Elutia Inc (NASDAQ: ELUT) is a regenerative medicine and medical device company developing drug-eluting biologic (DEB) products that combine biologic matrices with localized drug delivery for reconstructive surgery. As of the 10-K filed March 13, 2026, Elutia is a pre-commercial stage company focused on its DEB platform following two significant divestitures: the sale of its Orthobiologics Business to Berkeley on November 8, 2023 for approximately $14.6 million upfront plus up to $20.0 million in earn-out payments, and the sale of its CIED Business to BSC CPI on October 1, 2025 for up to $88 million, with $80.4 million paid at closing. Its remaining pipeline centers on NXT-41 and NXT-41x, targeting applications including breast reconstruction. Headquarters are in Gaithersburg, Maryland, in a 26,598-square-foot facility signed in March 2025. The company relies on independent sales agents and direct sales forces to reach physicians and surgeons. Cash needs are expected to be met through equity or debt financing, as the company does not generate meaningful operating revenue from continuing operations.

Revenue model

Elutia does not generate revenue from continuing operations as of the filing date. Its historical revenue came from transactional product sales of CIED and Orthobiologics products, both of which have been divested. Future revenue, if any, would come from commercializing DEB pipeline products, contingent on FDA marketing authorization. Elutia retains earn-out rights of 10% of Berkeley's annual revenue from specified Orthobiologics products for five years post-closing, though no earn-out payments had been received as of the filing date.

Products and services

Current pipeline: NXT-41 and NXT-41x, DEB platform products under development for reconstructive surgery including breast reconstruction. Divested CIED products (sold October 1, 2025): CanGaroo, CanGaroo RM, EluPro, and related CIED envelope products. Divested Orthobiologics products (sold November 8, 2023): included SimpliDerm (human-derived acellular dermis), ProxiCor, Tyke, VasCure, and cardiovascular repair products. EluPro validated the technical feasibility of the DEB platform prior to divestiture.

Customers and end markets

Target customers are physicians, surgeons, and other healthcare professionals performing implant-based and reconstructive procedures. End markets include reconstructive surgery and breast reconstruction. Prior CIED customers were in the cardiac implantable electronic device market. Sales are supported through in-person and online educational programs directed at clinical professionals. No customer concentration data is disclosed in the filing excerpts.

Value-chain role

Elutia is a developer and manufacturer of biologic-based medical products, operating across R&D, manufacturing, and direct commercial sales. It uses a direct sales force supplemented by independent sales agents and commercial partners. Manufacturing for NXT-41 and NXT-41x is planned at its Gaithersburg, Maryland facility, subject to FDA marketing authorization.

Geographic exposure

Elutia's primary operations and headquarters are in Gaithersburg, Maryland. The filing references U.S. markets as the primary commercial focus. No specific international revenue breakdown is disclosed in the filing excerpts.

Competitors

Gore (Gore-tex), Terumo (Vascutek), AbbVie (AlloDerm, Strattice), MTF (FlexHD), Stryker (DermACELL), Evergen, formerly RTI Surgical (Cortiva), Integra (SurgiMend)

Source: SEC 10-K, filed 2026-03-13

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