Core Insights - Nuwellis, Inc. has received FDA 510(k) clearance for a new size of its Dual Lumen Extended Length Catheter (dELC), enhancing its fluid management technology platform [1][2][5] Company Strategy - The clearance aligns with Nuwellis' multi-year plan to develop a comprehensive fluid management platform that integrates therapy delivery, venous access, and implementation support for hospitals and clinics [2][3] - The company's growth strategy focuses on three key areas: critical care, cardiac surgery recovery, and outpatient heart failure programs [2] Product Details - The dELC is designed for reliable peripheral venous access for up to 72 hours, supporting the Aquadex FlexFlow® and Aquadex SmartFlow® systems for ultrafiltration therapy [4][7] - The product portfolio now includes two coil-reinforced, 6F catheters with insertable lengths of 11 cm and 15 cm, catering to various patient anatomies and clinical workflows [5][9] Clinical Relevance - The dELC aims to provide dependable peripheral access across inpatient and outpatient settings, enhancing workflow efficiency and therapy delivery confidence [3][9] - The Aquadex SmartFlow system is indicated for temporary or extended use in patients with fluid overload unresponsive to medical management, emphasizing its clinical applicability [7]

TABLE OF CONTENTS As filed with the Securities and Exchange Commission on August 28, 2024 Registration No. 333-281563 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Nuwellis, Inc. (Exact name of registrant as specified in its charter) (Name, Address, Including Zip Code, and Telephone Number, Including Area Code, of Agent for Service) Delaware 3845 68-0533453 (State or Other Jurisdiction of Incorporat ...

TABLE OF CONTENTS As filed with the Securities and Exchange Commission on August 14, 2024 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Nuwellis, Inc. (Exact name of registrant as specified in its charter) Delaware 3845 68-0533453 (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 12988 Va ...

As filed with the Securities and Exchange Commission on April 17, 2024 Registration No. 333-276562 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 5 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 TABLE OF CONTENTS Nuwellis, Inc. (Exact name of registrant as specified in its charter) Delaware 3845 68-0533453 (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identif ...

TABLE OF CONTENTS As filed with the Securities and Exchange Commission on March 13, 2024 Registration No. 333-276562 Nuwellis, Inc. (Exact name of registrant as specified in its charter) Delaware 3845 68-0533453 (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial Classification Code Number) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 4 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 (I.R.S. Employer Identif ...

TABLE OF CONTENTS As filed with the Securities and Exchange Commission on February 5, 2024 Registration No. 333-276562 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 2 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Nuwellis, Inc. (Exact name of registrant as specified in its charter) Delaware 3845 68-0533453 (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Ident ...

TABLE OF CONTENTS As filed with the Securities and Exchange Commission on January 30, 2024 Registration No. 333-276562 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Nuwellis, Inc. (Exact name of registrant as specified in its charter) Delaware 3845 68-0533453 (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Ident ...

TABLE OF CONTENTS As filed with the Securities and Exchange Commission on January 17, 2024 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Nuwellis, Inc. (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial Classification Code Number) 12988 Valley View Road Eden Prairie, Minnesota 55344 (952) 345-4200 (Add ...

As filed with the Securities and Exchange Commission on September 20, 2023 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 TABLE OF CONTENTS (Primary Standard Industrial Classification Code Number) 12988 Valley View Road Eden Prairie, Minnesota 55344 (952) 345-4200 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 NUWELLIS, INC. (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of Incorporation or Organization) (A ...