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BCS

Current Report · Items 8.01, 9.01 · 8-K

TELA Bio, Inc.

TELANASDAQEQUITYCurrent

Other Events

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.

Filed Oct 5, 2026Accepted Oct 5, 2026, 8:05 AM EDTCIK 1561921Accession 0001104659-26-113506
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Company context

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.

Current securities

Recent company filings

  1. Submission of Matters to a Vote of Security HoldersOct 8, 2026
  2. Other EventsOct 6, 2026
  3. Entry into a Material Definitive AgreementSep 29, 2026
  4. Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of ListingSep 18, 2026
  5. 4 filingSep 16, 2026

Registered securities in this filing

TELA Bio, Inc. · 8-K · Filed 2026-10-05

As filed in this accession. Current/historical status below comes from the governed listing record; the cover itself remains exact to this filing.

Common Stock, par value $0.001 per share

Symbol
TELA
Exchange
NASDAQ
Classification
COMMON
Status
Current
Filing context

Context: AsOf2026-10-05

Dimensions: Not supplied

Accession 000110465926113506 · 1 registered-security cover member

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Disclosure sections

Items 8.01, 9.01

Select an item to read the extracted section. The as-filed document remains the primary evidence.

Item 8.01Item 8.01 - Other Events
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.
Filed exhibits (1)
EX-99.1 (by filename) tm2627013d1_ex99-1.htm

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 earn…

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