Viveve Announces Issuance of New Device and Methods Patent in U.S

Rhea-AI Summary

Viveve Medical, Inc. (NASDAQ:VIVE) announced the issuance of U.S. Patent No. 11,154,349 by the USPTO, enhancing its intellectual property portfolio related to its dual-energy technology. CEO Scott Durbin highlighted the company's commitment to intellectual property protection, enabling its clinical development and commercialization strategies. Viveve is advancing clinical trials in stress urinary incontinence (SUI), with recent FDA-approved protocol changes aimed at improving study efficacy. Positive outcomes may support new SUI indications in the U.S.

Positive

• Issuance of U.S. Patent No. 11,154,349 enhances Viveve's intellectual property portfolio.
• Recent FDA-approved protocol changes for the PURSUIT trial aim to improve efficacy and study design.
• Potential new SUI indication in the U.S. based on positive results from ongoing trials.

Negative

• None.

Issuance further expands and strengthens Company's intellectual property portfolio

ENGLEWOOD, CO / ACCESSWIRE / October 28, 2021 / Viveve Medical, Inc. (NASDAQ:VIVE), a medical technology company focused on women's intimate health, today announced that the United States Patent and Trademark Office (USPTO) recently issued U.S. Patent No. 11,154,349. The awarded patent further strengthens the Company's intellectual property portfolio and intellectual property coverage for Viveve's innovative technology and methods of remodeling tissue.

"We are pleased to have secured our most recent additional patent covering our dual-energy technology in the U.S. This latest issuance reflects our continued commitment to securing the highest achievable levels of protection for our robust intellectual property portfolio," said Scott Durbin, Viveve's chief executive office. "We look forward to continuing to advance our global clinical development and commercialization strategy supported by our strong intellectual property estate and completing enrollment in our U.S. pivotal PURSUIT trial in the near future."

About Viveve

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 stress urinary incontinence (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 Investigational Device Exemption (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.

Safe Harbor Statement

All statements in this press release that are not based on historical fact are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. While management has based any forward-looking statements included in this press release on its current expectations, the information on which such expectations were based may change. These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties, and other factors, many of which are outside of our control, which could cause actual results to materially differ from such statements. Such risks, uncertainties and other factors include, but are not limited to, the fluctuation of global economic conditions, the impact of the novel coronavirus termed COVID-19 on our clinical development and regulatory review and clearances and on the manufacturing, placements and patient utilization of our Viveve Systems, the performance of management and our employees, our ability to obtain financing, our evaluation of strategic alternatives, our ability to obtain approval or clearance for sale of our medical device for all indications sought, competition, general economic conditions and other factors that are detailed in our periodic and current reports available for review at www.sec.gov. Furthermore, we operate in a highly competitive and rapidly changing environment where new and unanticipated risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. We disclaim any intention to, and undertake no obligation to, update or revise forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware, unless required by law.

Viveve is a registered trademark of Viveve, Inc.

Investor Relations contacts:
Amato and Partners, LLC
Investor Relations Counsel
admin@amatoandpartners.com

Media contact:
Bill Berry
Berry & Company Public Relations
(212) 253-8881
bberry@berrypr.com

SOURCE: Viveve Medical, Inc.

View source version on accesswire.com:
https://www.accesswire.com/670021/Viveve-Announces-Issuance-of-New-Device-and-Methods-Patent-in-US

FAQ

What is the latest patent issued to Viveve Medical?

Viveve Medical received U.S. Patent No. 11,154,349, strengthening its intellectual property portfolio.

How does the new patent impact Viveve Medical's business?

The patent enhances Viveve's intellectual property protection for its dual-energy technology, supporting its clinical and commercialization strategies.

What clinical trials is Viveve Medical currently undertaking?

Viveve is advancing its PURSUIT trial for stress urinary incontinence, with recent FDA-approved protocol changes.

What is the significance of the PURSUIT trial for Viveve Medical?

Positive results from the PURSUIT trial may support a new SUI indication in the U.S., enhancing Viveve's market potential.