On July 30, 2018, the FDA issued a public statement and sent letters to a number of companies in the medical aesthetics industry expressing concerns regarding “vaginal rejuvenation” procedures using energy-based devices. As previously disclosed, Hologic, Inc. (the “Company”) and its division, Cynosure, received such a letter relating to the MonaLisa Touch® laser (the “MLT Letter”). As a leader in women’s health, Hologic has a strong track record of developing products based on science and clinical evidence, as well as meeting our regulatory obligations. As such, we take the FDA’s recent statements very seriously.
Cynosure recently launched the TempSure™ Vitalia handpiece and probe under an FDA 510(k) clearance and was marketing the device for heating of vaginal tissue. Although the FDA did not mention Vitalia in its recent comments or the MLT Letter, Cynosure has carefully considered the FDA’s broader concerns and elected to suspend marketing and distribution of Vitalia handpieces andsingle-use probes until it has confirmed they meet all regulatory requirements for devices in this category. Cynosure is also asking customers to return any Vitalia handpieces and unused probes they have purchased. Cynosure has had no reports of adverse effects associated with the use of the Vitalia handpiece and probe and has not been made aware of any patient harm associated with their use. A letter describing these decisions is being sent to customers today.
This action is limited to the Vitalia probe and handpiece and does not affect other Hologic gynecology products such as the MonaLisa Touch laser. In addition, the TempSure System remainsFDA-cleared and may continue to be used with its various other handpieces, including TempSure Envi.
The Company had previously forecast that revenue from TempSure Vitalia would be approximately $7 million in the fourth quarter of fiscal 2018. In addition, any returns of Vitalia handpieces, unused probes and TempSure systems are expected to be recorded as a reduction to revenue, primarily in the fourth quarter of fiscal 2018. Because the number of these returns is uncertain, Hologic is not able to accurately forecast the financial effect, including any potential impact on the full-year and fourth-quarter financial guidance provided on July 31, 2018, of these decisions at this time. Hologic is committed to marketing our products in compliance with FDA requirements and believes a higher level of scrutiny from regulatory authorities will benefit our customers and patients. We share the same goals as FDA – clinically strong products that improve patient lives and are marketed responsibly.
Limitation on Incorporation by Reference. The information furnished in 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 such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act except as set forth by specific reference in such a filing.
Cautionary Note Regarding Forward-Looking Statements. The information in this Form8-K contains forward-looking statements that involve certain risks and uncertainties which could cause actual results to differ materially from those expressed or implied by these statements. Such risks and uncertainties include the number of customers who return product, the views of the FDA regarding product claims and other factors that are described in the filings made by the Company with the SEC, including our Annual Report on Form10-K. The Company does not undertake to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
