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.