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

Rhea-AI Summary

Viveve Medical (NASDAQ: VIVE) announced the issuance of U.S. Patent No. 10,980,596 for its dual-energy technology device, further strengthening its intellectual property portfolio. CEO Scott Durbin expressed optimism about advancing global clinical development, supported by recent patent expansions in key markets. The Viveve System, focused on women's intimate health, utilizes patented technology for neocollagenesis. Ongoing clinical trials for stress urinary incontinence (SUI) have seen FDA-approved protocol changes intended to enhance the study's efficacy and size, with positive results potentially leading to new U.S. indications.

Positive

• Issuance of U.S. Patent No. 10,980,596 enhances intellectual property portfolio.
• Recent FDA-approved protocol changes for SUI trials aim to improve study efficacy.
• Ongoing global clinical development strategy supported by strong patent estate.

Negative

• None.

ENGLEWOOD, CO / ACCESSWIRE / June 10, 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. 10,980,596 for Viveve's dual-energy technology device. The awarded patent further strengthens the Company's intellectual property portfolio and expands its patent claims in the U.S.

"We are pleased to have secured the new patent for our Viveve® System in the U.S. The issued patent is the latest addition to our robust intellectual property portfolio, which was recently expanded by patents issued in two key Asia Pacific markets and a U.S. stress urinary (SUI) patent issued in the fall of last year," said Scott Durbin, Viveve's chief executive officer. "We look forward to continuing to advance our global clinical development and commercialization strategy supported by a strong intellectual property estate."

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 United States, 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 more than 50 countries.

Viveve continues to advance its clinical development program in SUI. Recently 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.

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.

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FAQ

What is the significance of the new patent issued to Viveve Medical on June 10, 2021?

The U.S. Patent No. 10,980,596 enhances Viveve's intellectual property portfolio, allowing for expanded claims related to its dual-energy technology device.

How do recent changes in the PURSUIT trial impact Viveve Medical's future?

FDA-approved changes to the PURSUIT trial protocol are designed to strengthen the overall study and potentially support a new SUI indication in the U.S. if successful.

What technology does the Viveve System use for women's intimate health?

The Viveve System employs Cryogen-cooled Monopolar Radiofrequency technology to deliver volumetric heating while cooling surface tissue, promoting neocollagenesis.

What markets have recently seen patent expansions for Viveve Medical?

Recent patent expansions have occurred in two key Asia Pacific markets, in addition to the U.S. patent issued.