BILLERICA, Mass., June 20, 2017 (GLOBE NEWSWIRE) — ConforMIS, Inc. (NASDAQ:CFMS), a medical expertise firm that gives knee alternative implants custom-made to suit every affected person’s distinctive anatomy, right this moment introduced it has obtained FDA 510(ok) clearance of the Firm’s major iTotal Hip alternative system.
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“Having handled over 50,000 sufferers with custom-made knee alternative implants, ConforMIS brings over a decade of expertise in patient-specific expertise to the hip alternative market,” mentioned Mark Augusti, Chief Govt Officer and President of ConforMIS. “FDA clearance of iTotal Hip demonstrates the power to use our proprietary iFit® image-to-implant expertise to different joints. There was a pattern in the direction of personalised healthcare and we consider sufferers count on and deserve personalised therapy.”
The ConforMIS iTotal Hip system options proprietary iFit expertise just like that used to design, manufacture and ship custom-made knee implants. The system makes use of ConforMIS’s patient-specific expertise, single-use 3D printed devices and just-in-time supply mannequin to create a system that requires restricted reusable devices.
“Commonplace hip alternative surgical procedure may be difficult, presenting dangers of dislocation, discrepancies in leg size and restricted reproducibility,” mentioned Scott Ball, MD, Division of Orthopaedic Surgical procedure, College of California, San Diego and a member of the iTotal Hip design crew. “With the power to attain a greater match to a affected person’s personal anatomy, the iTotal Hip system goals to handle these shortcomings and enhance affected person outcomes.”
“We count on to leverage synergies with gross sales representatives, surgeons and hospitals upon restricted launch, which is anticipated for 2019,” added Augusti. “We’re excited in regards to the alternative iTotal Hip represents in increasing our product portfolio to handle a broader orthopedic market with our proprietary expertise.”
In the USA, roughly 400,000 hip replacements had been carried out in 2016. The worldwide hip joint reconstruction market is projected at over $6B.
About ConforMIS, Inc.
ConforMIS is a medical expertise firm that makes use of its proprietary iFit Picture-to-Implant expertise platform to develop, manufacture and promote joint alternative implants which can be individually sized and formed, or custom-made, to suit every affected person’s distinctive anatomy. ConforMIS affords a broad line of custom-made knee implants and pre-sterilized, single-use devices delivered in a single package deal to the hospital. In medical research, ConforMIS iTotal CR demonstrated superior medical outcomes, together with higher perform and better affected person satisfaction, in comparison with conventional, off-the-shelf implants. ConforMIS owns or solely in-licenses roughly 450 issued patents and pending patent purposes that cowl custom-made implants and patient-specific instrumentation for all main joints.
Cautionary Assertion Relating to Ahead-Wanting Statements
Any statements on this press launch about future expectations, plans and prospects for ConforMIS, together with statements about ConforMIS’s improvement of the iTotal Hip implant system, potential medical, financial or different impacts and benefits of utilizing custom-made implants, in addition to different statements containing the phrases “anticipate,” “consider,” “proceed,” “might,” “estimate,” “count on,” “intend,” “could,” “would possibly,” “plan,” “potential,” “predict,” “venture,” “ought to,” “goal,” “will,” or “would” and related expressions, represent forward-looking statements inside the which means of the secure harbor provisions of The Non-public Securities Litigation Reform Act of 1995. We could not really obtain the plans, intentions or expectations disclosed in our forward-looking statements, and you shouldn’t place undue reliance on our forward-looking statements. Precise outcomes or occasions might differ materially from the plans, intentions and expectations disclosed within the forward-looking statements we make because of quite a lot of dangers and uncertainties, together with dangers associated to our product improvement and commercialization efforts, and the opposite dangers and uncertainties described within the “Danger Elements” sections of our public filings with the Securities and Trade Fee. As well as, the forward-looking statements included on this press launch symbolize ConforMIS’s views as of the date hereof. ConforMIS anticipates that subsequent occasions and developments could trigger ConforMIS’s views to alter. Nonetheless, whereas ConforMIS could elect to replace these forward-looking statements in some unspecified time in the future sooner or later, ConforMIS particularly disclaims any obligation to take action. These forward-looking statements shouldn’t be relied upon as representing ConforMIS’s views as of any date subsequent to the date hereof.
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