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Fly News Breaks for July 30, 2018
HOLX, VIVE
Jul 30, 2018 | 15:13 EDT
Craig-Hallum analyst Matt Hewitt noted that the FDA published seven "Letters to Industry" that were sent to companies that may be violating the law for inappropriately marketing their energy-based devices for vaginal "rejuvenation," but noted that Viveve (VIVE) was not amongst them. He views this as a positive for Viveve, as it signals that the FDA is cracking down on the off-label promotion that he thinks has been a key commercial challenge for the company. Viveve is the only one in the space currently performing a trial for sexual function, placing it "miles ahead of the competition" in terms of obtaining an actual label, added Hewitt, who keeps a Hold rating on the stock due to concerns over the company's operating cash flow burn and uncertainty about financials. The Fly notes that Cynosure, a unit of Hologic (HOLX), was among the companies to receive an FDA warning.
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