0001140361-24-046166 | 10-Q | XBRL Viewer

Subsequent Events	9 Months Ended
Subsequent Events	Sep. 30, 2024
Subsequent Events [Abstract]
Subsequent Events	Note 9- Subsequent Events On October 20, 2024 (the “Effective Date”), Nuwellis, Inc. (the “Company”) and SeaStar Medical Holding Corporation (“SeaStar”) entered into a Confidential Settlement Agreement and Release (the “Settlement Agreement”), which terminated the License and Distribution Agreement entered into by the Company and SeaStar, dated as of December 27, 2022 (the “Distribution Agreement”) and the Supplier and Distributor Quality Agreement dated as of March 5, 2024 (the “Supply Agreement,” and together with the Distribution Agreement, the “SeaStar Agreements”) pursuant to which SeaStar appointed the Company as its exclusive distributor for the sale and distribution of SeaStar’s product, QUELIMMUNE ™ with SeaStar agreeing to pay the Company $900,000 before December 31, 2024. The Company is accounting for the settlement as a gain contingency and will record the gain at the earlier of when the contingency is realized or realizable. The Company received payment of $500,000 on October 22, 2024 and was recognized in October 2024. On November 5, 2024, the Company announced the entry into definitive agreements for the immediate exercise of certain outstanding warrants issued by the Company on April 30, 2024 (collectively, the “Existing Warrants”) to purchase up to an aggregate of 1,832,517 shares of the Company’s common stock at their current exercise price of $2.10 per share for total gross proceeds of approximately $3.8 million, prior to deducting inducement agent fees and estimated offering expenses. An additional $1.3 million of gross proceeds was received through the exercise of warrants over the last week in accordance with their original terms. In consideration for the immediate exercise of the Existing Warrants, the Company will issue Series I common stock purchase warrants (the “Series I Warrants”) and Series II common stock purchase warrants (the “Series II Warrants”) to purchase up to an aggregate of 3,665,034 shares of common stock. The Series I Warrants will have an exercise price of $1.94, will be exercisable six (6) months from the date of issuance, and will have a term of five (5) years from the date of exercisability. The Series II Warrants will have an exercise price of $1.94, will be exercisable six (6) months from the date of issuance, and will have a term of two (2) years from the date of exercisability. The Series I Warrants and Series II Warrants are fixed priced and do not contain any variable pricing features. The Series I Warrants and Series II Warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements under Section 4(a)(2) of the Securities Act of 1933 (the “Securities Act”), and, along with the shares of common stock issuable upon their exercise, have not been registered under the Securities Act, and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (the “SEC”) or an applicable exemption from such registration requirements. The securities were offered only to accredited investors. The Company has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable upon exercise of the Series I Warrants and Series II Warrants.

