September 13, 2018

Hologic subsidiary to lose $15M after FDA warns of device claims

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Hologic's Marlborough location

Marlborough medical device maker Hologic is expecting revenues from subsidiary Cynosure to be about $15 million less after it halted sales of a device due to a government warning.

Westford-based Cynosure, an aesthetic laser treatment firm, said Wednesday the loss is due to lost sales of Tempsure Vitalia in the fourth quarter, refunds and rebates associated with prior sales of the device, unused devices and reduced sales of the MonaLisa Touch.

The company on Aug. 13 said it was suspending marketing and sales of its TempSure Vitalia devices after the U.S. Food and Drug Administration issued a warning letter to the company and others about claims such devices can be used for vaginal rejuvination.

The company received such a letter for its MonaLisa Touch device, but suspended sales of its TempSure Vitalia device. Sales of the MonaLisa Touch device continue while the company works to resolve the issue with the FDA.

The FDA last month 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 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.

Hologic's other businesses have had a strong quarter, so the Cynosure losses aren't expected to reduce the company's expected $800 million to $815 million revenue in the quarter.

The company did not say when it would 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," the company said.

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.


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