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ELUT

ELUTIA INC.

Biopharma developer (SEC filing verified)·Commercial·Gaithersburg, MD, United States·CEO: Dr. C. Randal Mills Ph.D.
CardiovascularInfectious Disease

ELUT evidence brief

What we can confirm

BioSniper Score:
7.7 / 10
Market Cap:
$35.9M
Lead Asset:
elupro (Approved)

What it means

The company data is ready for cross-source review; unsupported conclusions remain unknown.

What to watch

Market Cap: $35.9M · Lead Asset: elupro (Approved)
BioSniper AIPage evidence connected

Prepared research question

What matters most for ELUT—catalysts, financial risk and supporting evidence?

Run cited research

Traceable citations · Unknowns marked

BioSniper AI · ELUT

ELUTIA INC. (ELUT) is a biotech company developing drug-eluting biomatrix technologies, primarily focused on its next-generation antibiotic-eluting biomatrix NXT-41x for the plastic and reconstructive surgery market, with recent financing activities extending its cash runway into 2029.

Key risk: Profitability uncertainty

7.7/10

BioSniper Score

Based on 3 of 6 signals

Limited data coverage

Market Cap

$35.9M

Cash Runway

—

Lead Asset

elupro (Approved)

Next Catalyst

—

Financial data as of Jun 30, 2026.

Tracking 3 pipeline candidates · 3 clinical trials for ELUTIA INC..

AI OverviewAI overview is shown in English only.

ELUTIA INC. (ELUT) is a biotech company developing drug-eluting biomatrix technologies, primarily focused on its next-generation antibiotic-eluting biomatrix NXT-41x for the plastic and reconstructive surgery market, with recent financing activities extending its cash runway into 2029.

  • Cash & equivalents of $19.9M as of 2026-06-30 [sec].
  • Total revenue of $2.4M and net income of -$7.6M as of 2026-06-30 [sec].
  • Shareholders' equity of $15.7M as of 2026-06-30 [sec].
  • Received $8M payment from Boston Scientific in October 2026, fully funded into 2029 [news · published 2026-10-01].
  • NXT-41x clearance expected in the first half of 2027 [news · published 2026-08-18].

What works

  • Elutia has secured multiple non-dilutive financing sources in 2026, including an $8M Boston Scientific payment, a $15M loan from Avenue Capital Group, and the sale of SimpliDerm for up to $11M, strengthening its balance sheet ahead of the NXT-41x launch [news · published 2026-10-01][news · published 2026-08-13][news · published 2026-08-18].
  • The company is now fully funded through the first year of the expected NXT-41x launch and into 2029, reducing near-term liquidity risk [news · published 2026-10-01].
  • NXT-41x targets a $1.5 billion U.S. plastic and reconstructive surgery market with high post-operative infection rates (15–20%), offering a clear clinical need [news · published 2026-08-18][news · published 2026-08-13].

What to weigh

  • Elutia expects to incur operating losses and negative cash flows for the foreseeable future and is unable to predict when it will become profitable, with the risk of never achieving profitability [sec_mda · as of 2026-08-14].
  • The company's future viability depends on its ability to generate cash flows from product sales or raise additional capital, creating ongoing financial uncertainty [sec_mda · as of 2026-08-14].
  • NXT-41x clearance is not expected until the first half of 2027, meaning the company must sustain operations without a major new product revenue stream for at least another year [news · published 2026-08-18].

From the filings

Quoted directly from source documents.

  • Elutia is fully funded into 2029 following the Boston Scientific payment.

    “The Company is now fully funded through the first year of the expected NXT-41x launch and into 2029”

    News · October 1, 2026

  • NXT-41x clearance is expected in the first half of 2027.

    “NXT-41x clearance expected in the first half of 2027”

    News · August 18, 2026

  • Elutia expects to incur operating losses and negative cash flows for the foreseeable future.

    “We expect to incur operating losses and negative cash flows from operations for the foreseeable future as we advance our development and commercialization of NXT-41 and NXT-41x.”

    SEC MD&A · August 14, 2026

  • NXT-41x targets a $1.5 billion market with 15–20% infection rates.

    “NXT-41x is an antibiotic-eluting biomatrix designed to address post-operative infection in the $1.5 billion U.S. plastic and reconstructive surgery market”

    News · August 18, 2026

Risks & what to watch (3)›

Key risks

  • Profitability uncertainty — Elutia expects operating losses and negative cash flows for the foreseeable future and may never become profitable [sec_mda · as of 2026-08-14].
  • Dependence on NXT-41x success — Future viability depends on generating cash flows from product sales, primarily NXT-41x, which is not cleared until 1H27 [sec_mda · as of 2026-08-14][news · published 2026-08-18].
  • Regulatory clearance delay risk — Any delay in FDA 510(k) clearance of NXT-41x could push back revenue generation and strain cash reserves [news · published 2026-08-18].

What to watch

  • FDA 510(k) clearance of NXT-41x, expected in the first half of 2027 [news · published 2026-08-18].
  • Activation of the second $5M tranche from the Avenue Capital loan, contingent on NXT-41x clearance [news · published 2026-08-13].
  • Potential additional milestone payments from the SimpliDerm sale (up to $3M over 18 months) [news · published 2026-08-18].
  • Quarterly financial results to monitor cash burn and revenue trends as the company approaches NXT-41x launch [sec].

Sources: News · SEC MD&A · Generated October 13, 2026 · How we verify sources →

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Evidence & data

Score breakdownBased on 3 of 6 signals · derived from public data

Cash RunwayN/A

Cash runway data unavailable

Financial Health7.3

D/E 1.77 · 0% dilution

Pipeline Maturity10.0

Lead: Approved

Pipeline Breadth5.9

3 candidates

Catalyst MomentumN/A

No upcoming catalysts tracked

Insider SignalN/A

No insider transactions in the last 180 days

Pipeline

Regulatory

Financials

Institutional Holdings

Source: SEC Form 13F · as of Mar 2026

Institutional holders

35

Total value held

$15.9M

Showing top 10 of 35 institutional holders of ELUTIA INC.. Open the full 13F history after sign-in.

Short Interest

as of May 21, 2026
% of float
0.3%
Days to cover
1.8
Shares short
126,205
Daily short volume (Oct 12, 2026)
24.2%

Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →

ELUT short interest

Governance

Frequently asked questions

What is the AI investment thesis for ELUTIA INC.?

ELUTIA INC. (ELUT) is a biotech company developing drug-eluting biomatrix technologies, primarily focused on its next-generation antibiotic-eluting biomatrix NXT-41x for the plastic and reconstructive surgery market, with recent financing activities extending its cash runway into 2029.

What is ELUTIA INC.'s lead drug candidate?

ELUTIA INC.'s most advanced tracked candidate is elupro (Approved) for Mitigate complications associated with the implantation of electronic medical devices such as pacemakers, internal defibrillators and neurostimulation devices.

Who is the CEO of ELUTIA INC.?

Dr. C. Randal Mills Ph.D. is the chief executive officer of ELUTIA INC. (ELUT).

Where is ELUTIA INC. headquartered?

ELUTIA INC. (ELUT) is headquartered in Gaithersburg, MD, United States.

What therapeutic areas does ELUTIA INC. focus on?

ELUTIA INC. develops therapies across Cardiovascular, Infectious Disease.

923 companies304,844 SEC filings22,644 clinical trials100% citation-verification pass rate (7d)How we verify →

The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.