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Elutia Inc
NASDAQ:ELUT

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Elutia Inc
NASDAQ:ELUT
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Price: 1.07 USD Market Closed
Market Cap: $45.7m

Elutia Inc
Investor Relations

Aziyo Biologics, Inc. operates as a biotechnology company. The company is headquartered in Silver Spring, Maryland and currently employs 151 full-time employees. The company went IPO on 2020-10-08. The firm is a commercial-stage company that serves two markets with products based on its biomatrix platforms. The company offers a drug-eluting biologic technology: a fusion of natural biologic material and extended antibiotic release, for device implantation and soft tissue reconstruction. Its first product is CanGaroo Envelope, used for the stabilization of implantable cardiac devices, such as pacemakers and defibrillators. Its second product is SimpliDerm Acellular Dermal Matrix, used primarily in breast reconstruction following mastectomy. The company is also engaged in the development of CanGaroo RM, which adds the antibiotics rifampin and minocycline for sustained delivery directly to the surgical site. The Company’s products are used by electrophysiologists and plastic surgeons.

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Last Earnings Call
Fiscal Period
Q4 2025
Call Date
Mar 11, 2026
AI Summary
Q4 2025

Revenue: Reported $3.3 million in Q4 revenue, up 16% from $2.8 million a year ago, driven by return to direct distribution.

Margins: Adjusted gross margin improved to 66.8% from 56.5% a year ago (up 12 percentage points).

Cash & balance sheet: $44.4 million in cash on hand plus $8 million in escrow; paid off SWK debt (~$28 million) after selling BioEnvelope.

Pipeline & timing: Submitted NXT-41 to FDA; company expects clearance for NXT-41 toward the end of the first half of 2026 and anticipates NXT-41x clearance and a second-half 2026 launch.

Market opportunity: Targeting breast reconstruction, a $1.5 billion market with ~162,000 reconstructions annually and high infection rates (registry 12%–37%; company cites 15%–20%).

Strategic moves: Hired new CCO Pete Ligotti and added board member Guido Neels; exploring strategic options for SimpliDerm to focus resources on 41x.

Clinical potential: Management highlighted prior studies showing local antibiotic delivery reduced infections 62% and 82% in different cohorts and said they aim for sustained local antibiotic coverage (~30 days) to reduce postoperative infections.

Key Financials
Revenue
$3.3 million
Revenue (prior year quarter)
$2.8 million
Adjusted gross margin
66.8%
Net loss from continuing operations
$6.5 million
Adjusted EBITDA (loss)
$4.2 million
Cash on hand plus escrow
$44.4 million
Debt payoff to SWK
~$28 million paid
Shares outstanding (common)
42.8 million common shares
Prefunded warrants outstanding
4.5 million
Total diluted share equivalent
47.3 million (common + prefunded warrants)
Market size (breast reconstruction)
$1.5 billion
Annual breast reconstructions
162,000 procedures
Registry infection rate (range)
12%–37% (company cites 15%–20% conservatively)
Implant loss due to complications
Up to 1 in 5 implant loss
Hospital economic burden per infection
$48,000
BioEnvelope sale proceeds
$88 million
Regulatory timing for NXT-41
Expect clearance toward end of first half of 2026
Anticipated 41x launch
Targeting second-half 2026 launch after 41x clearance
Earnings Call Recording
Other Earnings Calls

Management

Dr. C. Randal Mills Ph.D.
Co-Founder, President & CEO and Director
No Bio Available
Mr. Matthew B. Ferguson
Chief Financial Officer
No Bio Available
Dr. Michelle LeRoux Williams Ph.D.
Chief Scientific Officer
No Bio Available
Ms. Courtney Guyer
Vice President of Marketing
No Bio Available
Dr. Sonali Fonseca Ph.D.
VP & Head of Emerging Businesses
No Bio Available
Mr. Jeffry D. Hamet
Senior VP of Finance, Treasurer & Secretary
No Bio Available

Contacts

Address
MARYLAND
Silver Spring
12510 Prosperity Drive, Suite 370
Contacts
+12402471143
elutia.com
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