Highlights Cryolife Q3

BioGlue revenues were a record $36.5 million for the first nine months of 2008, compared to $32.4 million in the first nine months of 2007, an increase of 13%. This increase was primarily due to the aggregate impact of a favorable product mix, and a 4% increase in the number of BioGlue milliliters shipped, which increased revenues by 10%, and an increase in average selling prices, which increased revenues by 3%..........

Other medical device revenues in the third quarter and nine months of 2008 included $549,000 and $726,000 in sales of Hemostase MPH, which we began distributing in May of this year.........

During the quarter we were awarded another grant of $848,000, of which $212,000 has been received from the Department of Defense for our continued development of our BioFoam surgical matrix product. Our CE mark application for BioFoam is targeted to be submitted to our European notified body in December. We would expect that we would receive approval for the BioFoam CE mark in April of ’09.
Our plans are to launch this product throughout Europe beginning in the second quarter of 2009. After CE approval, we plan to conduct several post-approval studies to evaluate BioFoam in liver resections. These will be conducted at three European clinics, with approximately 15 patients per clinic.
For approval in the United States, we will need to submit an IDE application and conduct a clinical trial. We are currently targeting a December submission for the BioFoam IDE. The U.S. human study indication will be as an adjunct to control bleeding following liver resection surgery. We will initially be requesting a pilot clinical study at one or two centers, in 10 to 20 patients. We would expect our follow on pivotal U.S. study to include up to 200 patients. We estimate that it will take about two years to complete the pilot and pivotal studies in the United States.........

Other medical device revenues, which consist primarily of sales of Hemostase MPH, are expected to be between $4.5 and $5.5 million in 2009. Product and tissue processing revenues could be affected by several factors, including but not limited to, the general economic environment, and its effect on demand for the company’s products and processed tissues, and changes in foreign currency exchange rates, and their effects on revenues generated in international markets. Again, this guidance assumes foreign currency exchange rates stay near current levels...............

And from the Q & A.

Greg Brash - Sidoti & Company
Okay, and is the -- just one last question, is the Hemostase MPH, is that tracking your expectations? Are you pleased with how the product is selling and the physician feedback?
Ashley Lee
Yes, we are, we’re getting a lot of attraction with that product, and we think it’s also very complimentary to BioGlue, and we think that it’s had some impact on the BioGlue sales increases.
Greg Brash - Sidoti & Company
Okay, I mean do you think doctors are pretty brand-loyal on this market? Obviously, you’re doing pretty well, and you’re still initial launch year, but are they pretty open to trying the product?
Ashley Lee
They are open to trying the product. When you see it work, it’s a very impressive visual reaction, because it works instantaneously so I think from that stand and it’s effective, so I think that it will continue to grow.
Greg Brash - Sidoti & Company
Okay, thanks guys.

Source: seekingalpha

CPC Appoints Medical Product Service GmbH as Authorized European Representative for MedClose

SARASOTA, Fla., Oct. 29 /PRNewswire-FirstCall/ -- CPC of America, Inc.(OTC Bulletin Board: CPCF), a company focused on the development of therapeutic devices for use in endovascular procedures, today announced that it is implementing a European strategy for the development and distribution of its MedClose(TM) investigational-stage medical device. In the roll out of its strategy, CPC announced an agreement with Medical Product Service GmbH (MPS) of Germany to act as authorized European representative for the Company in seeking European regulatory approval for MedClose(TM) Vascular Closure Device(VCD). MedClose(TM) is an extravascular puncture-closure device intended to be used with a biological sealant for diagnostic and interventional cardiovascular procedures. According to published third party research, European VCD market sales for2008 are projected to total approximately $160 million. Industry experts forecast that in Europe, the penetration of VCDs into minimally invasive cardiovascular procedures will experience a 9% compound annual growth rate and drive VCD sales and revenues."The European Union offers significant opportunities to broaden theMedClose(TM) market potential," said Rod Shipman, chairman and chief executive officer of CPC of America. "By aligning ourselves with MPS, we are setting a critical path to market in Europe. Our team will work closely with MPS inbuilding key partnerships and navigating the European regulatory regime and clinical trials. We recognize the need for a safe, reliable closure system that reduces time to hemostasis and allows for faster patient ambulation and,when necessary, wound re-access. With MedClose(TM), we aim to fill that need in the U.S. and Europe."As CPC's authorized representative in Europe, MPS will provide service under the respective CE marking requirements that apply in the European Union.MPS's role will include vigilance reporting, communicating with competent authorities in individual member states, assisting in securing international product registrations, and preparing and completing dossiers for clinical trials and CE markings."MPS knows that physicians operating in catheter laboratories across theEU demand precise instruments that help improve patient safety and outcomes,"said Gehard Fromel, Principal Regulatory Consultant of MPS. "We are eager to collaborate with CPC to bring to market a product that may help the European medical community and their patients."
About Medclose
The MedClose™ VCS is a medical device that is designed to seal femoral arterial puncture sites in patients who have undergone diagnostic or interventional catheterization procedures. It utilizes a proprietary catheter delivery vascular closure system that is designed to enhance manual compression by delivering a biologic sealant which creates an elastic coagulum that is fully resorbed within 10 to 14 days.

