FX Shoulder USA, Inc. to Begin Clinical Study on Stemless Reversed Total Shoulder
DALLAS, /PRNewswire/ --
FX Shoulder USA, Inc. will begin in December 2018 the FDA approved Investigational Device Exemption (IDE) clinical study of the Easytech Reversed stemless, a shoulder prosthesis, with its first implantation scheduled for December.
Easytech Reversed Stemless is an innovative shoulder arthroplasty implant that will be under clinical study with (9) sites and (12) surgeons across the U.S. participating. Building on the current success in France (home of FX Shoulder USA's parent company, FX Solutions), where over 800 Easytech Stemless Reversed prostheses have been successfully implanted, FX Shoulder USA is slated to enroll patients at two (2) investigational sites in December and continue enrollment with additional sites beginning in January 2019.
"The Easytech Reversed may be exactly what the U.S. market is in need of, and a reversed stemless prosthesis could potentially be the future of shoulder arthroplasty," said Baptiste Martin, CEO of FX Shoulder USA. "We are excited to begin our clinical study and enthusiastic to see the results with each successive case throughout. There is a lot of excitement among the surgeon investigators for Easytech Reversed," he continued. In Europe, as per the article in Med Device Online dated April 11, 2018, stemless implants are projected to surpass stemmed implants by 2025.
Founded in 2011, FX Solutions has developed a large, unique and innovative range of prosthetic shoulder products, which include the Easytech Reversed Stemless. FX Solutions is now the second largest player in the French market, with more than 3,000 prostheses sold in 2018.
FX Shoulder USA, based in Dallas, Texas, is the direct provider of FX Solutions shoulder replacement devices in the U.S. FX Shoulder USA was founded in January 2018 and focuses exclusively on shoulder arthroplasty with a growing distribution network.
Statements in this press release, other than statements of historical fact, are forward-looking statements, are based on our current plans and expectations and are subject to risks and uncertainties that might cause actual results to differ materially from those such statements express or imply. The business and operations of the company are subject to substantial risks which increase the uncertainty inherent in forward-looking statements. These risks and uncertainties include, but are not limited to, our ability to generate sufficient revenue to fund our commercial operations and development programs; and risks related to the development of Stemless Reversed shoulder prostheses, including regulatory approvals, mandates, oversight and other requirements. In this press release, forward looking statements include those concerning the development of the Stemless Reversed shoulder prosthesis, its safety and efficacy profile, its potential to benefit patients and our ability to make it available to those patients. We disclaim any intention or duty to update forward-looking statements made in this press release.
SOURCE FX Shoulder USA