novel product to surgeons and their patients. We are not planning on conducting new clinical trials to support our response. Ethicon is taking a phased approach to the development of the Fibrin Pad, including building a state-of-the-art facility to scale up supply in order to meet anticipated demand.

Ethicon Endo-Surgery achieved operational growth of 3.4% in the third quarter of 2011, with the U.S. sales down 2.5% and sales outside the U.S. up 7.6% operationally. Growth was driven by increased market share for advanced sterilization products and outside the U.S., new product launches and the continued shift to minimally-invasive surgery drove double-digit growth for harmonic products and strong sales results for Endo products....

Steve Beuchaw - Morgan Stanley, Research Division

We'd always be happy to join you in any of those discussions. One other question. I just wanted to get your latest thoughts, Dominic, on where things are headed with the FDA approval processes, both the 5, 10-Ks in for novel technologies. On one hand it seems like we're seeing an acceleration of legislative activity aimed at making these processes simpler, but then on the other hand we see CMS and the FDA working harder to coordinate approval and reimbursement for new technologies. So at this stage, to what extent do you think these are good indicators of where things might go? Maybe 5, 10-Ks get more predictable, and new technologies get a little bit more scrutiny. Where do you see this going?

Dominic J. Caruso

Yes, it's a great question. Look, we would just be speculating if we gave you sort of any definitive kind of position on this. But it is true that there is a movement to try to differentiate, if you will, the products that should get 5, 10-K and rapid approval in the marketplace because of relatively low risk or they're obviously the predicate devices. It's something that should be comparable to the current device and differentiate those from the products that would require more sort of PMA and extensive clinical trials as the products become or those development innovations become more complex. I think a company like Johnson & Johnson having the expertise that we have across a broad portfolio of not only medical device products, but obviously our pharmaceutical business as well positions us very well to have those kinds of discussions and dialogue with the FDA of what's appropriate in evaluating the particular product in question. So I would just say you've made a good observation. I can't predict where it's going to come or how it's going to come out, but I believe that we're in a great position to have that dialogue with the FDA and help them arrive at a sensible solution for the industry.

Vascular Solutions Q3 2011

Net sales of hemostat products (primarily consisting of the D-Stat Dry, D-Stat Flowable and D-Stat Radial products) were $5.7 million in the third quarter, a decrease of 6% from the third quarter of 2010 and a decrease of 4% from the second quarter of 2011. "The hemostatic patch market has become even more price competitive. At the very end of the second quarter we launched our new Silver versions of the D-Stat Dry and Thrombix(R) products, which add an antimicrobial ingredient to the patches while leaving our pricing unchanged. We continue to expect these Silver versions to allow us to at least maintain our market-leading position in the hemostat patch market into 2012," Mr. Root said.

As previously disclosed, King Pharmaceuticals, Inc. notified Vascular Solutions on July 6, 2011, that it was electing to not proceed further with efforts to obtain a surgical use indication from the FDA for the company's Thrombi-Gel products and to not complete development of the company's Thrombi-Paste products. As a result, Vascular Solutions recognized an additional $2.6 million of license revenue during the third quarter of 2011 as the remaining deferred license revenue originally allocated to the Thrombi-Paste products and the surgical use indication of the Thrombi-Gel products as part of the agreements entered into with King in 2007. Starting in the fourth quarter of 2011, amortization of deferred revenue is expected to be $87,000 per quarter.


Hemostat Products: It appears that revenues will continue to be flat or declining in Vascular Solution’s hemostat product lines. Management cited competitive pricing pressure for Vascular Solution’s D-Stat Dry product. However, the company could see upside if Marine Polymer’s injunction against competitor HemCon is enforced. Marine Polymer was awarded an injunction in September but Hemcon was subsequently given a stay. The injunction would prevent HemCon from selling such products as the HemCon Bandage and the Chitoflex and Dental Dressings. Vascular Solutions management did say that launches of Silver versions of the D-Stat Dry and Thrombix products, which include a new antimicrobial ingredient, would enable the company to maintain hemostat market share.

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.....

Cryolife announce first patients enrolled for BioFoam (Bovine) trial.

