VIVEVE MEDICAL INC - VIVE STOCK NEWS

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.

Viveve Medical has initiated its multicenter, randomized, double-blinded trial named PURSUIT, focusing on stress urinary incontinence (SUI). This trial, approved by the FDA, aims to enroll 390 subjects across 30 U.S. sites. Improved patient selection criteria are expected to enhance the evaluation of the primary efficacy endpoint, which targets a 50% reduction in urine leakage at 12 months post-treatment. Positive results could lead to a new marketing application for the company's CMRF technology in the U.S.

Viveve Medical, Inc. (NASDAQ: VIVE) has successfully completed an upsized underwritten public offering, raising approximately $27.6 million. The offering included 4,607,940 Class A Units and 2,450,880 Class B Units, each priced at $3.40 per unit. The Class A units consist of common stock and warrants, while the Class B units consist of Series C convertible preferred stock and warrants. Following the offering, Viveve's total outstanding common stock is now 7,838,076 shares.

The funds will support ongoing clinical trials and advancements in women's health technologies.

ENGLEWOOD, CO / ACCESSWIRE / January 14, 2021 - Viveve Medical, Inc. (NASDAQ:VIVE) announced an upsized underwritten public offering aiming for gross proceeds of approximately $24 million, with a potential increase to $27.6 million if underwriters exercise their over-allotment option. The offering consists of Class A Units priced at $3.40 each, comprising common stock and warrants, and Class B Units, similarly priced, including Series C convertible preferred stock and warrants. The offering is set to close around January 19, 2021, pending customary conditions.

Viveve Medical, Inc. (NASDAQ: VIVE) has secured compliance with NASDAQ's $1.00 minimum bid price requirement as of December 16, 2020, ensuring continued listing on the NASDAQ Capital Market. The company previously received a compliance notice on April 21, 2020, due to its stock falling below this threshold for over 30 days. Following guidance related to the COVID-19 pandemic, Viveve regained compliance by maintaining a closing bid price of over $1.00 for 10 consecutive trading days.

Viveve Medical (NASDAQ:VIVE) has received FDA approval to enhance its pivotal PURSUIT trial for treating stress urinary incontinence (SUI) in women. Modifications include increasing the trial size to 390 subjects and refining patient selection criteria to strengthen data reliability. The trial will compare the efficacy of the Viveve procedure against a sham treatment. A successful outcome could facilitate Viveve's market entry for SUI. With 25-30 million affected women globally, the Viveve procedure aims to provide a non-invasive solution, potentially transforming women's intimate health.

Viveve Medical, Inc. (NASDAQ:VIVE) has received 510(k) clearance from the FDA to expand its manufacturing capacity for consumable treatment tips used with its Cryogen-cooled Monopolar Radiofrequency technology. This approval is expected to enhance supply chain efficiency, reduce manufacturing costs, and position the company to meet increasing demand. CEO Scott Durbin highlighted the operational benefits, including reduced manufacturing risks. Additionally, the company is preparing to launch its pivotal PURSUIT trial focused on improving stress urinary incontinence in the U.S.

Viveve Medical, focusing on women's health, reported Q3 2020 revenues of $1.5 million, up from $1.1 million in Q3 2019. The company has a global installed base of 865 Viveve Systems. Despite COVID-19 challenges, positive results emerged from the stress urinary incontinence (SUI) feasibility study, bolstering the upcoming PURSUIT trial. Total operating expenses dropped to $3.6 million, leading to a net loss of $4.8 million for the quarter. Viveve also received FDA IDE approval for the PURSUIT trial and strengthened its intellectual property with a new SUI patent.