Ethics &
Compliance

At Nuwellis, our ethics are the foundation of how we interact with patients, customers, clinicians, suppliers, consultants, and each other, and integrity is an essential element of our Guiding Principles.

Code of Business Conduct and Ethics

We maintain policies and practices that support strong governance and transparency and ensure compliance with all applicable laws, regulations, and industry codes.  Our Code of Business Conduct and Ethics sets out the standards for how we conduct ourselves.  A copy of the code may be found here.

AdvaMed

Nuwellis is a member of Advanced Medical Technology Association, or AdvaMed, and has certified our commitment to compliance to the AdvaMed Code of Ethics 2020. A copy of that code may be found here.

Compliance Hotline

If one of our stakeholders believes that someone may be violating the law or the standards of our Code of Business Conduct and Ethics, the individual may report such suspected violation through our Compliance Hotline.  The hotline is available to use 24 hours a day.  The hotline is maintained by an independent company, Lighthouse.  Reports to the hotline will remain completely confidential and anonymous, at the election of the individual initiating the report.

Reports to our Compliance Hotline may be made by:

Phone
Website

Sunshine Act Reports

Nuwellis collaborates with healthcare professionals (HCPs) in the development, clinical use, and training on the safe and effective uses of our products.  These collaborations may result in payments or “transfers of value” to physicians and teaching hospitals that are reportable to the U.S. government under the “Sunshine Act” (a part of the Affordable Care Act). Examples of transfers of value that we provide include, among other things, compensation for consulting services, meals provided at educational programs or other business meetings, and grants for third-party educational events and third-party research and clinical studies.

Open Payments is a U.S. government program that collects information about the payments and other “transfers of value” that drug and device companies make to physicians and teaching hospitals under the Sunshine Act. This data is then made available to the public each year at www.cms.gov/openpayments. You may be able to find specific data on payments made by Nuwellis using the search tool located on the Open Payments website.

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