Stockholders' Equity (Details) $ / shares in Units, $ in Thousands, $ in Millions												3 Months Ended				9 Months Ended		12 Months Ended
	Aug. 23, 2024 USD ($) $ / shares shares	Jul. 24, 2024 USD ($) $ / shares shares	Jun. 26, 2024	Jun. 06, 2024	Apr. 30, 2024 USD ($) Warrant $ / shares shares	Oct. 17, 2023 USD ($) $ / shares shares	Oct. 17, 2023 AUD ($)	Oct. 12, 2023 shares $ / shares	Jun. 19, 2023 Tranches $ / shares shares	Mar. 12, 2019	Nov. 27, 2017 USD ($)	Sep. 30, 2024 USD ($) $ / shares shares	Jun. 30, 2024 shares	Jun. 30, 2023 shares	Mar. 31, 2023 USD ($) shares	Sep. 30, 2024 USD ($) $ / shares shares	Sep. 30, 2023 USD ($)	Dec. 31, 2023 USD ($) $ / shares shares	Aug. 30, 2024 $ / shares	Aug. 13, 2024 $ / shares shares
Class of Stock Disclosures [Abstract]
Preferred stock, shares outstanding (in shares)												0				0		0
Common stock, par value (in dollars per share) \| $ / shares												$ 0.0001				$ 0.0001		$ 0.0001
Converted warrant \| $												$ 4,217			$ 7,623
Period of warrants expected to vest																48 months
Gross proceeds from public stock offering \| $																$ 2,403	$ 0
Preferred stock, par value (in dollars per share) \| $ / shares												$ 0.0001				$ 0.0001		$ 0.0001
Common stock warrant liability \| $												$ 480				$ 480		$ 2,843
Reverse stock split			0.028
Minimum [Member]
Class of Stock Disclosures [Abstract]
Reverse stock split				0.20
Maximum [Member]
Class of Stock Disclosures [Abstract]
Reverse stock split				0.014
At-the-Market Program [Member]
Class of Stock Disclosures [Abstract]
Issuance of common stock, net (in shares)																		18,781
Gross proceeds from public stock offering \| $																		$ 2,300
Net proceeds from public stock offering \| $																		$ 2,100
Aggregate cash fee paid to underwriter or placement agent																3.00%
April 2024 Offering [Member]
Class of Stock Disclosures [Abstract]
Issuance of common stock, net (in shares)					240,571
Warrants to purchase shares of common stock (in shares)					3,214,288															2,710,734
Exercise price of warrants (in dollars per share) \| $ / shares					$ 2.1							$ 2.97				$ 2.97				$ 2.49
No of warrants converted to equity (in shares)												2,651,426
Converted warrant \| $												$ 4,200
Gross proceeds before deducting placement agent fees and commissions and offering expenses \| $					$ 2,700
Issuance of common stock for pre-funded warrants (in shares)					80,854
Common stock offering price per share (in dollars per share) \| $ / shares					$ 8.4
Number of warrants included in each unit \| Warrant					1
Warrants to purchase common shares (in shares)					1.50							398,488				398,488
Warrant expiry period					5 years											5 years
Gross proceeds before deducting the placement agent fees and other offering expenses \| $					$ 2,700
August 2024 Offering [Member]
Class of Stock Disclosures [Abstract]
Warrants to purchase shares of common stock (in shares)	14,501
Exercise price of warrants (in dollars per share) \| $ / shares	$ 3.04425																		$ 2.1
Gross proceeds before deducting the placement agent fees and other offering expenses \| $	$ 892,000
Warrants to Purchase Common Stock [Member] \| April 2024 Offering [Member]
Class of Stock Disclosures [Abstract]
Warrants to purchase common shares (in shares)					1
Number of trading days					5 days											5 days
Floor price per share (in dollars per share) \| $ / shares					$ 2.1							$ 2.1				$ 2.1
Supply Agreement [Member] \| Maximum [Member]
Class of Stock Disclosures [Abstract]
Period for ultrafiltration services																10 years
Supply Agreement [Member] \| DaVita Warrant [Member]
Class of Stock Disclosures [Abstract]
Warrants to purchase shares of common stock (in shares)									36,830
Common stock, par value (in dollars per share) \| $ / shares									$ 0.0001
Exercise price of warrants (in dollars per share) \| $ / shares									$ 115.49
Number of tranches \| Tranches									4
Supply Agreement [Member] \| DaVita Warrant [Member] \| Tranche One [Member]
Class of Stock Disclosures [Abstract]
Percentage of warrants expected to vest									25.00%
Supply Agreement [Member] \| DaVita Warrant [Member] \| Tranche Two [Member]
Class of Stock Disclosures [Abstract]
Percentage of warrants expected to vest									25.00%
Period of warrants expected to vest																12 months
Supply Agreement [Member] \| DaVita Warrant [Member] \| Tranche Three [Member]
Class of Stock Disclosures [Abstract]
Percentage of warrants expected to vest									25.00%
Period of warrants expected to vest																24 months
Supply Agreement [Member] \| DaVita Warrant [Member] \| Tranche Four [Member]
Class of Stock Disclosures [Abstract]
Percentage of warrants expected to vest									25.00%
Period of warrants expected to vest																36 months
Supply Agreement [Member] \| DaVita Warrant [Member] \| Maximum [Member]
Class of Stock Disclosures [Abstract]
Warrants to be exercised for amount of shares ownership percentage in entity									19.90%
Securities Purchase Agreement [Member]
Class of Stock Disclosures [Abstract]
Issuance of common stock, net (in shares)		469,340
Warrants to purchase shares of common stock (in shares)		938,680
Exercise price of warrants (in dollars per share) \| $ / shares		$ 3.99
Gross proceeds before deducting placement agent fees and commissions and offering expenses \| $		$ 2,000
Common stock offering price per share (in dollars per share) \| $ / shares		$ 4.24
Warrant expiry period		5 years
Securities Purchase Agreement [Member] \| July 2024 Offering [Member]
Class of Stock Disclosures [Abstract]
Issuance of common stock, net (in shares)		469,340
Warrants to purchase shares of common stock (in shares)		938,680
Exercise price of warrants (in dollars per share) \| $ / shares		$ 3.99
Gross proceeds before deducting placement agent fees and commissions and offering expenses \| $		$ 2,000
Net proceeds after deducting placement agent fees and commissions and offering expenses \| $		$ 1,500
Common stock offering price per share (in dollars per share) \| $ / shares		$ 4.24
Warrant expiry period		5 years
Securities Purchase Agreement [Member] \| August 2024 Offering [Member]
Class of Stock Disclosures [Abstract]
Issuance of common stock, net (in shares)	483,351
Warrants to purchase shares of common stock (in shares)	483,351
Common stock, par value (in dollars per share) \| $ / shares	$ 0.0001
Exercise price of warrants (in dollars per share) \| $ / shares	1.72
Common stock offering price per share (in dollars per share) \| $ / shares	1.845
Series F Convertible Preferred Stock [Member]
Class of Stock Disclosures [Abstract]
Number of consecutive trading days considered for expiration																20 days
Number of consecutive trading days																30 days
Percentage of volume weighted average price of common stock											300.00%
Trading volume for each trading day \| $											$ 7,000
Conversion price (in dollars per share) \| $ / shares	$ 542.01
Preferred stock, shares outstanding (in shares)												127				127		127
Preferred stock, par value (in dollars per share) \| $ / shares												$ 0.0001				$ 0.0001		$ 0.0001
Series F Convertible Preferred Stock [Member] \| Minimum [Member]
Class of Stock Disclosures [Abstract]
Aggregate cash fee paid to underwriter or placement agent										7.00%
Series F Convertible Preferred Stock [Member] \| Maximum [Member]
Class of Stock Disclosures [Abstract]
Aggregate cash fee paid to underwriter or placement agent										8.00%
Series J Convertible Preferred Stock [Member] \| October 2023 Offering [Member]
Class of Stock Disclosures [Abstract]
Issuance of common stock, net (in shares)								150,000
Warrants to purchase shares of common stock (in shares)								0.5
Number of shares in one unit (in shares)								1
Original issue discount percentage								40.00%
Additional shares issuable upon declaration of dividends (in shares)								362,933
Common stock offering price per share (in dollars per share) \| $ / shares								$ 15
Preferred stock, par value (in dollars per share) \| $ / shares								$ 0.0001
Number of warrants included in each unit								1
Common Stock [Member]
Class of Stock Disclosures [Abstract]
Issuance of common stock, net (in shares)												952,658	321,417	18,781
No of warrants converted to equity (in shares)															300
Converted warrant \| $												$ 0			$ 0
Common Stock [Member] \| Series J Convertible Preferred Stock [Member] \| October 2023 Offering [Member]
Class of Stock Disclosures [Abstract]
Common stock, par value (in dollars per share) \| $ / shares								$ 0.0001
Warrants [Member]
Class of Stock Disclosures [Abstract]
Common stock warrant liability \| $						$ 7,800
Warrants [Member] \| October 2023 Offering [Member]
Class of Stock Disclosures [Abstract]
Gross proceeds before deducting placement agent fees and commissions and offering expenses \| $						2,250
Net proceeds after deducting placement agent fees and commissions and offering expenses \| $						$ 1,500
Financing expense \| $							$ 2.7
Warrants [Member] \| Series J Convertible Preferred Stock [Member] \| October 2023 Offering [Member]
Class of Stock Disclosures [Abstract]
Warrants to purchase shares of common stock (in shares)						0.5
Exercise price of warrants (in dollars per share) \| $ / shares						$ 262.5
Warrants term												3 years				3 years

Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands	3 Months Ended				9 Months Ended		12 Months Ended
	Sep. 30, 2024	Mar. 31, 2024	Sep. 30, 2023	Mar. 31, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023
Operating Activities:
Net loss	$ 2,358	$ (4,330)	$ (3,370)	$ (6,485)	$ (9,697)	$ (14,700)
Adjustments to reconcile net loss to cash flows used in operating activities:
Depreciation and amortization					227	253
Stock-based compensation expense					374	513
Change in fair value of warrant liability	(3,882)		0		(4,602)	755
Warrant financing costs	0		0		5,607	0
Net realized gain on marketable securities					0	(65)
Changes in operating assets and liabilities:
Accounts receivable					658	(19)
Inventory, net					120	325
Other current assets					(275)	(551)
Other assets and liabilities					(13)	(16)
Accounts payable and accrued expenses					(486)	(1,678)
Net cash used in operating activities					(8,087)	(15,183)
Investing Activities:
Proceeds from sale of marketable securities					0	578
Additions to intangible assets					0	(99)
Purchases of property and equipment					(37)	(185)
Net cash provided by (used in) investing activities					(37)	294
Financing Activities:
Issuance of common stock from offering					2,403	0
Proceeds from the exercise of Series J Convertible Preferred Warrants					501	0
Proceeds from the exercise of April 2024 Warrants					1,182	0
Issuance of July and August 2024 Common Stock and Warrants					2,160	0
Proceeds from ATM stock offerings, net					0	2,108
Payments on finance lease liability					0	(20)
Net cash provided by financing activities					6,246	2,088
Effect of exchange rate changes on cash					(15)	(6)
Net decrease in cash and cash equivalents					(1,893)	(12,807)
Cash and cash equivalents - beginning of period		$ 3,800		$ 17,737	3,800	17,737	$ 17,737
Cash and cash equivalents - end of period	1,907		4,930		1,907	4,930	$ 3,800
Supplemental cash flow information
Non-cash impact of conversion of warrants to common stock					0	6,868
Reclassification of April 2024 warrants to equity					4,217	0
Issuance of Series J Preferred Stock for exercise of warrants					1,857	0
Issuance of Common Stock for conversion of Series J Preferred Stock					1,535	0
Deemed dividend on Series J Preferred Stock	$ 0		$ 0		$ 541	$ 0