Falling apart over Omrix

When I added Omrix Biopharmaceuticals Ltd. (Nasdaq:OMRI) to my portfolio, tracked by "Globes", I noted that it was a profitable biotechnological company in a most interesting niche - biosurgical sealants for the prevention of hemostasis in surgery - and that it was not an all or nothing company, like Pharmos Corp. (Nasdaq: PARSD), for example, where one failed trial can wipe almost an entire investment. It now turns out that while Omrix may not be of the all or nothing genre, it is a real madhouse for investors like me, who were looking for an oasis of tranquility in the biotechnology sector, a sector that has traditionally been fraught with risk.
Since the beginning of the year, Omrix has managed to issue a severe warning (in March) for the fourth quarter of 2007, plunge heavily, and replace its CFO a second time. At the beginning of this month, on the eve of Yom Kippur of all times, it issued an announcement in which it reported positive interim results in the important trial of its advanced surgical sealant, following which the share rose strongly, just as the collapse on the markets was moving into high gear. The news made the fast a bit easier to handle, but the joy was short-lived.
By the next day, Yom Kippur itself, Omrix had already updated investors with the announcement that it was halting the trial due to the occurrence of a critical fault, just a day after declaring it a success. Investors like me switched on their computers after Yom Kippur ended, only to find that the share had plummeted for the second time in six months. Later on in the month, Omrix tried to put the fiasco of the failed trial behind it with a reassuring announcement to investors about a strong third quarter. But Omrix's weary investors found little cause for cheer, and the share barely moved at all.
The denouement came last Friday when Omrix joyfully announced the resumption of the trial, as if nothing had happened at all. "We got it wrong, there was no fault," was what the announcement amounted to, and the company's share regained just a small part of the ground it lost on Yom Kippur. One can imagine how investors, who abandoned the stock on Yom Kippur after it crashed 40% following the announcement of the fault, felt last Friday when Omrix revealed it never actually happened.
The analysts covering Omrix are also finding that their patience is wearing thin. In its latest review, Citigroup describes the company's astounding u-turn as "one step forward, three steps back, one step forward." It assumes that the fault occurred for one of two reasons - either a technical failure due to human error, or bleeding in another place not treated by the sealant. Until such time as they receive further clarification, which will most likely be forthcoming on November 6, when Omrix unveils its results, Citigroup's analysts are retaining the lukewarm "Hold" recommendation they issued following the company's stiff warning in March, with a target price of just $15.
On top of all this, the Omrix roller coaster has been dogged by sporadic rumors that it could be sold for around $25 a share. The identity of the possible buyers regularly changes. Among those rumored to be in the frame are Ofer Group, Johnson & Johnson Inc. (NYSE: JNJ), Omrix's partner in the marketing and development of the aforementioned sealant and, according to "Globes", also European pharmaceutical giant Bayer AG (LSE: BYR; XETRA: BAY).

