Healthcare Industry News: Shoulder system
News Release - March 12, 2007
Exactech, Inc. Cleared by FDA for U.S. Distribution of Equinoxe(R) Reverse Shoulder
GAINESVILLE, Fla., March 12 (HSMN NewsFeed) -- Exactech Inc. (Nasdaq: EXAC ), a developer and producer of bone and joint restoration products including orthopaedic implants and biologic materials, announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to market the Equinoxe® Reverse Shoulder, the latest component in the company's shoulder arthroplasty line.A "reverse" shoulder is designed for patients who have an irreparable rotator cuff and osteoarthritis. The Equinoxe Reverse Shoulder is compatible with the Equinoxe primary stem, allowing surgeons to change from a primary to a reverse without removing the humeral stem.
Exactech CEO Bill Petty said, "With the introduction of our Equinoxe Reverse Shoulder, we have continued the precedent of innovation that we established with the Equinoxe primary and fracture Shoulder systems. The shoulder market is rapidly growing and we are pleased that we have a prosthesis that will help address the clinical challenges that surgeons have faced thus far with reverse shoulders."
Lynn Crosby, M.D., a leading shoulder surgeon and member of the design team, said, "The Equinoxe Reverse Shoulder is an exciting new product that has been designed to address some of the limitations or challenges inherent in other reverse Shoulder systems. I've been pleased to work with an international team of surgeons who brought a great deal of clinical and surgical expertise to this product's development."
Exactech plans to initiate targeted clinical evaluation of the Equinoxe Reverse Shoulder in its second quarter with full-scale release targeted for the second half of 2007. Reverse shoulders have only recently been introduced in the U.S. market. According to industry sources, approximately 49,000 shoulder replacements were performed in the U.S. in 2006, which is a 12% increase from 2005. Roughly 6% of that increase is attributed to reverse shoulder replacement.
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. Exactech's 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 and Australia, in addition to more than 25 countries in Europe, Asia and Latin America. Copies of Exactech's 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/exacprofile.aspx.
Questions should be directed to Frank Hawkins or Julie Marshall of Hawk Associates, Inc. at (305) 451-1888, e-mail: info@hawkassociates.com. To receive future releases in e-mail alerts, sign up at http://www.hawkassociates.com/email.aspx.
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 company's expectations or beliefs concerning future events of the company's 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 company's 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 company's products and the effects of government regulation. Results actually achieved may differ materially from expected results included in these statements.
Source: Exactech
Issuer of this News Release is solely responsible for its
content.
Please address inquiries directly to the issuing company.
