Channel Medsystems Receives FDA Approval for Cerene® Cryotherapy Device to Treat Heavy Menstrual Bleeding

VCBeat (WeChat ID: vcbeat) has learned that the Cerene Cryotherapy Device, a novel endometrial cryoablation system developed by biotechnology company Channel Medsystems, has recently received marketing approval from the U.S. Food and Drug Administration (FDA) for the treatment of heavy menstrual bleeding in women. The device had previously obtained CE marking in the European Union in June 2017.

Channel Medsystems, founded in 2009, is a biotechnology company based in California, USA, dedicated to developing innovative healthcare technologies to meet the needs of female patients and advance the women’s health industry. To date, the company has secured six rounds of financing. In 2015, it raised $22 million in Series C funding, led by Third Point Ventures.

Menstrual blood consists of endometrial tissue and blood from uterine vessels. It is understood that menstrual blood loss exceeding 80 mL per cycle is classified as menorrhagia. Statistics indicate that approximately 9%–30% of women of reproductive age suffer from menorrhagia, with the incidence increasing with age and peaking before menopause. Menorrhagia is associated with conditions such as uterine fibroids, polyps, and adenomyosis, and endometrial ablation is the most common treatment method.

Currently, common endometrial ablation devices on the market rely on electrical current to generate thermal effects, causing coagulation and shedding of the endometrium to treat menorrhagia. Procedures using such devices often require general anesthesia and carry significant surgical risks. In contrast, the Cerene Cryotherapy Device is an endometrial cryoablation system that reduces menstrual bleeding by freezing the endometrium. It does not require general anesthesia; the procedure is simple and safe, can be performed in an office setting rather than an operating room, and takes less than three minutes. The device involves inserting a probe into the uterus and releasing nitrogen dioxide into a balloon. The nitrogen dioxide freezes the target tissue, causing the thickened endometrium to shed. The balloon prevents nitrogen dioxide leakage, thereby avoiding damage to surrounding tissues.

Currently, Boston Scientific, a global leader in medical technology companies, holds a 20% stake in Channel Medsystems. In November 2017, the two companies entered into an agreement stipulating that if the Cerene Cryotherapy Device received FDA approval by September 30, 2019, Boston Scientific would acquire the remaining 80% of Channel Medsystems’ shares for $275 million. However, due to charges of embezzlement filed against Dinesh Shankar, Vice President of Channel Medsystems, Boston Scientific decided to terminate the agreement. Channel Medsystems has since filed a lawsuit with the court seeking specific performance of the acquisition agreement, and the case is currently under trial.

(Compiled by Jiao Yanli)