Source: Globes

Omrix Biopharmaceuticals Announces Patient Enrollment Will Resume In Fibrin Pad U.S. Phase II Clinical Trial In Mild to Moderate Bleeding

Omrix Biopharmaceuticals, Inc. ("Omrix”) (NASDAQ: OMRI), a fully-integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products, announced today that the Fibrin Pad U.S. Phase II clinical trial in mild to moderate bleeding will resume patient enrollment and continue with no modifications.
On October 9, 2008, the Company announced that the U.S. Phase II clinical trial had been suspended in order to investigate an incident of post-operative bleeding. This event met the stopping rules, as outlined in the clinical trial protocol.
Per the clinical trial protocol, upon the suspension of the study, a Data Safety Monitoring Board, or DSMB, reviewed the data related to the event. The DSMB has concluded their investigation and authorized the trial to recommence.
About the Fibrin Pad
The Fibrin Pad builds on the Company's aprotinin-free fibrin sealant technology incorporated into EVICEL Fibrin Sealant (Human). The Fibrin Pad is designed for the management and rapid control of mild, moderate and severe bleeding. This next generation, fully absorbable biosurgical product candidate combines medical device and proprietary biological components which form an instant clot when they come in contact with blood.

Excerpt Vascular Solutions Inc. Q3 2008

.........Our highest sales product category in the third quarter was our hemostat products, with $5.8 million in net revenue in the third quarter, a decrease of 4% from the third quarter of 2007. The three causes for the decline were the continued reduction in sales of our Duett sealing device, which is our legacy product that we have chosen to not actively promote, the as-planned conversion from hospital pricing to distributor pricing in Germany as a result of the switch to a distributor sales model, and the decline in sales to King Pharmaceuticals.
In the third quarter of 2008, King purchased $90,000 of Thrombi-Gel and Thrombi-Pad, with an additional order planned but delayed by us until the fourth quarter due to our recently completed facility expansion. We recently -- we expect King purchases to continue at the current level until we receive FDA approval for the surgical indication for the Thrombi-Gel product, which we currently target for the end of 2009.
D-Stat Dry sales were essentially constant on a sequential quarter basis, as we have maintained our leading market share in the face of intense price competition from the non-thrombin patches.

Omrix Q3 revenue beats Wall Street view

Oct 20 (Reuters) - Biopharmaceutical company Omrix Biopharmaceuticals Inc reported a 35 percent rise in its third-quarter revenue, beating analysts' average estimate, and raised its full-year product sales outlook.
The company reported preliminary quarterly revenue of $21.3 million, compared with $15.8 million a year earlier. Analysts on average expect the company to post a revenue of $19.1 million, according to Reuters Estimates.
Omrix sees 2008 product sales of $70 million to $72 million, up from its prior forecast of $68 million to $71 million.
The company reaffirmed that it expects its biosurgery product sales in 2008 to increase about 75 percent from a year ago.
The company said its product sales guidance is partly based on the current biosurgery sales outlook provided by Ethicon Inc, a unit of Johnson & Johnson.
Ethicon has exclusive sales and marketing rights to Omrix's biosurgical products in the United States and the European Union.
Omrix shares closed at $14.48 on Friday on Nasdaq.

New Cardiology Agreement for Abbott

CHARLOTTE, N.C., Oct 09, 2008 (BUSINESS WIRE) -- Premier Purchasing Partners, LP, today announced new agreements for hemostasis and compression products for use in cardiology with Abbott Laboratories, Inc. of Abbott Park, Ill., and TZ Medical, Inc. of Portland, Ore.
The 36-month agreements, effective November 1, 2008, are available to acute and continuum of care members of the Premier healthcare alliance.
About Premier Inc., 2006 Malcolm Baldrige National Quality Award recipient
Serving more than 2,000 U.S. hospitals and 53,000-plus other healthcare sites, the Premier healthcare alliance and its members are transforming healthcare together. Owned by not-for-profit hospitals, Premier operates one of the leading healthcare purchasing networks and the nation's most comprehensive repository of hospital clinical and financial information. A subsidiary operates one of the nation's largest policy-holder owned, hospital professional liability risk-retention groups. A world leader in helping healthcare providers deliver dramatic improvements in care, Premier is working with the United Kingdom's National Health Service North West and the Centers for Medicare & Medicaid Services to improve hospital performance. Headquartered in San Diego, Premier has offices in Charlotte, N.C., Philadelphia and Washington. For more information, visit www.premierinc.com.

