Form 8-K VIVEVE MEDICAL, INC. For: 03 August

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UNITED STATES SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 8-K

REPORT IN PROGRESS

In compliance with Article 13 or 15 (d) of the

1934 Stock Exchange Act

Report date (Date of first reported event): August 3, 2021

VIVEVE MEDICAL, INC.

(Exact name of the declarant as specified in his charter)

Delaware

1-11388

04-3153858

(State or other jurisdiction of

incorporation)

(Commission file number)

(IRS employer

ID number.)

345 Inverness Drive South, Building B, Suite 250

Englewood, Colorado

80112

(Address of the main executive offices)

(Postal code)

Cardholder phone number including area code: (720) 696-8100

Securities registered under section 12 (b) of the Act:

Title of each class Trading symbol (s)

Name of each exchange on which

registered

Ordinary actions LIVE Nasdaq Capital Market

Check the appropriate box below if the filing of Form 8-K is intended to simultaneously satisfy the filer obligation under any of the following provisions:

Written communications in accordance with Rule 425 of the Securities Act (17 CFR 230.425)

Solicitation of documents in accordance with Rule 14a-12 of the Exchange Act (17 CFR 240.14a-12)

Pre-launch communications in accordance with Rule 14d-2 (b) of the Exchange Act (17 CFR 240.14d-2 (b))

Pre-launch communications pursuant to Exchange Act Rule 13e-4 (c) (17 CFR 240.13e-4 (c))

Indicate with a check mark whether the declarant is an emerging growth company within the meaning of Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.

Emerging, growing company ☐

If it is an emerging growth company, indicate with a check mark whether the declarant has chosen not to use the extended transition period to comply with the new financial or revised accounting standards provided for under Article 13 (a) of the Exchange Act. ☐

Item 7.01.

FD Regulation Disclosure.

On August 3, 2021, the Company issued a press release entitled “Viveve Announces Continued Expansion of Its Intellectual Property Portfolio with Grant of Canadian Patent”. A copy of the Company’s press release is attached hereto as Exhibit 99.1 to this current report on Form 8-K and incorporated herein by reference.

The information in Section 7.01 of this current report on Form 8-K, including the attached Exhibits 99.1, is provided and will not be considered “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934. , as amended (the “Exchange Act”), or otherwise subject to the obligations of this section, neither shall it be deemed to be subject to the requirements of amended section 10 of the SK Regulation, nor shall it be deemed to be incorporated by reference in any filing of the Company under the Titles Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any language of general incorporation in such filing. The provision of this information hereby should not be taken as an admission as to the importance of this information.

Item 9.01.

Financial statements and supporting documents.

(d) Exhibitions

SIGNATURES

In accordance with the requirements of the Securities Exchange Act of 1934, the declarant has duly caused this report to be signed on his behalf by the undersigned, duly authorized.

Date: August 3, 2021

Viveve Medical, Inc.

By:

/ s / Scott Durbin

Scott Durbin

Chief Executive Officer

Room 99.1

Viveve Announces Continued Expansion of Its Intellectual Property Portfolio with Canadian Patent Grant

Englewood, CO August 3, 2021 Viveve Medical, Inc. (NASDAQ: VIVE), a medical technology company focused on the intimate health of women, today announced that the Canadian Intellectual Property Office (CIPO) has recently issued Canadian Patent No. 3028905 for the Viveve dual energy device and method. The granted patent further strengthens the Company’s intellectual property portfolio.

“We are delighted that the Canadian patent has been granted for our dual-energy device. The addition of this new patent strengthens our intellectual property portfolio, which was recently expanded by a US patent, two Asia-Pacific patents in South Korea and Taiwan, respectively, and a US patent on urinary incontinence in l ‘effort (UIE) issued in fall 2020, ”said Scott Durbin, CEO of Viveve. “We look forward to continuing to advance our global clinical development and commercialization strategy supported by our strong intellectual property heritage. “

About Viveve

Viveve Medical, Inc. is a medical technology company focused on the intimate health of women. Viveve is committed to providing new solutions to improve the general well-being and quality of life of women. The internationally patented Viveve® system incorporates cryogen-cooled monopolar radio frequency technology to uniformly provide volumetric heating while gently cooling surface tissues to generate neocollagenesis in a single 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 authorizations have been received for vaginal laxity and / or improved indications of sexual function in over 50 countries.

Viveve continues to advance its clinical development program in SUI. The recently reported and FDA approved modifications to the US PURSUIT Pivotal Trial protocol are intended to strengthen the overall study and its potential to meet its primary efficacy endpoint. The changes to the study, including an increase in trial size and more stringent patient selection criteria, are the result of advice from Viveve’s clinical advisory committee after reviewing the positive results of the feasibility and preclinical studies. of the company’s EUI. Viveve received FDA approval of its IDE application to conduct the multi-center, randomized, double-blind, sham-controlled PURSUIT trial for improvement of SUI in women in July 2020 and the FDA approval of its requested changes to the IDE protocol, as reported on Dec. 10. 2020. The trial launch was reported on January 21, 2021 and subject recruitment is underway. If positive, PURSUIT trial results may support new indication of SUI in US

For more information, visit www.viveve.com.

Safe Harbor Declaration

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. Statements forward-looking statements included in this press release about its current expectations, the information on which those expectations were based may change. These forward-looking statements are based on a number of assumptions about future events and are subject to a number of risks, uncertainties and other factors, many of which are beyond our control, which could cause the results actual differ significantly from these statements. These risks, uncertainties and other factors include, but are not limited to, fluctuating global economic conditions, the impact of the novel coronavirus called COVID-19 on our clinical development and regulatory review and approvals, and on manufacturing, placements. and patient use. of our Viveve Systems, the performance of management and our employees, our ability to obtain financing, our assessment of strategic alternatives, our ability to obtain approval or authorization to sell our medical device for all the indications sought , competition, general economic conditions and other factors which are detailed in our periodic and current reports available for review at www.sec.gov. In addition, we operate in a highly competitive and rapidly changing environment where new and unforeseen risks may arise. Therefore, investors should not rely on forward-looking statements as a prediction of actual results. We disclaim any intention and assume no obligation to update or revise any forward-looking statements to reflect events or circumstances which subsequently occur or of which we subsequently become aware, except as required by law.

Viveve is a registered trademark of Viveve, Inc.

Investor Relations Contacts:
Amato and Partners, LLC
Investor Relations Advisor
[email protected].com

Media contact:
Bill berry
Public Relations Berry & Company
(212) 253-8881
[email protected]


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