Form 8-K VIVEVE MEDICAL, INC. For: Oct 28

October 30, 2020 8:37 AM EDT

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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): October 28, 2020

 

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 5.02.

Departure of Directors or Principal Officers; Election of Directors; Appointment of Principal Officer.

 

On October 28, 2020, the Board of Directors (the “Board”) of Viveve Medical, Inc. (the “Company”) appointed Sharon Collins Presnell, Ph.D., to serve as a member of the Board, as an independent Class II director, effective October 28, 2020. Concurrent with her election as a director of the Company, Dr. Presnell was appointed to the Audit Committee of the Board (the “Audit Committee”).

 

There are no arrangements or understandings between Dr. Presnell and any other persons pursuant to which Dr. Presnell was selected as a director of the Company, and, other than disclosed below, there are no transactions in which Dr. Presnell has an interest requiring disclosure under Item 404(a) of Regulation S-K.

 

Dr. Presnell has served as President of the Amnion Foundation, a registered 501(c)3 medical research organization, since January 2019, and as founder and president of the CYTOStrategy Consulting Group, an expert consulting group for pharma and regenerative medicine industries, since November 2018. From January 2015 to November 2018, Dr. Presnell served as President of Samsara Sciences, Inc., a biotechnology company and wholly owned subsidiary of Organovo Holdings, Inc. Dr. Presnell served as Chief Scientific Officer of Organovo, a public medical laboratory and research company, from April 2013 to November 2018, and as Chief Technology Officer and Executive Vice President of R&D of Organovo from May 2011 to March 2013. Dr. Presnell served as Senior Vice President of Regenerative Medicine & Biology of Tengion, Inc., a public development-stage regenerative medicine company, from October 2010 to April 2011, and as Vice President of Regenerative Medicine of Tengion from February 2007 to October 2010. From July 2001 to January 2007, Dr. Presnell served in various roles for Becton, Dickinson and Company, a public medical device and life sciences technology company, most recently served as Director of R&D in Cell and Tissue Biology. Prior to her career with medical device and biotechnology companies, Dr. Presnell was an Assistant Professor at The University of North Carolina at Chapel Hill from June 1998 to June 2001. Dr. Presnell has served as board member of the Coulter Translational Research Partnership at the University of Virginia since 2017, and as a board member of the North Carolina State University College of Life Sciences Foundation since 2016. Dr. Presnell is a member of the American Society of Investigative Pathology, the American Society of Nephrology, and the International Society of Cell Transplantation, serves on the editorial board of the journal “3D Printing and Additive Manufacturing,” and remains an active NIH reviewer as an industry representative in the biomedical engineering space. Dr. Presnell holds a B.S. in Biology from North Carolina State University and a Ph.D. in Experimental & Molecular Pathology from the Medical College of Virginia/Virginia Commonwealth University School of Medicine. The Company believes Dr. Presnell is qualified to serve on its Board because of her academic background, as well as her experience as an executive officer of both publicly and privately held medical and biotechnology research companies.

 

In connection with her appointment and pursuant to the Company’s Independent Director Compensation Policy, as amended and in effect, Dr. Presnell was granted stock options pursuant to the Company’s 2013 Stock Option and Incentive Plan (the “Plan”) to acquire 330,000 shares of the Company’s common stock, par value $0.0001 (the “Common Stock”). The options, which will be evidenced by the Company’s standard form of stock option agreement under the Plan, shall vest in three equal, annual installments over a period of three years following the date of grant, subject to Dr. Presnell’s continued service to the Company through each vesting date, and shall have an exercise price equal to the closing price of the Common Stock on October 28, 2020.

 

 

 

In addition, Dr. Presnell shall receive (i) an equity award in the form of stock options to purchase 165,000 shares of Common Stock following each annual meeting of the Company’s stockholders, and (ii) compensation in accordance with the Company’s standard compensation policies and practices for the Board, the components of which were disclosed in the Company’s Proxy Statement for its 2020 Annual Meeting of Stockholders, filed with the Securities and Exchange Commission on May 18, 2020, in the section titled “Director Compensation.”

 

Dr. Presnell is expected to stand for election to the Board at the 2022 Annual Meeting of the Stockholders.

 

 

 

Item 7.01.

Regulation FD Disclosure.

 

On October 30, 2020, the Company issued a press release announcing the appointment of Dr. Presnell as a director of the Company. A copy of the press release is furnished herewith as Exhibit 99.1 to this report.

