Form 8-K

8-K — TELA Bio, Inc.

Accession: 0001104659-26-113506

Filed: 2026-10-05

Period: 2026-10-05

CIK: 0001561921

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — tm2627013d1_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (tm2627013d1_ex99-1.htm)

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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 5, 2026

TELA Bio, Inc.

(Exact name of registrant as specified in its

charter)

Delaware

001-39130

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 ¨

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 October 5, 2026, TELA Bio, Inc. issued a press release announcing

that it has received U.S. Food and Drug Administration 510(k) clearance for its Liora Monofilament Scaffold product. 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:

Exhibit

Number

Description

99.1

Press

Release of TELA Bio, Inc., dated October 5, 2026.

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/ Heather Getz

Name:

Heather Getz

Title:

Chief Executive Officer and Director

Date: October 5, 2026

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2627013d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

TELA Bio Announces

510(k) Clearance for LioraTM Monofilament Scaffold for Soft Tissue Reinforcement

MALVERN, PA, October 5, 2026 -- TELA Bio, Inc. (“TELA

Bio” or the “Company”), a commercial-stage medical technology company focused on providing innovative soft-tissue reconstruction

solutions, today announced that the U.S. Food and Drug Administration has granted 510(k) clearance for the Company's Liora Monofilament

Scaffold (“Liora”) product.

Liora is a fully resorbable surgical mesh device for soft tissue reinforcement

that will enable TELA Bio to expand its footprint in the soft tissue reconstruction market and is the first implant to be fully developed

in the Company’s ISO 8 certified cleanroom in Malvern, PA.

“FDA 510(k) clearance is a significant milestone for TELA

Bio as Liora is the first fully resorbable synthetic product in our portfolio to be designed and produced in-house by our team of innovative

engineers,” said Heather Getz, CEO of TELA Bio. “The addition of Liora to our portfolio expands the options available to surgeons

and patients for their soft tissue reconstruction needs.”

The Company will provide more details on the upcoming third quarter

earnings call, expected to be hosted in early November.

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 Bio's management. Such

forward-looking statements include, without limitation, statements relating to the anticipated benefits from the Company’s cost

reduction initiatives; and other statements regarding the Company’s future plans, objectives, and financial and operational performance.

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 statements, including, but not limited to statements relating to

the anticipated benefits and commercial opportunity arising from the 510(k) clearance of the Liora Monofilament Scaffold; the impact

to our business from macroeconomic conditions, including recessionary concerns, banking instability, increasing market interest rates,

monetary policy changes, changes in trade policies, including tariffs and trade protection measures, and inflationary pressures, potentially

impacting our ability to market our products, including the launch of new products; demand for our products related to changes in volumes

or frequency of surgical procedures, including due to outbreak of illness or disease, cybersecurity events impacting hospital operations,

potential hospital closures, labor and hospital staffing shortages, supply chain disruptions to critical surgical and hospital supplies,

pricing pressures or any other applicable adverse healthcare economic factors; our ability to achieve or sustain profitability; our ability

to gain market acceptance for our products and to accurately forecast and meet customer demand; our ability to compete successfully; our

ability to successfully reduce our operating expenses through our cost reduction initiatives and to realize the anticipated benefits from

such initiatives; that data from earlier studies related to our products and interim data from ongoing studies may not be replicated in

later studies or indicative of future data; our ability to enhance our product offerings, including successful launch of new products;

our ability to maintain expanded market access; product development and manufacturing problems; capacity constraints or delays in production

of our products; maintenance of coverage and adequate reimbursement for procedures using our products; and product defects or failures.

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 Bio 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

Louisa Smith

ir@telabio.com

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