Elutia, Inc..
ELUT.US | Manufacture of medical and dental instruments and supplies
Elutia, Inc., formerly known as Conformis, Inc., is a commercial-stage medical technology company focused on advancing the science of regenerative medicine and tissue engineering to transform outcomes for patients. The company develops, manufactures, and markets implantable tissue regeneration produ...Show More
Better Health for All
-10
Elutia's primary product, EluPro, is the first FDA-cleared antibiotic-eluting biomatrix for cardiac implantable electronic devices (CIEDs) and neurostimulators.
1
It addresses 5-7% complication rates in over 600,000 annual U.S. CIED implants
2
by preventing infections and promoting tissue regeneration. Studies show EluPro reduces procedural difficulty by 43%, eases generator mobilization by 46%, and lead mobilization by 41%.
3
The company is also developing a pipeline for higher-risk procedures like breast reconstruction, where one in three patients suffer serious complications.
4
EluPro received a 2025 Edison Award for innovation.
5
The core function of EluPro is preventative, aiming to avoid post-surgical complications. Research and development expenses were $905,000 in Q1 2025, representing 8.7% of total operating expenses.
6
Elutia utilizes 7 Group Purchasing Organizations to expand access to EluPro nationwide.
7
However, the company has a negative safety record. A Class 2 recall occurred in 2013 for a wound drain.
8
More recently, the FDA issued a Warning Letter in June 2024 to Berkeley Biologics, LLC (formerly Elutia, Inc.) for significant violations related to Viable Bone Matrix products manufactured between January 2022 and June 2023.
9
These products were deemed unapproved new drugs with manufacturing deficiencies, including failures in donor screening for communicable diseases, and the company's responses were deemed inadequate.
10
Elutia sold its Orthobiologics business, which included these products, in November 2023, meaning current revenue is not from these harmful products.
11
The company conducts clinical studies, including the HEAL study and a real-world outcomes study, but details on ethical conduct are not provided.
Fair Money & Economic Opportunity
0
Elutia, Inc. is a medical technology company that develops, manufactures, and markets implantable tissue regeneration products to hospitals, surgeons, and healthcare providers. The provided articles do not contain any evidence that the company offers lending, deposit, or other financial services to consumers. Therefore, all KPIs related to financial services, such as underserved client share, pricing fairness, exploitative fee exposure, inclusion initiatives, data accessibility for financial data, fair lending compliance, wealth building outcomes for customers, profit reinvestment in community finance, financial literacy initiatives, debt burden ratio, geographic inclusion for banking, and product simplicity for financial products, are not applicable to its core business model and no relevant data is available in the provided articles.
Fair Pay & Worker Respect
0
The provided articles do not contain specific, quantitative data for Elutia, Inc. regarding any of the Fair Pay & Worker Respect KPIs. explicitly states that data for metrics such as living wage coverage, CEO median pay ratio, collective bargaining share, safety incident rate, pay equity ratio, worker engagement score, turnover rate, labor violation incidents, insecure contract share, and health insurance coverage is "Not available" or "Not enough CEO ratings yet" for Elutia.
1
, which discusses CEO-to-worker pay ratios, does not mention Elutia, Inc. specifically.
2
Fair Trade & Ethical Sourcing
0
No evidence available to assess Elutia, Inc. on Fair Trade & Ethical Sourcing.
Honest & Fair Business
-20
The company has a Code of Business Conduct and Ethics, effective August 5, 2021, which includes an ethics hotline available 24/7 for anonymous reporting and explicitly prohibits retaliation against employees or directors who report violations in good faith.
1
The Audit Committee Charter, effective April 22, 2024, further establishes procedures for the receipt, retention, and treatment of accounting and auditing complaints, including confidential, anonymous submissions.
2
The company is committed to complying with the U.S. Foreign Corrupt Practices Act (FCPA) and other anti-corruption laws, prohibiting bribes, kickbacks, and inducements to foreign officials.
3
However, the policy does not specify the frequency or effectiveness metrics of training, nor does it detail due diligence for high-risk transactions or customization for high-risk areas.
Kind to Animals
-50
The company uses porcine tissue in products such as CanGaroo and cardiovascular products, with the CanGaroo RM Antibacterial Envelope specifically utilizing decellularized extracellular matrix derived from porcine small intestinal submucosa.
1
Animal testing was conducted on the CanGaroo RM Antibacterial Envelope, including pharmacokinetics and a bacterial challenge model in rabbits.
2
There is no explicit mention of an animal testing policy.
3
No War, No Weapons
0
Elutia, Inc. does not derive revenue from arms or defense contracts, as its core business is focused on medical products for women's health and cardiovascular markets.
1
The company develops advanced medical products using human and porcine tissue for surgical reconstruction, with no indication of dual-use technology or military applications.
2
Its operations and sales occur domestically, meaning there are no sales to embargoed regimes or exports requiring end-user certificates.
3
There is no evidence of exposure to controversial weapons, defense-related lobbying, or any involvement in military or conflict-related activities, making many KPIs not applicable to its business model.
4
Planet-Friendly Business
0
No specific, concrete data points were found in the provided articles to assess Elutia, Inc. against any of the Planet-Friendly Business KPIs.
1
Multiple articles explicitly state that sustainability data for Elutia, Inc. is unavailable or not publicly disclosed, making it impossible to score its environmental performance.
2
Respect for Cultures & Communities
0
No specific, concrete data points were found in the provided articles to assess Elutia, Inc. against any of the KPIs for 'Respect for Cultures & Communities'. The articles focus on product development, sales, and business partnerships with Group Purchasing Organizations, which are not considered indigenous or local community groups for the purpose of these KPIs.
1
The careers page explicitly states a lack of relevant data for these metrics.
2
Safe & Smart Tech
0
No evidence available to assess Elutia, Inc. on Safe & Smart Tech.
Zero Waste & Sustainable Products
0
No specific, quantitative data regarding Elutia, Inc.'s performance on waste diversion, product recyclability, packaging sustainability, recycled content, single-use plastic reduction, take-back programs, circular design, waste reduction initiatives, hazardous waste management, product durability, repairability, waste audit frequency, zero waste certification, waste disposal violations, material efficiency, packaging-to-product ratio, waste reduction targets, supplier waste requirements, or customer waste education was found in the provided articles.
1