Viveve (NSDQ:VIVE) said today it it won regulatory clearance from Australia’s Therapeutic Goods Administration for its Viveve non-surgical treatment for post-partum laxity of the vaginal introitus.
The Sunnyvale, Calif.-based company said it inked a distribution partnership deal in Australia and New Zealand with medical product supplier Device Consulting, which will support the regional distribution of the Viveve system throughout the regions.
“Our regulatory approval in Australia and our distribution partnership with Device Consulting represent important milestones in our rapidly expanding efforts to build a global commercial infrastructure for the Viveve System. Our research shows that vaginal laxity is a significant risk and concern for women following pregnancy. We believe that the clinically demonstrated safety and efficacy profile of this painless procedure will position the Viveve Treatment as the best alternative for a condition that can profoundly impact a woman’s sexual satisfaction and quality of life. We look forward to bringing the advantages of the Viveve System to women in this region who are living with the challenges of vaginal laxity,” Viveve CEO Patricia Scheller said in a prepared statement.
“The Viveve System is precisely aligned with our mission to bring high-quality and clinically proven technologies to physicians and their patients. Our goal is to more efficiently communicate the advantages of the Viveve procedure to clinicians and all women who may benefit from the treatment,” device consulting GM & CEO Milivoj Boltuzic said in a press release.
In early August, Viveve said it won regulatory approval from the Ministry of Food and Drug Safety in South Korea for its Viveve non-surgical treatment for post-partum laxity of the vaginal introitus.
The company said it already inked an exclusive distribution partnership in South Korea with JOYMG, a medical device distributor in the region.