 

The information furnished in this Current Report on Form 8-K under this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such a filing.

 

 

 

Item 8.01.

 Other Events.

 

As previously disclosed, on May 4, 2020, Karen Zaderej resigned from the Board, the Audit Committee, the Compensation Committee of the Board, and the Governance and Nominating Committee of the Board, resulting in the Company no longer complying with Nasdaq Listing Rule 5605(b)(1), which requires that the majority of the Board be composed of independent directors, and Nasdaq Listing Rule 5605(c)(2)(A), which requires that the Audit Committee be comprised of at least three directors who meet certain independence and other requirements. The Nasdaq Stock Market LLC ("Nasdaq") provided the Company with a cure period to regain compliance with these listing rules through the earlier of (A) the Company’s next annual meeting of stockholders or (B) November 2, 2020.

 

On October 28, 2020, as disclosed in Item 5.02, Dr. Presnell, whom the Company has determined satisfies the independence standards of the applicable Nasdaq Listing Rules, was appointed to the Board and the Audit Committee.

 

On October 29, 2020, the Company received a letter from Nasdaq noting that, as a result of the appointment of Dr. Presnell to the Board and Audit Committee, the Company evidenced compliance with requirements for continued listing on Nasdaq.

 

 

 

Item 9.01.

Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit

No.

  

Description

  

  

99.1

 

Press Release issued by Viveve Medical, Inc., dated October 30, 2020.

 

 

 

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: October 30, 2020 

Viveve Medical, Inc.

 

  

  

By:  

/s/ Scott Durbin

  

  

  

Scott Durbin 

  

  

  

Chief Executive Officer

  

 

 

 

Exhibit 99.1

 

Viveve Appoints New Independent Board Director

 

 

 

ENGLEWOOD, CO – October 30, 2020 - Viveve Medical, Inc. (NASDAQ: VIVE), a medical technology company focused on women’s intimate health, today announced that Sharon Collins Presnell, Ph.D. has joined the Viveve board of directors and its audit committee, effective October 28, 2020. The appointment of Dr. Presnell brings the company in compliance with the corporate governance requirements under Listing Rules 5605(b)(1) and 5605(c)(2) of the Nasdaq Stock Market.

 

“It is with pleasure that I welcome Dr. Presnell to our board, especially during this period of momentum in our stress urinary incontinence clinical development program,” said Steve Basta, chairman of the Viveve board of directors. “Sharon’s experience spans academic, start-up, and Fortune 500 environments and includes the successful development of both technical and commercial strategies related to cell-based therapies. She brings exceptional research and development experience in cellular pathology and scientific leadership that will contribute greatly as Viveve advances its dual energy technology platform and pivotal PURSUIT trial in stress incontinence.”

 

“We are excited to have Dr. Presnell join the board of directors and recognize the high level of scientific expertise in cellular pathology that she brings to the company. We look forward to working with her to further demonstrate our technology’s cellular mechanism of action in the treatment of female stress urinary incontinence,” remarked Scott Durbin, Viveve’s chief executive officer.

 

Dr. Sharon Presnell currently serves as President of the Amnion Foundation, a not-for-profit organization ethically addressing birth tissue-derived cells in regenerative medicine and drug development. Concurrently, she is the founder/owner of CytoStrategy and provides life sciences consulting services to companies and organizations throughout the U.S. and E.U. Holding a B.S in cellular biology and Ph.D. in experimental pathology, Dr. Presnell transitioned from a university faculty position to Director of R&D at Becton Dickinson. Her previous executive leadership positions in the biotech industry include the role of President at Samsara Sciences, Inc., a wholly owned subsidiary of Organovo, Inc. where she held positions as Chief Scientific Officer, Chief Technology Officer and Executive Vice President of R&D. Sharon has served continuously as a scientific, technical, and translational reviewer for the NIH for over 20 years. Her specialty is developing strategies for the successful development of nascent technologies, including considerations of science, organizational structure, and economic factors.

 

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. The positive topline results reported from the 3-arm feasibility study and the preclinical study outcomes are intended to support the initiation of the pivotal PURSUIT trial and strengthen its potential to achieve its primary efficacy endpoint. As announced on July 7, 2020, Viveve received FDA approval of its Investigational Device Exemption application to conduct the multicenter, randomized, double-blinded, sham-controlled PURSUIT Trial for improvement of SUI in women.

 

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, the outcome of our assessment of strategic alternatives, 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

 

 


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