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
Continuing-operations losses widened despite higher revenue and gross margin, while Elutia expects its funding to cover commercialization through 2028.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Elutia (ELUT) reported third-quarter revenue growth while preparing a fourth-quarter 2026 FDA submission for its NXT-41x antibiotic-coated surgical matrix. Revenue rose 20.4% to $1.137 million, and GAAP gross margin increased to 61.7% from 52.8%. Continuing-operations net loss widened to $6.5 million from $1.0 million; overall net loss narrowed to $1.3 million from $3.9 million.
NXT-41x met prespecified endpoints in a rabbit antibacterial study, with no viable bacteria recovered after either bacterial challenge. Elutia expects a clearance decision in the first half of 2027, a soft launch in the second half and full commercialization in 2028. It received $26 million without an equity offering through asset-sale proceeds, an escrow release and borrowing, which it expects to fund operations through the first full commercial year. September-end cash was $29.1 million, excluding an $8 million receipt on October 1.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Major pointBoston Scientific released the full $8 million escrow on October 1, 2026. 24% of market cap
- Major pointSimpliDerm sale to Cellution Biologics closed August 17, providing $8 million at closing. 24% of market cap
- Major point. Forward-looking: it has not happened yet and may not happen.Avenue Capital facility provided $10 million at closing, with another $5 million available after NXT-41x FDA clearance. 30% of market cap
- Moderate point. Forward-looking: it has not happened yet and may not happen.NXT-41x FDA submission planned for fourth-quarter 2026 following the antibacterial study.
- Moderate point. Forward-looking: it has not happened yet and may not happen.NXT-41x clearance decision expected first-half 2027; soft launch planned second-half 2027 and full launch in 2028.
- Moderate pointThird-quarter revenue increased 20.4% to $1.137 million from $944,000 a year earlier.
- Moderate pointNine-month Cardiovascular revenue grew 65%; net sales reached $3.306 million versus $2.007 million.
- Moderate pointThird-quarter GAAP gross margin increased to 61.7% from 52.8% a year earlier.
- Moderate pointThird-quarter net loss narrowed to $1.3 million from $3.9 million a year earlier.
- Moderate pointNine-month operating loss narrowed to $21.846 million from $22.277 million a year earlier.
8 minor points
- Minor pointNXT-41x rabbit study met prespecified endpoints, with no viable bacteria recovered after either bacterial challenge.
- Minor point. Forward-looking: it has not happened yet and may not happen.NXT-41 FDA clearance decision remains expected in fourth-quarter 2026.
- Minor point. Forward-looking: it has not happened yet and may not happen.Elutia expects funding to last through 2028's first full commercial year, without requiring a Cardiovascular sale.
- Minor pointThird-quarter adjusted gross margin, excluding intangible amortization, increased to 85.5% from 81.3%.
- Minor pointThird-quarter sales and marketing expense fell to $756,000 from $921,000 a year earlier.
- Minor pointThird-quarter net litigation costs decreased to $117,000 from $853,000 a year earlier.
- Minor pointThird-quarter discontinued operations generated $5.2 million income, versus a $2.8 million loss a year earlier.
- Minor point. Forward-looking: it has not happened yet and may not happen.Automated coating capacity supports at least $300 million in revenue; Elutia targets gross margins above 80% at scale.
Negative
- Major pointAvenue Capital's $15 million loan facility adds borrowing obligations; $10 million was funded at closing. 45% of market cap
- Moderate pointThird-quarter continuing-operations net loss widened to $6.5 million from $1.0 million a year earlier.
- Moderate pointThird-quarter operating loss widened to $6.896 million from $5.869 million a year earlier.
- Moderate point. Forward-looking: it has not happened yet and may not happen.SimpliDerm payments of up to $3 million over 18 months depend on technology-transfer and commercial milestones. 9% of market cap
- Moderate pointSeptember-end cash declined to $29.093 million from $36.350 million at December 31, 2025, before October's escrow receipt.
- Moderate pointStockholders' equity declined to $15.325 million from $27.672 million at December 31, 2025.
4 minor points
- Minor pointThird-quarter adjusted EBITDA loss widened to $5.6 million from $3.4 million a year earlier.
- Minor pointThird-quarter research and development expense increased to $2.977 million from $1.088 million a year earlier.
- Minor pointThird-quarter general and administrative expense increased to $3.748 million from $3.505 million a year earlier.
