Viveve Regulatory Executive Named Among Top 25 Women Leaders in Medical Devices

Rhea-AI Summary

Viveve Medical, Inc. (NASDAQ:VIVE) announced that Suzon Lommel, its Senior VP of Regulatory and Quality Affairs, has been recognized as one of the Top 25 Women Leaders in Medical Devices for 2021 by The Healthcare Technology Report. CEO Scott Durbin praised her invaluable contributions to the company and the medical device industry. Viveve specializes in women's intimate health and is advancing clinical trials for stress urinary incontinence (SUI). The company has received FDA approval for changes aimed to enhance the PURSUIT trial protocol, potentially supporting new SUI indications in the U.S.

Positive

• Suzon Lommel's recognition highlights Viveve's leadership in the medical device sector.
• FDA-approved changes to the PURSUIT trial may strengthen its efficacy and support new SUI indications.
• The Viveve System has received international regulatory approvals in over 50 countries.

Negative

• None.

Healthcare Technology Report award recognizes outstanding contributions by SVP Suzon Lommel to advance innovative technologies that can transform patient outcomes

ENGLEWOOD, CO / ACCESSWIRE / January 28, 2021 / Viveve Medical, Inc. (NASDAQ:VIVE), a medical technology company focused on women's intimate health, announced today that Suzon Lommel, the Company's Senior Vice President of Regulatory and Quality Affairs, has been named by The Healthcare Technology Report as one of The Top 25 Women Leaders in Medical Devices of 2021.

"The entire Viveve organization congratulates Suzon for her outstanding contributions to the medical device industry and this well-deserved recognition. Her extensive regulatory expertise and contributions to our company have been and continue to be invaluable. She is an outstanding role model highlighting the extraordinary contributions that women are making in this field today," said Scott Durbin, Viveve's Chief Executive Officer.

"It is an honor to be included with the other women recognized in The Healthcare Technology Report's Top 25 Women Leaders in Medical Devices of 2021. I am especially pleased that many women who have dedicated their careers to advancing innovative medical technologies that improve patient outcomes are being recognized," said Ms. Lommel. "This honor also highlights the work that our entire team at Viveve has done in developing innovative technologies to address significant areas of unmet need in women's intimate health."

The Healthcare Technology Report annually recognizes top-performing women who have demonstrated a depth of specialized knowledge and leadership to make a positive impact in the medical device field. Showing qualities including adaptability, ingenuity, and patient-centricity, awardees play a central role in advancing the competitiveness of their companies and technologies. They also serve as mentors and role models to promote and support leadership opportunities for women in the healthcare technology sector.

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 stress urinary incontinence (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. If positive, results from the PURSUIT trial may support a new SUI indication in the U.S.

For more information visit Viveve's website at 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 recognition did Viveve Medical receive in 2021?

Viveve Medical's Suzon Lommel was named one of the Top 25 Women Leaders in Medical Devices by The Healthcare Technology Report in 2021.

What is Viveve Medical's focus?

Viveve Medical focuses on women's intimate health and advancing technologies to improve overall well-being.

What is the significance of the FDA-approved changes to the PURSUIT trial?

The FDA-approved changes aim to strengthen the PURSUIT trial protocol for stress urinary incontinence, potentially leading to new indications in the U.S.

Where has the Viveve System received regulatory approvals?

The Viveve System has received international regulatory approvals in over 50 countries for various women's health indications.