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Organization (Industry)

ELUTIA INC.

ClinicalTrials.gov lists ELUTIA INC. as lead sponsor of 14 trials. It has 3 active development programs.

US Industry Manufacturer CIK 0001708527
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3 0 2010 2026

Trials started per year with this organization as sponsor or collaborator, 1990 onward. The series also counts trials where the organization is a collaborator; the lead-sponsor trial count does not.

2026 is partial: 0 registered with a 2026 start date. The dashed outline is the pace from the 0 registered with a start date through September, planned starts included, not adjusted; not a forecast. No forecast is made for this organization: it averages 0.2 trial starts a year over the five years to September, under the 5 a year the method needs.

This page covers ELUTIA INC.: 14 lead-sponsored trials and 1 legal-entity registration.

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Disease areas (9)

Shown in this order: most trials first.

Disease areas
Disease area Trials
Coronary Disease 3
Intervertebral Disc Degeneration 2
Spondylolisthesis 2
Spondylosis 2
Breast Neoplasms 1

Trials by start year as sponsor or collaborator (9)

Shown in this order: most recent first. 2026 is partial: trials registered with a 2026 start date so far, not a full year.

Show the table of trials by start year as sponsor or collaborator
Trials by start year as sponsor or collaborator
Year Trials started
2025 1
2021 3
2020 1
2019 2
2018 1
2015 3
2014 1
2012 1
2010 1

Recruitment duration, a model prediction: none of the 14 trials evaluated at the 2026-10-09 snapshot is predicted and still running. Source: ClinicalTrials.gov / AACT (CTTI), public domain.

Active development programs (3)

Shown in this order: max phase, then active trials.

Active development programs
Drug Disease area Max phase Trials
Demineralized Bone Matrix Spondylolisthesis Not reported 1
Demineralized Bone Matrix Spondylosis Not reported 1
Demineralized Bone Matrix Intervertebral Disc Degeneration Not reported 1

Sponsor delivery record (1)

Enrollment hit target: the share of this sponsor's lead-sponsored trials whose actual enrollment reached the planned enrollment. On time: the share whose actual primary completion date was no later than the planned date. Each share counts only trials where we observed an estimated figure before the actual one, and n is that number of trials. Below 5 trials the count is shown as a fraction, not a percentage.

Sponsor delivery record
Enrollment Timeline
29% hit target (n=7) 33% on time (n=6)

Journals published in (3)

Shown in this order: most published in first.

Journals published in
Journal Publications
Frontiers in cardiovascular medicine 1
Journal of cardiothoracic surgery 1
Journal of orthopaedic surgery and research 1

US granted patents (1)

Patents are not classified by disease area in the source, so this is the organization's overall portfolio, not a split by disease.

US granted patents
US patents granted Granted in the last 5 years Most recent grant
2 1 2025-03-11

SEC-reported annual financials (8)

Shown in this order: newest fiscal year first; SEC EDGAR XBRL companyfacts, USD as reported.

SEC-reported annual financials
Fiscal year Revenue (USD) Net income (USD) R&D (USD)
2025 not reported 53,380,000 4,163,000
2024 not reported -53,949,000 2,998,000
2023 not reported -37,656,000 4,399,000
2022 not reported -32,897,000 7,727,000
2021 not reported -24,832,000 9,266,000
2020 not reported -21,825,000 5,954,000
2019 not reported -11,939,000 2,400,000
2018 not reported not reported not reported

Financing and grant events (49)

Shown in this order: most recent first.

Financing and grant events
Date Round type Amount (USD) Source
2026-07-16 Other financing not disclosed Sec extracted
2026-07-16 Other financing not disclosed Sec extracted
2025-10-01 Other financing 80 Sec extracted
2025-10-01 Debt financing not disclosed Sec extracted
2025-10-01 Royalty / licensing not disclosed Sec extracted

FDA recalls (2)

Shown in this order: most recent first.

FDA recalls
Product Classification Initiated
BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2. BioEnvelope (Large) (single pack); 3. BioEnvelope (Extra Large) (single pack); 4. BioEnvelope (Extra Extra Large) (single pack); 5. BioEnvelope (Large) (5-pack); 6. BioEnvelope (Medium) (5-pack); 7. BioEnvelope (Extra Extra Large) (5-pack); 8. BioEnvelope (Extra Large) (5-pack) Product Usage: The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. Class II 2019-08-21
CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack); 2. CanGaroo Envelope (Medium) (single pack); 3. CanGaroo Envelope (Extra Large) (single pack); 4. CanGaroo Envelope (Extra Extra Large) (single pack); 5. CanGaroo Envelope (Large) (5 pack); 6. CanGaroo Envelope (Medium) (5 pack); 7. CanGaroo Envelope (Extra Large) (5 pack); 8. CanGaroo Envelope (Extra Extra Large) (5 pack) Product Usage: The CanGaroo Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators. Class II 2019-08-21

Manufacturing and distribution sites (1)

Manufacturing and distribution sites
Facility Location Regulators Member organization
ELUTIA INC. Gaithersburg, US FDA

Climate targets, as filed (1)

Climate targets, as filed
Reporting year Net-zero target
2025 not disclosed

Workforce and board diversity, as filed (1)

Workforce and board diversity, as filed
Reporting year Workforce % women Board % women
2025 not disclosed not disclosed

Latest dated events (67)

Shown in this order: newest first.

Latest dated events
Date Event Source
2026-07-16 Financing Funding rounds and grants (NIH RePORTER + SEC EDGAR)
2026-07-16 Financing Funding rounds and grants (NIH RePORTER + SEC EDGAR)
2025-10-01 Financing Funding rounds and grants (NIH RePORTER + SEC EDGAR)
2025-10-01 Royalty / licensing Funding rounds and grants (NIH RePORTER + SEC EDGAR)
2025-10-01 Debt facility Funding rounds and grants (NIH RePORTER + SEC EDGAR)

CLIA clinical laboratory certificates (1)

CLIA clinical laboratory certificates
Lab Certificate Status
AZIYO BIOLOGICS, INC Certificate of compliance Terminated

Biomarker capability evidence (12)

Shown in this order: tier desc, then gene symbol.

Biomarker capability evidence
Gene Role Evidence
MMRN1 Trial sponsor Named in trial inclusion criteria
MMRN1 Trial sponsor Named in trial inclusion criteria
MMRN1 Trial sponsor Named in trial inclusion criteria
MMRN1 Trial sponsor Named in trial inclusion criteria
MMRN1 Trial sponsor Named in trial inclusion criteria

Not on this page

Checked, with nothing recorded for this organization: companies grouped under this page, related companies not grouped here, approved assets, fda warning letters, fda untitled letters, fda inspection record, fda import refusals, organization relationships, and biomarkers this organization publishes on.