Cohera Medical Wins Pittsburgh Technology Council's 2008 Tech 50 Rising Star Award

PITTSBURGH, Oct. 20 /PRNewswire/ -- Cohera Medical Inc. today announced that it has received the Pittsburgh Technology Council's 2008 Tech 50 Rising Star Award. The Tech 50 Awards recognize accomplished technology-oriented companies in southwestern Pennsylvania. The Rising Star award is given to a young (less than three years old) entrepreneurial company that offers the most unique products or services among the contending companies and shows promise of becoming a significant economic force in the area. "We are extremely pleased that Cohera Medical's tissue adhesive technology has been recognized for its innovation and economic potential,"said Patrick Daly, chief executive officer of Cohera Medical. "TissuGlu(R),our lead product candidate for use in securing planes of tissue in plastic surgery procedures, is a truly novel product candidate that shows significant potential for improving clinical outcomes and patient care. We also look forward to developing our surgical adhesive technology for otherproducts as well."

About Cohera Medical Cohera Medical Inc. is a Pittsburgh-based company that is developing are volutionary line of wound management products and surgical adhesives.Cohera Medical's products are based on a unique chemical design that is purely synthetic, easy to use, biocompatible and fully resorbable. The company's lead product in development, TissuGlu, is a sprayable bonding agent for plastic surgery procedures. TissuGlu adheres flaps of tissue after surgical procedures, eliminating the spaces where fluid accumulates and reducing wound drainage. Cohera Medical is also developing surgical adhesives targeting mesh fixation and small bone fixation, which will fill similar market needs in both orthopedics and general surgery. For more information, visit http://www.coheramed.com. TissuGlu and the other Cohera products have not yet been approved for medical use by the Food and Drug Administration (FDA) in the U.S. or by any other country's regulatory authority.

Highlights from Baxter Q3 Earnings Report

..........First, within our regenerative medicine business, we continue to augment our biosurgery portfolio. During the third quarter, we announced a licensing agreement with Innocoll Pharmaceuticals for exclusive US marketing rights for their gentamicin surgical implant. This is the first biodegradable, antibiotic surgical sponge used as an adjunct therapy for prevention and treatment of surgical site infections. This product is already approved and available in 49 countries and is currently in two Phase III clinical trials in the United States.
Also within regenerative medicine, we are advancing programs and achieving milestones with our partners, Kuros Biosurgery AG. This partnership is focused on the development and commercialization of a portfolio of hard and soft tissue repair products. These products will be based on Baxter's fibrin-based biomatrix TISSEEL fibrin sealant, combined with Kuros proprietary biologics and associated binding technology.
Our development partner Kuros is currently enrolling patients in a number of Phase II clinical programs which if successful and confirmed in Phase III trials, will allow us to enter the fast-growing orthobiologic market.
...........Turning to the Plasma business. In the quarter, plasma protein sales of $338 million increased 37% with currency benefiting sales by 11 percentage points. Performance continues to be driven by the ongoing double-digit growth in global demand for plasma proteins and improved pricing. US plasma protein sales increased 7%, while international sales increased 59%. As we discussed last quarter, strong international growth was expected due to a difference year-over-year in the timing of shipments for FEIBA and PD Factor VIII tenders in the Latin American markets.
Antibody therapy sales increased 25% and totaled $307 million with currency benefiting sales by 3 percentage points. Growth was once again driven by conversion to GAMMAGARD LIQUID, pricing improvements, and strong growth in demand. Sales of our Regenerative Medicine business totaled $104 million and increased 27% with currency contributing 6 percentage points of growth. This is the result of growth of our core portfolio of products, TISSEEL, FLOSEAL and COSEAL.

Omrix shares whipsaw on Evicel nod

Omrix Biopharmaceuticals Ltd. probably wants to forget last week, when its share fell 35% after the clinical trial of its fibrin pad was suspended because of safety problems. Subsequently, however, and without any new announcement about the trial, the share recovered half the loss. Omrix closed at $15 yesterday, giving a market cap of $256 million, up from its low point of $11.60 five days after the trial suspension was announced.
Yesterday's 3.4% rise in Omrix's share can be attributed to the company obtaining European Medicines Agency (EMEA) marketing approval for Evicel liquid fibrin sealant, the company's surgical sealant and the product of its kind in the US. Johnson & Johnson (NYSE: JNJ) Ethicon Inc., which markets Evicel in the US, will also market it in Europe.