Nature of Business and Basis of Presentation, Going Concern, Revenue Recognition, Accounts Receivable and Inventories (Details) $ / shares in Units, $ in Thousands					3 Months Ended		9 Months Ended		12 Months Ended
	Nov. 05, 2024 USD ($) $ / shares shares	Aug. 23, 2024 USD ($) $ / shares shares	Jul. 24, 2024 USD ($) $ / shares shares	Apr. 30, 2024 USD ($) Warrant $ / shares shares	Sep. 30, 2024 USD ($) Customer $ / shares shares	Sep. 30, 2023 Customer	Sep. 30, 2024 USD ($) Customer $ / shares shares	Sep. 30, 2023 USD ($) Customer	Dec. 31, 2023 USD ($) Customer $ / shares	Aug. 30, 2024 $ / shares	Aug. 13, 2024 $ / shares shares
Going Concern [Abstract]
Accumulated deficit					$ (297,323)		$ (297,323)		$ (287,626)
Common stock, par value (in dollars per share) \| $ / shares					$ 0.0001		$ 0.0001		$ 0.0001
Reduce our monthly cash burn rate							40.00%
Merit increases to base salaries of named executive officer or employee							$ 0
Cash bonuses to named executive officer or employee							0
Gross proceeds received through exercise of warrants							$ 501	$ 0
Revenue Recognition [Abstract]
Accounts receivables maximum credit period from invoice date							30 days
Allowance for doubtful accounts					$ 0		$ 0		$ 0
Inventories [Abstract]
Finished Goods					538		538		393
Work in Process					220		220		207
Raw Materials					1,150		1,150		1,472
Inventory Reserves					(44)		(44)		(75)
Total					$ 1,864		$ 1,864		$ 1,997
Subsequent Event [Member]
Going Concern [Abstract]
Warrants to purchase shares of common stock (in shares) \| shares	1,832,517
Exercise price of warrants (in dollars per share) \| $ / shares	$ 2.1
Gross proceeds prior to deducting inducement agent fees and estimated offering expenses	$ 3,800
Gross proceeds received through exercise of warrants	$ 1,300
Net Sales [Member]
Revenue Recognition [Abstract]
Number of major customers \| Customer					2	2	1	2
Accounts Receivable [Member]
Revenue Recognition [Abstract]
Number of major customers \| Customer							2		2
Customer One [Member] \| Net Sales [Member] \| Customer Concentration Risk [Member]
Revenue Recognition [Abstract]
Concentration risk percentage					12.00%	21.00%	16.00%	17.00%
Customer One [Member] \| Accounts Receivable [Member] \| Customer Concentration Risk [Member]
Revenue Recognition [Abstract]
Concentration risk percentage							16.00%		14.00%
Customer Two [Member] \| Net Sales [Member] \| Customer Concentration Risk [Member]
Revenue Recognition [Abstract]
Concentration risk percentage					10.00%	11.00%		12.00%
Customer Two [Member] \| Accounts Receivable [Member] \| Customer Concentration Risk [Member]
Revenue Recognition [Abstract]
Concentration risk percentage							11.00%		15.00%
Securities Purchase Agreement [Member]
Going Concern [Abstract]
Issuance of common stock, net (in shares) \| shares			469,340
Warrants to purchase shares of common stock (in shares) \| shares			938,680
Common stock offering price per share (in dollars per share) \| $ / shares			$ 4.24
Exercise price of warrants (in dollars per share) \| $ / shares			$ 3.99
Warrant expiry period			5 years
Gross proceeds before deducting placement agent fees and commissions and offering expenses			$ 2,000
Series I Warrants and Series II Warrants [Member] \| Subsequent Event [Member]
Going Concern [Abstract]
Warrants to purchase shares of common stock (in shares) \| shares	3,665,034
Series I Warrants [Member] \| Subsequent Event [Member]
Going Concern [Abstract]
Exercise price of warrants (in dollars per share) \| $ / shares	$ 1.94
Warrant expiry period	5 years
Warrants exercisable period	6 months
Series II Warrants [Member] \| Subsequent Event [Member]
Going Concern [Abstract]
Exercise price of warrants (in dollars per share) \| $ / shares	$ 1.94
Warrant expiry period	2 years
Warrants exercisable period	6 months
April 2024 Offering [Member]
Going Concern [Abstract]
Issuance of common stock, net (in shares) \| shares				240,571
Issuance of common stock for pre-funded warrants (in shares) \| shares				80,854
Warrants to purchase shares of common stock (in shares) \| shares				3,214,288							2,710,734
Common stock offering price per share (in dollars per share) \| $ / shares				$ 8.4
Number of warrants included in each unit \| Warrant				1
Warrants to purchase common shares (in shares) \| shares				1.50	398,488		398,488
Exercise price of warrants (in dollars per share) \| $ / shares				$ 2.1	$ 2.97		$ 2.97				$ 2.49
Warrant expiry period				5 years			5 years
Gross proceeds before deducting placement agent fees and commissions and offering expenses				$ 2,700
Gross proceeds before deducting the placement agent fees and other offering expenses				$ 2,700
April 2024 Offering [Member] \| Warrants to Purchase Common Stock [Member]
Going Concern [Abstract]
Warrants to purchase common shares (in shares) \| shares				1
Number of trading days				5 days			5 days
Floor price per share (in dollars per share) \| $ / shares				$ 2.1	$ 2.1		$ 2.1
August 2024 Offering [Member]
Going Concern [Abstract]
Warrants to purchase shares of common stock (in shares) \| shares		14,501
Exercise price of warrants (in dollars per share) \| $ / shares		$ 3.04425								$ 2.1
Gross proceeds before deducting the placement agent fees and other offering expenses		$ 892,000
August 2024 Offering [Member] \| Securities Purchase Agreement [Member]
Going Concern [Abstract]
Issuance of common stock, net (in shares) \| shares		483,351
Warrants to purchase shares of common stock (in shares) \| shares		483,351
Common stock offering price per share (in dollars per share) \| $ / shares		$ 1.845
Exercise price of warrants (in dollars per share) \| $ / shares		1.72
Common stock, par value (in dollars per share) \| $ / shares		$ 0.0001

Nature of Business and Basis of Presentation (Tables)

9 Months Ended

Sep. 30, 2024

Nature of Business and Basis of Presentation [Abstract]

Inventories

Inventories consisted of the following:

(in thousands)	September 30, 2024			December 31, 2023
Finished Goods	$	538		$	393
Work in Process		220			207
Raw Materials		1,150			1,472
Inventory Reserves		(44	)		(75	)
Total	$	1,864		$	1,997

Potential Shares of Common Stock not Included in Diluted Net Loss Per Share

The following table sets forth the potential shares of common stock that are not included in the calculation of diluted net loss per share because to do so would be anti-dilutive as of the end of each period presented:

	September 30
	2024		2023

Stock options		3,890		3,101
Warrants to purchase common stock		4,112,197		37,401
Series F convertible preferred stock		68,961		254
Series J convertible preferred stock		67		—
Total		4,185,115		40,756

Reconciliation of Reported Net Loss with Reported Net Loss Per Share

The following table reconciles reported net loss with reported net loss per share for each of the three and nine months ended September 30:

	Three months ended September 30					Nine months ended September 30
	2024		2023			2024			2023
(in thousands, except per share amounts)
Net income (loss)	$	2,358	$	(3,370	)	$	(9,697	)	$	(14,700	)
Deemed dividend attributable to Series J Convertible Preferred Stock		—		—			541			—
Net loss attributable to common shareholders	$	2,358	$	(3,370	)	$	(9,156	)	$	(14,700	)
Weighted average shares outstanding		1,352		53			647			41
Basic and diluted loss per share	$	1.74	$	(63.27	)	$	(14.99	)	$	(357.42	)

Commitments and Contingencies	9 Months Ended
Commitments and Contingencies	Sep. 30, 2024
Commitments and Contingencies [Abstract]
Commitments and Contingencies	Note 8—Commitments and Contingencies Employee Retirement Plan: The Company has a 401(k) retirement plan that provides retirement benefits to all eligible U.S. employees. Eligible employees may contribute a percentage of their annual compensation, subject to Internal Revenue Service limitations, with the Company matching a portion of the employees’ contributions at the discretion of the Company.