ATLANTA, Oct. 24, 2011 /PRNewswire via COMTEX/ -- CryoLife, Inc., CRY +2.52% , a leading tissue processing and medical device Company focused on cardiac and vascular surgery, today announced that it has enrolled the first patient in its U.S. Investigational Device Exemption (IDE) clinical trial for its BioFoam® Surgical Matrix protein hydrogel technology. In connection with the trial, BioFoam will be used as an adjunct to conservative measures of achieving hemostasis on newly resected liver parenchyma.
The approved IDE is for a prospective, multicenter, randomized feasibility study evaluating safety outcomes of BioFoam as compared to a standard topical hemostatic agent. The feasibility investigation will be conducted at up to three investigational sites and will enroll 20 eligible subjects with 10 subjects in each treatment group.
"We are pleased to begin enrolling patients in our IDE study, which is a milestone in our efforts to obtain BioFoam approval for distribution in the U.S.," said Steven G. Anderson, CryoLife president and chief executive officer. BioFoam is based on the same protein hydrogel technology platform from which BioGlue Surgical Adhesive was developed read more HERE.

A keratin biomaterial gel hemostat derived from human hair: evaluation in a rabbit model of lethal liver injury.

Abstract

Effective hemostatic dressings that are compatible with tissues are needed. Keratins are a class of biomaterials that can be derived by extraction of proteins from human hair. We have recently discovered that keratin biomaterials have hemostatic characteristics and hypothesize that a keratin hydrogel having the ability to absorb fluid and bind cells may be an effective hemostat. The goal of this study was to test a keratin hydrogel and evaluate it compared to current hemostats. Thirty-two New Zealand white rabbits received a lethal liver injury. Eight animals each were assigned to negative control, QuickClot, HemCon bandage, and keratin treatment groups. Vital stats and other data were recorded during surgery and all surviving animals were sacrificed after 72 h. Histology was conducted on all surviving animals. Twenty-four-hour survival rates were 0%, 62.5%, 62.5%, and 75% for the negative control, QuickClot, HemCon, and keratin groups, respectively. Other outcomes included blood loss, mean arterial pressure, heart rate, shock index, and liver histology. All of the hemostats were statistically better than the negative control group at late operative time points. The keratin group consistently performed as well as, or better than, the commercial hemostats. Histology showed an interesting healing response at the hemostat-liver interface in the keratin group.

Surgeons get tips and tricks for contending with antiplatelet therapy

Lisbon, Portugal - A session on the best practice for operating on patients taking antiplatelet therapies was well received at the European Association for Cardio-Thoracic Surgery (EACTS) 2011 Annual Meeting this week, with attendees saying they welcomed advice on this topic in light of the newer antiplatelet agents coming onto the market.
Surgeons generally want to stop antiplatelet therapy several days before an operation to reduce bleeding risk, but this can have a negative impact in terms of thrombotic events, particularly if a patient has recently had a drug-eluting stent (DES) placed. And while there are recommendations for when to stop antiplatelet therapy prior to surgery—generally advised at five days beforehand for clopidogrel, three days for ticagrelor, and seven days for prasugrel—"the reality is that very often we have to proceed with surgery much faster," surgeon Dr A Pieter Kappetein (Erasmus Medical Center, Rotterdam, the Netherlands) told the meeting.

Cardiologist Dr Freek Verheugt (Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands) acknowledged that "the eternal difficulty for the surgeon is balancing the risks of bleeding and thrombosis," in a sentiment that was echoed in another talk on "tips and tricks for operating under antiplatelet therapy," given by Dr Miguel Sousa Uva (Hospital da Cruz Vermelha Portuguesa, Lisbon).

Both Verheught and Sousa Uva stressed that the key to determining what to do about dual antiplatelet therapy in the face of surgery is to use individual risk assessment, on a case-by-case basis, and they advised using an algorithm to aid in this decision, taken from the latest European guidelines on revascularization.

Following the session, cochair Dr Jose Luis Pomar (Hospital Clinico de Barcelona, Spain) observed: "This is a very interesting topic. After this, I believe we are still ignorant, but perhaps we have a bit more understanding than before."