as of 11-09-2026 12:51pm EST
Elutia Inc develops proprietary drug-eluting biomatrix products for use in surgical reconstruction and related applications. These products are designed to improve the interaction between implanted medical devices and patients. Its products include CanGaroo, designed for implantable electronic devices, and SimpliDerm, used in soft tissue repair, with functions related to implant support and wound management. The company operates in two segments: Women's Health and Cardiovascular. The majority of revenue is derived from the Women's Health segment.
| Founded: | 2015 | Country: | United States |
| Employees: | N/A | City: | SILVER SPRING |
| Market Cap: | 35.6M | IPO Year: | 2020 |
| Target Price: | N/A | AVG Volume (30 days): | 73.7K |
| Analyst Decision: | N/A | Number of Analysts: | N/A |
| Dividend Yield: | N/A | Dividend Payout Frequency: | N/A |
| EPS: | -0.35 | EPS Growth: | 146.77 |
| 52 Week Low/High: | $0.50 - $1.39 | Next Earning Date: | 11-05-2026 |
| Revenue: | $12,293,000 | Revenue Growth: | -49.57% |
| Revenue Growth (this year): | -38.99% | Revenue Growth (next year): | -42.67% |
| P/E Ratio: | -2.38 | Index: | N/A |
| Free Cash Flow: | -46686000.0 | FCF Growth: | N/A |
SEC 8-K filings with transcript text
Nov 5, 2026 · 100% conf.
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Exhibit 99.1
Elutia Reports Third Quarter 2026 Results: As Plastic Surgeons Cite Infection Risk in Every Breast Research Session During National Meeting, NXT-41x Heads to FDA This Quarter, Fully Funded Through Launch
●Infection is a Major Unmet Need in Plastic and Reconstructive Surgery: Infection risk was cited in all 11 breast research sessions at the American Society of Plastic Surgeons’ annual meeting, with serious infection rates reported as high as 23%.
●NXT-41x In Vivo Study Supports Planned Q4 2026 FDA Submission: The GLP rabbit antibacterial study achieved its prespecified performance endpoints, with no viable bacteria recovered after either the 8-log MRSA challenges or the 6-log E. coli challenges, demonstrating robust eradication of relevant pathogens.
●$26 Million in Capital Received: Elutia added $26 million without an equity offering, which is expected to fund the company through the anticipated clearance and first full-year of NXT-41x commercialization in 2028.
●Cardiovascular Revenue Grows 20%: Elutia's cardiovascular business delivered 20% year-over-year revenue growth in the third quarter of 2026 and 65% growth for the first nine months of 2026.
GAITHERSBURG, Md., November 5, 2026 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a drug delivery company built to stop surgical infections, today provided a business update and announced financial results for the third quarter ended September 30, 2026.
“Patients and surgeons have been ignored for too long,” said Dr. Randy Mills, Chief Executive Officer of Elutia. “Walking the ASPS annual meeting in Houston, I was astonished by the disconnect between what surgeons are worried about and what industry is offering. Infection came up in all 11 breast research sessions, with rates reported as high as 23%. Those numbers tell the story of an unacceptable problem and the definition of a serious unmet medical need.
“We are out to solve it, and will take the next step this quarter with the NXT-41x FDA submission. After adding $26 million without an equity offering, we believe we have the technology, the team, and the capital to advance NXT-41x toward anticipated clearance in the first half of 2027 and through the first full year of commercial launch in 2028. In doing so, we will help patients thrive without compromise.”
Infection Has Become a Major Focus at ASPS. No Commercial Product Addresses It.
At Plastic Surgery The Meeting 2026 (PSTM 2026), the annual meeting of the American Society of Plastic Surgeons held October 15 to 18 in Houston, the program highlighted a major gap between the prevalence and severity of surgical infections and the lack of products to address them.
Infection risk and prevention were discussed in all 11 breast research sessions, and 70 of 135 (51.9%) oral research presentations addressed infection.
Infection is common despite current best practices. Independent investigators presented data at the meeting showing:
●In a study of 1,094 breasts undergoing immediate implant-based surgery, infection rates were 17.6% in women who did not receive chemotherapy before surgery and 23.0% in those who did (Lopes A, et al., PSTM 2026).
●Another study of 419 breasts treated with perioperative and postoperative antibiotics found infection rates of 19.3% (Fernandez K et al., PSTM 2026).
More systemic antibiotics do not help. In a multicenter study of 4,647 patients at 170 healthcare organizations, extending antibiotics past 24 hours did not reduce infection at 30, 60 or 90 days (Yadav K, et al., PSTM 2026).
The gap on the floor. Despite the intense focus on infection across the scientific program, no commercially available product on the exhibit floor addressed infection in breast surgery. Elutia is developing NXT-41x to address this gap and deliver localized antibiotic therapy directly to the surgical site in reconstructive surgery.
