60-person clinical trial to investigate therapeutic device as an alternative to opioids following sinus surgeries
SAN FRANCISCO–(BUSINESS WIRE)–Tivic Health® Systems, Inc., (Nasdaq: TIVC), a commercial-phase healthtech company focused on bioelectronic medicine, today 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 today is part of an initiative to identify new alternatives for treating pain following such surgeries.
“Bioelectronic devices work by modulating the electrical activity in peripheral and central nerves to mitigate both symptoms and underlying causes of health concerns,” said Jennifer Ernst, CEO of Tivic Health. “By supporting this investigator-initiated study, we will be testing a new product extension of Tivic Health’s bioelectronic device for sinus pain and congestion with the goal of minimizing study subject’s pain and their need for pain medication. We are delighted by this opportunity to work with a world-class research team in exploring the first extension of Tivic Health’s bioelectronic platform to a new application area.”
About Tivic Health Systems, Inc.
Tivic Health Systems, Inc. is a commercial-phase healthtech company delivering non-invasive bioelectronic treatments that provide consumers choice in the treatment of inflammation and related conditions. For more information visit https://tivichealth.com @TivicHealth
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