Operating Leases (Details) $ in Thousands	9 Months Ended
Operating Leases (Details) $ in Thousands	Sep. 30, 2024 USD ($) ft² $ / ft²
Operating Leases [Abstract]
Area of property leased under operating lease \| ft²	23,000
Monthly rent and common area maintenance charges \| $	$ 34
Annual base rent (per square foot)	10.5
Minimum [Member]
Operating Leases [Abstract]
Annual increase per square foot (in dollars per square foot)	0.32
Maximum [Member]
Operating Leases [Abstract]
Annual increase per square foot (in dollars per square foot)	0.34

Stockholders' Equity	9 Months Ended
Stockholders' Equity	Sep. 30, 2024
Stockholders' Equity [Abstract]
Stockholders' Equity	Note 3 – Stockholders’ Equity Series F Convertible Preferred Stock: On November 27, 2017, the Company closed on an underwritten public offering of Series F convertible preferred stock and warrants to purchase shares of common stock The Series F convertible preferred stock has full ratchet price-based anti-dilution protection, subject to customary carve-outs, in the event of a down-round financing at a price per share below the conversion price of the Series F convertible preferred stock (which protection will expire if, during any 20 of 30 consecutive trading days, the volume weighted average price of the Company’s common stock exceeds 300% of the then-effective conversion price of the Series F convertible preferred stock and the daily dollar trading volume for each trading day during such period exceeds $7,000,000). Effective for every stock offering or reverse stock split, the conversion price of the Series F convertible preferred stock has been recalculated based on the offering price. As of August 23, 2024 (the most recent stock offering), the conversion price of the Series F convertible preferred stock was recalculated to $542.01. As of September 30, 2024, and December 31, 2023, 127 shares of the Series F convertible preferred stock remained outstanding. 2023 At-the-Market Program: In March 2023, the Company filed a Prospectus Supplement to its Registration Statement on Form S-3 with the SEC in connection with a proposed At-the-Market Securities offering (the “At-the-Market Program”). During 2023, the Company issued 18,781 shares of common stock under the At-the-Market Program for gross proceeds of approximately $2.3 million. Net proceeds totaled approximately $2.1 million after deducting the underwriting discounts and commissions and other costs associated with the offering. The Company terminated its At-the-Market Program in July of 2024. Supply Agreement Warrants: On June 19, 2023, we entered into a Supply and Collaboration Agreement (the “Supply Agreement”) with DaVita Inc., a Delaware corporation (“DaVita”), pursuant to which DaVita would pilot the Aquadex ultrafiltration therapy system to treat adult patients with congestive heart failure and related conditions within select U.S. markets. The pilot program launched by the end of fourth quarter 2023 and extended through May 31, 2024 (the “Pilot”). On May 31, 2024, DaVita and Nuwellis amended the Supply and Collaboration Agreement extending the Pilot term through August 31, 2024. Through the Pilot, ultrafiltration therapy using Aquadex would be offered at a combination of DaVita’s hospital customer and outpatient center locations, with both companies collaborating on the roll-out of the therapy, clinician training, and patient support. At the conclusion of the Pilot, DaVita had the option, in its sole discretion, to extend the Supply Agreement with the Company for continued provision of both inpatient and outpatient ultrafiltration services for up to 10 years (“Ultrafiltration Services Approval”). The parties agreed to terminate the Supply Agreement effective August 21, 2024. In conjunction with the Supply Agreement, the Company issued DaVita a warrant to purchase up to an aggregate of 36,830 shares of common stock of the Company, par value $0.0001 per share, at an exercise price of $115.49 per share (the “DaVita Warrant”), provided that at no time can the DaVita Warrant be exercised for an amount of shares that would represent greater than 19.9% ownership in the Company subject to certain vesting milestones. The DaVita Warrant was expected to vest in four tranches as follows: (i) 25% upon receipt of notice to extend the Supply Agreement past the initial pilot-term; (ii) 25% upon the attainment by the Company of a net revenue achievement from DaVita’s efforts pursuant to the Supply Agreement within twelve months of Ultrafiltration Services Approval; (iii) 25% upon the attainment by the Company of a net revenue achievement from DaVita’s efforts pursuant to the Supply Agreement within twenty-four months of Ultrafiltration Services Approval; and (iv) 25% upon the attainment by the Company of a net revenue achievement from DaVita’s efforts pursuant to the Supply Agreement within thirty-six months of Ultrafiltration Services Approval. This warrant terminated with the termination of the Supply Agreement on August 21, 2024. On August 21, 2024, the Company and DaVita Inc., a Delaware corporation (“DaVita”) entered into a Termination Agreement and mutually agreed to terminate its Supply and Collaboration Agreement, dated as of June 19, 2023, as amended (the “Supply Agreement”) and the related Common Stock Purchase Warrant (the “Warrant”) and Registration Rights Agreement (the “Registration Rights Agreement”), each dated as of June 19, 2023. The Supply Agreement, Warrant and Registration Rights Agreement are collectively referred to herein as the “DaVita Agreements”. The termination of the Davita Agreements was effective immediately. The respective rights and obligations of each party under the Supply Agreement that survive termination pursuant to the terms and conditions set forth therein shall continue and all rented and unused Products (as defined in the Supply Agreement) shall be returned to the Company. The vesting milestones pursuant to the terms of the Supply Agreement were never attained and therefore the Warrant never vested. Additionally, because the Ultrafiltration Services Approval (as defined in the Supply Agreement) was never attained, the registration rights pursuant to the terms of the Registration Rights Agreement were never in effect. October 2023 Offering: On October 12, 2023, Nuwellis, Inc. entered into a Placement Agency Agreement with Lake Street Capital Markets, LLC and Maxim Group LLC, pursuant to which the Company issued and sold, in a best efforts registered public offering by the Company, 150,000 units, with each Unit consisting of (A) one share of the Company’s Series J Convertible Redeemable Preferred Stock, par value $0.0001 per share, and (B) one warrant to purchase one-half of one (0.50) share of Series J Convertible Preferred Stock, at a price to the public of $15.00 per Unit, less placement agent fees and commissions. The public offering price of $15.00 per Unit reflects the issuance of the Series J Convertible Preferred Stock with an original issue discount of 40%. The Company also registered under the Registration Statement (as defined below) an additional 362,933 shares of Series J Convertible Preferred Stock that will be issued, if and when the Company’s Board of Directors declares such dividends, as paid in-kind dividends and the shares of Common Stock issuable upon conversion of the Series J Convertible Preferred Stock issued as PIK dividends. The Units, the shares of Series J Convertible Preferred Stock, the Warrants, the PIK Dividend Shares, the PIK Conversion Shares as well as the shares of Series J Convertible Preferred Stock issuable upon exercise of the Warrants and the shares of the Company’s common stock, par value $0.0001 per share, issuable upon conversion of the Series J Convertible Preferred Stock, were offered and sold by the Company pursuant to an effective registration statement on Form S-1. The closing of the Offering contemplated by the Placement Agency Agreement occurred on October 17, 2023. On October 17, 2023, the Company also entered into a warrant agency agreement with the Company’s transfer agent, Equiniti Trust Company, LLC, who acts as warrant agent for the Company, setting forth the terms and conditions of the Warrants sold in this Offering. Each Warrant has an exercise price of $262.50 per one-half of one (0.5) share of Series J Convertible Preferred Stock, is immediately exercisable and will expire three (3) years from the date of issuance. There is no established trading market for the Series J Convertible Preferred Stock or the Warrants and we do not expect a market to develop. In addition, we do not intend to list the Series J Convertible Preferred Stock or the Warrants on The Nasdaq Capital Market or any other national securities exchange or any other nationally recognized trading system. The gross proceeds to the Company from the October 17, 2023, Offering were $2.25 million. Net proceeds were approximately $1.5 million after deducting placement agent fees and commissions and