Nuwellis, Inc.
For the period ended Jun 30, 2026. Filed Aug 13, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2026 · Filed Aug 13, 2026
NUWE$4.58-1.7%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-15.
0001140361-26-021649
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-13.
0001140361-26-032810
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 43 previous paragraphs and 51 current paragraphs.
28 unchanged; 9 reworded; 9 added; 6 removed; 0 previous and 5 current paragraphs rearranged.
Tables are not compared: 2 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (9)
Current report
Closed a registered public offering on June 8, 2026, raising approximately $6.0 million in gross proceeds.
Current report
Effectuated a one-for-thirty-five (1-for-35) reverse stock split of the Company’s common stock, effective June 25, 2026.
Current report
Appointed Mike McCormick as Chief Executive Officer effective June 30, 2026.
Current report
Research and Development (R&D)
Current report
Comparison of six months ended June 30, 2026 to six months ended June 30, 2025
Current report
Net Sales
Current report
Costs and Expenses
Current report
Cost of Goods Sold
Current report
Selling, General and Administrative
Removed paragraphs (6)
Previous report
Completed the asset acquisition of Rendiatech, Inc. on March 17, 2026, adding automated continuous kidney function monitoring technology to our cardiorenal platform.
Previous report
Appointed Carisa Schultz as Chief Financial Officer effective February 2, 2026.
Previous report
Continued execution of strategic realignment, including substantial payment of international exit obligations and full manufacturing transition to KDI Precision Manufacturing.
Previous report
The Company completed the asset acquisition of Rendiatech Ltd. on March 17, 2026. The transaction was accounted for as an asset acquisition under ASC 805-50. The purchase price was allocated to the individual assets acquired and liabilities assumed on a relative fair value basis, resulting in the recognition of inventory, non-compete agreements, and the immediate expensing of $552 thousand of in-process research and development (IPR&D) that had no alternative future use. There were no operations from the acquired Rendiatech assets between the acquisition date and March 31, 2026, and the transaction was not material to the Company’s results of operations or cash flows for the three months ended March 31, 2026. See Note 10 – Asset Acquisition for additional information regarding the transaction and the purchase price allocation.
Previous report
(in thousands)
Previous report
On March 17, 2026, we completed the acquisition of Rendiatech Ltd., which utilized $125 thousand of net cash (after $24 thousand of cash acquired in the business) and the issuance of equity (150,000 shares of common stock and 30,000 stock options). Transaction costs associated with the acquisition were expensed in selling, general and administrative expenses.
Reworded paragraphs (9)
Previous wording
Nuwellis is dedicated to advancing cardiorenal care by enabling earlier, safer, and more controlled fluid management for patients. Activities since inception have consisted principally of raising capital, performing research and product development, and conducting preclinical and clinical studies. During 2016, we acquired the Aquadex Business and announced that we were halting all clinical evaluations of our prior technology, the C-Pulse System. Since then, our activities have consisted mainly of expanding our sales and marketing efforts, as well as continued development of clinical evidence and new product development efforts. As March 31, 2026, we had an accumulated deficit of $320.9 million, and we expect to incur losses for the foreseeable future. To date, we have been funded by public and private equity financings. Although we believe that we will be able to successfully fund our operations in the future, there can be no assurance that we will be able to do so or that we will ever operate profitably.
Current wording
Nuwellis is dedicated to advancing cardiorenal care by enabling earlier, safer, and more controlled fluid management for patients. Activities since inception have consisted principally of raising capital, performing research and product development, and conducting preclinical and clinical studies. During 2016, we acquired the Aquadex Business and announced that we were halting all clinical evaluations of our prior technology, the C-Pulse System. Since then, our activities have consisted mainly of expanding our sales and marketing efforts, as well as continued development of clinical evidence and new product development efforts. As of June 30, 2026, we had an accumulated deficit of $325.7 million, and we expect to incur losses for the foreseeable future. To date, we have been funded by public and private equity financings. Although we believe that we will be able to successfully fund our operations in the future, there can be no assurance that we will be able to do so or that we will ever operate profitably.
Previous wording
Revenue is generated mainly from the sale of consoles and blood filters and catheters used in conjunction with the Aquadex System consoles. We sell primarily in the United States to hospitals and clinics through our direct salesforce. The increase in sales in the current year period is primarily due to a 633% increase in console sales, and a 15% increase in circuits reflecting continued increases in the number of patients treated with the Aquadex therapy.
