Conformis, Inc. (NASDAQ:CFMS) rose Friday after the company announced it received 510(k) clearance by the Food and Drug Administration for patient-specific instrumentation developed by the Company under its License Agreement and Development Agreement with Howmedica Osteonics.
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 $11.0 million from Stryker.
“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 CEO Mark Augusti.
“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.”
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.
CFMS gained 6.5 cents, or 7.6%, to 92.5 cents