Tivic Health Systems, Inc. announced initiation of its second clinical study investigating the extension of the company's bioelectronic platform, offering a potentially new alternative to opioids for post-operative care following sinus surgeries. This 60-person double-blind, randomized controlled trial will be conducted with an international hospital leading in medical and scientific training, biomedical research, and patient care. Tivic Health currently offers an FDA-cleared bioelectronic treatment for sinus pain and nasal congestion - a condition that impacts over 200-million U.S. adults.

The upcoming trial will investigate the extensibility of Tivic Health's platform as a specialized treatment for pain following functional endoscopic sinus surgery, an intervention involving removal or modification of bone and tissue in the sinus airway passages. Tivic Health previously completed an open-label pilot study with the U.S. Institute for Advanced Sinus Care and Research comparing different programming modes for the device. Clinical measures for the newly initiated study will include postoperative pain and use of opiate medication during the study period.

Over one million sinus and nasal surgeries are conducted in the U.S. every year and most patients are prescribed opioid medications to treat postoperative pain. The clinical research program announced January 19, 2022 is part of an initiative to identify new alternatives for treating pain following such surgeries.