- Minor point. Forward-looking: it has not happened yet and may not happen.Additional Avenue funding of $5 million depends on NXT-41x FDA clearance.
Key Figures
- Net sales
- $1.1 million vs. $0.9 million; up 20.4%
- Third quarter 2026 vs. third quarter 2025
- GAAP gross margin
- 61.7% vs. 52.8%
- Third quarter 2026 vs. third quarter 2025
- Adjusted gross margin
- 85.5% vs. 81.3%
- Non-GAAP; third quarter 2026 vs. third quarter 2025
- Net loss from continuing operations
- $6.5 million vs. $1.0 million
- Third quarter 2026 vs. third quarter 2025
- Net loss
- $1.3 million vs. $3.9 million
- Third quarter 2026 vs. third quarter 2025
- Capital received
- $26 million
- Added without an equity offering
- Bacterial challenge results
- 8-log MRSA and 6-log E. coli challenges; no viable bacteria recovered
- GLP rabbit antibacterial study
- Revenue capacity
- At least $300 million
- Automated drug-coating system positioned for commercial production
Previous Earnings Reports
-
Reported up to $26 million in non-equity funding and milestones for NXT-41x through launch.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
mrsa medical
adjusted ebitda financial
non-gaap financial
AI-generated analysis. How Rhea-AI works. Not financial advice.
- 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 delivered20% year-over-year revenue growth in the third quarter of 2026 and65% growth for the first nine months of 2026.
GAITHERSBURG, Md., Nov. 05, 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 “We are out to solve it, and will take the next step this quarter with the NXT-41x FDA submission. After adding |
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 (
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 and23.0% 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,
Surgeons back the approach. At PSTM 2026, Elutia held an in-person meeting of its NXT-41x Surgeon Steering Committee, which provided very positive feedback on the design and performance of NXT-41x. Surgeons were clear: “It’s about the drugs being in the right place at the right time.” For NXT-41x, the right place means powerful antibiotics uniformly distributed across the entire surgical site, where systemic antibiotics fail to reach. The right time means 30 days of coverage, through drain removal.
Built for launch. Elutia’s automated drug-coating system is positioned for commercial production, with at least
Funding Milestones Achieved
Elutia delivered all three funding milestones it named in August, on schedule:
- October 1: Boston Scientific released the full
$8 million held in escrow from the 2025 sale of the BioEnvelope business, with no claims. - August 17: Elutia closed the sale of its SimpliDerm business to Cellution Biologics Inc., receiving
$8 million at closing. Elutia is also eligible to receive up to$3 million in contingent technology transfer and commercial milestone payments over 18 months. - August 11: Elutia closed a
$15 million loan facility with Avenue Capital Group, with$10 million funded at closing and an additional$5 million available following NXT-41x FDA clearance.
Collectively, these transactions added
Cardiovascular sales grew
Funded Catalysts
| Milestone | Expected Timing |
| Avenue loan, SimpliDerm close, | Delivered |
| NXT-41 FDA clearance decision | 4Q 2026 |
| NXT-41x FDA submission | 4Q 2026 |
| Potential Cardiovascular transaction | 4Q 2026 |
| NXT-41x FDA clearance decision | 1H 2027 |
| NXT-41x commercial soft launch | 2H 2027 |
| NXT-41x full commercial launch | 2028 |
Third Quarter 2026 Financial Results
Net sales and operating results discussed below reflect continuing operations. For the three-month period ended September 30, 2026, as compared to the same period of 2025:
- Net sales were
$1.1 million , compared to$0.9 million , an increase of20.4% . - Gross margin on a GAAP basis was
61.7% , compared to52.8% . - Adjusted gross margin (a non-GAAP measure which excludes non-cash amortization of intangibles) was
85.5% , compared to81.3% . A reconciliation of GAAP gross margin to adjusted gross margin is included in the accompanying financial tables. - Total operating expenses were
$7.6 million , compared to$6.4 million . The increase was driven by a$1.9 million increase in research and development expense supporting the NXT-41 and NXT-41x programs, partially offset by a$0.7 million reduction in net litigation costs. - Loss from operations was
$6.9 million , compared to$5.9 million . - Net loss from continuing operations was
$6.5 million , compared to$1.0 million . - Income from discontinued operations was
$5.2 million , compared to a loss of$2.8 million . - Net loss was
$1.3 million , compared to$3.9 million . - Adjusted EBITDA (a non-GAAP measure that excludes from net loss certain non-operating, non-cash and non-recurring items) was a loss of
$5.6 million , compared to a loss of$3.4 million . A reconciliation of net loss to adjusted EBITDA is included in the accompanying financial tables. - Cash and cash equivalents at September 30, 2026 were
$29.1 million . On October 1, 2026, the Company received the$8 million Boston Scientific holdback, which is not included in this balance.