Current wording
Revenue is generated mainly from the sale of consoles and blood filters and catheters used in conjunction with the Aquadex System consoles. We sell primarily in the United States to hospitals and clinics through our direct salesforce. The increase in sales in the current year period is primarily due to a 209% increase in console sales, and a 9% increase in circuits reflecting continued increases in the number of patients treated with the Aquadex therapy.
Previous wording
The increase in selling, general and administrative expense was primarily driven by increased headcount and sales related compensation from a 26.2% increase in sales vs prior year, and higher professional services fees.
Current wording
The increase in selling, general and administrative expenses was primarily driven by increased headcount and sales related compensation from a 14.1% increase in sales vs prior year, and higher professional services fees.
Previous wording
The increase in R&D expenses was primarily driven by the Rendiatech asset acquisition, increased headcount and compensation-related expense and higher consulting fees associated with increased sustained engineering expense and improvements to our quality system.
Current wording
The increase in R&D expenses was primarily driven by increased headcount and compensation-related expenses and higher consulting fees associated with increased sustained engineering expenses and improvements to our quality system.
Previous wording
We have funded our operations primarily through cash on hand, equity issuances, and at-the-market offerings. As of March 31, 2026, and December 31, 2025, cash, cash equivalents, and restricted cash were $2.2 million and $1.2 million, respectively.
Current wording
We have funded our operations primarily through cash on hand, equity issuances, and at-the-market offerings. As of June 30, 2026, and December 31, 2025, cash, cash equivalents, and restricted cash were $4.0 million and $1.2 million, respectively.
Previous wording
Our business strategy and ability to fund operations depend on growing the Aquadex business through expanded sales, product adoption, and cost control, as well as the successful integration of the Rendiatech technology. We expect to seek additional financing in the future, primarily through equity offerings or the existing At-The-Market program.
Current wording
Our business strategy and ability to fund operations depend on growing the Aquadex Business through expanded sales, product adoption, and cost control, as well as the successful integration of the Rendiatech technology. We expect to seek additional financing in the future, primarily through equity offerings or the existing At-The-Market program assuming adequate shelf availability as calculated under SEC rules.
Previous wording
Net cash used in operating activities was $3.1 million for the three months ended March 31, 2026, compared to $2.5 million for the comparable prior-year period. This primarily reflects our net loss, partially offset by non-cash items (e.g., stock-based compensation, depreciation, warrant fair value changes) and changes in working capital.
Current wording
Net cash used in operating activities was $6.3 million for the six months ended June 30, 2026, compared to $4.6 million for the comparable prior-year period. This primarily reflects our net loss, partially offset by non-cash items (e.g., stock-based compensation, depreciation, warrant fair value changes) and changes in working capital.
Previous wording
Net cash used in investing activities was $284 thousand, primarily for property and equipment purchases and cash paid for the Rendiatech acquisition (net of cash acquired).
Current wording
Net cash used in investing activities was $293,000 and $4,000 for the six months ended June 30, 2026 and 2025 respectively, primarily for property and equipment purchases and cash paid for the Rendiatech Acquisition (net of cash acquired).
Previous wording
Net cash provided by financing activities was $4.4 million, primarily from proceeds under the January PIPE Warrants.
Current wording
Net cash provided by financing activities was $9.4 million for the six months ended June 30, 2026, primarily from proceeds under the January 2026 PIPE warrants, January 2026 Warrant Inducement, and June 2026 Financing.
Rearranged current paragraphs (5)
Current report — wording carried from elsewhere
Revenue is generated mainly from the sale of disposable blood filters and catheters used in conjunction with the Aquadex system consoles. We sell primarily in the United States to hospitals and clinics through our direct salesforce. We sell outside of the United States to independent specialty distributors who in turn sell to hospitals and clinics in their geographic regions. The increase in sales in the current year period is primarily due to a 361% increase in console sales, and a 12% increase in circuits reflecting continued increases in the number of patients treated with the Aquadex therapy.
Current report — wording carried from elsewhere
Our costs and expenses were as follows:
Current report — wording carried from elsewhere
The decrease in cost of goods sold for the six months ended June 30, 2026, compared to the six months ended June 30, 2025, was primarily due to the increase in margin from switching to contract manufacturing, KDI Precision Manufacturing.
Current report — wording carried from elsewhere
The increase in selling, general and administrative expenses was primarily driven by increased headcount and sales related compensation from a 20.5% increase in sales vs prior year, and higher professional services fees.
Current report — wording carried from elsewhere
The increase in R&D expenses was primarily driven by increased headcount and compensation-related expenses and higher consulting fees associated with increased sustained engineering expenses and improvements to our quality system.