Omrix Biopharmaceuticals Receives Approval from European Medicines Agency for Evicel Liquid Fibrin Sealant (Human)

NEW YORK - (Business Wire) OMRIX Biopharmaceuticals, Inc. (“Omrix” or the “Company”) (NASDAQ: OMRI), a fully-integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products, announced today that it has received approval from the European Medicines Agency (EMEA) for Evicel, the Company’s liquid fibrin sealant.
The EMEA’s approval permits EVICEL to be marketed in Europe under the following indication, “As a supportive treatment in surgery where standard surgical techniques are insufficient for improvement of hemostasis. Evicel is also indicated as suture support for hemostasis in vascular surgery.”
EVICEL is currently marketed in the US by Johnson & Johnson Wound Management, a division of ETHICON, INC., a Johnson & Johnson company, with a general hemostasis in surgery indication.
With an EMEA approval, EVICEL is licensed for marketing in the 27 countries of the European Union, or EU. Per the terms of Omrix’ and ETHICON’s supply and distribution agreement, ETHICON has the marketing rights for the EU.

About EVICEL

EVICEL™ is an all-human, plasma-derived fibrin sealant currently indicated in the US as an adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques is ineffective or impractical. It does not contain aprotinin, which has been associated with adverse health effects. EVICEL™ is easy to use and readily available for time-sensitive needs in the operating room. The product is sold as a frozen liquid and requires less than one minute preparation time after thawing.

St. Jude Medical Announces U.S. and European Approval of Angio-Seal Evolution Vascular Closure Device

St. Jude Medical, Inc. (NYSE:STJ) today announced U.S. Food and Drug Administration (FDA) and European CE Mark approval of the Angio-Seal(TM) Evolution(TM) Vascular Closure Device. The approval and global launch was announced at the Transcatheter Cardiovascular Therapeutics conference in Washington, D.C.
The Angio-Seal Evolution device is designed to enable physicians to quickly and effectively seal femoral artery punctures made during minimally invasive catheter-based procedures. Effectively sealing the puncture helps achieve hemostasis (cessation of bleeding) quickly, enabling the patient to walk and resume activities sooner.
The Angio-Seal Evolution platform features an entirely new delivery system that significantly reduces the variability that can occur as physicians deploy and secure the Angio-Seal closure system. Consistent with its Angio-Seal predecessors, Angio-Seal Evolution achieves hemostasis through the deployment of an anchor, suture and collagen seal (each of which is bioabsorbable). With Evolution, however, single-handed deployment has been made possible for the first time, which enables physicians to more easily support the puncture site. The new device's automated collagen compaction system ensures consistent compaction of the collagen against the exterior wall of the vessel reducing procedural variables. With fewer variables in device deployment, physicians gain greater control and consistency in achieving rapid, safe and reliable hemostasis for their patients.
"The Angio-Seal Evolution takes a major step forward by automatically compacting the collagen," said Robert J. Applegate, M.D., Wake Forest University Baptist Medical Center, Winston-Salem, N.C. "The confidence it provides physicians in closing the puncture in such a short period of time with such effectiveness is outstanding."
More than 13 million catheterizations are performed worldwide each year to open narrowed or blocked arteries and perform other cardiovascular procedures. During catheterizations, physicians insert a catheter (a thin tube) through a puncture made in the femoral artery in the upper thigh and guide it through the blood vessels to the point of care. Treatments such as balloons, stents and medications are then delivered through the catheter. Once a procedure is complete and the catheter is removed, bleeding from the puncture in the femoral artery must be stopped quickly.
Unlike most vascular closure devices, the Angio-Seal Evolution closure system is fully absorbed by the body within 60 to 90 days. This reduces risks associated with foreign material left permanently in the body and allows for repeat procedures without concerns about prior placement of closure devices.
"The Angio-Seal Evolution embodies St. Jude Medical's commitment to providing physicians with more control over patient outcomes while reducing procedural variability," said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular Division. "We are confident the Evolution platform will further enhance Angio-Seal's position as the recognized leader in vascular closure and provide physicians with increased confidence in the ease of device deployment and predictability."