Conference Call
Elutia will host a conference call on November 5, 2026 at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time to discuss its third quarter 2026 financial results and business performance. The conference call can be accessed using the following information:
Webcast: Click here
Dial-In: Click here
To receive the dial-in number, as well as your personalized PIN, you must register at the above link. Once registered, you will also have the option to have the system dial out to you once the conference call begins. If you forget your PIN prior to the conference call, you can simply re-register.
Please log in approximately 10 minutes prior to the scheduled start time. A live and archived webcast of the event will be available on the “Investors” section of the Elutia website at http://investors.elutia.com.
About Elutia
Elutia Inc. (Nasdaq: ELUT) is a drug delivery company built to stop surgical infections. The Company developed and launched EluPro, the first antibiotic-eluting bioenvelope designed to protect patients receiving pacemakers and defibrillators, and in 2025 sold that business to Boston Scientific Corporation. Elutia’s lead program, NXT-41x, builds on the same drug-eluting platform and is designed to deliver two powerful antibiotics directly to the surgical site, stopping infection before it starts. Elutia’s mission is humanizing medicine so patients can thrive without compromise. For more information, visit www.Elutia.com.
Non-GAAP Disclosure
In addition to the Company’s financial results determined in accordance with U.S. GAAP, the Company provides non-GAAP measures that it determines to be useful in evaluating its operating performance and liquidity. The Company presents in this press release the following non-GAAP financial measures: earnings before interest, taxes, depreciation and amortization ("EBITDA"), adjusted earnings before interest, taxes, depreciation and amortization ("adjusted EBITDA"), adjusted gross margin and adjusted gross profit. The Company defines EBITDA as GAAP net loss excluding interest expense, income tax expense, depreciation and amortization, and the Company defines adjusted EBITDA as EBITDA excluding income or loss from discontinued operations, stock-based compensation, FiberCel and VBM litigation costs, loss or gain on revaluation of warrant and derivative liabilities, warrant issuance expenses and loss or gain on revaluation of revenue interest obligation. The Company defines adjusted gross profit and adjusted gross margin as GAAP gross profit and GAAP gross margin, respectively, excluding amortization of acquired intangible assets. The amortization of these intangible assets will recur in future periods until such intangible assets have been fully amortized. Management believes that presentation of non-GAAP financial measures provides useful supplemental information to investors and facilitates the analysis of the Company’s core operating results and comparison of operating results across reporting periods. The Company uses this non-GAAP financial information to establish budgets, manage the Company’s business, and set incentive and compensation arrangements. Non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. However, non-GAAP financial information is presented for supplemental information purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with U.S. GAAP. For a reconciliation of these non-GAAP measures to GAAP, see below "Non-GAAP Reconciliations of EBITDA and Adjusted EBITDA" and "Non-GAAP Reconciliations of Adjusted Gross Profit and Adjusted Gross Margin."
