On August 13, 2018, MarketWatch reported (“Hologic’s stock drops after suspension of marketing of Vitalia TempSure device”) that Hologic’s (NasdaqGS: HOLX) stock shares
. . . fell 2.9% in premarket trade Monday, after [Hologic, Inc.] said its Cynosure division will suspend marketing and distribution of its Vitalia TempSure device for heating of vaginal tissue, while it considers the Food and Drug Administration’s concerns over ‘vaginal rejuvenation’ procedures using energy-based devices. Cynosure received a letter from the FDA relating to its MonaLisa Touch laser, but although the letter didn’t mention Vitalia, has elected to consider the concerns and is asking customers to return purchased devices. The company said it has had no reports of adverse effects associated with the Vitalia device and has not been made aware of any patient harm. . . . (Emphasis added.)
Hologic’s Form 8-K in this regard stated:
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. . . . and its division, Cynosure, received such a letter relating to the MonaLisa Touch® laser (the “MLT Letter”). . . .
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 and single-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 remains FDA-cleared and may continue to be used with its various other handpieces, including TempSure Envi.
[Hologic] 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. . . . (Emphasis added.)