Nuwellis, Inc. Files S-1/A Amendment

TL;DR

<b>Nuwellis, Inc. has filed an S-1/A amendment, providing updated financial and corporate information.</b>

AI Summary

Nuwellis, Inc. (NUWE) filed a Amended IPO Registration (S-1/A) with the SEC on February 5, 2024. Nuwellis, Inc. (formerly CHF Solutions, Inc.) filed an S-1/A amendment on February 5, 2024. The company was incorporated in Delaware and has its principal executive offices in Eden Prairie, MN. Nuwellis, Inc. operates in the Electromedical & Electrotherapeutic Apparatus industry (SIC 3845). The filing references financial data for fiscal years ending December 31, 2020, 2021, and 2022, as well as the period ending September 30, 2023. Previous company names include Sunshine Heart, Inc. (name change in 2010) and CHF Solutions, Inc. (name change in 2017).

Why It Matters

For investors and stakeholders tracking Nuwellis, Inc., this filing contains several important signals. This S-1/A filing indicates ongoing efforts by Nuwellis to update its registration statement, which could be in preparation for a future offering or to comply with regulatory requirements. The amendment provides a snapshot of the company's financial structure and history, including previous name changes and preferred stock series, which is crucial for investors assessing its stability and evolution.

Risk Assessment

Risk Level: medium — Nuwellis, Inc. shows moderate risk based on this filing. The company has undergone multiple name changes and is filing an S-1/A, suggesting potential ongoing financial activities or restructuring that require regulatory updates, which can introduce uncertainty.

Analyst Insight

Monitor future filings for details on any capital raises or significant business developments following this S-1/A amendment.

Key Numbers

• 2024-02-05 — Filing Date (S-1/A filing date)
• 1231 — Fiscal Year End (Company's fiscal year end)
• 333-276562 — SEC File Number (SEC file number for the registration)
• 2023-09-30 — Reporting Period End Date (Latest interim reporting period end date)

Key Players & Entities

• Nuwellis, Inc. (company) — Filer name
• CHF Solutions, Inc. (company) — Former company name
• Sunshine Heart, Inc. (company) — Former company name
• Eden Prairie, MN (location) — Business address city and state
• 3845 (industry_code) — Standard Industrial Classification code
• 2024-02-05 (date) — Filing date
• 2017-05-23 (date) — Date of name change
• 2010-11-24 (date) — Date of name change

Forward-Looking Statements

• Nuwellis, Inc. will proceed with a public offering of securities within the next 6-12 months. (Nuwellis, Inc.) — medium confidence, target: 2025-02-05
• The capital raised will primarily be used to fund research and development for new electromedical devices. (Nuwellis, Inc.) — low confidence, target: 2025-02-05

FAQ

Risk Factors

• Regulatory Compliance [high — regulatory]: The company operates in a highly regulated industry, requiring adherence to various FDA and international regulations for its medical devices.
• Financial Viability [medium — financial]: The company's financial statements and disclosures in the S-1/A filing will be scrutinized for its ability to continue as a going concern.
• Product Development and Commercialization [medium — operational]: Success depends on the effective development, regulatory approval, and market adoption of its medical technologies.

Key Dates

• 2024-02-05: S-1/A Filing — Amendment to the registration statement, indicating updated information for investors and regulators.
• 2017-05-23: Name Change — Company changed name from CHF Solutions, Inc. to Nuwellis, Inc.