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements can be identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential," "promise" or similar references to future periods. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including any statements and information concerning our future interactions with the U.S. Food and Drug Administration ("FDA") regarding NXT-41 and NXT-41x; the planned submission of NXT-41x to the FDA in the fourth quarter of 2026; expectations for FDA clearance of NXT-41 and NXT-41x, including the timing and anticipated success thereof; preparations for the commercial launch of NXT-41x, including the timing, scale and anticipated success thereof; the sufficiency of our capital resources to fund the Company into 2029, including through anticipated FDA clearance and the first full year of commercial launch of NXT-41x, without an equity offering; the availability of the additional
Contacts
Investors:
Elutia Investor Relations
ir@elutia.com
Financial Tables
| ELUTIA INC. | ||||||||
| CONSOLIDATED BALANCE SHEET DATA | ||||||||
| (Unaudited, in thousands) | ||||||||
| Assets | September 30, 2026 | December 31, 2025 | ||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 29,093 | $ | 36,350 | ||||
| Accounts receivable, net | 1,466 | 1,734 | ||||||
| Inventory | 272 | 438 | ||||||
| Insurance receivables of litigation costs | 2,527 | 4,846 | ||||||
| Prepaid expense and other current assets | 8,809 | 10,271 | ||||||
| Current assets of discontinued operations | — | 2,179 | ||||||
| Total current assets | 42,167 | 55,818 | ||||||
| Property and equipment, net | 2,830 | 2,511 | ||||||
| Intangible assets, net | 720 | 1,529 | ||||||
| Operating lease right-of-use assets, and other | 2,476 | 2,492 | ||||||
| Total assets | $ | 48,193 | $ | 62,350 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 6,962 | $ | 9,143 | ||||
| Current portion of revenue interest obligation | 4,325 | 4,400 | ||||||
| Contingent liability for legal proceedings | 3,465 | 11,241 | ||||||
| Other current liabilities | 1,278 | 355 | ||||||
| Total current liabilities | 16,030 | 25,139 | ||||||
| Long-term debt, net | 8,098 | — | ||||||
| Long-term revenue interest obligation | — | 2,828 | ||||||
| Warrant and derivative liabilities | 4,201 | 3,124 | ||||||
| Other long-term liabilities | 4,539 | 3,587 | ||||||
| Total liabilities | 32,868 | 34,678 | ||||||
| Stockholders' equity: | ||||||||
| Common stock | 44 | 43 | ||||||
| Additional paid-in capital | 207,894 | 203,842 | ||||||
| Accumulated deficit | (192,613 | ) | (176,213 | ) | ||||
| Total stockholders' equity | 15,325 | 27,672 | ||||||
| Total liabilities and stockholders' equity | $ | 48,193 | $ | 62,350 | ||||
| ELUTIA INC. | ||||||||||||||||||
| CONSOLIDATED STATEMENT OF OPERATIONS | ||||||||||||||||||
| (Unaudited, in thousands, except share and per share data) | ||||||||||||||||||
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||||
| Net sales | $ | 1,137 | $ | 944 | $ | 3,306 | $ | 2,007 | ||||||||||
| Cost of goods sold | 435 | 446 | 1,299 | 1,248 | ||||||||||||||
| Gross profit | 702 | 498 | 2,007 | 759 | ||||||||||||||
| Operating expenses: | ||||||||||||||||||
| Sales and marketing | 756 | 921 | 2,423 | 1,889 | ||||||||||||||
| General and administrative | 3,748 | 3,505 | 11,173 | 10,770 | ||||||||||||||
| Research and development | 2,977 | 1,088 | 7,477 | 2,948 | ||||||||||||||
| Litigation costs, net | 117 | 853 | 2,780 | 7,429 | ||||||||||||||
| Total operating expenses | 7,598 | 6,367 | 23,853 | 23,036 | ||||||||||||||
| Loss from operations | (6,896 | ) | (5,869 | ) | (21,846 | ) | (22,277 | ) | ||||||||||
| Interest (income) expense, net | 278 | 265 | 135 | (42 | ) | |||||||||||||
| Other (income) expense, net | (679 | ) | (5,098 | ) | 621 | (10,971 | ) | |||||||||||
| Loss before provision for income taxes | (6,495 | ) | (1,036 | ) | (22,602 | ) | (11,264 | ) | ||||||||||
| Provision for income taxes | 8 | 8 | 86 | 24 | ||||||||||||||
| Net loss from continuing operations | (6,503 | ) | (1,044 | ) | (22,688 | ) | (11,288 | ) | ||||||||||
| Income (loss) from discontinued operations | 5,218 | (2,824 | ) | 6,288 | (6,123 | ) | ||||||||||||
