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Exactech Initiates Multi-Center Clinical Trial for New Cartilage Regeneration Technology


Published on 2011-12-19 06:36:47 - Market Wire
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GAINESVILLE, Fla.--([ ])--[ Exactech, Inc ]. (Nasdaq: EXAC), a developer and producer of bone and joint restoration products for hip, knee, shoulder, spine and biologic materials announced today it has initiated a prospective, randomized, multi-center, clinical trial to evaluate the safety and effectiveness of a new cartilage repair technology.

"This is the first time a one-step, single-surgery system has allowed transplantation of a patientas own cartilage processed to facilitate regeneration of focal defects"

The first of 92 surgeries planned for the study was successfully performed December 1, 2011, by Professor Ching-Chuan Jiang, M.D., and Dr. Hong-Sen Chiang, at the National Taiwan University Hospital (NTUH) in Taipei, Taiwan. The study will include one-year follow-up of patients treated for focal chondral or osteochondral lesions of the knee, and will provide the basis for a premarket approval application to the Taiwan Food and Drug Administration upon its completion.

The new technology incorporates a novel tissue processing system that allows for preparation of a patientas own cartilage for delivery to the site of a cartilage defect in a single-stage procedure. The system uses both mechanical and chemical processing to increase the potential for cartilage regeneration.

aCartilage repair has become a strategic focus of Exactechas biologic research and development efforts,a said Bruce Thompson, senior vice president and general manager of Exactechas Spine and Biologics Division. aExactech believes cartilage repair can offer an early intervention, regenerative approach to treating patients who present with cartilage defects, which is often a precursor to osteoarthritis.a

aThis is the first time a one-step, single-surgery system has allowed transplantation of a patientas own cartilage processed to facilitate regeneration of focal defects,a said Professor Jiang. aIt is our hope that this clinical trial will prove our implant technique to be effective in regenerating native cartilage.a

Exactech licensed the technology in 2008 from Industrial Technology and Research Institute of Taiwan (ITRI) and NTUH and has spent three years conducting research and development.

Initiation of this clinical trial represents a major milestone in Exactechas plan for commercialization of its cartilage regeneration technology in multiple global markets, including the United States and Europe. Exactech will follow the particular regulatory requirements of the intended markets to assure the most timely introduction of the technology for the benefit of patients in these markets.

About Exactech

Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactechas orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech, Inc. can be found at [ http://www.exac.com ]. Copies of Exactechas press releases, SEC filings, current price quotes and other valuable information for investors may be found at [ http://www.exac.com ] and [ http://www.hawkassociates.com ].

An investment profile on Exactech may be found at [ http://www.hawkassociates.com/profile/exac.cfm ]. To receive future releases in e-mail alerts, sign up at [ http://www.hawkassociates.com/about/alert ].

This release contains various forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which represent the companyas expectations or beliefs concerning future events of the companyas financial performance. These forward-looking statements are further qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include the effect of competitive pricing, the companyas dependence on the ability of third party manufacturers to produce components on a basis which is cost-effective to the company, market acceptance of the companyas products and the effects of government regulation. Results actually achieved may differ materially from expected results included in these statements.

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