Levi & Korsinsky announces it has commenced an investigation of Hologic, Inc. (“Hologic” or “the Company”) (NASDAQGS: HOLX) concerning possible violations of federal securities laws. Hologic is the parent company of Cynosure, Inc.
On July 30, 2018, the U.S. Food and Drug Administration issued a statement warning against the use of “energy-based devices” to perform vaginal “rejuvenation” and/or cosmetic vaginal procedures and stated it was aware of certain manufacturers inappropriately marketing energy-based devices. The FDA further disclosed it had sent a letter to Cynosure notifying the Company that marketing for its MonaLisa Touch may violate the Federal Food, Drug, and Cosmetic Act. Then on August 13, 2018, Hologic filed an 8-K stating that “Although the FDA did not mention Vitalia in its recent comments or the [MonaLisa Touch] 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.” Following this news, shares of Hologic fell from a close of $40.66 per share on August 10, 2018, to a close of $39.02 on August 13, 2018.