ConforMIS (NSDQ:CFMS) released 2nd quarter earnings that slimly topped Wall Street’s expectations, seeing shares dip slightly in response. The Bedford, Mass.-based company reported losses of $14.1 million, or 34¢ per share, on sales of $19.3 million for the 3 months ended June 30. That amounts to a 29% increase in losses while sales grew a smaller […]
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ConforMIS touts satisfaction survey for iTotal CR custom knee replacement
ConforMIS (NSDQ:CFMS) said yesterday that results from an ongoing 300-patient study of its iTotal CR knee replacement system indicate a high rate of satisfaction among individuals implanted with the system. Results from the multi-center, prospective study were presented at the 2016 SICOT International Orthopedic “Specialized Knee Surgery” Conference in Wurzburg, Germany last week. “A satisfied patient […]
ConforMIS plunges on lowered outlook, search for new CEO
Shares of ConforMIS (NSDQ:CFMS) closed down nearly -8% yesterday and plunged another -40% in after-hours trading, after the medical device company lowered its outlook for the rest of the year and said it’s looking for a new CEO to replace founder Dr. Phillip Lang. Losses widened 5.4% to -$15.0 million, or -37 per share, on sales […]
ConforMIS yanks FDA clearance bid for iTotal hip, shares slide
ConforMIS (NSDQ:CFMS) shares slid today after the medical device company said it’s withdrawing its bid for FDA clearance for the iTotal personalized hip replacement after the federal safety watchdog raised questions about the bid. Bedford, Mass.-based ConforMIS said the FDA raised “a number” of questions about its 510(k) clearance application – too many for the company to […]
Patent troll files swath of suits against ortho companies
WiLan company Orthopedic Innovations is looking to bring in damages for infringed intellectual properties, filing 5 separate patent suits against major orthopedic companies last October. The suits are in relation to a patent it holds over “technologies related to a gap checking method and apparatus for shaping a femur preparatory to implanting a knee prosthesis,” […]
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 […]
J-Pac names new CFO, ops VP | Personnel Moves
J-Pac Medical said it named former GI Supply finance chief Michael Dolge to be its new CFO and tapped Phil Littlefield, a medtech veteran, to be its vice president of operations. Somersworth, N.H.-based J-Pac, which makes implantable textiles and offers packaging and manufacturing services to the medical device industry, said Dolge’s resume includes stints at […]
Avedro CEO Muller is out | Personnel Moves
Avedro said CEO David Muller stepped down shortly after it closed a $32 million equity round last month, replaced on an interim basis by COO Brian Roberts, the former CFO at Insulet (NSDQ:PODD). Waltham-based Avedro said Muller left to “pursue other opportunities.” “On behalf of the board and all the Avedro employees, I want to thank […]
ConforMIS resumes knee implant production, releases Q3 earnings
ConforMIS (NSDQ:CFMS) said yesterday it resumed full production of its knee implants which had been on hold due to a recall, and released its Q3 earnings, topping rev but missing earnings per share expectations. ConforMIS reported losses of $17.1 million, or 45¢ per share, on sales of $13.5 million for the 3 months ended September 30. That […]
ConforMIS looks to get back on line this month, affirms guidance
ConforMIS (NSDQ:CFMS) said today that it expects to get its customized knee implants back on line this month, after an independent investigation of the problem behind the recall of some 950 of its customized knee implants found no further cause for concern. Last August Bedford, Mass.-based ConforMIS said it had received 3 complaints of moisture on the patient-specific instrumentation […]
ConforMIS plunges on recall, guidance cut
ConforMIS (NSDQ:CFMS) shares plunged nearly 19% today after the Bedford, Mass.-based company recalled some 950 of its customized knee replacements and cut its outlook for the rest of the year. The company received 3 complaints of moisture on the patient-specific instrumentation used with the implants, although all 3 procedures went off without a hitch, ConforMIS said. The […]