Offering expenses payable by the Company. The Company used the net proceeds from the Offering for working capital and for general corporate purposes. The Series J Convertible Preferred Stock is classified as mezzanine equity and accreted to reflect its redemption value as of each reporting date. The accretion will be reflected as a deemed dividend adjustment to arrive at net loss attributed to common stockholders for earnings per share calculations. The Warrants are recorded as a liability and re-measured at fair value as of each reporting date with fair value changes being recorded as non-operating income or expense. The Warrants were valued on day 1 and exceeded the gross proceeds of the offering. This resulted in a day 1 financing expense of $2.7 million. April 2024 Offering: On April 30, the Company closed on a best efforts public offering of 240,571 shares of its common stock, 80,854 shares of its common stock for pre-funded warrants and warrants to purchase up to an aggregate of 3,214,288 shares of its common stock at a combined public offering price $8.40 per share. All pre-funded warrants were exercised on the date of the offering. Each share of common stock (or prefunded warrant in lieu thereof) was sold together with one warrant to purchase one and a half shares of common stock. The warrants have an exercise price of $2.10 per share, were exercisable immediately upon issuance, and will expire five years following the date of issuance. Each whole common warrant entitles the holder thereof to purchase one share of common stock. The common warrants contain a reset of the exercise price, effective upon the Warrant Stockholder Approval, to a price equal to the lesser of (i) the then exercise price, (ii) the lowest volume weighted average price for the five trading days immediately following the date we effect a reverse stock split in the future and (iii) if we effect a reverse stock split prior to obtaining the Warrant Stockholder Approval, the lowest volume weighted average price for the five trading days immediately following the date we obtain the Warrant Stockholder Approval. The Company secured the Warrant Stockholder Approval on June 6, 2024. Subsequent to June 30 2024, the number of shares underlying the common warrants were adjusted to 2,710,734 shares and the exercise price was adjusted to $2.49 per share. In addition, the common warrants provided for full ratchet anti-dilution adjustment to the exercise price and number of shares underlying the common warrants upon our issuance of our common stock or common stock equivalents at a price per share that is less than the exercise price of the common warrants, subject to certain exemptions. In no event will the exercise price of the common warrants with respect to either adjustment be reduced below a floor price of $2.10. The gross proceeds to the Company from the offering, before deducting the placement agent fees and other offering expenses were approximately $2.7 million. The warrants offered in this financing were originally classified as a liability on the balance sheet. An independent valuation of the warrants was performed and reviewed with management, and the valuation at issuance was $7.8 million. The warrants had down-round protection and the price was reset from the July 2024 and the August 2024 offerings. At the August 2024 offering, the exercise price of these warrants were adjusted to $2.10, which represented the floor price on these warrants. As the price floor was hit, there was no further down-round protection. The warrants were re-evaluated and classified as equity as of September 30, 2024. During the quarter, there were 398,488 of warrants exercised at a weighted average exercise price of $2.97. The warrants are fair valued on the date of exercise and the adjustment to fair value is recorded to Additional Paid in Capital. There were 2,651,426 of warrants converted to equity resulting in $4.2 million to Additional Paid in Capital. July 2024 Offering: On July 24, 2024, the Company announced that it had entered into a definitive securities purchase agreement with certain institutional investors for the purchase and sale of 469,340 shares of the Company's common stock at a price of $4.24 per share of common stock in a registered direct offering priced at-the-market under Nasdaq rules. In addition, in a concurrent private placement, the Company issued the investors warrants to purchase up to 938,680 shares of common stock. The warrants have an exercise price of $3.99 per share, will be exercisable immediately following the date of issuance and have a term of five years from the date of issuance. The warrants issued in this offering were concluded to be equity classified. The closing of the registered direct offering and the concurrent private placement occurred on July 25, 2024. The gross proceeds to the Company from the registered direct offering and the concurrent private placement were approximately $2.0 million. After deducting placement agent fees and other offering expenses payable by the Company, net proceeds were approximately $1.5 million. The Company intends to use the net proceeds from the offering for working capital and for general corporate purposes. August 2024 Offering: On August 23, 2024, the Company entered into a placement agency agreement with Ladenburg Thalmann & Co. Inc. and a securities purchase agreement with certain purchasers pursuant to which the Company agreed to sell, in a registered direct offering, an aggregate of 483,351 shares of the Company’s common stock, $0.0001 par value per share, at a purchase price of $1.8450 per Share and accompanying Common Warrant. The Shares were sold pursuant to the Company’s effective shelf registration statement on Form S-3 (File No. 333-280647), including a base prospectus contained therein, which was originally filed with the Securities and Exchange Commission (the “SEC”) on July 1, 2024, and was declared effective by the SEC on July 9, 2024, and a related prospectus supplement, dated August 23, 2024, related to the Registered Offering. Pursuant to the Purchase Agreement, in a concurrent private placement the Company also agreed to sell and issue to the Purchasers, warrants to purchase up to 483,351 shares of Common Stock. The Common Warrants have an exercise price of $1.72 per share, are immediately exercisable and expire on the fifth anniversary on the effective date of the registration statement to be filed for the purpose of registering the Common Warrant Shares. The warrants issued in this offering were concluded to be equity classified. The gross proceeds of the Offering, before deducting the Placement Agent’s fees and expenses and other offering expenses payable by the Company and excluding the net proceeds, if any, from the exercise of the Common Warrants or Placement Agent Warrants, will be approximately $892,000. The Offering closed on August 26, 2024. The Company also issued to the Placement Agent, or its designees, warrants to purchase up to 14,501 shares of our Common Stock as part of the compensation payable to the Placement Agent in connection with this offering. The Placement Agent Warrants are not registered pursuant to the prospectus supplement and the accompanying prospectus. The Placement Agent Warrants have substantially the same terms as the Common Warrants described above, except that the Placement Agent Warrants will have an exercise price of $3.04425 per share and will expire August 23, 2029. Underwriter and Placement Agent Fees: In connection with the offerings described above, the Company paid the underwriter or placement agent, as applicable, an aggregate cash fee of either 7% or 8% of the aggregate gross proceeds raised in each of the offerings, except with respect to the issuances made pursuant to the At-the-Market Program, for which the placement fee was equal to 3% of the aggregate gross proceeds. At the Company’s annual meeting of stockholders on June 6, 2024, its stockholders approved a proposal to amend the Company’s Fourth Amended and Restated Certificate of Incorporation to effect a reverse split of the Company’s outstanding Common Stock at a ratio in the range of 1-for-5 to 1-for-70 to be determined at the discretion of our Board of Directors. On June 26, 2024, the Company’s board of directors approved a one-for-thirty-five reverse stock split of the Company’s issued and outstanding shares of common stock (the “Reverse Stock Split”). On June 27, 2024, the Company filed with the Secretary of State of the State of Delaware a Certificate of Amendment to its Certificate of Incorporation (the “Certificate of Amendment”) to affect the Reverse Stock Split. The Reverse Stock Split became effective as of 5:00 p.m. Eastern Time on June 27, 2024, and the Company’s common stock began trading on a split-adjusted basis when the market opened on June 28, 2024. All share and per-share amounts have been retroactively adjusted to reflect the reverse stock splits for all periods presented.