| Net loss | $ | (1,285 | ) | $ | (3,868 | ) | $ | (16,400 | ) | $ | (17,411 | ) | ||||||
| Net loss per share — basic | $ | (0.03 | ) | $ | (0.09 | ) | $ | (0.37 | ) | $ | (0.43 | ) | ||||||
| Net loss per share — diluted | $ | (0.04 | ) | $ | (0.19 | ) | $ | (0.37 | ) | $ | (0.66 | ) | ||||||
| Weighted average common shares outstanding — basic | 44,313,491 | 42,431,314 | 43,847,094 | 40,965,925 | ||||||||||||||
| Weighted average common shares outstanding — diluted | 47,538,170 | 46,957,199 | 43,847,094 | 45,492,271 | ||||||||||||||
| ELUTIA INC. | |||||||||||||||
| NON-GAAP GROSS PROFIT AND NON-GAAP GROSS MARGIN RECONCILIATIONS | |||||||||||||||
| (Unaudited, in thousands) | |||||||||||||||
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||
| Net sales | $ | 1,137 | $ | 944 | $ | 3,306 | $ | 2,007 | |||||||
| Gross profit | 702 | 498 | 2,007 | 759 | |||||||||||
| Intangible asset amortization expense | 270 | 269 | 810 | 807 | |||||||||||
| Adjusted gross profit (Non-GAAP) | $ | 972 | $ | 767 | $ | 2,817 | $ | 1,566 | |||||||
| Gross margin | 61.7 | % | 52.8 | % | 60.7 | % | 37.8 | % | |||||||
| Adjusted gross margin percentage (Non-GAAP) | 85.5 | % | 81.3 | % | 85.2 | % | 78.0 | % | |||||||
| ELUTIA INC. | |||||||||||||||
| EBITDA AND ADJUSTED EBITDA RECONCILIATIONS | |||||||||||||||
| (Unaudited, in thousands) | |||||||||||||||
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||
| Net loss | $ | (1,285 | ) | $ | (3,868 | ) | $ | (16,400 | ) | $ | (17,411 | ) | |||
| Interest expense (income), net (1) | 278 | 265 | 135 | (42 | ) | ||||||||||
| Provision for income taxes | 8 | 8 | 86 | 24 | |||||||||||
| Depreciation and amortization | 350 | 279 | 1,029 | 877 | |||||||||||
| Earnings before interest, taxes, depreciation and amortization ("EBITDA") (Non-GAAP) | (649 | ) | (3,316 | ) | (15,150 | ) | (16,552 | ) | |||||||
| (Income) loss from discontinued operations | (5,218 | ) | 2,824 | (6,288 | ) | 6,123 | |||||||||
| Stock-based compensation | 860 | 1,334 | 2,696 | 3,450 | |||||||||||
| Litigation costs, net (2) | 117 | 853 | 2,780 | 7,429 | |||||||||||
| (Gain) loss on revaluation of warrant and derivative liabilities (3) | (661 | ) | (5,098 | ) | 768 | (12,518 | ) | ||||||||
| Warrant issuance expenses | — | — | — | 105 | |||||||||||
| Loss on revaluation of revenue interest obligation (4) | — | — | — | 1,442 | |||||||||||
| Adjusted EBITDA (Non-GAAP) | $ | (5,551 | ) | $ | (3,403 | ) | $ | (15,194 | ) | $ | (10,521 | ) | |||
(1) Represents interest expense recorded on all outstanding long-term debt as well as the revenue interest obligation.
(2) Represents litigation costs consisting primarily of legal fees and the estimated and actual costs to resolve the outstanding FiberCel and VBM litigation cases offset by the amounts recovered and recoverable under insurance, indemnity and contribution agreements for such costs.
(3) Represents the non-cash revaluation of Common Warrants, Prefunded Warrants, Avenue Warrants and Avenue Conversion Option.
(4) Represents the non-cash revaluation of the revenue interest obligation.
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/74698ba9-1b32-44ee-8324-de770595e26b
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
When does Elutia expect NXT-41x FDA submission, clearance and launch?
Elutia plans to submit NXT-41x to the FDA in fourth-quarter 2026, expects a clearance decision in first-half 2027 and plans a soft launch in second-half 2027. Full commercial launch is planned for 2028.
What did Elutia's NXT-41x antibacterial study show?
NXT-41x met its prespecified endpoints in a rabbit study, with no viable bacteria recovered from the matrix or surrounding tissue after an 8-log MRSA or 6-log E. coli challenge. Bacteria were applied to the uncoated side. All animals receiving a matrix without antibiotics developed heavy bacterial colonization.
Does Elutia need to sell its Cardiovascular business to fund NXT-41x commercialization?
Elutia expects its current funding to cover the first full year of NXT-41x commercialization without a Cardiovascular transaction. A potential sale remains targeted for fourth-quarter 2026, but the company is considering a transaction only on terms it believes reflect the business's value.