Core Insights - SeaStar Medical Holding Corporation announced positive early post-approval clinical experience for QUELIMMUNE therapy, showing strong survival rates in pediatric patients with Acute Kidney Injury (AKI) and sepsis [1][2][3] Group 1: Clinical Data and Outcomes - The SAVE Registry reported a 76% survival rate at Day 28 and Day 60, and a 71% survival rate at Day 90 for pediatric patients treated with QUELIMMUNE therapy [3] - No device-related adverse events or infections were observed in the first 21 patients, indicating a favorable safety profile [3][5] - Among patients treated with QUELIMMUNE and requiring extracorporeal membrane oxygenation (ECMO), a 60% survival rate was noted at Day 90 [4] Group 2: Regulatory and Adoption Insights - The FDA initially required 300 patients for the SAVE Registry but reduced the target to 50 after reviewing data from the first 21 patients [5] - QUELIMMUNE therapy has been adopted by several top-rated children's medical centers across the United States [6] Group 3: Company Background and Product Information - SeaStar Medical focuses on transforming treatments for critically ill patients facing organ failure, with QUELIMMUNE being its first commercial product approved in 2024 [12][13] - The Selective Cytopheretic Device (SCD) therapy aims to neutralize overactive immune cells and mitigate destructive hyperinflammation, with potential applications in various acute and chronic conditions [11]

Core Viewpoint - U.S. stock futures are mostly lower, with Nasdaq 100 futures down approximately 0.1% [1] Group 1: Company Movements - SeaStar Medical Holding Corp (NASDAQ:ICU) shares fell 9.5% to $0.21 in pre-market trading following a 1-for-10 reverse split announcement [1] - Coincheck Group NV (NASDAQ:CNCK) decreased by 11% to $2.28 in pre-market trading [2] - Ascent Solar Technologies, Inc. (NASDAQ:ASTI) dropped 7.6% to $4.67 after a 30% increase on Tuesday [2] - Jet.AI Inc (NASDAQ:JTAI) fell 5.3% to $0.82 after a 28% decline on Tuesday, despite announcing a joint venture with Choo Choo Express for a 50-mw data center in Nevada [2] - Lifestance Health Group Inc (NASDAQ:LFST) declined 3.7% to $6.80 in pre-market trading [2] - Precision Drilling Corp (NYSE:PDS) fell 3.3% to $66.96 in pre-market trading [2] - Vasta Platform Ltd (NASDAQ:VSTA) decreased by 3.1% to $4.80 in pre-market trading [2]

Core Viewpoint - U.S. stock futures are mostly lower, with Nasdaq 100 futures down approximately 0.1% [1] Group 1: Company Movements - SeaStar Medical Holding Corp (NASDAQ:ICU) shares fell 9.5% to $0.21 in pre-market trading following a 1-for-10 reverse split announcement [1] - Coincheck Group NV (NASDAQ:CNCK) decreased by 11% to $2.28 in pre-market trading [2] - Ascent Solar Technologies, Inc. (NASDAQ:ASTI) dropped 7.6% to $4.67 after a 30% increase on Tuesday [2] - Jet.AI Inc (NASDAQ:JTAI) fell 5.3% to $0.82 after a 28% decline on Tuesday, despite announcing a joint venture for a 50-mw data center in Nevada [2] - Lifestance Health Group Inc (NASDAQ:LFST) declined 3.7% to $6.80 in pre-market trading [2] - Precision Drilling Corp (NYSE:PDS) fell 3.3% to $66.96 in pre-market trading [2] - Vasta Platform Ltd (NASDAQ:VSTA) decreased by 3.1% to $4.80 in pre-market trading [2]