- Definition

The entire disclosure for equity.

+ References

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+ Details

Subsequent Events (Details) - USD ($)			9 Months Ended
Subsequent Events (Details) - USD ($)	Nov. 05, 2024	Oct. 22, 2024	Sep. 30, 2024	Sep. 30, 2023	Oct. 20, 2024
Stockholders' equity [Abstract]
Gross proceeds received through exercise of warrants			$ 501,000	$ 0
Subsequent Event [Member]
Stockholders' equity [Abstract]
Aggregate purchase of warrants (in shares)	1,832,517
Warrant exercise price per share (in dollars per share)	$ 2.1
Gross proceeds prior to deducting inducement agent fees and estimated offering expenses	$ 3,800,000
Gross proceeds received through exercise of warrants	$ 1,300,000
Subsequent Event [Member] \| Series I Warrants and Series II Warrants [Member]
Stockholders' equity [Abstract]
Aggregate purchase of warrants (in shares)	3,665,034
Subsequent Event [Member] \| Series I Warrants [Member]
Stockholders' equity [Abstract]
Warrant exercise price per share (in dollars per share)	$ 1.94
Warrant expiry period	5 years
Warrants exercisable period	6 months
Subsequent Event [Member] \| Series II Warrants [Member]
Stockholders' equity [Abstract]
Warrant exercise price per share (in dollars per share)	$ 1.94
Warrant expiry period	2 years
Warrants exercisable period	6 months
Subsequent Event [Member] \| SeaStar Medical Holding Corporation [Member]
Subsequent Event [Line Items]
Agreement settlement amount receivable					$ 900,000
Agreement settlement amount received		$ 500,000