NXT-41x Heads to FDA This Quarter
The FDA review of NXT-41 (biologic surgical matrix without drug) remains on track, with a clearance decision anticipated this quarter. Elutia also intends to submit NXT-41x, its leading drug delivery program, to FDA in the fourth quarter of 2026, following positive results from a key performance study supporting the submission.
NXT-41x demonstrates potent antibacterial activity. NXT-41x is a biologic matrix with an antibiotic coating on one side only. In a GLP rabbit study of infection, the bacterial challenge was applied directly to the uncoated side, a worst-case test. NXT-41x met its predetermined performance endpoints, achieving complete eradication of an 8-log MRSA and a 6-log E. coli challenge, with no viable bacteria recovered from either the matrix or the surrounding tissue. By contrast, 100% of animals implanted with a matrix without antibiotics developed heavy colonization by the offending pathogens. MRSA, short for methicillin-resistant Staphylococcus aureus, is a highly
Aug 13, 2026 · 100% conf.
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Exhibit 99.1
Elutia Secures Up to $26 Million to Fund NXT-41x Through Commercial Launch; Reports Second Quarter 2026 Results
Independent Blinded Survey of 50 Plastic Surgeons Validates Demand; NXT-41 and NXT-41x Remain On-Track
●Funded through launch: secured up to $26 million of capital without an equity offering
●The unmet need is real: 86% of surgeons surveyed say the matrices they use today increase infection risk
●The demand is strong: 96% of surgeons surveyed are interested in adopting NXT-41x; 92% responded they would champion it at their hospital value analysis committee
●On track: NXT-41 FDA clearance decision expected in 4Q 2026; NXT-41x FDA clearance decision expected in 1H 2027
●
GAITHERSBURG, Md., August 13, 2026 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix technologies, today provided a business update and announced financial results for the second quarter ended June 30, 2026.
“We have intentionally focused Elutia where our strengths create the greatest value for patients and shareholders,” said Dr. Randy Mills, Chief Executive Officer of Elutia. “We believe we are now funded through the anticipated clearance and full commercial launch of NXT-41x, our antibiotic-eluting biomatrix for use in plastic and reconstructive surgical procedures. And we did it without an equity offering.
“As we approach anticipated FDA clearance decisions and launch, surgeon interest in NXT-41x has exceeded our expectations. In an independent study of 50 board-certified plastic and reconstructive surgeons, 86% said matrices used today increase infection risk, 96% believed our antibiotic combination would be effective at preventing infection, and 92% said they would help get NXT-41x approved at their hospital’s value analysis committee.
“Having successfully created value with this technology in the pacemaker market, we are now applying it to a larger market with a substantially greater unmet need. And we believe we have the team and capital to execute.”
Capital Secured to Support NXT-41x Through Clearance and Commercial Launch
Elutia has secured up to $26 million of additional capital to support the Company through the anticipated clearance of NXT-41x and its first full year of commercial launch in 2028, without an equity offering:
●$15 million credit facility, including $10 million funded at closing and an additional $5 million available following NXT-41x FDA clearance
●Up to $11 million from the SimpliDerm divestiture, including $8 million in cash at closing and up to $3 million in contingent technology transfer and commercial milestone payments
In addition, the Company anticipates receiving the full $8 million held in escrow from the 2025 divestiture of the BioEnvelope business, with release expected in the fourth quarter of this year.
Independent Blinded Survey Validates Surgeon Demand for NXT-41x
An independent market research firm conducted a blinded survey of 50 board-certified plastic and reconstructive surgeons across 28 states. The surgeons average 11.6 years in practice and perform about 140 complex reconstructive procedures annually.
Surgeons Say the Problem Is Real
●Surgeons estimate a 17% surgical-site infection rate in the published literature for these procedures.
●86% (95% confidence interval (CI): 74–93%) report that matrices used today increase infection risk.
Surgeons View NXT-41x as Differentiated and Mechanistically Sound
●98% (CI: 90–99.6%) rated NXT-41x new and different from products available today.
●96% (CI: 87–99%) rated the combination of rifampin and minocycline effective, with 64% (CI: 50–76%) describing it as extremely effective at reducing surgical site infections. No respondents rated the combination ineffective.
Surgeon Intent to Adopt NXT-41x Is Strong
●100% (CI: 93–100%) indicated they would use NXT-41x in diabetic patients and in patients with high BMI, who together represent approximately one third of all reconstruction patients.
●96% (CI: 87–99%) expressed interest in incorporating NXT-41x into their general practice.
●92% (CI: 81–97%) indicated willingness to approach their hospital value analysis committee in support of NXT-41x.
Interest measures are based on ratings of 4 or 5 on a five-point scale. All results are reported with 95% Wilson confidence intervals; where responses were unanimous, the lower bound of the interval is 93%.
