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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): March 3, 2022

 

TELA Bio, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   001-37526   45-5320061

(State or other jurisdiction of

incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

 

1 Great Valley Parkway, Suite 24

Malvern, Pennsylvania

 

19355
(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number, including area code: (484) 320-2930

 

Not Applicable

(Former name or former address, if changed since last report.)

 

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))

 

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, par value $0.001 per share   TELA   Nasdaq Global Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company x

 

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 8.01 Other Events.

 

On March 3, 2022, TELA Bio, Inc. (the “Company”) issued a press release announcing the commercial launch of the Company’s SiteGuard No Rinse Antimicrobial Solution for use in plastic reconstructive surgery. A copy of this press release is filed as Exhibit 99.1 hereto and incorporated herein by reference.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

The following exhibit is being filed herewith:

 

Exhibit No.

 

Document

99.1   Press Release of TELA Bio, Inc., dated March 3, 2022.
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.

 

  TELA BIO, INC.
   
  By: /s/ Antony Koblish
  Name: Antony Koblish
  Title: President, Chief Executive Officer and Director

 

Date: March 3, 2022

 

 

 

Exhibit 99.1

 

TELA Bio Announces U.S. Commercial Launch of SiteGuardTM No Rinse Antimicrobial Solution

 

Company expands product portfolio with focus on addressing surgical site infections in plastic reconstructive surgery

 

MALVERN, PA March 3, 2022 – TELA Bio, Inc. (NASDAQ: TELA), a commercial-stage medical technology company focused on providing innovative soft-tissue reconstruction solutions that optimize clinical outcomes by prioritizing the preservation and restoration of the patient’s own anatomy, today announced the commercial launch of its SiteGuard No Rinse Antimicrobial Solution for use in plastic reconstructive surgery.

 

SiteGuard utilizes Next Science’s proprietary XBIO® Technology that supports surgical site and post-operative infection control by addressing the biofilms that make bacteria more resistant to traditional antimicrobial agents, disinfectants, and host immune defenses. XBIO Technology deconstructs biofilm, destroys the bacteria enveloped in the solution and defends against bacterial recolonization. There is no known bacterial resistance to XBIO Technology and the no-rinse delivery allows the solution to provide over five hours of ongoing protection against bacterial biofilms with exceptional rates of pathogen removal.

 

“SiteGuard is a complementary technology that we believe enhances our mission to deliver a portfolio of next-generation soft-tissue solutions that are both clinically effective and economically impactful,” said Antony Koblish, President and CEO of TELA Bio. “Early test market experience with SiteGuard has been encouraging and we look forward to broadening awareness and usage of the technology nationwide.”

 

In November 2021, TELA Bio entered into an exclusive distribution agreement to market Next Science’s proprietary antimicrobial surgical wash in the US plastic reconstructive surgery market. SiteGuard is the first adjunctive soft-tissue technology that we believe will complement TELA Bio’s soft-tissue preservation and restoration mission which prioritizes leveraging the patient’s natural healing response while minimizing the long-term exposure to permanent synthetic materials.

 

About TELA Bio, Inc.

 

TELA Bio, Inc. (NASDAQ: TELA) is a commercial-stage medical technology company focused on providing innovative technologies that optimize clinical outcomes by prioritizing the preservation and restoration of the patient’s own anatomy. The Company is committed to providing surgeons with advanced, economically effective soft-tissue reconstruction solutions that leverage the patient’s natural healing response while minimizing long-term exposure to permanent synthetic materials. For more information, visit www.telabio.com.

 

 

 

Caution Regarding Forward-Looking Statements

 

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations are forward-looking statements and reflect the current beliefs of TELA's management, including with respect to the commercial launch of SiteGuard. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated by such forward-looking. These risks and uncertainties are described more fully in the "Risk Factors" section and elsewhere in our filings with the Securities and Exchange Commission and available at www.sec.gov, including in our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Any forward-looking statements that we make in this announcement speak only as of the date of this press release, and TELA assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise after the date of this press release, except as required under applicable law.

 

Investor Contact

Greg Chodaczek

347-620-7010

ir@telabio.com

 

Media Contact

Alyson Kuritz

908-892-7149

alyson@0to5.com