Channel Medsystems last week won pre-market approval from the FDA for its Cerene endometrial cryoablation device, starting the clock on a mandatory three-year post-approval study.
Cerene, which is designed to treat heavy but benign bleeding in premenopausal women for whom child bearing is complete, won CE Mark approval in the European Union in June 2017. The PMA granted March 28 is based on 12-month data from the 242-patient Clarity pivotal trial, which must now be extended for another 36 months, according to the FDA.
Emeryville, Calif.-based Channel Medsystems must follow at least 85% of Clarity patients out to three years, documented by two years worth of bi-annual reports detailing a variety of outcomes, the federal safety watchdog said.
“We are extremely pleased by the results of the Clarity study and the positive feedback we have received about the Cerene device, both from study investigators and numerous gynecologists surveyed,” president & CEO Ric Cote said in prepared remarks. “The Cerene device provides gynecologists with the first realistic option for treatment in their office, a setting that is more comfortable for women and significantly less expensive for the healthcare system. The shift away from the operating room that the Cerene device enables could potentially reduce the cost to treat heavy menstrual bleeding by hundreds of millions of dollars annually.”
“Channel Medsystems has developed a treatment that is easy to use, is reproducible in any setting of care and is very well tolerated without anesthesia. The development of new technology like the Cerene device could allow gynecologists to provide a safe, effective, affordable and convenient treatment to the millions of women who seek care for heavy menstrual bleeding annually in the United States,” added study investigator Dr. Ted Anderson of Nashville’s Vanderbilt University Medical Center.
Channel Medsystems has raised at least $47.6 million in a series of funding rounds that included Boston Scientific (NYSE:BSX), which acquired a 20% stake for $20.6 million spread over two of the rounds. In November 2017 the companies agreed to a deal that would have seen Boston acquire the remaining 80% for $275 million if it won FDA approval by Sept. 30 of this year.
The agreement foundered in the wake of an alleged embezzlement scheme in which federal prosecutors indicted then-quality assurance VP Dinesh Shankar on six counts of mail fraud. Channel sued to enforce the buyout, claiming that Shankar’s theft didn’t affect Channel’s pivotal trial or impede its the PMA bid it filed last August. The case is still under way in a Delaware state court.