Conformis Announces Achievement of Third Milestone Under Development and License Agreements
Conformis, Inc. (NASDAQ:CFMS) announced FDA clearance for its patient-specific instrumentation (PSI) for Stryker’s Triathlon® Total Knee System. This marks the completion of the joint development agreement with Stryker, allowing Conformis to receive $11 million. CEO Mark Augusti emphasized the importance of this achievement despite recent global challenges and highlighted future plans for a long-term distribution agreement to manufacture and supply PSI to Stryker. This initiative aims to enhance shareholder value by meeting the growing demand for outpatient joint replacement surgeries.
- FDA clearance for PSI system unlocks $11 million from Stryker.
- Successful completion of joint development agreement with Stryker.
- Focus on long-term distribution agreement for manufacturing PSI.
- Potential to meet increasing demand for outpatient joint replacements.
- None.
BILLERICA, Mass., April 22, 2021 (GLOBE NEWSWIRE) -- Conformis, Inc. (NASDAQ:CFMS) announced today that it received 510(k) clearance by the U.S. Food and Drug Administration for patient-specific instrumentation (“PSI”) developed by the Company under its License Agreement and Development Agreement with Howmedica Osteonics Corp., a wholly owned subsidiary of Stryker Corporation also known as Stryker Orthopaedics. With the clearance of this PSI system, which is designed for use with Stryker’s Triathlon® Total Knee System, the Company has achieved the third of three milestones under the agreements and will receive
“With the recent FDA clearance, we are pleased to have attained the last milestone of our project and to report the successful conclusion of our joint development agreement with Stryker,” said Mark Augusti, President and Chief Executive Officer. “Despite the global challenges of the last 12 months, the dedication of our project and support teams has enabled us to achieve this major milestone on schedule. We now will turn our efforts to focusing on our long-term distribution agreement, under which Conformis will manufacture and supply PSI to Stryker. We continue to believe this initiative will create shareholder value as we satisfy the increasing demand for efficient outpatient ambulatory surgery center joint replacement.”
About Conformis, Inc.
Conformis is a medical technology company that uses its proprietary iFit® Image-to-Implant® technology platform to develop, manufacture, and sell joint replacement implants and instruments that are individually sized and shaped, which we refer to as personalized, individualized, or sometimes as customized, to fit each patient’s unique anatomy. Conformis offers a broad line of sterile, personalized knee and hip implants and single-use instruments delivered to hospitals and ambulatory surgical centers. In clinical studies, the Conformis iTotal® CR knee replacement system demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants. Conformis owns or exclusively in-licenses issued patents and pending patent applications that cover personalized implants and patient-specific instrumentation for all major joints.
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