TELA Bio
NASDAQ: TELAMALVERN, PA

Fig. 01 · Market

The company's $1.8B
estimate, by repair type.

OviTex is used in hernia repair and abdominal wall reconstruction; OviTex PRS in plastic and reconstructive surgery. The company's estimate of the total addressable annual U.S. market for OviTex (10-K); not a revenue forecast.

Figure 1Annual U.S. market, by repair type
Complex/moderate ventral and abdominal wall 105,000 repairs $630M Simple ventral 395,000 repairs $590M Inguinal 645,000 repairs $540M Hiatal 42,000 repairs $42M Company estimate (10-K), not a revenue forecast = $1.8B
Annual U.S. total addressable market (OviTex)
$1.8B Company estimate (10-K)

Fig. 02 · Platform

Layers of ovine
tissue, stitched
with polymer thread.

Polymer is about 5% of OviTex Core, 1S and 2S by mass (company, 10-K). Depending on configuration, the company says its polymer content is about 75% less than the most widely implanted permanent synthetic mesh (10-K).

Figure 2Ovine layers, polymer thread
polymer thread layer of ovine rumen tissue OviTex Core four layers OviTex 1S six layers OviTex 2S eight layers
Polymer by mass, OviTex Core, 1S and 2S
~5% Company, 10-K

Fig. 03 · New clearance

Liora, a new mesh,
cleared by the FDA.

FDA 510(k) clearance for the Liora Monofilament Scaffold, announced Oct 5, 2026: cleared for soft-tissue reinforcement, specifically in muscle-flap transfer procedures, as temporary support to help secure the flaps (FDA 510(k) summary). The Oct 5 release gives no launch date or sales.

Figure 3OviTex, OviTex PRS and Liora
OviTex Hernia repair and abdominal wall reconstruction First sold in the U.S. 2016 OviTex PRS Plastic and reconstructive surgery First sold in the U.S. 2019 Liora Resorbable PLGA mesh 510(k) letter Sep 28 · announced Oct 5, 2026 NEW CLEARANCE

A 510(k) clearance is an FDA finding of substantial equivalence to a predicate device; it is not an approval. The FDA summary says that finding was not based on clinical performance data.

Liora 510(k), announced
Oct 5, 2026 8-K · FDA letter Sep 28

Fig. 04 · Revenue

H1 2026 revenue down 1%,
after a 16% rise in 2025.

Q2 revenue was down 4%. The 10-Q cites lower OviTex PRS sales and U.S. price/mix pressure (H1 revenue by line, Note 4: PRS down 15%, OviTex up 5%). 2026 revenue guidance was withdrawn Aug 10 (8-K).

Figure 4Revenue, $M, from a zero baseline
$0 FULL YEAR · 10-K $69.3M FY2024 $80.3M FY2025 +16% FIRST HALF · 10-Q, UNAUDITED $38.7M H1 2025 $38.4M H1 2026 −1%
Net loss, H1 2026
$23.5M H1 2025: $21.2M, up 11% · 10-Q

Fig. 05 · Funding and risk

Substantial doubt
about going concern.

The company's Aug 11 10-Q states substantial doubt about its ability to continue as a going concern, citing recurring losses and a forecast probable miss of its loan's minimum-revenue covenant. Unless waived or amended, default could let the lender accelerate the $60.0M principal (due Nov 2030) and accrued interest; the company does not expect to have the liquidity to repay it.

Figure 5Cash against the term loan, $M
Cash, Dec 31, 2025 $50.8M Cash, Jun 30, 2026 $30.4M Term loan principal at Jun 30, 2026 $60.0M Cash excludes restricted cash (10-Q). Loan at principal, due Nov 2030.

Lenders agreed on Sep 28, after the 10-Q, not to test that covenant for the Q3 and Q4 2026 quarters only (8-K).

Going concern
Substantial doubt 10-Q, Aug 11
Substantial going-concern doubt · 10-Q, Aug 11
View Investor Relations
Forward-looking statements (e.g., Q3 timing, Liora's prospects) are uncertain; actual results may differ materially. Not an offer to sell or buy securities, or investment advice. 2026 figures (H1, Q2, Jun 30 balances) are unaudited. 10-Q: substantial doubt about going concern. Risks: loan covenant default; more financing and dilution; reverse split approved, none intended now; CEO/CFO changes; OviTex made by one contract manufacturer. Figures are from SEC filings through Oct 8; Q3 results (expected early November) may change them. See Risk Factors in TELA Bio's SEC filings.