8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 14, 2023

VIVEVE MEDICAL, INC.

(Exact name of registrant as specified in its charter)

Delaware	1-11388	04-3153858
(State or other jurisdiction of incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)

345 Inverness Drive South, Building B, Suite 250 Englewood, Colorado	80112
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code: (720) 696-8100

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading symbol(s)	Name of each exchange on which registered
Common Stock	VIVE	Nasdaq Capital Market

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

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.

Emerging growth company     ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.     ☐ 

Item 2.05. Costs Associated with Exit or Disposal Activities.

On January 14, 2023, the Board of Directors (the “Board”) of Viveve Medical, Inc. (the “Company”) approved a reduction of the Company’s workforce. The Company expects to record a charge of approximately $25,000 in the first quarter of 2023 relating to the reduction in force, which is expected to consist of healthcare and benefits related costs and expenses. The Company’s management will continue to re-evaluate the estimated costs and expenses set forth above and may revise the estimated restructuring charge as appropriate, consistent with generally accepted accounting principles.

Item 3.01. Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing.

As previously reported, on November 29, 2022, the Company received notice from the Listing Qualifications Staff (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) indicating that, based upon the Company’s non-compliance with the minimum bid price and stockholders’ equity requirements for continued listing on The Nasdaq Capital Market, as set forth in Nasdaq Listing Rules 5550(a)(2) (the “Bid Price Rule”) and 5550(b)(1) (the “Equity Rule”), respectively, the Company’s securities were subject to delisting unless the Company timely requested a hearing before the Nasdaq Hearings Panel (the “Panel”).

On December 5, 2022, the Company requested a hearing before the Panel, which temporarily stayed the suspension of trading and delisting of the Company’s common stock. The hearing is scheduled for January 19, 2023.

As a result of the Company’s business prospects following the Company’s PURSUIT clinical trial as described in Item 8.01 of this Current Report on Form 8-K (including Exhibit 99.1), the Company is unable to present a plan to regain compliance with the Bid Price Rule and the Equity Rule to the Panel at the hearing. Accordingly, Nasdaq will delist the Company by filing a Form 25 Notification of Delisting with the Securities and Exchange Commission. Following the effectiveness of the delisting, the Company intends to file a Form 15 with the Securities and Exchange Commission to suspend its reporting obligations under the Securities Exchange Act of 1934, as amended.

Item 8.01. Other Events.

On January 17, 2023, the Company issued a press release entitled “Viveve Announces Topline Results from Pivotal U.S. PURSUIT Trial for Treating Female Stress Urinary Incontinence.” The press release announced that the Company’s PURSUIT clinical trial did not meet its primary and several secondary endpoints. As a result of Company’s business prospects after the PURSUIT clinical trial, the Company has implemented a significant reduction in force and will explore strategic options, including a sale of the Company’s business or assets or a wind-down of the Company’s operations. The contents of Item 2.05 and Item 3.01 of this Current Report on Form 8-K are incorporated herein by reference. The Company will provide further information when available.

A copy of the Company’s press release is filed herewith as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Description
99.1	Press Release issued by the Company on January 17, 2023.
104	Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: January 17, 2023	Viveve Medical, Inc.
	By:	/s/ Scott Durbin
		Scott Durbin
		Chief Executive Officer

EX-99.1

Exhibit 99.1

Viveve Announces Topline Results from Pivotal U.S. PURSUIT Trial for Treating Female Stress Urinary Incontinence

Study's primary efficacy endpoint was not achieved at 12 months post-treatment

Company has implemented a reduction in force

Company will seek strategic alternatives and will be delisted from Nasdaq

ENGLEWOOD, CO – January 17, 2023 – Viveve Medical, Inc. (NASDAQ: VIVE), a medical technology company focused on women's health and the treatment of female stress urinary incontinence (SUI), today announced topline result from the U.S. Pivotal PURSUIT clinical trial. PURSUIT was a multicenter, randomized, double-blinded, sham-controlled U.S. study to evaluate the safety and efficacy of the Viveve treatment for SUI in women. The results were obtained by the company on Friday evening, January 13, 2023.

The PURSUIT study did not meet its primary endpoint of achieving a statistically significant higher proportion of patients who experienced greater than a 50% reduction in urine leakage compared to baseline on the standardized 1-hour Pad Weight Test at 12 months post-treatment in the active treatment group versus the sham control group. The analysis was conducted on the intent-to-treat population of 415 subjects. Subjects were randomized in a 2:1 ratio for the active (N=279) and the sham (N=136) treatments at approximately 30 clinical sites in the U.S. The proportion of patients with over a 50% reduction in leakage in the active group was 49.8%, and the proportion of patients with over a 50% reduction in leakage in the sham group was 56.7% (p-value = 0.2035). The study also did not meet several secondary endpoints. There were no serious device-related adverse events reported.

"We are extremely disappointed that the PURSUIT trial did not achieve its primary efficacy endpoint. Based on the reported results, we do not see a path forward, nor do we intend to pursue FDA registration of our Viveve® System and its dual-energy treatment for SUI in women," said Scott Durbin, Viveve's chief executive officer.

"We want to thank our investigators, clinical sites, and patients for their dedicated efforts and participation in the U.S. PURSUIT trial. Additionally, I want to personally acknowledge the extraordinary efforts of the entire Viveve organization over the last three years, including our clinical advisors and consultants, for their contributions to Viveve's SUI development program," concluded Mr. Durbin.

Due to the company’s business prospects following the SUI trial, the company has significantly reduced its workforce and intends to explore strategic options, including a sale of the company’s business or assets, and/or a wind-down of the company’s operations.

Further, as previously disclosed, the company’s securities are subject to delisting from the Nasdaq Stock Market unless the company presents a plan to regain compliance with Nasdaq’s continued listing standards before the Nasdaq hearings panel. The company has a hearing before the panel on January 19, 2023. As a result of the company’s business prospects following the SUI trial, the company is unable to present a plan to regain compliance with Nasdaq’s continued listing standards at the hearing. Accordingly, Nasdaq will delist the company by filing a Form 25. Following the effectiveness of the delisting, the company intends to file a Form 15 with the Securities and Exchange Commission to suspend its reporting obligations under the Securities Exchange Act of 1934, as amended.

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 timing, progress and results of our evaluation of strategic alternatives, including whether or not the evaluation of alternatives results in any transaction, 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

XML

Document And Entity Information	Jan. 14, 2023
Document Information [Line Items]
Entity, Registrant Name	VIVEVE MEDICAL, INC.
Document, Type	8-K
Document, Period End Date	Jan. 14, 2023
Entity, Incorporation, State or Country Code	DE
Entity, File Number	1-11388
Entity, Tax Identification Number	04-3153858
Entity, Address, Address Line One	345 Inverness Drive South, Building B, Suite 250
Entity, Address, City or Town	Englewood
Entity, Address, State or Province	CO
Entity, Address, Postal Zip Code	80112
City Area Code	720
Local Phone Number	696-8100
Title of 12(b) Security	Common Stock
Trading Symbol	VIVE
Security Exchange Name	NASDAQ
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity, Emerging Growth Company	false
Amendment Flag	false
Entity, Central Index Key	0000879682