Viveve Announces Issuance of New Method Patent for Stress Urinary Incontinence in Australia
Patent strengthens and expands Viveve's intellectual property portfolio for the treatment of stress urinary incontinence
ENGLEWOOD, CO – September 23, 2021 - Viveve Medical, Inc. (NASDAQ: VIVE), a medical technology company focused on women's intimate health, today announced that the Australian Patent Office has issued Patent No. 2016324168 covering Viveve's unique method of treatment to address stress urinary incontinence (SUI) in women. The newly granted patent strengthens the Company's intellectual property portfolio as subject enrollment advances in its U.S. pivotal PURSUIT clinical trial for SUI in women.
Viveve's dual-energy technology has demonstrated its ability to activate fibroblasts and initiate collagen formation in underlying vaginal tissue in a non-invasive, painless and comfortable procedure. When applied in the area of the urethra and tissue surrounding the bladder neck, the technology's unique mechanism of action may strengthen and improve the function of connective tissues, improve vaginal structural integrity and reduce urethral hypermobility, a leading cause of SUI in women.
"We are pleased with the issuance of the SUI patent in Australia. The addition of this new patent strengthens the Company's already robust intellectual property portfolio, recently expanded by a U.S. and two Asia Pacific patents and a U.S. SUI patent issued in the fall of 2020. As we continue to advance our pivotal PURSUIT trial, our strong IP position supports Viveve's focus to develop and commercialize a new method for the treatment of SUI pending regulatory approval," said Scott Durbin, Viveve's chief executive officer.
"Currently, there is an enormous unmet need in the market for a non-invasive, safe, efficacious, and durable SUI treatment. We look forward to completing enrollment in our PURSUIT clinical trial early in the fourth quarter of this year. Positive results from this trial may support a new U.S. indication for the treatment of moderate SUI in women," concluded Mr. Durbin.
Viveve Medical, Inc. is a medical technology company focused on women's intimate health. Viveve is committed to advancing new solutions to improve women's overall well-being and quality of life. The internationally patented Viveve® System incorporates Cryogen-cooled Monopolar Radiofrequency technology to uniformly deliver volumetric heating while gently cooling surface tissue to generate neocollagenesis in a single in-office session. In the U.S., the Viveve® System is cleared by the Food and Drug Administration (FDA) for use in general surgical procedures for electrocoagulation and hemostasis. International regulatory approvals and clearances have been received for vaginal laxity and/or improvement in sexual function indications in 50 countries.
Viveve continues to advance its clinical development program in SUI. Previously reported FDA approved changes to the U.S. pivotal PURSUIT trial protocol are intended to strengthen the overall study and its potential to achieve its primary efficacy endpoint. Study changes including an increase in the trial's size and more strict patient selection criteria were a result of guidance from Viveve's Clinical Advisory Board upon review of positive results from the Company's SUI feasibility and preclinical studies. Viveve received FDA approval of its IDE application to conduct the multicenter, randomized, double-blinded, sham-controlled PURSUIT trial for improvement of SUI in women in July 2020 and FDA approval of its requested amendments to the IDE protocol as reported on December 10, 2020. Initiation of the trial was reported on January 21, 2021 and subject enrollment is underway. If positive, results from the PURSUIT trial may support a new SUI indication in the U.S.
For more information visit www.viveve.com.
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Viveve is a registered trademark of Viveve, Inc.
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