Viveve Medical, Inc. (NASDAQ:VIVE), a medical technology company focused on women’s intimate health, today announced that the American Medical Association (AMA) has issued a new Category III Current Procedural Terminology (CPT®) code for the Company’s dual-energy procedure effective January 1, 2022. The new code establishes a pathway for potential reimbursement for Viveve’s noninvasive treatment under evaluation in the PURSUIT trial to improve stress urinary incontinence (SUI) in women if approved by the U.S. Food and Drug Administration (FDA) for this indication.
The new Category III CPT code for Viveve’s dual-energy procedure is defined as: endovaginal cryogen-cooled, monopolar radiofrequency remodeling of the tissue surrounding the female bladder neck and proximal urethra for urinary incontinence. Category III CPT codes are AMA approved for new and developing technology, procedures and services. They allow for specific data collection and assessment over time for potential Category I qualification.
“The AMA approval of a new Category III CPT code is a significant milestone in our SUI clinical development and commercialization strategy. Issuance of the new code reflects the strong clinical evidence and potential benefit of our noninvasive, dual-energy procedure for improving SUI in women as reviewed by the AMA and supported by key medical specialty societies. Importantly, the new code establishes a pathway for potential reimbursement for the Company to pursue as we advance and complete our pivotal PURSUIT trial in the U.S.,” said Scott Durbin, Viveve’s chief executive officer. “Our strategic focus is to address the current unmet need of the estimated 11 million women in the U.S who suffer daily from SUI with an effective, noninvasive treatment option. Pending potential positive results from our PURSUIT trial and a potential new SUI indication in the U.S., we believe the Viveve procedure could become a preferred SUI treatment option that may be broadly covered by insurance in the future.”
