GAINESVILLE, Fla.--(BUSINESS WIRE)--Exactech, Inc. (Nasdaq: EXAC), a developer and producer of bone and joint restoration products for hip, knee, shoulder and spine, announced today the successful first surgery using its new Equinoxe® Humeral Reconstruction Prosthesis, which is among three new Exactech revision systems making their clinical debut. Last week, Exactech announced the first clinical experiences with its new revision knee and hip systems.
The humeral reconstruction prosthesis is designed to offer flexibility for complex cases with significant proximal humeral bone loss. It is intended for primary or revision arthroplasty procedures and anatomic oncology procedures. It is the first modular prosthesis cleared for significant proximal bone loss in reverse procedures.
Orthopaedic surgeon and design team member Thomas Wright, MD, of University of Florida Department of Orthopaedics and Rehabilitation in Gainesville, Fla., performed the first case using the new shoulder system.
“This novel prosthesis is an eloquent solution to a brutal clinical problem,” Dr. Wright said. “There was really no other viable solution for this patient. It was gratifying to see that this implant and technique simplified a challenging case and addressed the unique needs of this patient.”
A key feature of the humeral reconstruction prosthesis is its modularity, with a platform stem and multiple sizes to reconstruct the length of the humeral resection. The system’s design also provides biomechanical advantages, several soft tissue fixation options and rotational stability, due to unique plasma/HA coated collars that provide additional fixation and dual offset collars and distal stems that are designed to provide optimal fit.
“This is the culmination of years of development,” said Mark Scarborough, MD, a design team member and chair of orthopaedic oncology at University of Florida Department of Orthopaedics and Rehabilitation. “The design team and corporate professionals worked diligently to create an innovative implant that would help surgeons improve patients’ quality of life. This first case is validation that our design is as effective as we imagined it would be and can dramatically impact patients’ lives.”
Exactech Chief Executive Officer David Petty said, “This is the third first surgery with a new revision system from Exactech in the last week. The revision shoulder system is the only one on the market that combines a humeral reconstruction stem with a reverse platform, extending our Equinoxe shoulder’s long history of delivering unique solutions to improve patient outcomes.”
Exactech worked closely with a design team of experienced revision upper extremity specialists and orthopaedic oncology surgeons to develop this prosthesis: Pierre-Henri Flurin, MD, Clinique du Sport (Merignac, France); Parker Gibbs, MD, University of Florida Department of Orthopaedics and Rehabilitation (Gainesville, Fla.); Pietro Ruggieri, MD, The Rizzoli Institute (Bologna, Italy); Mark Scarborough, MD, University of Florida Department of Orthopaedics and Rehabilitation (Gainesville, Fla.); Thomas Wright, MD, University of Florida Department of Orthopaedics and Rehabilitation (Gainesville, Fla.); and Joseph Zuckerman, MD, NYU Hospital for Joint Diseases (New York, N.Y.).
Pilot launch is scheduled through the remainder of the year with full market availability in the United States in 2016.
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, 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 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.
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.