Better Health for All

Nuwellis's Aquadex ultrafiltration therapy provides substantial health benefits, including a 60% reduction in heart failure events at 30 days, a 53% reduction in readmissions, and an 81% decrease in hospitalizations per patient per year, with rehospitalizations 48% less than the national average.

The therapy has expanded to 47 pediatric centers, improving outcomes for this vulnerable population. Nuwellis is also sponsoring the REVERSE-HF clinical study, demonstrating investment in health innovation. However, the company initiated a Class 1 recall of 845 units of its AquaFlexFlow UF 500 Plus extracorporeal blood circuit due to alarms that could lead to acute volume depletion, especially in pediatric patients, with 3 reported injuries and potential for serious injury or death. The recall was posted January 16, 2025, and the FDA determined the cause is under investigation. The reimbursement rate for Aquadex SmartFlow therapy increased by 397% to $1,639 per day, effective January 1, 2025, from $413. The company implies that training for healthcare providers is necessary for Aquadex use, but no specific support initiatives are detailed.

Fair Money & Economic Opportunity

Nuwellis, Inc. is a medical device company focused on developing, manufacturing, and commercializing therapies for acute heart failure.

Its business model involves selling and supporting the Aquadex system and related disposables to healthcare providers. The provided articles discuss a public offering, training programs for medical devices, and studies on its ultrafiltration therapy. There is no evidence that Nuwellis, Inc. operates as a financial institution or offers any financial products or services to consumers, such as lending, insurance, or deposit services. Therefore, all KPIs related to fair money and economic opportunity are scored as '0' because they are not applicable to the company's core business.

Honest & Fair Business

Nuwellis has a Code of Business Conduct and Ethics.

The company provides a 24/7 compliance hotline managed by an independent company (Lighthouse), where reports are confidential and anonymous. Nuwellis also complies with the Sunshine Act, reporting payments and transfers of value to healthcare professionals, with this data publicly available on the Open Payments website.

Kind to Animals

Nuwellis, Inc. engages in animal testing, conducting pre-clinical studies on animals to assess product safety.

This indicates that no products are certified cruelty-free. The company's reliance on animal testing for safety profiles, without any evidence of employing non-animal methods, suggests that no validated non-animal methods are used. There is no specific policy information beyond the fact that animal testing occurs, implying a vague policy that permits routine non-essential testing. The company does not provide transparent reporting on the number of animals used, but its active engagement in animal testing places it in a negative tier for animal testing volume.

No War, No Weapons

The provided article details Nuwellis, Inc.'s partner SeaStar Medical receiving FDA correspondence for a Selective Cytopheretic Device (SCD) for pediatric acute kidney injury.

It focuses on the medical device's regulatory approval and intended commercialization. No information or specific data points are present regarding arms manufacturing, military contracts, dual-use technologies, sales to sanctioned regimes, peacebuilding initiatives, or any other metrics relevant to the 'No War, No Weapons' ethical value.

Planet-Friendly Business

The provided articles do not contain any specific, concrete data points or facts related to environmental performance, targets, or initiatives for Nuwellis, Inc.

There is no information available regarding greenhouse gas emissions, renewable energy usage, water consumption, waste diversion, green building certifications, or any climate-related policies or investments. The articles explicitly state the absence of data for all relevant KPIs. Therefore, no KPIs under the 'Planet-Friendly Business' value can be scored based on the evidence provided.

Safe & Smart Tech

The provided articles do not contain sufficient specific, quantitative, or actionable evidence to score any of the KPIs for Safe & Smart Tech. While mentions general cybersecurity practices such as employee training, multi-factor authentication, encryption levels, and security testing (simulations, drills, penetration tests), it lacks the specific metrics (e.g., percentage of employees trained, percentage of systems covered by MFA, percentage of data encrypted, patching timeframes, or data breach details) required by the rubric's quantitative thresholds.

Information regarding AI ethics, privacy certifications, data minimization, and digital rights advocacy is explicitly stated as not provided or absent. An FDA recall for a medical device safety issue, as detailed in , is not relevant to compliance with privacy regulations (e.g., GDPR, CCPA) or other cybersecurity KPIs.