Nuwellis Inc Stock Price, News & Analysis

Nuwellis (NUWE) has priced a $4.3 million public offering consisting of 406,755 common shares and 14,085,998 pre-funded warrants, along with Series A and B Warrants. The offering is priced at $0.30 per share with accompanying warrants, while pre-funded warrants are priced at $0.2999. The Series A and B Warrants allow holders to purchase up to 43,478,259 and 14,492,753 shares respectively, with a $0.30 exercise price and 5-year term following stockholder approval. Series A Warrants include a one-time price reset provision tied to potential reverse stock splits, while Series B Warrants offer a zero-cash exercise option. Ladenburg Thalmann & Co. Inc. is serving as the sole book-runner, with closing expected around June 10, 2025. The company plans to use proceeds for working capital, general corporate purposes, and potential acquisitions.

Nuwellis (NUWE) reported its Q1 2025 financial results with revenue of $1.9 million, up 3% year-over-year. Key highlights include 38% growth in pediatric revenue and 4% increase in consumables utilization. The company achieved significant cost reductions with operating expenses decreasing 31% to $4.1 million. However, gross margin declined to 56.0% from 64.1% in Q1 2024. The company's Aquadex therapy received higher CMS reimbursement, with facility fees increasing nearly four-fold to $1,639 per day effective January 2025. The quarter ended with $2.6 million in cash and no debt, while net loss improved to $3.0 million ($0.69 per share) compared to $3.8 million ($24.11 per share) in Q1 2024.

Nuwellis (NUWE) has finalized a strategic manufacturing agreement with KDI Precision Manufacturing to outsource the assembly of key Aquadex product components. Under the agreement, KDI will take over assembly responsibilities for the Aquadex SmartFlow® Console, AquaFlexFlow® Blood Circuits, and dELC® Catheters. The partnership aims to enhance operational efficiency and reduce costs while maintaining product quality.

KDI, an ISO 13485 certified and FDA registered company founded in 1982, specializes in medical manufacturing with over 80% of its business in healthcare products. To ensure continuity, current Nuwellis assembly employees will be hired by KDI. Notably, KDI's CEO Vitaliy Epshteyn previously served as Nuwellis' SVP of Operations, Engineering, and QA/RA for 6 years.

Nuwellis (NASDAQ: NUWE) has expanded its Aquadex SmartFlow® therapy to two additional pediatric centers in the Southeastern United States, bringing the total to 47 pediatric centers using their fluid management solution. The Aquadex system is designed for controlled fluid removal in patients weighing 20 kg and above, offering a nurse-managed, bedside-compatible therapy for children facing fluid overload. This expansion represents growing recognition of early, precise fluid management as crucial for better outcomes in pediatric care. The technology provides care teams with a gentle approach to managing fluid overload in critically ill children, where the margin for error is particularly narrow.

Nuwellis (Nasdaq: NUWE) has secured U.S. Patent No. 12,280,007 for an innovative self-emptying fluid bag design that enhances clinical workflow efficiency. The patent, issued on April 22, 2025, features a novel siphon mechanism that enables automatic drainage without disconnecting from the scale, maintaining precise weight-based measurements.

The technology aims to reduce manual intervention requirements while preserving system accuracy in treating fluid overload in critically ill patients. While not planned for immediate implementation, the design could be incorporated into future Aquadex SmartFlow system updates, including the Vivian pediatric-focused CRRT device under development.

The patent received a 224-day extension to its standard term from the USPTO, representing one of several initiatives by Nuwellis to expand its intellectual property portfolio and advance fluid management innovation.

Nuwellis (NUWE), a commercial-stage medical technology company specializing in fluid overload solutions, has scheduled its first quarter 2025 financial results announcement for May 13, 2025. The company will host a conference call and webcast at 9:00 AM ET to discuss the results and provide a business update.

Investors can access the live webcast through the company's investor relations website at ir.nuwellis.com, or join the conference call by dialing 1-800-579-2543 (U.S.) or 1-785-424-1789 (international) using conference ID: NUWEQ1. An audio recording will be available on the company's investor website after the call.

Nuwellis (NUWE) reported Q4 and full year 2024 financial results, showing mixed performance. Q4 revenue decreased 9% year-over-year to $2.3 million, while consumables utilization grew 21% and Critical Care revenue increased 35%. The company achieved a gross margin of 58.4%, up from 54.4% in the prior year quarter.

Notable highlights include a four-fold CMS payment increase to $1,639 for Aquadex Ultrafiltration Therapy in outpatient settings, effective January 2025. New clinical data showed Aquadex reduced heart failure events by 60% compared to IV diuretics. The company successfully reduced operating costs by $5.9 million (26%) year-over-year.

Q4 operating loss improved to $2.4 million from $3.6 million, with net loss per share of $0.44. As of December 31, 2024, Nuwellis had no debt and $5.1 million in cash and cash equivalents.

Nuwellis Inc (Nasdaq: NUWE) announced that Nestor Jaramillo, Jr. has retired as President, CEO, and director, effective February 18, 2025. John Erb, the current Chairman of the Board, has been appointed as Interim President and CEO.

The company plans to engage an executive search firm to identify a permanent CEO. Erb, who has served as a director since September 2012 and chairman since October 2012, previously served as president and CEO of Nuwellis from November 2015 to January 2021. He was also executive chairman and CEO of CHF Solutions, Inc., the previous owner of the Aquadex™ system.

Nuwellis (NUWE) announced promising findings from an updated analysis of the AVOID-HF study, published in JACC: Heart Failure. The study, led by Dr. Sean P. Pinney and Dr. Maria V. DeVita, revealed that patients treated with Aquadex SmartFlow ultrafiltration therapy showed a 60% reduction in heart failure events at 30 days compared to traditional IV diuretics.

The reanalysis of the AVOID-HF study included a broader dataset and demonstrated trends toward fewer hospitalizations and improved quality of life for patients using Aquadex therapy. Nuwellis plans to continue research through its REVERSE-HF trial to further establish the clinical and economic benefits of ultrafiltration therapy versus conventional treatments.