Regulatory Review and Manufacturing Progressing on Schedule
Regulatory and development activities for both NXT-41 (biologic surgical matrix without drug) and NXT-41x continue to advance according to plan. Elutia recently held a productive meeting with the FDA regarding the NXT-41 submission, which remains on track. The Company continues to expect FDA clearance for NXT-41 in the fourth quarter of 2026 and for NXT-41x in the first half of 2027.
Elutia also completed the installati
May 14, 2026 · 100% conf.
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Exhibit 99.1
Elutia Reports First Quarter 2026 Results and Highlights NXT-41x Progress Toward $1.5 Billion U.S. Plastic and Reconstructive Surgery Market
●NXT-41 review advancing collaboratively with FDA, informing NXT-41x submission preparations
●Brought a new automated manufacturing process online, supporting a gross margin target of more than 80% at scale
●Chief Commercial Officer Pete Ligotti's initial surgeon engagement confirming significant unmet need and market opportunity
●Strong balance sheet with $36.5 million in cash and escrowed proceeds from the BioEnvelope business divestiture
●Conference call today at 5:00 p.m. ET / 2:00 p.m. PT
GAITHERSBURG, Md., May 14, 2026 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) ("Elutia" or the "Company"), a pioneer in drug-eluting biomatrix technologies, today reported a business update and financial results for the first quarter ended March 31, 2026.
Dr. Randy Mills, CEO of Elutia, said: "Up to 20% of women undergoing reconstructive surgery after mastectomy develop serious infections. To us, that is unacceptable. That's why we're developing NXT-41x.
"This quarter, we advanced every facet of our mission. The FDA review of NXT-41 is progressing well and is providing valuable insights for the NXT-41x submission. Our new automated manufacturing process is installed and operating, supporting gross margin targets above 80% at scale. Lastly, Pete Ligotti, our new Chief Commercial Officer, is in the field with surgeons, and their feedback confirms both the size and severity of the need.
"It is increasingly clear that in the estimated $1.5 billion breast reconstructive surgery market, NXT-41x has the potential to be a blockbuster and improve outcomes for women with breast cancer. I'm proud of what this team has accomplished and their unwavering commitment to humanizing medicine so patients can thrive without compromise."
Business Highlights
NXT-41 510(k) Review Advancing. FDA review of the 510(k) submission for NXT-41, the base biologic matrix, is progressing through a collaborative dialogue with the agency. Anticipated clearance is on track for the fourth quarter of 2026. The Company's interactions with the FDA during this review have helped to refine the submission package for NXT-41x, an antibiotic-eluting product, with anticipated clearance in the first half of 2027.
Manufacturing Automation Supports an Expected Gross Margin Above 80%. Elutia advanced startup work on the at-scale production equipment required for NXT-41x, including a robotic coating system used to apply the drug-eluting layer to the biologic matrix. The Company expects this manufacturing platform to support a gross margin in excess of 80%, while enabling pricing designed to capture significant market share.
Commercial Launch Confidence Building. Pete Ligotti, Chief Commercial Officer, has spent his first months at Elutia in direct engagement with surgeons across the U.S. breast reconstruction community. Surgeon feedback is confirming the magnitude of the unmet need, with post-operative infection rates of 15 to 20 percent in a $1.5 billion U.S. market that has seen no meaningful innovation in the standard of care. Elutia is conducting quantitative market research to independently validate the scale of the opportunity, helping refine target accounts, patient populations and commercialization priorities ahead of launch.
Strategic Processes for SimpliDerm and Cardiovascular Advancing. The previously announced exploration of a SimpliDerm divestiture is progressing well. Separately, the Company has also received multiple inbound inquiries for the acquisition of its Cardiovascular product line and is evaluating the opportunity. Elutia will provide further updates as appropriate.
Balance Sheet. Total cash and escrow funds at March 31, 2026, were $36.5 million, comprised of $28.5 million in cash on hand and $8.0 million held in escrow related to the BioEnvelope business divestiture, with the escrowed funds expected to be released in the fourth quarter of 2026.
First Quarter 2026 Financial Results
Net sales and operating results discussed below reflect continuing operations. For the three-month period ended March 31, 2026, as compared to the same period of 2025:
●Overall net sales were $3.1 million, compared to $3.0 million, an increase of 6%.
●Net sales of SimpliDerm were $2.1 million, compared to $2.6 million.
●Net sales of Cardiovascular products were $1.0 million, compared to $0.3 million.
●Gross margin on a GAAP basis was 57.9%, compared to 46.8%.
●Adjusted gross margin (a non-GAAP measure which excludes non-cash amortization of intangibles) was 66.5%, compared to 55.9%. A reconciliation of GAAP gross margin to adjusted gross margin is included in the accompanying financial tables.
●Total operating expenses were $8.2 million, consistent with the prior year period.
●Net loss from continuing opera
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