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European clinical studies published in a new book entitled "Vertebral Osteoporotic Compression Fractures" reflect the first prospective clinical trials to assess the use of new biomaterial specifically designed to replace and reinforce load-bearing bone in the spine weakened by osteoporosis and metastatic disease.

Studies show that CORTOSS provides stability and rapid pain relief when injected into fractured vertebrae.

Orthovita, Inc. (NASDAQ NM / NASDAQ Europe: VITA), a leading developer of orthopedic biomaterials, has announced clinical data showing that company's CORTOSS(TM) Synthetic Cortical Bone Void Filler provides stability and rapid pain relief in a high percentage of patients with fractured vertebra caused by osteoporosis and metastatic disease. The clinical studies were made public in Vertebral Osteoporotic Compression Fractures ((C) 2003), a new compendium of recent research published by Lippincott Williams & Wilkins.

CORTOSS is a high-strength, biocompatible, bone-bonding, self-setting composite engineered to mimic the characteristics of the human body's hard, weight-bearing cortical bone. Administered directly to the affected area using a pre-filled, unit dose disposable cartridge, CORTOSS has the capacity to provide immediate weight-bearing support to fractured vertebra.

In one of the newly-published studies, CORTOSS was percutaneously injected into the fractured vertebra of 24 patients with pain related to vertebral fractures caused by osteoporotic and metastatic disease. The majority of patients (88%) reported a significant reduction in pain almost immediately after treatment, according to study authors Jean Palussiere, Institut Bergonie, Service de Radiologie, Bordeaux, France; Jerome Berge, Service de Neuroradiologie, Diagnostique et Therapeutique Centre Hospitalier Pellegrin, Bordeaux, France; Afshin Gangi, Hopitaux Universitaires de Strasbourg, Hospices Civiles, Strasbourg, France; and Herve Deramond, Service de Radiologie A, CHU Amiens-Hopital Nord, Amiens, France.

In a separate study of vertebroplasty, in vitro evaluations were performed to compare the use of CORTOSS to polymethylmethacrylate (PMMA), the orthopedic bone cement that is widely used "off-label" in vertebral augmentation procedures. Mechanical, radiographic and temperature evaluations were performed following injections of CORTOSS and PMMA into cadaver vertebral bodies. The study, conducted by Marek Szpalski, Hopitaux Iris Sud-Moliere Longchamp, Universite Libre de Bruxelles, Bruxelles, Belgium; Robert Gunzburg, Department of Orthopaedics, Eeuwfeesikliniek, Antwerpen, Belgium; and Herve Deramond, Service de Radiologie A, CHU Amiens-Hopital Nord, Amiens, France, found that CORTOSS injected vertebral bodies were almost twice as strong as vertebral bodies injected with PMMA. Unlike PMMA, CORTOSS restored the vertebral bodies to the normal stiffness, reducing the risk of added stress or unnatural stiffness that might affect adjacent vertebral bodies. CORTOSS was also found to have a much lower peak temperature elevation during curing in the vertebral bodies, reducing the risk of thermal tissue damage. In addition, CORTOSS was readily visualized during and after injection, allowing for excellent monitoring of its placement under fluoroscopy or in post-operative imaging studies.

"These studies indicate that CORTOSS synthetic bone void filler is a much stronger, safer and more effective material for use in vertebral augmentation, and overcomes many of the shortcomings of PMMA bone cement," said Marek Szpalski, M.D., co-editor of Vertebral Osteoporotic Compression Fractures and lead author of one of the studies.

CORTOSS was approved in Europe on January 13, 2003, for use in vertebral augmentation. CORTOSS has been marketed in Europe since January 2002 for the fixation of bone screws used in patients with weak bone caused by osteoporosis. Orthovita recently announced that patient enrollment has started in US clinical studies to assess the use of CORTOSS in vertebral compression fractures.

"These studies further confirm our findings that CORTOSS represents a major advance in our ability to treat patients who are suffering from spinal fractures" said Antony Koblish, president and chief executive officer of Orthovita. "We are very pleased that CORTOSS is now available in Europe as an alternative to bone cement for the thousands of patients who suffer from fractures in the spine each year."

Unlike polymethylmethacrylate (PMMA), CORTOSS does not contain volatile monomers that have the potential for significant side effects. CORTOSS has constant flow characteristics, ensuring predictable and consistent fill patterns of the treated vertebrae. CORTOSS also does not require premixing, allowing the physician greater control over when the material can be applied during the procedure, even when spread over multiple time points. In animal studies, it has been demonstrated that the CORTOSS-to-bone interface continues to be strengthened over time, with more bone being formed and integrated onto and into the material.

According to the U.S. National Osteoporosis Foundation, 700,000 vertebral fractures occur annually. The most common causes of vertebral compression fractures are osteoporosis associated with aging or chronic steroid use and metastatic disease. Each year, over 270,000 vertebral compression fractures are clinically diagnosed in the U.S. alone, with the number expected to rise in the years ahead. Vertebral compression fractures cause prolonged back pain and disability as well as posture shortening. Patients are typically treated with external bracing, analgesics and bed rest. In some cases, patients are left with persistent pain and limited mobility. Bed rest and reduced mobility can have significant effects on a patient's quality of life and on subsequent morbidity and mortality. Standard medical therapy for vertebral compression fractures can also lead to additional bone mineral loss, thus increasing the risk of subsequent fractures.

About the company

Orthovita is a biomaterials company with proprietary technologies applied to the development of biostructures, synthetic biologically active tissue engineering products for restoration of the human skeleton. Its focus is on developing novel products for use in spine surgery and in the repair of osteoporotic fractures. It is also addressing a broad range of clinical needs in the trauma market.

The company has applied its technologies to the development of several products, VITOSS(R) Synthetic Cancellous Bone Void Filler, CORTOSS(R) Synthetic Cortical Bone Void Filler and RHAKOSS(TM) Synthetic Bone Spinal Implant.

In addition, the company hs developed IMBIBE(TM) Bone Marrow Aspirate Syringe used with VITOSS and ALIQUOT(TM) Microdelivery System used with CORTOSS.

VITOSS is a resorbable calcium phosphate scaffold that is highly porous and composed of extremely fine calcium phosphate mineral that allows for resorption, cell seeding and ingrowth of host bone. VITOSS is cleared for sale in the U.S. and Australia, and approved for sale under a CE Mark in Europe.

CORTOSS is a high-strength, biocompatible, self-setting composite engineered specifically to mimic the strength characteristics of human cortical bone. CORTOSS is cleared for sale in Australia and is approved for sale under a CE Mark in Europe for use in screw augmentation and vertebral augmentation procedures. We have completed post-marketing human clinical studies of CORTOSS in Europe for its use in hip compression screw augmentation. We are conducting clinical studies for the use of CORTOSS in vertebral compression fracture repair in the U.S. CORTOSS is not available for commercial distribution in the U.S.

RHAKOSS is under development as a preformed, bioactive, bone-bonding composite that mimics the natural dual cortical-cancellous composition of human bone, providing high strength while also allowing for the ingrowth of host bone to address the vertebral interbody fusion and spinal reconstruction market. We are conducting clinical studies of RHAKOSS in Europe required to obtain a CE Mark for its use as an interbody fusion device.

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Publication:Worldwide Biotech
Geographic Code:1USA
Date:Mar 1, 2003

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