Financial Performance - Multi Ways Holdings Ltd reported net revenue of $26.44 million for the first half of 2025, representing an increase of 87.65% from $14.09 million in the same period last year [1] - The company's shares rose 59.6% to $0.40 in pre-market trading following the financial results announcement [1] Stock Movements - Indaptus Therapeutics Inc saw a surge of 62.1% to $3.21 after disclosing a significant investment by David E. Lazar [4] - X3 Holdings Co Ltd increased by 43.5% to $0.24 after previously dipping 90% [4] - Northann Corp rose 38.8% to $0.24 after engaging advisory services for business development [4] - Dynavax Technologies Corp gained 37.7% to $15.33 following Sanofi's agreement to acquire the company at $15.50 per share, valuing it at $2.2 billion [4] - Starfighters Space Inc shares jumped 18.2% to $15.30 amid post-IPO volatility [4] - Sidus Space Inc rose 17% to $1.93 after announcing a $25 million offering [4] - UiPath Inc increased by 8.7% to $17.35 after being announced as a member of the S&P Midcap 400 [4] Declines in Stock Prices - Picocela Inc fell 26.1% to $0.27 after a significant increase the previous day [4] - Can Fite Biopharma declined 25% to $0.18 following a reverse share split announcement [4] - Femasys Inc dropped 11.8% to $0.71 after filing a prospectus for a $9.8 million common stock offering [4] - SeaStar Medical Holding Corp fell 9.5% to $0.21 after announcing a reverse split [4] - EUDA Health Holdings Ltd dipped 8.3% to $1.75 after a previous jump of 41% [4]

Core Insights - Coeptis Therapeutics, Inc. is facing significant challenges in capital utilization and return generation within the competitive biotechnology sector [1] - The company's Return on Invested Capital (ROIC) is -91.29%, while its Weighted Average Cost of Capital (WACC) is 5.55%, leading to a negative ROIC to WACC ratio of -16.45, indicating inefficiencies in capital utilization [2] - In contrast, ZyVersa Therapeutics, Inc. demonstrates strong capital efficiency with a positive ROIC of 220.45% and a WACC of 7.54%, resulting in a favorable ROIC to WACC ratio of 29.23 [4] Company Comparisons - Cardio Diagnostics Holdings, Inc. has a ROIC of -60.70% and a WACC of 16.84%, yielding a less severe ROIC to WACC ratio of -3.60 compared to Coeptis [3] - SeaStar Medical Holding Corporation and Dermata Therapeutics, Inc. also report negative ROICs of -121.49% and -194.54%, respectively, with ROIC to WACC ratios of -7.04 and -31.71, highlighting similar challenges in generating returns above their cost of capital [5]

Market Overview - U.S. stocks traded lower, with the Nasdaq Composite falling more than 1% on Thursday, while the Dow decreased by 0.50% to 45,889.75 and the S&P 500 dropped 0.94% to 6,575.35 [1] - Consumer staples shares increased by 0.5% on Thursday, contrasting with a 1.5% decline in communication services stocks [1][2] Economic Indicators - Initial jobless claims decreased by 14,000 to 218,000 in the third week of September, better than market estimates of 235,000 [3][12] - U.S. wholesale inventories fell by 0.2% month-over-month to $898.8 billion in August, against expectations of a 0.1% increase [12] - Durable goods orders rose by 2.9% month-over-month to $312.1 billion in August, surpassing market estimates of a 0.5% decline [12] - The U.S. trade deficit in goods narrowed by $17.3 billion to $85.5 billion in August, compared to market estimates of $95.65 billion [12] - The U.S. economy grew at an annualized rate of 3.8% in the second quarter, an increase from the previous estimate of 3.3% [12] Commodity Market - Oil prices decreased by 0.5% to $64.66, while gold fell by 0.1% to $3,766.60 [6] - Silver prices increased by 1.4% to $44.805, whereas copper declined by 0.6% to $4.7865 [6] Company Performance - PepGen Inc. shares surged 107% to $5.51 following the announcement of a $100 million public offering priced at $3.20 per share [10] - SciSparc Ltd. shares rose 79% to $6.86 after announcing a quantum computing-enabled 3D protein modeling initiative [10] - Plus Therapeutics, Inc. shares increased by 40% to $0.5640 due to a national coverage agreement with UnitedHealthcare [10] - SeaStar Medical Holding Corporation shares plummeted 50% to $0.6226 after a recommendation to continue a pivotal trial [10] - Erayak Power Solution Group Inc. shares fell 31% to $0.0493 after a previous jump [10] - Cemtrex, Inc. shares dropped 29% to $0.4470 following the approval of a reverse stock split [10]

