August 13, 2018

FDA warns Hologic over device's vaginal rejuvenation claims

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Hologic's Marlborough location

Marlborough medical device company Hologic is suspending the marketing and distribution of a vaginal heating device after the company receiving a warning about overstating the health benefits of a similar device from the U.S. Food and Drug Administration.

In a filing with the Securities and Exchange Commission on Monday, Hologic said its subsidiary Cynosure will suspend sales of its Vitalia handpieces and single-use probes until it has confirmed they meet all regulatory requirements.

Cynosure is asking customers to return any of those devices. The company has no reports of adverse effects associated with the devices, it said in the filing.

The move to suspend the Vitalia program comes after another Cynosure device, the MonaLisa Touch, was the subject of a letter from the FDA about some inconsistencies in its approved use and its actual use.

The FDA said the device was cleared for a variety of uses, but not for several uses listed on the device's website, including for vaginal and vulvar health, menopause symptom relief, vaginal wall healing and other vaginal uses.

The FDA also said a component of the device may have been modified from the previous cleared device.

The agency is requesting the company to provide it with proof of clearance for those uses and state its case as to whether or not its required to obtain additional approval for the marketed uses.

In a broader letter to the industry, the FDA said it has not approved or cleared any energy-based devices for vaginal rejuvenation to treat a variety of symptoms.

"The treatment of these symptoms or conditions by applying energy-based therapies to the vagina may lead to serious adverse events, including vaginal burns, scarring, pain during sexual intercourse, and recurring/chronic pain," the agency said.

In a July 31 conference call with investors discussing the company's performance, Hologic Chairman, President and CEO Steve MacMillan acknowledged receipt of the FDA's letter and said the company is analyzing those concerns.

The Mona Lisa Touch represents less than 10 percent of Cynosure's sales, he said.

Since that letter, the company's stock has dropped more than 9 percent, as of premarket trading Monday.

In an email to WBJ, Hologic spokeswoman Jane Mazur said the company is continuing sales of MonaLisa Touch while it works with the FDA on the issue.

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