Hologic (NSDQ:HOLX) said today that its subsidiary Cynosure is suspending marketing and distribution of its TempSure Vitalia handpieces and probes after the FDA released a warning about a lack of evidence to support certain “vaginal rejuvenation” products late last month.
The Marlborough, Mass.-based company said that it takes “the FDA’s recent statements very seriously” and that it is suspending sales of the device “until it has confirmed they meet all regulatory requirements for devices in this category.”
Hologic said it is reaching out to customers to return any Vitalia handpieces and unused probes that have been purchased so far, and added that it has not received any reports of adverse effects associated with the use of the device.
The company also said that it received a letter from the FDA late last month related into its MonaLisa Touch laser, but did not state any plans to halt distribution or marketing of the device.
“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 wrote in an SEC filing.
Hologic said that it previously forecast approximately $7 million in revenue associated with the TempSure Vitalia for the fourth quarter of this year, and that any returns of the devices are expected to be recorded as a reduction to revenue, primarily during the fourth quarter.
“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,” the company wrote in an SEC filing.
The returns should only serve as “an incremental setback” for the company’s Cynosure aesthetics division, according to Leerink Partners analyst Richard Newitter.
Newitter said that Cynosure has been “struggling for the last 12 months” and that the suspension will likely push back the re-acceleration trajectory of the subsidiary even further.
Hologic has been looking to advance its Cynosure division, which it acquired last March for $1.7 billion, in an effort to expand its focus on women’s health into the cosmetic and aesthetics market.