Core Points - PepGen Inc. announced an underwritten public offering of common stock and pre-funded warrants, leading to a 112.4% increase in its share price to $5.65 in pre-market trading [1] - Other notable stock movements include OFA Group rising 49.6% to $1.99 due to a partnership announcement, and WORK Medical Technology Group increasing 50.4% to $0.1693 after a significant drop the previous day [5] - Lithium Americas Corp. gained 36.8% to $8.21 following reports of Trump officials seeking an equity stake in the company related to a $2.26 billion loan renegotiation [5] Gainers - Immuneering Corporation rose 30% to $12.00 after pricing a $175 million public offering and a $25 million private placement [5] - 22nd Century Group, Inc. gained 37.7% to $2.08 after securing $9.5 million from an insurance claim settlement [5] - ClearPoint Neuro, Inc. increased by 12.8% to $21.76 after a previous gain of 58% [5] Losers - SeaStar Medical Holding Corporation dipped 43.3% to $0.7035 following a recommendation to continue a pivotal trial [5] - Cemtrex, Inc. shares fell 27.7% to $0.4530 after approving a 1-for-15 reverse stock split [5] - Lunai Bioworks Inc. declined 25.3% to $0.1290 after announcing a 10-for-1 reverse stock split [5]

Company Overview - SeaStar Medical Holding Corporation is a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life [3] - The company's first commercial product, QUELIMMUNE, is based on its patented Selective Cytopheretic Device (SCD) technology and was approved by the FDA in 2024 [3] - QUELIMMUNE is the only FDA-approved product for the ultra-rare condition of life-threatening acute kidney injury (AKI) due to sepsis in critically ill pediatric patients [3] Product and Technology - The Selective Cytopheretic Device (SCD) therapy has received Breakthrough Device Designation for six therapeutic indications from the FDA, which may facilitate a faster approval process and better reimbursement dynamics [3] - SeaStar Medical is currently conducting a pivotal trial of its SCD therapy in adult patients with AKI requiring continuous renal replacement therapy (CRRT), a condition affecting over 200,000 adults in the US annually [3] Upcoming Events - SeaStar Medical will participate in the HC Wainwright 27th Annual Global Investment Conference, with a presentation scheduled for September 5, 2025, at 7:00 am Eastern Time [1][2]

Market Overview - U.S. stocks showed mixed performance with the Dow Jones index falling approximately 0.2% to 43,011.70, while the NASDAQ rose by 0.20% to 19,953.27 and the S&P 500 increased by 0.02% to 6,093.14 [1] - Information technology shares experienced a notable increase of 0.8%, while real estate stocks declined by 1.3% [1] Commodities - Crude oil prices rose by 2.5% to $65.99, gold increased by 0.3% to $3,343.80, silver was up 1% to $36.070, and copper rose by 0.7% to $4.9605 [5] European Markets - European shares were generally lower, with the eurozone's STOXX 600 falling by 0.74%, Spain's IBEX 35 Index down 1.59%, London's FTSE 100 down 0.46%, Germany's DAX 40 down 0.61%, and France's CAC 40 slipping by 0.76% [6] Asian Markets - Asian markets closed higher, with Japan's Nikkei gaining 0.39%, Hong Kong's Hang Seng Index up 1.23%, China's Shanghai Composite rising 1.04%, and India's BSE Sensex increasing by 0.85% [7] Company News - Plus Therapeutics, Inc. saw its shares surge by 59% to $0.2968 following FDA clearance for its investigational new drug application for REYOBIQ [9] - QuantumScape Corporation's shares rose by 36% to $5.88 after achieving a key milestone in integrating its advanced Cobra separator process [9] - SeaStar Medical Holding Corporation's shares increased by 49% to $0.5362 due to strategic actions for Nasdaq compliance [9] - Lifeward Ltd. experienced a drop of 38% to $0.6015 after announcing a public offering of 4 million shares at $0.65 per share [9] - Torrid Holdings Inc. shares fell by 37% to $3.1900 following the pricing of a secondary offering of 10 million shares at $3.50 per share [9] - Allot Ltd. shares decreased by 17% to $8.01 after announcing a public offering of 5 million shares at $8.00 per share [9] Economic Indicators - Sales of new single-family homes in the U.S. decreased by 13.7% to an annualized rate of 623,000 units in May [11] - U.S. building permits fell by 2% to an annualized rate of 1.394 million in May [11] - The volume of mortgage applications in the U.S. increased by 1.1% from the previous week [11] - U.S. crude oil inventories declined by 5.836 million barrels, significantly exceeding market estimates of a 0.75 million barrel decrease [11]

TABLE OF CONTENTS As filed with the Securities and Exchange Commission on February 5, 2024 Registration No. 333-276562 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 2 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Nuwellis, Inc. (Exact name of registrant as specified in its charter) Delaware 3845 68-0533453 (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Ident ...