Elutia (NASDAQ:ELUT) plans to submit its lead drug-delivery product, NXT-41x, to the Food and Drug Administration in the fourth quarter after a preclinical study met its specified endpoints, executives said on the company’s third-quarter earnings call.
CEO Randy Mills said Elutia expects an FDA clearance decision in the second quarter of 2027, followed by a soft commercial launch in the second half of that year and a full launch in 2028. The timetable is subject to regulatory review.
The company reported $1.1 million in third-quarter net sales from continuing operations, up 20% from a year earlier, while its net loss from continuing operations widened to $6.5 million from $1.0 million. The earlier period benefited from a $5.1 million noncash gain on the revaluation of warrant liabilities, CFO Matt Ferguson said.
Study Results and Regulatory Plans
NXT-41x is being developed as a drug-delivering surgical matrix for use in plastic and reconstructive surgery. Mills said infection remains a significant problem in breast reconstruction, citing research presented at a recent American Society of Plastic Surgeons meeting.
In a laboratory-practice-compliant rabbit implant study, NXT-41x met its prespecified performance endpoints after being challenged with MRSA and E. coli, Mills said. After seven days, researchers recovered no viable bacteria from the NXT-41x samples or surrounding tissue, while every animal receiving the matrix without antibiotics developed bacterial colonization, he said.
Mills also said a surgeon steering committee gave favorable feedback on the product’s design, handling and performance. He said surgeons emphasized the importance of distributing antibiotics across the surgical site and providing coverage through drain removal.
Elutia has a separate FDA submission for NXT-41, a surgical matrix without drugs, and expects a clearance decision this quarter. Mills said the company does not intend to commercialize NXT-41; instead, it used the submission to address regulatory questions about the underlying matrix. He said the two products are on independent pathways and NXT-41x does not depend on NXT-41 clearance.
During his closing remarks, Mills referred to a “second quarter submission” for NXT-41x, although he repeatedly said elsewhere on the call that Elutia planned to submit the product this quarter and expected a clearance decision in the second quarter of 2027. He cautioned that the clearance estimate could change, saying a decision could come as early as April or as late as September.
Mills said major performance testing is complete and the company is assembling the submission. Shelf-life stability testing is ongoing, he said.
Funding and Cardiovascular Business
Elutia ended September with $29.1 million in cash and cash equivalents. That figure excludes an $8 million holdback from Boston Scientific related to the 2025 sale of Elutia’s BioEnvelope business, which the company received on Oct. 1.
Ferguson said Elutia had added $26 million without an equity offering through the Boston Scientific payment, $8 million from the sale of its SimpliDerm business and $10 million received at the closing of an Avenue Capital Group loan facility. A further $5 million under the facility becomes available after NXT-41x FDA clearance, and Elutia is eligible for up to $3 million in contingent SimpliDerm technology-transfer payments.
Management believes the available funding will carry the company through anticipated NXT-41x clearance and the first year of its commercial launch, Ferguson said.
The company is also pursuing a potential sale of its cardiovascular product line. That business generated $1.1 million in third-quarter revenue, up 20% year over year, and revenue increased 65% in the first nine months of 2026, Ferguson said. He described interest from multiple parties and said a transaction was possible this quarter.
Mills said Elutia would sell the business only if the terms made sense, noting that it is growing and has high gross margins. “We’re not going to rush to get a bad deal done,” he said.
Launch Spending and Quarterly Results
Elutia has begun recruiting sales leadership and representatives, with a goal of covering 16 major U.S. territories by the end of 2027, Mills said. Those territories provide access to approximately half of the breast reconstruction market, he said. The company expects to use mostly direct representatives, supplemented by independent contractors.
Fergus said Elutia was still preparing its 2027 budget but aims to keep its cash burn rate from changing substantially as it moves toward launch.
Third-quarter operating expenses rose to $7.6 million from $6.4 million, driven by higher research and development spending that was partly offset by lower net litigation costs. The operating loss widened to $6.9 million from $5.9 million. Adjusted EBITDA was a loss of $5.6 million, compared with a $3.4 million loss a year earlier.
Gross margin under generally accepted accounting principles improved to 61.7% from 52.8%. Adjusted gross margin, which excludes noncash amortization of intangibles, rose to 85.5% from 81.3%, Ferguson said.
About Elutia (NASDAQ:ELUT)
Elutia Inc is a medical technology company focused on developing and commercializing biologic products designed to support tissue healing and improve the performance of implantable medical devices. The company combines human tissue-based materials with drug-delivery and regenerative medicine technologies.
Its product portfolio includes biologic envelopes used to protect and support cardiac implantable electronic devices, including pacemakers and defibrillators. Elutia also develops tissue matrices and other biologic products for orthopedic, wound care and related surgical applications, with products intended to support soft-tissue repair, reconstruction and healing.
The company was formerly known as Aziyo Biologics and adopted the Elutia name as part of its broader focus on bioelectronic medicine and regenerative healthcare.
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