CORTOSS(R) Podium Presentation and Poster To Be Presented At Radiological Society of North America Meeting In Chicago.

Prospective Randomized Pivotal Trial Of CORTOSS Versus PMMA In The Treatment Of Vertebral Compression Fractures; Preliminary Results At A Single Institution

Clinical Experience In Two Pilot Studies Using CORTOSS([R]) For Treating Vertebral Compression Fractures In Vertebroplasty And Kyphoplasty; 1 To 2 Year Follow-Up Of 40 Patients

MALVERN, Pa. -- Orthovita, Inc. (NASDAQ:VITA), a spine and biosurgery company, reported that H. Paul Hatten, Jr., M.D., from Indian River Radiology, Vero Beach, Florida, will make a podium presentation of a scientific paper titled "Prospective Randomized Trial Of CORTOSS Versus PMMA In The Treatment Of Vertebral Compression Fractures; Preliminary Results At A Single Institution", and that Phillip Maurer, M.D., from Pennsylvania Hospital, Philadelphia, Pennsylvania, will present a scientific poster titled "Clinical Experience In Two Pilot Studies Using CORTOSS([R]) For Treating Vertebral Compression Fractures In Vertebroplasty And Kyphoplasty; 1 To 2 Year Follow-Up Of 40 Patients" at the Radiological Society of North America (RSNA) meeting being held in Chicago from November 26 through December 1, 2006.

The podium presentation is on Tuesday, November 28, at 10:30 a.m. in Room N226 and will cover part of a pivotal study being conducted under an FDA Investigational Device Exemption (IDE) to assess the safety and efficacy of CORTOSS compared to commercially available PMMA bone cements. A total of 243 patients are to be enrolled in the pivotal study with a 2:1 randomization (162 patients treated using CORTOSS and 81 patients treated using a PMMA bone cement) at 19 sites. Patients are evaluated at pre-op, post-op, 72 hours, 1 week, 1, 3, 6, 12, and 24 months. Patient outcome will be assessed by Visual Analogue Scale (VAS), Oswestry Disability Index (ODI), SF-12 and maintenance of height and alignment at the level(s) treated. Among the inclusion criteria are a minimum VAS score of 50, a minimum ODI score of 30%, an osteoporotic compression fracture at one or two levels, presence of edema on MRI or bone scan and an informed patient consent. Exclusionary criteria include greater than 70% collapse, canal compromise, neurologic deficit at the level(s) to be treated or tumors. Post-operative CT and radiographs are being used to assess and quantify leakage. The results reported in the podium presentation are from the Indian River Radiology site in Vero Beach, Florida, which is one of approximately 19 clinical sites involved in the pivotal study.

At the Indian River Radiology site, 46 patients have been enrolled; 27 treated using CORTOSS and 19 treated using a PMMA bone cement. A total of 59 vertebral levels have been treated; 36 in the CORTOSS treated group and 23 in the PMMA treated group. The average age is 77 in the CORTOSS treated group and 78 in the PMMA treated group. Improvement in VAS and ODI scores was similar for both groups out to 6 months. The average volume of material injected in the CORTOSS treated group was 1.17 cc and 2.41 cc in the PMMA treated group. Leakages were observed on post-operative CT scans and found to be similar in both groups. All extravasations were asymptomatic with no cardio-pulmonary complications.

"These preliminary results suggest that CORTOSS may provide similar pain relief compared to PMMA bone cement with approximately 50% less material," said Dr. Hatten. "This may be due to the distinct interdigitated fill pattern obtained with CORTOSS, which may reduce the risk of leakage and emboli while employing a "start-stop" technique and precision delivery."

The scientific poster presentation is on Sunday, November 26, at 12:30 p.m. in Hall D and will cover a preliminary review of two pilot studies to assess the feasibility and clinical outcome using CORTOSS in treating osteoporotic vertebral compression fractures. The two FDA approved pilot IDE studies enrolled 40 patients using CORTOSS for the treatment of vertebral compression fractures using the vertebroplasty technique at three centers (20 patients) and the kyphoplasty technique at five centers (20 patients). Treatment was limited to one or two levels from T6 to L5. The objective was to compare the patients' condition prior to and after treatment, with each patient serving as his own control.