Ceremed Announces Collaborative Effort to Produce ApaTech's New Spinal Implant Actifuse(TM) Shape

LOS ANGELES, Oct 14, 2008 /PRNewswire via COMTEX/ -- Ceremed Inc. announced today that its collaborative effort with ApaTech Limited, a London based manufacturer of products for bone grafting, has resulted in the launch of ApaTech's latest product, Actifuse(TM) Shape, a novel, formable bone grafting solution. The new product combines Ceremed's AOC(TM) Biosoluble(TM) polymer with ApaTech's proprietary Actifuse(TM) microgranules. The resulting product's biostimulative properties are optimized by AOC's ability to be molded or cut to the contours of the grafting site.
The synthetic blend of alkylene oxide copolymers in AOC(TM) is water soluble allowing them to dissolve. The unique properties of the product include the dissolution of the product without swelling or inflammation as seen with some implant materials. The dissolved product is then eliminated from the body without further breakdown.
The launch of Actifuse Shape represents the culmination of a two year collaborative effort between the companies. The product will be manufactured in Ceremed's Los Angeles facility and shipped to ApaTech's distribution points in the UK and US. Ceremed has licensed the AOC(TM) technology to ApaTech Limited as the first of many projects in which the AOC(TM) technology is used as a passive carrier for bioactive materials and therapeutic agents. Several other derivative products related to the AOC(TM) technology are planned for release in the coming year. Ceremed currently distributes its Ostene(TM) bone hemostasis product in the United States and Europe.
"Ceremed is committed to the design and development of unique medical polymers to enhance the effectiveness of surgical procedures," says Tadeusz Wellisz, M.D., CEO of Ceremed. "We are actively seeking strategic alliances that greatly expand the impact of our products on the medical market. Ceremed's ability to rapidly bring products to market combined with the expertise in developing unique polymer blends makes us an exceptional partner for co-development."

Postoperative Bleeding Halts Fibrin Pad Trial; Omrix Falls

Only a day after reporting positive interim results from a Phase II study of its Fibrin Pad product in mild to moderate bleeding, Omrix Biopharmaceuticals Inc. said the study has been suspended to investigate an incident of postoperative bleeding.

Shares of the New York-based firm (NASDAQ:OMRI) plunged 34.5 percent, losing $6.14 Thursday to close at $11.67.

Interim analysis from the U.S. Phase II study, conducted after 90 patients were randomized 2-to-1 to receive Omrix's Fibrin Pad or Surgicel (Johnson & Johnson), showed that the Fibrin Pad was superior to Surgicel in controlling mild to moderate soft tissue bleeding during abdominal, retroperitoneal, pelvic and thoracic surgery.

The trial was designed to measure the proportion of subjects achieving hemostatic success at four minutes after randomization without requiring additional treatment during a subsequent six-minute observation period.

The trial was to continue enrolling patients until at least 100 subjects had been treated with Fibrin Pad, and prior to announcing the trial suspension, Omrix said it had expected to complete that enrollment by the end of this year or early next year.

The company has not disclosed any details of the suspension at this time, and representatives of Omrix could not be reached for comment.

The Fibrin Pad is designed to use the company's aprotinin-free fibrin sealant technology, the same technology that helped create Evicel, a liquid fibrin sealant that gained FDA approval as an adjunct to hemostasis in patients undergoing surgery when control of bleeding by standard surgical technique is neither effective nor practical.

As a next-generation, absorbable biosurgical product, the Fibrin Pad comprises a flexible biodegradable matrix that's coated with human fibrinogen and human thrombin and is designed to help form instant clots for rapid control of bleeding and for possible use on active bleeding sites.

It was not clear from the company's release when the incident of postoperative bleeding occurred in the U.S. Phase II trial, though analyst Jonathan Aschoff, of Brean Murray Carret & Co., wrote in a research note that it occurred after the 90th patient was enrolled and, therefore, was not included in the interim analysis.

Omrix also reported data from a separate ongoing Phase II trial in Israel that is designed to test Fibrin Pad in severe bleeding when the product is applied primarily on the bleeding site. And in that study, four patients have been treated to date with Fibrin Pad, one of whom experienced postoperative bleeding.

"While the detailed reason for this serious adverse event is still under investigation, the fact that it occurred in two patients treated with the Fibrin Pad so far" raises questions as to the product's safety profile, Aschoff wrote, adding that there likely would be some delay in the program, for which he previously had projected a mid-2010 market launch.

