ConforMIS sues Smith & Nephew, launches iTotal PS knee implant

ConforMIS (NSDQ:CFMS) leveled a lawsuit against Smith & Nephew (NYSE:SNN) this week, accusing the British orthopedics giant of trespassing on 8 patents covering the ConforMIS technology for patient-specific knee implants.

Bedford, Mass.-based ConforMIS also launched its iTotal PS, claiming it as the only customized posterior stabilized knee replacement system on the market.

The lawsuit against Smith & Nephew, filed in the U.S. District Court for Massachusetts, alleges that the London-based company’s Visionaire cutting guides, billed as “custom fit,” infringe the 8 ConforMIS patents. The Visionaire guides are used with off-the-shelf S&N implants, including the Journey II, Legion, and Genesis II devices, ConforMIS alleged.

The lawsuit accused Smith & Nephew of mis-promoting and inducing others to mispromote total knee arthroplasties using the Visionaire guides “as being ‘custom fit’ total-knee arthroplasty procedures, even though the end result uses a standard, off-the-shelf implant not customized for the patient.”

“Upon information and belief, this mispromotion has harmed ConforMIS by, on information and belief, diminishing its potential sales base and market share, and also diluting the strength of its patient-specific offering in the minds of the consuming public,” ConforMIS alleged.

ConforMIS also said the full launch of the iTotal PS follows a year-long limited release that saw the device implanted in more than 1,000 patients.

“The full launch of the iTotal PS nearly triples our addressable market. We believe this launch is our single biggest commercial opportunity to date,” founder, president & CEO Dr. Philipp Lang said in prepared remarks. “With iTotal PS, we have now greatly expanded the number of patients who will be candidates for our customized knee replacement implants. We are very excited to bring the benefits of customized knee replacements to surgeons who prefer a posterior-stabilized design. Since we initiated our limited launch of iTotal PS last year, the feedback from surgeons has been extremely positive.”

“The goal of a total knee replacement is a predictable outcome and a happy patient, every time. With off-the-shelf implants, most of the time we must make compromises,” added Dr. Jose Rodriguez of New York City’s Lenox Hill Hospital. “With ConforMIS, many of these compromises are eliminated because the implant fits anatomically. The reliability with which I can achieve a knee that fits better, and functions more naturally for my patients, is greater with iTotal PS than with standard, off-the-shelf implants.”

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