On August 13, 2018, Hologic, Inc. (NASDAQ: HOLX) issued a Form 8-K describing the decision by its Cynosure division to suspend marketing and distribution of its TempSure™ Vitalia handpieces and single-use probes, and to ask customers to return any Vitalia handpieces and unused probes they had purchased. Cynosure had launched the Vitalia handpiece and probe under an FDA 510(k) clearance and had been marketing the device for heating of vaginal tissue.

This decision was made in response to a public statement made by the FDA and letters it sent to Cynosure and other medical aesthetics companies expressing concerns regarding “vaginal rejuvenation” procedures using energy-based devices. Cynosure received such a letter relating to its MonaLisa Touch® laser.

The Company is now providing an update on the financial impact of its actions in advance of meetings with investors at the Morgan Stanley 16th Annual Global Healthcare Conference later this week.

Based on discussions with medical aesthetics customers over the last month, and relative to its financial guidance provided on July 31, 2018, the Company now expects Cynosure revenue in the current fourth quarter of fiscal 2018 to be approximately $15 million less than previously forecast. This estimate includes lost sales of TempSure Vitalia in the fourth quarter; refunds and rebates associated with prior sales of Vitalia handpieces, unused probes and TempSure systems; and reduced sales of MonaLisa Touch.

However, based on strong revenue trends in other parts of Hologic’s business in the current quarter to date, the Company is reaffirming its financial guidance provided on July 31, 2018. Specifically, the Company continues to expect revenue in the fiscal fourth quarter to be in the range of $800 to $815 million. Since refunds and rebates related to TempSure Vitalia will be recorded as reductions to revenue, which reduce operating income on a dollar-for-dollar basis, the Company now expects earnings per share (EPS) in the fiscal fourth quarter to be at the low end of its previous GAAP and non-GAAP guidance ranges.

Hologic cannot yet predict when it will resume selling TempSure Vitalia. The Company is committed to marketing its products in compliance with FDA requirements and believes a higher level of scrutiny from regulatory authorities will benefit its customers and patients.