Omrix also has submitted an application to UK regulatory authorities to begin a pivotal study of Fibrin Pad in soft tissue severe bleeding when applied adjunctively to the standard of care. That application is under review.

In addition to Evicel, Omrix markets Evithrom (topical human thrombin), a blood-clotting protein - using the same thrombin component as Evicel - for controlling bleeding during surgery. Evithrom gained approval in 2007 and is distributed by a division of Somerville, N.J.-based Ethicon Inc.

Outside of biosurgery, the company is developing several immunotherapy products, including intravenous immunoglobulin (IVIG) for immune deficiency and autoimmune diseases, as well as other antibody-based products targeting hepatitis B, West Nile virus and smallpox vaccine-related complications.

Omrix recorded total revenue of $19.2 million for the second quarter - $18.2 million of that came from product sales - and posted a net income of $3 million, or 17 cents per share. As of June 30, the firm had a cash position of $83.1 million.

Z-Medica Awarded $2.9 Million US Navy/Marine Corp Contract for Penetrating Wound Study Using its New Hemostatic Gauze

Wallingford, Conn. October 13, 2008 -- Z-Medica Corporation (Z-Medica), a medical products company focused on innovative hemostatic nano-technologies, today announced that it has been awarded a $2.9 million contract from the United States Navy and Marine Corps to fund large-scale human studies on stopping bleeding in penetrating wounds, using the company's new QuikClot® Combat Gauze™. The U.S. Department of Defense Committee on Tactical Combat Casualty Care recently selected QuikClot® Combat Gauze™ as the firstline hemorrhage treatment for tourniquet-resistant wounds for all branches of the U.S. military.
QuikClot(r) Combat Gauze(tm)
The clinical studies will take place at five major university and hospital trauma centers: Johns Hopkins University in Baltimore; the University of Miami; the University of Massachusetts Medical School in Worcester, Mass.; Vanderbilt University in Nashville; and Hartford Hospital in Hartford, Conn. Specifically, the study will address small entry/large exit wounds from high velocity bullets, traumatic injuries frequently encountered on the battlefield.

Interim Phase II Data Establishes Superiority Of Omrix Biopharma's Blood-clot Inducing Fibrin Pad Over Johnson & Johnson's SURGICEL

Wednesday, Omrix Biopharmaceuticals Inc. announced that according to the interim results of a phase II trial, its investigational Fibrin Pad, a blood-clot inducing material proved to be superior to SURGICEL, developed by Johnson and Johnson's Ethicon subsidiary. The Fibrin Pad is being evaluated as an adjunct to control mild to moderate soft tissue bleeding during abdominal, retroperitoneal, pelvic, and thoracic surgery.According to the interim analysis, 90 patients were randomized in the ratio of 2:1 to be treated with Fibrin Pad and SURGICEL, respectively. The primary efficacy end point measured the proportion of subjects achieving hemostatic success at 4 minutes after randomization with no re-bleeding requiring treatment during a subsequent 6-minute observation period. Hemostasis is defined as no detectable bleeding at the target bleeding site.The company noted that since the superiority of Fibrin Pad has been established, randomization has been stopped and additional non-randomized patients are currently being enrolled and treated with Fibrin Pad. Enrollment in the Fibrin Pad arm will continue until a minimum of 100 subjects are enrolled, according to Omrix.The company expects to complete enrollment of the additional 40 patients required to be treated with the Fibrin Pad by the end of 2008 or early 2009.In addition, the company said that till date seven patients have been enrolled in the Israeli Phase II exploratory clinical trial, which is being conducted outside of a U.S. Investigational New Drug application study. Four have been treated with the Fibrin Pad, of which one patient experienced post-operative bleeding, which was considered a serious adverse event.Omrix also revealed that it has submitted a clinical trial application, or CTA, in the United Kingdom to conduct a pivotal study to evaluate the safety and efficacy of the Fibrin Pad in soft tissue severe bleeding when the product is applied adjunctively to the standard of care. Omrix expects the CTA, which is currently under review to be approved by the end of 2008 or early 2009. The company plans to commence the study shortly thereafter.

