ConforMIS said today that the first surgeries involving the iTotal CR knee resurfacing system were successfully completed in hospitals around the U.S. And, according to a company release, the surgeries represent the first implantations of the only FDA-cleared personalized total knee system on the market.
Founded in 2004, privately held ConforMIS is based in Burlington, MA. According to its website, ConforMIS transforms traditional CT data into patient-specific implants and instrumentation employing two related 'image-to-implant' technology platforms. It further notes that aims to make the implant fit the patient rather than forcing the patient to fit the implant. To this end, the company's implants are individually sized and shaped to fit to each patient's unique anatomy. Thus, a surgeon is able to provide a custom solution that preserves more of a patient's joint and minimizes surgical trauma.
"After years of R&D investment in getting to this point, we are extremely pleased with the feedback from the first iTotal CR knee resurfacing system surgeries," said John Slamin, senior VP of Engineering at ConforMIS. "In my over 35 year career in knee replacement, I've been involved with many advances in knee replacement surgery. These first iTotal cases reinforce my belief that patient-specific knee replacement will redefine the category."
The company has drawn interest from an array of backers. Back in 2009, the company tapped government and private funds worldwide to raise $50 million in a Series D round. At the time, ConforMIS chairman and CEO Philipp Lang told Xconomy that his firm drew investments from sovereign funds of Kuwait and Singapore, as well as private equity investors such as previous backer Aeris Capital, of Zurich, Switzerland and Palo Alto, CA.
- see the ConforMIS release
ALSO: ConforMIS announced today that the iTotal CR received CE Mark certification on May 9. With this clearance, all ConforMIS products--including the previously launched iUni G2 and iDuo G2--are FDA cleared and CE Marked, supporting the company's multi-regional commercial approach. ConforMIS release