Conformis, Inc. (NASDAQ:CFMS) Files An 8-K Regulation FD Disclosure

Conformis, Inc. has received a warning letter from the U.S. Food and Drug Administration (FDA), dated December 10, 2019. The letter concerns the number of sterilization cycle failures relating to Vaporized Hydrogen Peroxide (VHP) sterilizers that the Company uses as a limited, alternative sterilization method for a small quantity of products. It does not question product sterility. The Company takes seriously the matters identified in the letter, has worked diligently to address the identified issues, and will respond to the FDA in a timely manner.

Notwithstanding instances of cycle failures, the Company’s quality system ensures that the sterility of products leaving the Wilmington facility has not been compromised. And because the VHP sterilizers are only used as a secondary sterilization method in limited circumstances, the Company does not anticipate any interruption in manufacturing or distribution, or with respect to the Company’s current new product launch schedule. The Company believes that the matters identified by the FDA can be resolved without a material impact to the Company’s financial results.

In addition, the Company has been planning to decommission and replace the VHP sterilizers. The Company previously procured, and has already validated, a new onsite sterilization unit and, in early December 2019, submitted a 510(k) premarket notification to the FDA for clearance of this new unit.

The information furnished under this Item 7.01 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as otherwise expressly stated in such filing.

Cautionary Statement Regarding Forward-Looking Statements

Statements in this Current Report on Form 8-K about our future expectations, plans and prospects, including statements about the anticipated timing of our product launches, and our financial position and results, total revenue, product revenue, gross margin, operations and growth, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. We may not actually achieve the forecasts disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual financial results could differ materially from the projections disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to our estimates and expectations regarding our revenue, gross margin, expenses, revenue growth and other results of operations, and the other risks and uncertainties described in the “Risk Factors” sections of our public filings with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this Form 8-K represent our views as of the date hereof. We anticipate that subsequent events and developments may cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.

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About Conformis, Inc. (NASDAQ:CFMS)

ConforMIS, Inc. is a medical technology company that uses its iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants. The Company’s products include iTotal CR, which is the cruciate-retaining, customized total knee replacement system to restore the natural shape of a patient’s knee; iTotal PS, which is the posterior cruciate ligament substituting, or posterior-stabilized, customized total knee replacement product to restore the natural shape of a patient’s knee; iDuo, which is the customized bicompartmental knee replacement system, and iUni, which is the customized unicompartmental knee replacement product for treatment of the medial or lateral compartment of the knee. Its iFit technology platform comprises three elements: iFit Design, iFit Printing and iFit Just-in-Time Delivery. The Company markets and sells its products in the United States, Germany, the United Kingdom, Austria, Ireland, Switzerland, Singapore and Hong Kong.