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Conformis Climbs as FDA Clears New Knee Replacement System

Conformis says its new knee replacement system, cleared by the FDA, offers faster delivery times and additional surgical options.
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Shares of Conformis  (CFMS)  jumped Monday after the medical device maker said the U.S. Food and Drug Administration cleared its Identity Imprint knee replacement system for marketing.

Identity Imprint is a total-knee-replacement system that Conformis says gives surgeon customers and their patients more options regarding the surgery. 

Identity Imprint "leverages our technical innovations and data from tens of thousands of personalized implant designs," Chief Executive Mark Augusti said in a statement. It gives surgeons "more traditional intraoperative flexibility and faster product availability."  

The company says it will be able to provide a patient-matched knee-replacement device in three weeks, half the time the Conformis' iTotal Identity knee-replacement requires. 

ITotal Identity is designed and manufactured individually to fit the each patient, "Identity Imprint combines predetermined implant sizes with standard and patient-specific surgical instrumentation," the Billerica, Mass., company said.

The global knee-joint-reconstruction market is projected at more than $9 billion, with about 1 million knee replacement expected to be performed in the U.S. this year, Conformis said.

"This offering is extremely well-positioned to meet the needs of the [ambulatory-surgical-center] care setting, but will provide value to in-patient hospital care as well, especially in the post-COVID environment," Agusti said. 

Conformis shares at last check were up 6.5% to 90 cents. They touched a 52-week high $1.49 in early February.