Nuwellis Inc Stock Price, News & Analysis

Nuwellis, Inc. (Nasdaq: NUWE) reported third-quarter results ending September 30, 2021, with total revenue of $1.9 million, a 3% decline year-over-year. Year-to-date revenue reached $6.3 million, showing a 16% increase compared to 2020 and a 52% increase versus pre-pandemic 2019. The company opened three new pediatric accounts, the largest addition in 2021, and announced an R&D partnership with Koronis Biomedical Technologies, backed by a $1.7 million NIH grant. Despite COVID-related challenges, Nuwellis ended Q3 with $28.4 million in cash and no debt.

Nuwellis, Inc. (NASDAQ: NUWE) was recognized at the 2021 R&D 100 Awards for its Aquadex SmartFlow® system, winning in the Analytical/Test category. This award highlights products with significant technological contributions. The Aquadex system effectively removes excess fluid from patients unresponsive to diuretics, with a removal rate of up to 500 mL per hour. Since its FDA clearance in February 2020 for pediatric use, it has been implemented in various leading hospitals. Nuwellis aims to expand treatment options in this vital area.

Nuwellis has been awarded the 2021 Governor's International Trade Award by Minnesota Governor Tim Walz, recognizing the company for its growth in foreign markets. This honor highlights Nuwellis' commitment to sustaining jobs in Minnesota while promoting its Aquadex SmartFlow® System, an ultrafiltration therapy for fluid-overloaded patients. The firm has expanded its operations internationally, including recent market entries in Austria, Israel, and the UAE, and holds distribution agreements covering 18 countries. In September 2021, Nuwellis received CE Mark certification for its 24-Hour Blood Circuit Set, further broadening its market reach.

Nuwellis, Inc. (NASDAQ: NUWE) announced the release date for its third quarter 2021 financial results, set for November 9, 2021. The company will also hold a conference call at 9:00 AM ET to discuss these results along with a general business overview. Investors can access the call via the company’s website or by dialing in. As a medical device company, Nuwellis focuses on innovative solutions for patients suffering from fluid overload, primarily through its Aquadex SmartFlow® system.

Nuwellis has received CE Mark Certification for its 24-Hour Blood Circuit Set (UF 500-24 Hour), enabling marketing in the EU and other recognized countries. This device, used with the Aquadex SmartFlow® system, enhances outpatient ultrafiltration treatment accessibility for patients not responding to diuretics. The certification supports Nuwellis' strategy to meet clinical and economic needs in Europe, particularly in outpatient settings, and addresses hospital capacity pressures exacerbated by the pandemic.

Nuwellis, Inc. (NASDAQ:NUWE) has successfully closed an underwritten public offering of 4,005,588 shares at $2.50 each, raising approximately $10 million, including the full exercise of an over-allotment option. The funds will be used for general corporate purposes, particularly enhancing commercialization efforts. The offering was executed under a shelf registration statement filed with the SEC. Ladenburg Thalmann & Co. served as the sole book-running manager for this transaction.

Nuwellis, Inc. (NASDAQ:NUWE) announced the pricing of an underwritten public offering of 3,483,120 shares at $2.50 each, generating approximately $8.7 million before expenses. An additional 522,468 shares may be purchased by underwriters within 45 days. The proceeds will support general corporate purposes, particularly commercialization efforts. The offering is part of a shelf registration statement filed with the SEC. Closing is expected on or about September 17, 2021, subject to customary conditions.

Nuwellis, Inc. (NASDAQ:NUWE) announced plans for an underwritten public offering of its common stock, with the possibility for underwriters to purchase an additional 15% of shares. Proceeds from the offering will be used for general corporate purposes, enhancing commercialization efforts. The offering is subject to market conditions, and no assurance can be made regarding completion or terms. Ladenburg Thalmann & Co. Inc. is the sole book-running manager for the offering, which follows the company’s effective shelf registration statement.

Nuwellis, Inc. (NASDAQ: NUWE) announced the approval of an equity award under its 2021 Inducement Plan for a new employee, effective September 13, 2021. The award includes an option to purchase 5,965 shares at an exercise price of $4.02, reflecting the stock's closing price on the grant date. The option vests over four years, with 25% vesting after the first year. Nuwellis specializes in medical devices, focusing on the Aquadex SmartFlow® system for treating fluid overload in patients. This award complies with NASDAQ Listing Rule 5635(c)(4), necessitating public notice of non-stockholder approved equity awards.