ELUTNasdaqBiological Products, (No Diagnostic Substances)US GAAP · USD

Elutia, Inc

Elutia Inc. develops proprietary biologic matrix products designed to improve how implanted devices and surgical materials interact with the body. The company has shifted toward a smaller core business after selling its CIED and orthobiologics businesses, and now focuses on biologic products for surgical reconstruction and cardiovascular repair, including SimpliDerm and its NXT-41 pipeline.

Ask about the company
Revenue12.3m USD
−15.0 %y/y
Operating profit (EBIT)-26.9m USD
+12.4 %y/y
EBIT margin-218.9%
−6.6 ppy/y
Net income53.4m USD
+198.9 %y/y
Free cash flow-46.7m USD
−100.3 %y/y

Fiscal year 2025 · change from previous year

Development 2020–2025

-40-200204060m USD2020: 43 m USD2020: EBIT -14 m USD20202021: 47 m USD2021: EBIT -23 m USD20212022: 49 m USD2022: EBIT -32 m USD20222023: 25 m USD2023: EBIT -31 m USD20232024: 14 m USD2024: EBIT -31 m USD20242025: 12 m USD2025: EBIT -27 m USD202512-27
RevenueOperating profit (EBIT)
Ask Clarifo about Elutia, Inc

Business

Share of revenue
Soft tissue reconstruction55 %

Human acellular dermal matrix products used in reconstructive surgery and wound-related applications.

Cardiovascular repair25 %

Biologic repair products used in vascular and cardiovascular surgical procedures.

Pipeline and development programs0 %

NXT-41 and NXT-41x programs intended to extend the biomatrix platform into new indications.

Discontinued CIED products20 %

Cardiac implantable electronic device envelope products sold in the 2025 divestiture.

Customers

Elutia sells primarily to hospitals and other healthcare facilities, with products used by surgeons in reconstructive and cardiovascular procedures. Prior to the 2025 divestiture, its CIED products were used by electrophysiologists and neurosurgeons; the remaining business is centered on surgical end users and the facilities that purchase implantable biologic materials.

Hospitals and healthcare facilities

Buy biologic matrices and repair products for use in operative procedures and implanted reconstruction.

Plastic and reconstructive surgeons

Use SimpliDerm in soft tissue reconstruction where biologic integration and clinical outcomes matter.

Cardiovascular surgeons

Buy cardiovascular repair products for vascular reconstruction and patching applications.

Electrophysiologists and neurosurgeons

Previously bought CIED envelope products such as EluPro and CanGaroo before the 2025 sale.

Strategy

Elutia is repositioning around its remaining biologic matrix platform after divesting non-core businesses. Near term, the company is focused on commercializing SimpliDerm and cardiovascular products while funding NXT-41 and NXT-41x development, with liquidity and capital access central to execution.

Commercialize core biologic productsShort term

The remaining business depends on growing SimpliDerm and cardiovascular sales to replace divested revenue streams.

Advance NXT-41 and NXT-41xMedium term

The pipeline is intended to extend the biomatrix platform into new applications and support future growth.

Strengthen liquidity and capital flexibilityShort term

The company expects operating losses and needs funding to support development and commercialization.

Geography

Elutia is a U.S.-based company with headquarters and primary operations in Gaithersburg, Maryland, plus a corporate office in San Diego. Its commercial activity has been concentrated in the United States, where it sold products through direct sales, independent agents, and, previously, a distribution partner for CIED products.

Risks

Elutia remains exposed to commercialization risk because its future depends on a small set of biologic products and on successful development of NXT-41 and NXT-41x. The company also faces going-concern and financing risk, plus intense competition from established biologic, bovine, and synthetic alternatives in surgical repair markets.

Sorted by severity
LowMediumHighLowMediumHighImpact →Likelihood →Going-concern and financing risk1Commercialization dependence on a narrow product base2Competitive pressure in biologic reconstruction markets3Regulatory and development risk4
Impact is the risk’s severity and likelihood how probable it is over the next few years, both assessed from the company’s reports. Numbers match the list.
  1. Going-concern and financing riskImpact: CriticalLikelihood: Medium

    Management disclosed substantial doubt about the ability to continue as a going concern without additional funding.

    ExposureCash burnEquity issuanceDebtAsset sales
  2. Commercialization dependence on a narrow product baseImpact: HighLikelihood: High

    After divestitures, the company relies on a smaller portfolio to generate revenue and fund operations.

    Exposure: SimpliDerm and cardiovascular repair products

  3. Competitive pressure in biologic reconstruction marketsImpact: HighLikelihood: High

    Competitors offer established acellular dermis, bovine, and synthetic alternatives with pricing and reimbursement advantages.

    Exposure: SimpliDerm and cardiovascular repair products

  4. Regulatory and development riskImpact: HighLikelihood: High

    NXT-41 and NXT-41x require successful development and FDA marketing authorization before they can contribute meaningfully.

    Exposure: Pipeline programs

Ask Clarifo about Elutia, Inc

Accounting

Judgemental items
Revenue recognition timing

Revenue is recognized when control transfers, but consignment and distributor inventory can shift revenue between periods.

Impact: Quarterly sales can be lumpy and harder to compare

Discontinued operations accounting

The orthobiologics and CIED businesses were sold, so results and gains/losses must be separated from continuing operations.

Impact: Reported revenue and margins no longer reflect the divested businesses

Revenue interest obligation

Ligand payments depend on future product sales and include minimum payments, requiring estimation and liability accounting.

Impact: Affects expense recognition and cash flow

Going-concern assessment

Management disclosed substantial doubt about liquidity, which influences disclosure and investor interpretation.

Impact: Signals financing dependence and potential dilution

Similar listed companies

Publicly listed companies with a comparable business focus.

Intellia Therapeutics, Inc.

NTLA · In Vitro & In Vivo Diagnostic Substances

BioCardia, Inc.

BCDA · Biological Products, (No Diagnostic Substances)

Celularity Inc

CELU · Pharmaceutical Preparations

Eledon Pharmaceuticals, Inc.

ELDN · Pharmaceutical Preparations

TELA Bio, Inc.

TELA · Surgical & Medical Instruments & Apparatus

ENvue Medical, Inc.

FEED · Orthopedic, Prosthetic & Surgical Appliances & Supplies

Last updated: 24/09/2026