Nuwellis Strengthens Organization with Appointment of Brian Johnson as Director of Quality and Regulatory Affairs

Nuwellis appoints Brian Johnson to lead quality and regulatory functions as it advances product development and commercialization efforts in cardiorenal care.

Rhea-AI Summary

Nuwellis (NUWE) appointed Brian Johnson as Director of Quality and Regulatory Affairs, bringing 13 years of medical device quality and regulatory experience.

Johnson has led quality systems, regulatory activities, audits and product development at prior employers, including Baxter/Vantive and ATL Medical, where he helped reduce monthly customer complaints by 80%. He holds a Master of Science in Regulatory Affairs and Services and a Bachelor of Science in Manufacturing Engineering Technology. At Nuwellis, he will oversee quality systems, audits, supplier and contract manufacturer oversight, and regulatory compliance, working cross‑functionally to support product quality, continuous improvement and advancement of the company’s cardiorenal technology portfolio.

Market Context

NUWE's prior close was $0.8449 before publication; a comparable Aug 6 R&D leadership appointment was...

Analysis

NUWE's prior close was $0.8449 before publication; a comparable Aug 6 R&D leadership appointment was followed by a 4.68% decline, providing relevant organizational-expansion context without an established response to this announcement.

Key Figures

Medical device experience: 13 years Prior facility oversight: 257 employees Complaint reduction: 80%

Medical device experience

13 years

Brian Johnson's quality and regulatory background

Prior facility oversight

257 employees

Two research and development facilities at Baxter/Vantive

Complaint reduction

80%

Monthly customer complaints reduced at ATL Medical

Historical Context

1 past event · Latest: Aug 06

1 event

1. Aug 06

   R&D leadership appointment

   24h Move

   -4.7%

   Appointed a principal R&D engineer to advance existing and new product programs

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

quality systems, regulatory compliance, contract manufacturer

3 terms

quality systems technical

"13 years of medical device quality and regulatory experience"

A quality system is the organized set of policies, procedures, records and controls a company uses to ensure its products or services meet regulatory standards and customer expectations. It covers everything from design and production to testing, complaint handling and internal audits, like a recipe book and checklist that keeps processes consistent. Investors care because effective quality systems reduce the risk of recalls, fines, production delays and reputational damage that can affect earnings and valuation.

regulatory compliance regulatory

"including quality systems, audits, supplier and contract manufacturer oversight, and regulatory compliance"

Regulatory compliance is the process of ensuring that a company follows all applicable laws, rules, and standards set by government authorities or industry bodies. It is important to investors because it helps prevent legal penalties, financial losses, and reputational damage, contributing to the overall stability and trustworthiness of a business. Think of it as following the rules of a game to play fairly and avoid penalties.

contract manufacturer technical

"supplier and contract manufacturer oversight"

A contract manufacturer is a company hired to produce goods or products for another company under a contractual agreement, often using the hiring company's designs and specifications. Investors watch them because they affect costs, product quality and supply reliability—similar to outsourcing baking to a specialized bakery: if the baker is fast and consistent, the brand can grow with lower overhead; if not, sales and profits can suffer.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Experienced medical device quality and regulatory leader brings 13 years of experience supporting quality systems, regulatory compliance, audits and product development

MINNEAPOLIS, Sept. 16, 2026 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company committed to delivering solutions for patients with cardiorenal conditions, today announced the appointment of Brian Johnson as Director of Quality and Regulatory Affairs. Johnson brings 13 years of medical device quality and regulatory experience, with a proven track record leading quality systems, regulatory activities, audits and product development initiatives. His appointment strengthens Nuwellis' quality and regulatory capabilities as the Company continues to invest in the expertise needed to advance product development, commercialization and initiatives across the cardiorenal continuum.

"Brian's experience leading quality and regulatory functions within medical device organizations makes him an important addition to our team," said Mike McCormick, Nuwellis President and Chief Executive Officer. "As we continue to advance our product portfolio and execute on multiple strategic initiatives, Brian brings the leadership and technical expertise needed to enhance our quality and regulatory capabilities while supporting our focus on innovation and execution."

Prior to joining Nuwellis, Johnson served as Senior Quality Manager at Baxter/Vantive, providing quality oversight for two research and development facilities supporting 257 engineering and management employees. Previously, he held quality leadership roles at ATL Medical, where he led research and development and manufacturing quality activities and helped reduce monthly customer complaints by 80%. Johnson holds a Master of Science in Regulatory Affairs and Services from St. Cloud State University and a Bachelor of Science in Manufacturing Engineering Technology from Brigham Young University.

In his new role, Johnson will lead Nuwellis’ quality management and regulatory activities, including quality systems, audits, supplier and contract manufacturer oversight, and regulatory compliance. He will work cross-functionally with product development, operations and commercial teams to support product quality and the continued advancement of Nuwellis’ technology portfolio. Johnson will also support continuous improvement initiatives as the Company advances multiple product development programs.

The appointment of Johnson builds on Nuwellis' continued investment in the expertise needed to support product development and commercialization. The Company has also recently added expertise in medical affairs and engineering, further strengthening its capabilities across clinical development, product innovation, quality and regulatory execution as Nuwellis advances multiple strategic initiatives.

About Nuwellis
Nuwellis, Inc. (Nasdaq: NUWE) is a medical technology company committed to delivering solutions for patients with cardiorenal conditions. The Company develops solutions designed to support patient care through monitoring, therapy, and data-informed clinical decision-making across acute and chronic care settings. Nuwellis' strategy includes expanding its portfolio through internally developed technologies and strategic commercial partnerships that broaden its presence across acute and chronic critical care. For more information, visit www.nuwellis.com.

Forward-Looking Statements
Certain statements in this release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding the new market opportunities and anticipated growth in 2026 and beyond. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risks associated with our ability to execute on our commercialization strategy, the possibility that we may be unable to raise sufficient funds necessary for our anticipated operations, our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. Nuwellis does not assume any obligation to publicly update or revise any forward-looking statements, whether due to new information, future events or otherwise.

For further information, please contact:

Investor Relations:
CORE IR
ir@nuwellis.com

Media Contact:
CORE PR
media@nuwellis.com