MINNEAPOLIS - Nuwellis, Inc. (NASDAQ:NUWE), a medical device company, announced today that it has regained compliance with the Nasdaq Stock Market's minimum bid price and stockholders' equity requirements. This development allows the company's common stock to continue trading on the Nasdaq Capital Market under the ticker symbol "NUWE". According to InvestingPro data, the company's stock has experienced significant volatility, with a 95% decline year-to-date, though analysis suggests the stock may currently be undervalued.
The compliance confirmation came after Nuwellis undertook several financial maneuvers, including raising new equity and reducing liabilities. The company successfully raised $5.1 million in gross proceeds through warrant exercises and a recent warrant inducement transaction in November. Additionally, Nuwellis implemented a reverse stock split at a ratio of 1:35 on June 26, 2024. InvestingPro data shows the company maintains a healthy current ratio of 2.03 and holds more cash than debt on its balance sheet, though it's currently burning through cash rapidly.
Nestor Jaramillo, President and CEO of Nuwellis, stated that the company has made significant progress in improving its balance sheet and expanding its business, which has led to meeting Nasdaq’s stockholders' equity requirement of at least $2.5 million.
In line with the compliance, Nuwellis will undergo a mandatory panel monitor for one year from December 17, 2024, as part of Nasdaq's standard oversight procedures.
Nuwellis specializes in the Aquadex SmartFlow® system, a medical device designed for ultrafiltration therapy to treat patients with fluid overload. The company, based in Minneapolis with a subsidiary in Ireland, focuses on providing solutions for patients suffering from hypervolemia, where excess fluid is not responsive to medical management.
The company's forward-looking statements, as mentioned in the press release, highlight its intentions to maintain its securities' listing on Nasdaq, execute its commercialization strategy, and continue product development and commercialization efforts. With revenue of $8.97 million in the last twelve months and a gross profit margin of 63.65%, according to InvestingPro, the company faces various risks and uncertainties, including its ability to raise sufficient funds for operations and increase market acceptance of its products. For deeper insights into Nuwellis's financial health and growth prospects, investors can access comprehensive analysis and 14 additional ProTips through InvestingPro's detailed research reports.
This news is based on a press release statement from Nuwellis, Inc.
In other recent news, Nuwellis, Inc. has initiated a voluntary recall of specific lots of its AquaFlexFlow UF 500 Plus extracorporeal blood circuit, due to a malfunction potentially leading to Acute Volume Depletion in patients. The recall is currently being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). The company has reported five instances of product failure, with three cases resulting in patient dehydration necessitating the administration of fluids.
In financial developments, Nuwellis reported mixed results for the third quarter of 2024. Revenues were at $2.4 million, down 2% year-over-year but up 8% from Q2. However, the pediatric segment saw a revenue increase of 28%, and gross margins improved significantly to 70% from 57.3% the previous year.
In other company updates, Nuwellis raised $5.1 million through warrant exercises and settled a distribution agreement dispute with SeaStar Medical (TASE:PMCN), receiving $500,000. Looking ahead, Nuwellis is preparing for a new outpatient reimbursement code that could substantially increase ultrafiltration therapy reimbursement rates by 297%, effective January 1, 2025. The company also plans to initiate a clinical study of its Vivian product by the end of 2025.
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