Nuwellis Inc Stock Price, News & Analysis

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.

Nuwellis, Inc. (Nasdaq: NUWE) reported Q3 2022 revenue of $2.1 million, marking an 11% increase year-over-year. The gross margin remained solid at 61%, consistent with last year. The company activated three additional sites for the REVERSE-HF clinical study and announced positive AVOID-HF clinical data showing ultrafiltration's superior benefits for heart failure patients. Nuwellis also closed an $11.0 million public offering on October 18. The net loss was reduced to $3.9 million from $5.3 million a year prior. Cash and equivalents total approximately $12.1 million.

Nuwellis, Inc. (NUWE) announced promising clinical data demonstrating the efficacy of kidney replacement therapy using ultrafiltration for preterm neonates with end-stage kidney disease. A retrospective study revealed that 71% of the seven neonates studied survived to hospital discharge. The company aims to address unmet needs in neonatal fluid management and is developing a new pediatric CRRT device with partial funding from a $1.7 million NIH grant, collaborating with Koronis Biomedical Technologies Corporation.

Nuwellis, Inc. (NASDAQ: NUWE) will release its third quarter 2022 financial results on November 8, 2022. A conference call and webcast are scheduled for 9:00 AM ET, featuring management's discussion on the financial results and a business overview. Interested parties can join the live webcast on Nuwellis' Investors page or call in using the provided numbers with conference ID 10172214. Founded in Minneapolis, Nuwellis focuses on developing and commercializing the Aquadex SmartFlow® system for ultrafiltration therapy to aid patients with fluid overload.