Of the 20 patients treated using the vertebroplasty technique, eight were male and twelve were female, with an average age of 72, and 26 vertebrae were treated, with an average of 2.0 cc injected per vertebra. Of the 20 patients treated using the kyphoplasty technique, six were male and fourteen were female, with an average age of 79, and 26 vertebrae were treated, with an average of 4.2 cc per vertebra.

For the patients treated with CORTOSS using the vertebroplasty technique, VAS scores improved from 73 pre-op to 44 at 1 week, 32 at 1 month, 24.1 at 3 months, 33 at 12 months and 49 at 24 months. Similarly, ODI scores decreased from 52% pre-op to 42% at 1 week, 36% at 1 month, 29% at 3 months, 27% at 12 months and 33 % at 24 months.

For the patients treated with CORTOSS using the kyphoplasty technique, VAS scores improved from 78 pre-op to 38 at 1 week, 27 at 1 month, 22 at 3 months, 23 at 6 months, 13 at 12 months and 23 at 24 months. Similarly, ODI scores decreased from 61% pre-op to 50% at 1 week, 38% at 1 month, 33% at 3 months, 33% at 6 months 38% at 12 months and 33% at 24 months.

Leakages were analyzed on post-op CT scans and found to be similar in both groups. All extravasations were anatomically close to the vertebra and asymptomatic. No cardiac irregularities or pulmonary emboli were observed. Similar rates of secondary fractures were observed in each group.

"The preliminary results obtained in these two pilot IDE studies indicate that CORTOSS may be appropriate for the treatment of osteoporotic vertebral compression fractures," said Dr. Maurer. "These studies suggest a smaller volume of CORTOSS provides pain relief, as compared to the volumes reported in the literature for PMMA."

Other investigators in this study include Hyun Bae, M.D., from The Spine Institute at Saint John's Health Center, Santa Monica, California; William Beutler, M.D., and Walter Peppelman, M.D., from the Pennsylvania Spine Institute, Harrisburg, Pennsylvania; Raymond Linovitz, M.D., Timothy A. Peppers, M.D., and Erik Westerlund, M.D., from the CORE Orthopedic Medical Center, Encinitas, California; Isador Lieberman, M.D., from the Cleveland Clinic, Cleveland, Ohio; Choll Kim, M.D., from the University of California San Diego, San Diego, California; and Federico Girardi, M.D., from The Hospital for Special Surgery, New York, New York.

A prospective, randomized, controlled multi-center IDE study is underway in the U.S. designed to demonstrate that CORTOSS is safe and effective for the treatment of osteoporotic vertebral compression fractures. CORTOSS is not available for sale in the United States and is limited to investigational use.

About the Company

Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials and biologic technologies for the development and commercialization of synthetic, biologically active, tissue engineering products. We develop and market synthetic-based biomaterials products for use in spine surgery, the repair of fractures and a broad range of clinical needs in the trauma, joint reconstruction, revision and extremities markets. Our near-term commercial business is based on our VITOSS([R]) Bone Graft Substitute technology platforms, which are designed to address the non-structural bone graft market by offering synthetic alternatives to the use of autograft or cadaver-based bone material, and VITAGEL[TM] Surgical Hemostat, which is an adherent matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development program is focused on our internally developed CORTOSS([R]) Synthetic Cortical Bone technology platform, which is primarily designed for injections in osteoporotic spines to treat vertebral compression fractures. We work jointly with Kensey Nash Corporation to develop and commercialize synthetic-based biomaterial products, we market VITAGEL under a license granted by Angiotech Pharmaceuticals (US), Inc., and we continue to pursue similar relationships with other biomaterials companies.

This press release may contain forward-looking statements regarding Orthovita's current expectations of future events that involve risks and uncertainties, including, without limitation, our products; product safety, efficacy, regulatory approval, development and marketability; any future business relationships; and other aspects of our business. Such statements are based on management's current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Certain Risks Related to Our Business". Further information about these and other relevant risks and uncertainties may be found in Orthovita's filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.