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Elutia Inc. is a commercial-stage company focused on improving patient outcomes by leveraging biologics and local drug delivery technologies. The company specializes in reducing complications associated with implanted medical devices and promoting healthy tissue formation. Elutia sells innovative products across device protection, women's health, and cardiovascular care, targeting unmet clinical needs in these areas.
- Women's Health - Develops SimpliDerm, a human-based hydrated acellular dermal matrix (HADM) designed to enhance tissue incorporation and mitigate inflammation, used in breast reconstruction, sports medicine, hernia repair, and trauma reconstruction.
- Device Protection - Offers EluPro, a drug-eluting bioenvelope embedded with antibiotics to protect electronic medical devices from complications like infection and scar formation, and CanGaroo, a first-generation biomatrix without antibiotics.
- Cardiovascular - Provides specialized porcine small intestine submucosa for intracardiac and vascular patch applications, pericardial reconstruction, and TYKE products for neonatal patients, distributed exclusively through LeMaitre Vascular.
| Name | Position | External Roles | Short Bio | |
|---|---|---|---|---|
C. Randal Mills ExecutiveBoard | President and Chief Executive Officer | C. Randal Mills has been serving as the President and Chief Executive Officer of Elutia Inc. since August 2022 and has been a member of the Board of Directors since November 2015. | View Report → | |
Matthew Ferguson Executive | Chief Financial Officer (CFO) | Matthew Ferguson is the CFO of Elutia Inc. since September 2020. He previously held CFO positions at Bossa Nova Robotics, Avinger, Inc., Tethys Bioscience, Proteolix, and FoxHollow Technologies. | ||
Michelle Williams Executive | Chief Scientific Officer | Michelle Williams is the Chief Scientific Officer at Elutia since August 2022. Previously, she held executive roles including Executive Vice President and Chief Operating Officer at Elutia. |
- Given your current successful partnership with Boston Scientific for the EluPro rollout, how do you plan to manage potential distribution conflicts as you expand agreements with additional pacemaker players, and what measures are in place to maintain consistent product training and messaging?
- Can you clarify how you will differentiate operational cash burn from litigation settlement expenses moving forward, and what expectations do you have for litigation expenditure trends in 2025 based on recent case resolutions?
- With 100 centers actively ordering EluPro and ambitions to expand to a larger number of high-volume accounts, can you detail the cadence and key drivers for new active account additions throughout 2025, and what challenges might affect that pace?
- Considering the Q4 deceleration in SimpliDerm growth amid the transition from Sientra to Tiger Aesthetics, what specific strategies will you implement to resolve current disruptions and restore robust growth in your Women’s Health division?
- As you are increasing production capacity ahead of schedule and aiming for gross margins north of 70% with in-house manufacturing enhancements, how do you plan to balance the necessary capital investments against short-term profitability pressures?
Competitors mentioned in the company's latest 10K filing.
| Company | Description |
|---|---|
The EluPro and CanGaroo Envelopes compete with the synthetic envelope TYRX from this company. | |
Gore | ProxiCor, Tyke, and VasCure compete with bovine pericardium and synthetic patch materials produced by this company's Gore-tex. |
Terumo | ProxiCor, Tyke, and VasCure compete with synthetic patch materials produced by this company's Vascutek. |
SimpliDerm competes primarily against human-derived acellular dermis matrix meshes, including AlloDerm and Strattice from this company. | |
MTF | SimpliDerm competes primarily against human-derived acellular dermis matrix meshes, including FlexHD from this company. |
SimpliDerm competes primarily against human-derived acellular dermis matrix meshes, including DermACELL from this company. | |
Evergen | SimpliDerm competes primarily against human-derived acellular dermis matrix meshes, including Cortiva from this company. |
SimpliDerm also competes against animal-derived biological mesh products, such as SurgiMend from this company. |
Notable M&A activity and strategic investments in the past 3 years.
| Company | Year | Details |
|---|---|---|
Sientra | 2024 | In February 2024, Sientra filed for Chapter 11 bankruptcy and received debtor‑in‑possession financing from Deerfield Partners to facilitate a Section 363 sale. In April 2024, Tiger Aesthetics Medical acquired Sientra's assets, strategically aiming to leverage its fresh balance sheet to boost the distribution of the SimpliDerm product line, although uncertainties remain about whether Elutia's contracts will be assumed. |
Recent press releases and 8-K filings for ELUT.
- EluPro sales surged 84% sequentially and BioEnvelope revenue grew 31% YoY to $3.1M, showcasing strong product momentum .
- A new Boston Scientific distribution partnership has been established to accelerate product adoption, with early sales in over 50 hospitals .
- Q1 2025 financials include net sales of $6.0M (down from $6.7M YoY), operating expenses improved to $10.4M versus $11.3M, and a reduced adjusted EBITDA loss of $3.3M compared to $4.5M, with a cash balance of $17.4M as of March 31, 2025 .
- Q4 2024 Financial Performance: Revenue of $5.5M (annual $24.4M) with GAAP gross margin at 43% (up from 36%) and adjusted margin at 58% (up from 51%)
- EluPro Success: FDA-cleared EluPro shows strong clinical uptake—contributing about 30% of BioEnvelope sales with a 65% sales increase when centers switched from CanGaroo
- Reported robust Q4 and full year financial results with high demand for EluPro following its successful pilot launch; secured 67 approved EluPro accounts and key group purchasing agreements
- Strategic Partnerships: Expanded market reach via collaboration with Boston Scientific, leveraging 900 reps and increasing hospital VAC approvals from 100 centers
- Robust Cash Position: Maintained strong balance with $13.2M on hand and registered direct offering gross proceeds of $15.0M
- Litigation Update: Notable reduction in FiberCel litigation liability—from over $20M to $15.9M with outstanding cases falling from 79 to 43
- Elutia Inc. announced a registered direct offering of 5,520,000 shares at $2.50 per share and 480,000 pre‑funded warrants at $2.499 each, generating approximately $15.0 million, expected to close on February 4, 2025 .
- Lake Street Capital Markets is the exclusive placement agent, with proceeds intended for working capital and general corporate purposes .
- On February 3, 2025, Elutia Inc. filed its Form 8‑K for Q4 2024, detailing current operational and financial conditions .
- The filing provides preliminary net sales estimates for the year ended December 31, 2024, covering device protection, women’s health, and cardiovascular segments .
- It includes extensive forward‑looking statements outlining risks and uncertainties, and was signed by CFO Matthew Ferguson .