Elutia, Inc. operates as a biotechnology company. It develops biologic products to improve compatibility between medical devices and the patients who need them. The firm operates through the following segments: Device Protection, Women’s Health, Orthobiologics and Cardiovascular. The Device Protection segment includes biological envelope that remodels into systematically connected, vascularized tissue for the long-term pocket protection of certain cardiac and neurostimulator implantable electronic vehicles. The Women’s Health segment includes pre-hydrated, human acellular dermal matrix, or HADM, that is designed to enable rapid integration, cellular repopulation and rapid revascularization at the surgical site. The Orthobiologics segment includes a variety of viable matrices, produced with a proprietary process that is designed to protect and preserve native bone cells and reduce programmable cell death, for use in bone repair and fusion procedures. The Cardiovascular segment includes a portfolio of extracellular matrices that retain the natural composition of collagen, growth factors and proteins for use in vascular and cardiac repair and pericardial closure. The company was founded by Kevin L. Rakin and Charles Randal Mills on August 6, 2015 and is headquartered in Silver Spring, MD.
Clinical Trials
14
1 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
1
7.1%
Completed
10
71.4%
Withdrawn
3
21.4%
No approval data available
- Elutia Inc. has appointed Pete Ligotti as Chief Commercial Officer to lead the commercialization of NXT-41x, a next-generation antibiotic-eluting biomatrix for plastic and reconstructive surgery. - NXT-41x targets the breast reconstruction market where over 162,000 procedures are performed annually in the U.S., yet infection rates of 15% to 20% persist despite biological surgical mesh being standard in over 80% of cases. - The biologics for breast reconstruction market represents an estimated $1.5 billion total U.S. market opportunity, with Elutia anticipating FDA clearance for NXT-41x in 2027. - Ligotti brings twenty years of commercial execution experience in complex surgical markets, including building Integra LifeSciences' plastic and reconstructive surgery operation and scaling specialty surgical businesses to over $180 million in revenue.
- Elutia's engineered extracellular matrix envelope demonstrated 43% lower overall procedural difficulty during cardiac implantable electronic device reoperations in the multicenter HEAL study. - Preclinical data showed complete eradication of bacterial pathogens including MRSA while maintaining sustained antibiotic concentrations for up to two weeks. - The drug-eluting biomatrix technology addresses two key CIED challenges: preventing post-operative bacterial complications and reducing long-term surgical difficulties. - Elutia is expanding its pipeline to target higher-risk procedures like breast reconstruction, where one in three patients experience serious complications.
- Elutia Inc. has entered into a definitive agreement to sell its EluPro™ and CanGaroo® bioenvelopes to Boston Scientific Corporation for $88 million in cash, with the deal expected to close in Q4 2025. - The transaction validates Elutia's proprietary drug-eluting biologics platform and provides non-dilutive funding to advance its NXT-41 and NXT-41x pipeline targeting the $1.5 billion breast reconstruction market. - EluPro has demonstrated commercial success with seven national group purchasing organization contracts and more than 160 value analysis committee approvals since its launch. - The acquisition enables Elutia to eliminate outstanding debt, resolve litigation from its divested Orthobiologics business, and focus resources on its SimpliDerm franchise and breast reconstruction technologies.
- Elutia Inc. reported the first commercial use of EluPro, an FDA-cleared antibiotic-eluting biologic envelope for pacemakers and neurostimulators, with full launch slated for 2025. - Q3 financial results showed a slight decrease in overall net sales to $5.9 million, offset by a 19% increase in SimpliDerm sales and a net income improvement of $1.3 million. - The company is expanding its sales force and engaging with group purchasing organizations to broaden EluPro's market reach, supported by clinical studies and published data. - Elutia anticipates a favorable market reception for EluPro, aiming to redefine the BioEnvelope market and improve patient outcomes through strategic partnerships and national availability.
- ECU Health performed the first pacemaker implantation using Elutia's FDA-approved EluPro BioEnvelope, designed to prevent post-operative complications. - The EluPro BioEnvelope is the first antibiotic-eluting device for Cardiac Implantable Electronic Devices (CIEDs), addressing infection risks in vulnerable patients. - This advancement aims to improve patient outcomes and reduce complications associated with traditional pacemaker implantation procedures, especially for those with comorbidities. - The procedure highlights ECU Health's commitment to providing advanced cardiovascular care and reducing health disparities in eastern North Carolina.
- Elutia Inc. celebrates its first anniversary following a strategic shift towards drug-eluting biologics, marked by rebranding and a new mission. - The company secured FDA approval for EluPro, the first Antibiotic-Eluting BioEnvelope, and successfully completed an FDA inspection of its manufacturing facility. - Elutia achieved significant milestones, including the first implantation of EluPro and a 20% growth in proprietary product sales. - Elutia's stock value increased by over 170% in its first year, reflecting strong performance and increased shareholder value.
