Exactech Platform Fracture Stem for Shoulder Surgeries Receives FDA Clearance
GAINESVILLE, Fla. – March 2, 2010 -- Exactech Inc. (Nasdaq: EXAC), a developer and producer of bone and joint restoration products for hip, knee, shoulder, spine and biologic materials, announced today that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the company’s Equinoxe® Platform Fracture Stem, the latest addition to the company’s shoulder arthroplasty line.
GAINESVILLE, Fla. – March 2, 2010 -- Exactech Inc. (Nasdaq: EXAC), a
developer and producer of bone and joint restoration products for hip, knee,
shoulder, spine and biologic materials, announced today that the company has
received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to
market the company’s Equinoxe® Platform Fracture Stem, the latest addition to
the company’s shoulder arthroplasty line.
The Equinoxe® Platform Fracture Stem is designed to relieve pain
and restore function in shoulder patients with acute fractures of the proximal
humerus or a deficient, irreparable rotator cuff. It is compatible with
Exactech’s Equinoxe® Reverse shoulder components giving orthopaedic surgeons the
intra-operative flexibility to decide whether to perform a hemiarthroplasty or a
reverse total shoulder.
Joseph D. Zuckerman, MD, member of the design
team and professor and chairman of the NYU Hospital for Joint Diseases
Department of Orthopaedic Surgery, said, “The Equinoxe® Platform Fracture Stem
is an exciting new addition to Exactech’s shoulder implant product line. It is
designed to address some of the latest clinical challenges surgeons face in
shoulder arthroplasty. The platform system enables surgeons to convert a
well-fixed fracture stem to a reverse shoulder implant without the complexity
and potential complications of removal of a well-fixed stem.”
Exactech
is conducting clinical evaluations of the shoulder fracture stem this quarter,
with full market launch targeted for the second half of 2010. According to
industry reports, the number of shoulder replacement procedures increased more
than 10 percent to just over 70,000 procedures in 2009. Of these procedures,
there has been significant growth in the use of reverse shoulder prostheses.
About Exactech
Based in Gainesville, Florida,
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 30 markets in Europe, Asia and Latin America. Additional
information about Exactech, Inc. can be found at http://www.exac.com. An Exactech investment profile is online
at http://www.hawkassociates.com/profile/exac.cfm.
To receive e-mail alerts about EXAC, 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 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.
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Investor
Contacts:
Exactech CFO Jody Phillips at 352.377.1140
Hawk
Associates 305-451-1888
Julie Marshall or Frank Hawkins
exactech@hawkassociates.com

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