ConforMIS develops patient-specific knee implants and instrumentation using its proprietary iFit image-to-implant platform. The company’s core products include the iTotal® G2, iUni® G2 and iDuo® G2 systems, all cleared by the U.S. FDA and CE Marked in Europe. ConforMIS differentiates via a just-in-time delivery model with a small sterile kit containing implants and disposable instruments, reducing hospital inventory and sterilization costs. It holds more than 375 patents and patent applications across image processing, patient-specific systems, instrumentation, and manufacturing. The company plans to scale commercialization of the iTotal® G2 in the U.S. and abroad, advance manufacturing capabilities, and pursue new market opportunities. ConforMIS was founded in 2004 and is based in Bedford, Mass. ConforMIS designs, manufactures, and commercializes patient-specific orthopedic implants and instruments, focused primarily on knee osteoarthritis. The company offers a full line of personalized implants, including the iUni® G2 and iDuo® G2 partial knee solutions and the iTotal® CR total knee system. In 2011 ConforMIS more than doubled its revenues and received FDA 510(k) clearance for the iTotal® CR, described as the first and only patient-specific total knee implant on the market. Its proprietary portfolio includes more than 300 patents and patent applications across imaging software, implant design, instrumentation, surgical techniques, and manufacturing. The company targets a roughly $7 billion global knee osteoarthritis market and plans ongoing R&D into new product lines, expanded sales and marketing, and manufacturing build-out using the newly raised capital. ConforMIS designs and manufactures the iTotal customized knee replacement system, a patient-specific implant intended to serve patients underserved by current designs. The company recently won CE Mark approval for the European Union and received 510(k) clearance from the U.S. Food & Drug Administration in February. ConforMIS announced that the first successful surgeries using the customized device took place last month. To support scaling, the company secured a loan to expand its supply chain and manufacturing capacity. ConforMIS says the expansion is critical to its competitiveness within the orthopedics industry and to advancing a more personalized approach to osteoarthritis treatment. The company is pursuing production growth in Massachusetts while aiming to enhance patient outcomes through customized implants.

Total raised

$258M

Funding rounds

3

Latest round

Series E

Latest activity

Aug 2013