Elutia (NASDAQ:ELUT) reported second-quarter 2026 net sales of $2.4 million, down from $2.7 million a year earlier, while outlining plans to concentrate its resources on the development and commercialization of its NXT-41x drug-eluting surgical matrix for plastic and reconstructive surgery.
President and CEO Randy Mills said the company secured up to $26 million in additional capital through a credit facility and the planned sale of its SimpliDerm business, without issuing equity. Elutia expects the funding, together with existing cash and other anticipated proceeds, to support operations through the expected regulatory review and commercial launch of NXT-41x.
Sales Decline as SimpliDerm Production Is Disrupted
For the first six months of 2026, net sales were $5.5 million, compared with $5.7 million in the comparable prior-year period.
Elutia reported a GAAP gross margin of 59.6% for the second quarter, compared with 52.9% a year earlier. Adjusted gross margin, which excludes non-cash amortization of intangible assets, rose to 70.7% from 62.7%.
Total operating expenses fell to $9.4 million from $9.8 million. Net litigation costs declined by $1.9 million, while research and development expense increased by $1.5 million as the company continued work on NXT-41 and NXT-41x.
- Loss from operations was $8.0 million, compared with $8.4 million a year earlier.
- Net loss was $7.6 million, compared with $9.6 million in the prior-year quarter.
- Net loss from continuing operations was $7.6 million, compared with $7.1 million a year earlier.
- Adjusted EBITDA loss was $4.6 million, compared with a $3.0 million loss in the prior-year period.
Ferguson said the year-over-year improvement in overall net loss primarily reflected the absence of losses from the BioEnvelope business, which Elutia sold to Boston Scientific in October 2025 and now reports as discontinued operations.
Divestitures and Financing Support NXT-41x Focus
Elutia entered into a definitive agreement on July 11 to sell SimpliDerm for up to $11 million. The consideration includes $8 million in cash at closing and up to $3 million tied to technology-transfer and commercial milestones. The company expects the transaction to close during the third quarter.
The company also said it is continuing a strategic process involving its cardiovascular business, with a potential transaction anticipated in 2026. Following the completion of the divestiture efforts, Mills said Elutia intends to focus primarily on NXT-41x and the U.S. plastic and reconstructive surgery market, which the company estimates at approximately $1.5 billion.
Elutia ended the quarter with $19.9 million in cash. Since quarter-end, it received an initial $10 million under a $15 million credit facility with Avenue Capital Group. An additional $5 million would become available upon FDA clearance of NXT-41x.
The company also expects to receive $8 million in escrow from the prior BioEnvelope transaction at the start of the fourth quarter. Ferguson said that cash on hand and current or anticipated transaction proceeds total approximately $54 million, which Elutia believes provides funding through at least 2028.
Regulatory Timeline and Manufacturing Plans
NXT-41, the company’s biologic surgical matrix without an antibiotic component, remains under FDA review. Mills said Elutia recently held a meeting with the agency to discuss questions related to its submission and came away feeling positive about the program’s progress.
The company continues to expect a favorable clearance decision for NXT-41 in the fourth quarter of 2026. Elutia expects NXT-41x, which combines the matrix with local delivery of rifampin and minocycline, to receive FDA clearance in the first half of 2027.
Management said it plans a limited NXT-41x launch in the second half of 2027, focused largely on gaining approval from hospital value analysis committees, followed by a full commercial launch in 2028.
Elutia said it completed installation and operational qualification of an automated drug-coating system during the quarter, and that the system has produced NXT-41x. The company manufactures the product at its GMP facility in Gaithersburg, Maryland and said it is targeting gross margins above 80% at scale.
During the question-and-answer session, Mills said the company expects to have manufacturing capacity supporting at least $300 million in revenue at launch. He said future expansion would primarily require added personnel and production shifts rather than new space, equipment or production lines.
Surgeon Survey Points to Interest in NXT-41x
Elutia highlighted findings from an independently conducted, blinded survey of 50 board-certified plastic and reconstructive surgeons across eight states. According to Mills, respondents averaged 11.6 years in practice and performed roughly 140 implant-based reconstructions annually.
Survey participants estimated surgical-site infection rates at 17%, and 86% said the matrices they currently use increase the risk of surgical-site infection, according to the company.
Among other findings cited by Elutia:
- 96% of surveyed surgeons rated the rifampin and minocycline combination as effective at reducing surgical-site infection.
- 98% viewed NXT-41x as new and different from products currently available.
- All 50 respondents indicated they would use the product for high-risk patients, including patients with diabetes or high body mass index.
- 96% expressed interest in incorporating NXT-41x into their general practice.
- 92% said they would be willing to support the product before their hospital’s value analysis committee.
Mills said the company views hospital value analysis committees as a key gatekeeper for adoption and plans to use the limited 2027 launch period to build support within those organizations.
About Elutia (NASDAQ:ELUT)
Elutia, Inc is a biopharmaceutical company focused on the development of novel nitric oxide therapies based on its proprietary polymeric nitric oxide platform. This technology is designed to enable sustained, controlled release of nitric oxide to targeted tissues, potentially overcoming the delivery challenges associated with gaseous nitric oxide and small?molecule donors.
The company’s lead program is in preclinical development for pulmonary arterial hypertension, with additional research efforts aimed at other cardiovascular and respiratory conditions.