Key Financial Figures

• $0.48 — sumed combined public offering price of $0.48 per unit, which is equal to the closing
• $0.125 — hare under Nasdaq rule 5635(d) plus (b) $0.125 per whole share of common stock underly
• $0.0001 — d to the public in this offering, minus $0.0001. For each pre-funded warrant we sell,
• $24,000 — for 8.3 days at a cost of approximately $24,000 15 , to which reimbursement will only c
• $15.2 million — uch penalties can cost a hospital up to $15.2 million annually. 17, 18, 19 Treatments for F
• $3,975 — is demonstrated a total cost savings of $3,975, or 14.4%, per patient when using ultra

Filing Documents

• ny20017086x6_s1a.htm (S-1/A) — 4285KB
• ny20017086x6_ex1-1.htm (EX-1.1) — 166KB
• ny20017086x6_ex4-16.htm (EX-4.16) — 125KB
• ny20017086x6_ex4-17.htm (EX-4.17) — 127KB
• ny20017086x6_ex4-19.htm (EX-4.19) — 106KB
• ny20017086x6_ex5-1.htm (EX-5.1) — 21KB
• ny20017086x6_ex10-70.htm (EX-10.70) — 222KB
• ny20017086x6_ex23-2.htm (EX-23.2) — 2KB
• ny20017086x6_ex107.htm (EX-FILING FEES) — 25KB
• logo_nuwellis2.jpg (GRAPHIC) — 83KB
• logo_nuwellis2x1.jpg (GRAPHIC) — 49KB
• ny20017086x6_ex5-1img01.jpg (GRAPHIC) — 3KB
• 0001140361-24-005711.txt (&nbsp;) — 15472KB
• nuwe-20240205.xsd (EX-101.SCH) — 70KB
• nuwe-20240205_cal.xml (EX-101.CAL) — 75KB
• nuwe-20240205_def.xml (EX-101.DEF) — 524KB
• nuwe-20240205_lab.xml (EX-101.LAB) — 858KB
• nuwe-20240205_pre.xml (EX-101.PRE) — 702KB
• ny20017086x6_s1a_htm.xml (XML) — 1602KB

RISK FACTORS

RISK FACTORS 17 SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS 36

USE OF PROCEEDS

USE OF PROCEEDS 37 CAPITALIZATION 38

MANAGEMENT'S DISCUSSION AND ANALYSIS OF

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 40

BUSINESS

BUSINESS 47 CERTAIN RELATIONSHIPS AND RELATED PERSON TRANSACTIONS 65 MANAGEMENT 66

EXECUTIVE COMPENSATION

EXECUTIVE COMPENSATION 73

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT 79

DESCRIPTION OF CAPITAL STOCK

DESCRIPTION OF CAPITAL STOCK 80

DESCRIPTION OF SECURITIES WE ARE OFFERING

DESCRIPTION OF SECURITIES WE ARE OFFERING 97 PLAN OF DISTRIBUTION (CONFLICTS OF INTEREST) 100 LEGAL MATTERS 106 EXPERTS 106 WHERE YOU CAN FIND ADDITIONAL INFORMATION 106

FINANCIAL STATEMENTS

FINANCIAL STATEMENTS F- 1 TABLE OF CONTENTS ABOUT THIS PROSPECTUS This prospectus is part of a registration statement on Form S-1 that we filed with the Securities and Exchange Commission ("SEC"). It omits some of the information contained in the registration statement and reference is made to the registration statement for further information with regard to us and the securities being offered hereby. You should review the information and exhibits in the registration statement for further information about us and the securities being offered hereby. Statements in this prospectus concerning any document we filed as an exhibit to the registration statement or that we otherwise filed with the SEC are not intended to be comprehensive and are qualified by reference to the filings. You should review the complete document to evaluate these statements. You should not assume that the information contained in this prospectus is accurate on any date subsequent to the date set forth on the front of the document or that any information we have incorporated by reference is correct on any date subsequent to the date of the document incorporated by reference, even though this prospectus is delivered or securities are sold on a later date. Our business, financial condition, results of operations and prospects may have changed since those dates. You should read this prospectus and the additional information described below under "Where You Can Find Additional Information" before making an investment decision. You should rely only on the information contained in this prospectus and any free-writing prospectus that we authorize to be distributed to you. This prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted. For investors outside of the United States. We have not, and the placement agents have not, done anything that would permit this offering or posses

View Full Filing

View this S-1/A filing on SEC EDGAR