-- 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., Aug. 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 installation and operational qualification of its automated drug-coating system for commercial manufacturing. The system is designed to support target gross margins in excess of 80% at scale.
Product Divestitures Further Sharpen the Company's Focus
On July 16, 2026, Elutia signed a definitive agreement to sell its SimpliDerm business for up to $11 million in total consideration, including up to $3 million in contingent technology transfer and commercial milestone payments over the 18 months following closing, with closing expected in the third quarter of 2026. The Company's previously announced strategic process for its Cardiovascular business also continues to advance. Together with the 2025 divestiture of the BioEnvelope business, these transactions extend Elutia's runway and focus the organization on the launch of NXT-41x in the second half of 2027.
Funded Catalysts Ahead
Milestone Expected Timing ------------------------------------------------ ----------------- SimpliDerm business divestiture closing 3Q 2026 ------------------------------------------------ ----------------- Potential cardiovascular business transaction 2H 2026 ------------------------------------------------ ----------------- $8 million BioEnvelope escrow release 4Q 2026 ------------------------------------------------ ----------------- NXT-41 FDA clearance decision 4Q 2026 ------------------------------------------------ ----------------- NXT-41x FDA clearance decision 1H 2027 ------------------------------------------------ ----------------- NXT-41x commercial soft launch 2H 2027 ------------------------------------------------ ----------------- NXT-41x full commercial launch 2028 ------------------------------------------------ -----------------
Second Quarter 2026 Financial Results
Net sales and operating results discussed below reflect continuing operations. For the three-month period ended June 30, 2026, as compared to the same period of 2025:
-- Overall net sales were $2.4 million, compared to $2.7 million. The
decrease was the result of $0.7 million reduction in SimpliDerm revenue
due to a production disruption with the product's contract manufacturer,
offset by a $0.4 million increase in Cardiovascular revenue due to the
transition back to direct sales.
-- Gross margin on a GAAP basis was 59.6%, compared to 52.9%.
-- Adjusted gross margin (a non-GAAP measure which excludes non-cash
amortization of intangibles) was 70.7%, compared to 62.7%. A
reconciliation of GAAP gross margin to adjusted gross margin is included
in the accompanying financial tables.
-- Total operating expenses were $9.4 million, compared to $9.8 million. The
decrease was driven by a $1.9 million reduction in net litigation costs,
partially offset by a $1.5 million increase in research and development
expense supporting the NXT-41 and NXT-41x programs.
-- Loss from operations was $8.0 million, compared to $8.4 million.
-- Net loss from continuing operations was $7.6 million, compared to $7.1
million.
-- There was no loss from discontinued operations in the second quarter of
2026, compared to a loss of $2.5 million in the second quarter of 2025.
-- Net loss was $7.6 million, compared to $9.6 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 $4.6
million, compared to a loss of $3.0 million. A reconciliation of net loss
to adjusted EBITDA is included in the accompanying financial tables.
-- Cash and cash equivalents at June 30, 2026 were $19.9 million. This cash
position is expected to be augmented by up to an additional $34 million
from signed transactions, including $10 million already received from
Avenue Capital Group pursuant to a new loan agreement, $8 million held in
escrow in connection with the 2025 divestiture of the BioEnvelope
business, up to $11 million from the sale of the SimpliDerm business and
an additional $5 million available from the Avenue Capital loan facility
following FDA clearance of NXT-41x.
Conference Call
Elutia will host a conference call on August 13, 2026 at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time to discuss its second 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.