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.