Siemens Healthcare has signed a contract with the US Defense Advance Research Projects Agency

Siemens Healthcare has signed a contract with the US Defense Advance Research Projects Agency to develop a life-saving ultrasound device called the deep bleeder acoustic coagulation cuff (DBAC) that limits blood loss from the limbs of injured soldiers.
Partners at the University of Washington's Center for Industrial and Medical Ultrasound , the Texas A&M University's Institute for Preclinical Studies and Siemens Corporate Research will work together with Siemens Healthcare to achieve DARPA's goal of producing a prototype of the device in 18 months.
The DBAC is designed to limit blood loss from penetrating wounds to limbs, significantly reducing the risk of limb loss and death resulting from irreversible haemorrhagic shock.
Once applied to the limb, the cuff will be able to automatically detect the location and severity of the bleeding within it using ultrasound technology.
This will then trigger the cuff to emit and focus high-power energy towards the bleeding sites, speeding coagulation and halting bleeding.
The device is intended to be used by minimally-trained operators, curtailing bleeding in a minimal amount of time with automatic treatment and power shut-off.
The researchers will work in collaboration with the Combat Casualty Care Group at the US Army Medical Research and Material Command, surgeons from the Madigan Army Medical Center, and the US Army Institute for Surgical Research to develop the system.

Covidien Introduces the SprayShield TM Adhesion Barrier System to the European Marketplace

Covidien (NYSE: COV, BSX: COV), a leading global provider of healthcare products, today announced that its Surgical Devices business unit has introduced the SprayShield TM Adhesion Barrier System throughout Europe. The SprayShield Adhesion Barrier System offers surgeons a unique synthetic, sprayable hydrogel that provides a strong barrier between tissue and organ planes that helps reduce the development of post–surgical adhesions. The SprayShield Adhesion Barrier System, which has received CE–Mark, is indicated for use in both open and laparoscopic abdominopelvic surgical procedures as an adjunct to good surgical technique.
"The SprayShield Adhesion Barrier System represents yet another innovative solution delivered by our BioSurgery team," said Scott Flora, President, Surgical Devices, Covidien. "Like our other recent product introductions, including PleuraSeal TM lung sealant and VascuSeal TM vascular sealant, the SprayShield Adhesion Barrier System gives surgeons a new solution to help address an unmet clinical need," he added.
Adhesions frequently occur after surgery due to tissue trauma that forms connective tissue bridges, or internal bands in the body, that can connect internal structures and organs that normally are separated. Adhesions have been associated with post–operative complications such as pelvic pain, infertility and small bowel obstruction that may require additional surgery to resolve. A long–term comprehensive study of women who had prior pelvic surgery showed that approximately 35% were readmitted an average of 1.9 times over a 10–year period due to adhesion–related complications. Even during routine surgical procedures, the need to remove adhesions extends operating room time and can lead to increased blood loss and other complications.
The SprayShield Barrier technology is a synthetic, absorbable hydrogel delivered by an air–assisted sprayer. The device can be stored at room temperature and prepared in less than two minutes. The SprayShield Adhesion Barrier polymerizes within seconds when sprayed, enabling site–specific application, and is blue in color, allowing the surgeon to see the coverage and thickness of the material upon application. Post–operatively, the SprayShield Barrier continues to separate tissue and organ planes as healing progresses under the gel. After several days, the hydrogel breaks down into water–soluble molecules that are absorbed and cleared through the kidneys.
In addition to Europe, the SprayShield Adhesion Barrier System is available in certain Middle East markets and South Africa. It is not available in the United States at this time.

European co expresses interest in biotech co Omrix

Among the possible candidates to acquire Omrix is German giant Bayer.
Sources inform that a European company is interested in acquiring Israeli biosurgical and immunotherapy products maker Omrix Biopharmaceuticals Ltd. , and that it is offering a substantial premium on the company's $320 million market cap. The company is reportedly conducting due diligence.
Among the possible candidates to acquire Omrix is German pharmaceuticals giant Bayer AG (XETRA; BAY; LSE: BYR). Bayer markets products of Omrix competitor ZymoGenetics Inc. (Nasdaq: ZGEN) and is a partner of Omri, a company owned by Omrix CEO Robert Taub, who owns 15.7% of Omrix.