Nuwellis, Inc. - NUWE STOCK NEWS

Nuwellis, Inc. (Nasdaq: NUWE) reported preliminary unaudited revenues of approximately $2.3 million for Q4 2022 and $8.5 million for the full year, marking increases of 42% and 8% from the previous year. This growth is attributed to a strengthened sales strategy and market expansion beyond heart failure patients, with Pediatrics, Heart Failure, and Critical Care segments showing notable increases of 92%, 47%, and 24%, respectively. CEO Nestor Jaramillo emphasized their commitment to establishing the Aquadex SmartFlow® system as the standard for fluid overload treatment.

Nuwellis (Nasdaq: NUWE) has appointed Dr. John Jefferies as its new Chief Medical Officer, enhancing its leadership team as it pushes forward with clinical evidence supporting ultrafiltration for fluid overload patients. Dr. Jefferies, who brings over 20 years of cardiology expertise, will guide clinical and medical affairs and aid corporate development. He is currently the Chief of Cardiology at the University of Tennessee and has been part of Nuwellis' medical advisory board since 2019. This leadership change is expected to strengthen Nuwellis' position in the market.

Nuwellis, Inc. (Nasdaq: NUWE) held a special meeting of stockholders on January 4, 2023, where shareholders approved the Warrant Proposal to issue up to 66,226,752 common shares upon exercise of warrants from the October 2022 offering. A total of 3,815,782 shares, representing 36% of outstanding shares, were present. Votes tallied included 1,955,994 in favor and 1,791,220 against the proposal. Additionally, 1,971,645 votes were cast to authorize adjournments for further proxy solicitation if needed. The company focuses on treating fluid overload through its Aquadex SmartFlow system.

Nuwellis, Inc. (NUWE) has secured an exclusive U.S. license and distribution agreement with SeaStar Medical for its Selective Cytopheretic Device (SCD) aimed at treating acute kidney injury (AKI) in children. Nuwellis will leverage its salesforce to market the SCD to nephrologists and intensive care physicians. The FDA is expected to review the Humanitarian Device Exemption for SCD in early 2023, with a potential market launch by Q2 2023. The SCD aims to mitigate cytokine storms in critically ill patients and could significantly reduce dialysis dependency and ICU stays.

Nuwellis, Inc. (Nasdaq: NUWE) announced compliance with Nasdaq's minimum bid price requirement as of December 27, 2022. The company achieved a closing bid price of at least $1.00 per share for 10 consecutive business days, leading to the closure of the compliance matter. Nuwellis focuses on innovative solutions for fluid overload conditions, notably through the Aquadex SmartFlow® system offering ultrafiltration therapy. This system assists in fluid management for patients unresponsive to conventional medical treatments.

Nuwellis, Inc. (Nasdaq: NUWE) announced a peer-reviewed study published in the American Heart Journal Plus demonstrating the effectiveness of the Aquadex FlexFlow System in reducing heart failure hospitalizations and readmission rates. The 10-year analysis of 334 patients showed an 81% decrease in yearly heart failure hospitalizations and 48% less rehospitalization at 30 days compared to the national average. Additionally, 55% of patients experienced significant weight loss, and all maintained stable renal function. The findings suggest ultrafiltration is a safe and effective treatment for fluid overload in heart failure patients.

Nuwellis, Inc. (Nasdaq: NUWE) announced that its Special Meeting of Stockholders, held on December 7, 2022, was adjourned due to a lack of quorum, with less than one-third of outstanding shares represented. The meeting will reconvene on January 4, 2023, providing additional time for stockholders to vote on proposals outlined in the proxy statement filed on November 7, 2022. Approximately 31.69% of shares had been voted at the time of adjournment, and stockholders who have not yet voted are urged to do so by January 3, 2023, at 10:59 p.m. CST.

Nuwellis, Inc. (Nasdaq: NUWE) has received a 180-day extension from Nasdaq to meet the minimum bid price requirement of $1.00 per share, following the end of an initial compliance period on November 28, 2022. The new deadline to achieve compliance is May 29, 2023. If Nuwellis' shares close at or above $1.00 for 10 consecutive business days before this date, the company will be notified of compliance. This extension does not affect the current listing or trading of NUWE on the Nasdaq Capital Market.

Nuwellis, Inc. (Nasdaq: NUWE) announced the approval of equity awards for seven new employees under its 2021 Inducement Plan, effective November 15, 2022. These awards include options to purchase a total of 9,695 shares with an exercise price of $0.11 per share. The options vest over four years, with 25% vesting after the first year. This approval aligns with Nasdaq Listing Rule 5635(c)(4), which mandates public disclosure of such equity awards. Nuwellis aims to enhance patient care through its Aquadex SmartFlow® system, treating fluid overload in patients.