Income Taxes	9 Months Ended
Income Taxes	Sep. 30, 2024
Income Taxes [Abstract]
Income Taxes	Note 6 – Income Taxes The Company provides for a valuation allowance when it is more likely than not that it will not realize a portion of its deferred tax assets. The Company has established a full valuation allowance for its U.S. and foreign deferred tax assets due to the uncertainty that enough taxable income will be generated in those taxing jurisdictions to utilize the assets. Therefore, the Company has not reflected any benefit of such deferred tax assets in the accompanying condensed consolidated financial statements. As of September 30, 2024, there were no material changes to what the Company disclosed regarding tax uncertainties or penalties in its Annual Report on Form 10-K for the year ended December 31, 2023.

- Definition

The entire disclosure for income tax.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Nature of Business and Basis of Presentation, Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended						9 Months Ended
	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Sep. 30, 2024	Sep. 30, 2023
Potential shares of common stock that are not included in the calculation of diluted net loss per share [Abstract]
Potential shares of common stock that are not included in the calculation of diluted net loss per share (in shares)							4,185,115	40,756
Reported net loss with reported net loss per share [Abstract]
Net income (loss)	$ 2,358	$ (7,725)	$ (4,330)	$ (3,370)	$ (4,845)	$ (6,485)	$ (9,697)	$ (14,700)
Deemed dividend attributable to Series J Convertible Preferred Stock	0			0			541	0
Net income (loss) attributable to common shareholders	$ 2,358			$ (3,370)			$ (9,156)	$ (14,700)
Weighted average shares outstanding - basic (in shares)	1,351,939			53,265			647,079	41,128
Weighted average shares outstanding - diluted (in shares)	1,351,939			53,265			647,079	41,128
Basic loss per share (in dollars per share)	$ 1.74			$ (63.27)			$ (14.99)	$ (357.42)
Diluted loss per share (in dollars per share)	$ 1.74			$ (63.27)			$ (14.99)	$ (357.42)
Stock Options [Member]
Potential shares of common stock that are not included in the calculation of diluted net loss per share [Abstract]
Potential shares of common stock that are not included in the calculation of diluted net loss per share (in shares)							3,890	3,101
Warrants to Purchase Common Stock [Member]
Potential shares of common stock that are not included in the calculation of diluted net loss per share [Abstract]
Potential shares of common stock that are not included in the calculation of diluted net loss per share (in shares)							4,112,197	37,401
Series F Convertible Preferred Stock [Member]
Potential shares of common stock that are not included in the calculation of diluted net loss per share [Abstract]
Potential shares of common stock that are not included in the calculation of diluted net loss per share (in shares)							68,961	254
Series J Convertible Preferred Stock [Member]
Potential shares of common stock that are not included in the calculation of diluted net loss per share [Abstract]
Potential shares of common stock that are not included in the calculation of diluted net loss per share (in shares)							67	0

Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares	Sep. 30, 2024	Dec. 31, 2023
Stockholders' equity
Preferred stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Preferred stock, shares authorized (in shares)	39,352,000	39,352,000
Preferred stock, shares outstanding (in shares)	0	0
Common stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Common stock, shares authorized (in shares)	100,000,000	100,000,000
Common stock, shares issued (in shares)	1,866,890	162,356
Common stock, shares outstanding (in shares)	1,866,890	162,356
Series J Convertible Preferred Stock [Member]
Mezzanine Equity
Mezzanine equity, par value (in dollars per share)	$ 0.0001	$ 0.0001
Mezzanine equity, shares authorized (in shares)	600,000	600,000
Mezzanine equity, shares issued (in shares)	95	11,950
Mezzanine equity, shares outstanding (in shares)	95	11,950
Series A Junior Participating Preferred Stock [Member]
Stockholders' equity
Preferred stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Preferred stock, shares authorized (in shares)	30,000	30,000
Preferred stock, shares outstanding (in shares)	0	0
Series F Convertible Preferred Stock [Member]
Stockholders' equity
Preferred stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Preferred stock, shares authorized (in shares)	18,000	18,000
Preferred stock, shares issued (in shares)	127	127
Preferred stock, shares outstanding (in shares)	127	127

Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Condensed Consolidated Statements of Operations and Comprehensive Loss [Abstract]
Net sales	$ 2,367	$ 2,412	$ 6,418	$ 6,313
Cost of goods sold	711	1,031	2,097	2,718
Gross profit	1,656	1,381	4,321	3,595
Operating expenses:
Selling, general and administrative	2,702	3,428	10,544	13,582
Research and development	486	1,117	2,378	4,050
Total operating expenses	3,188	4,545	12,922	17,632
Loss from operations	(1,532)	(3,164)	(8,601)	(14,037)
Other income (expense), net	8	(204)	(87)	98
Financing Expense	0	0	(5,607)	0
Change in fair value of warrant liability	3,882	0	4,602	(755)
Income (loss) before income taxes	2,358	(3,368)	(9,693)	(14,694)
Income tax expense	0	(2)	(4)	(6)
Net income (loss)	2,358	(3,370)	(9,697)	(14,700)
Deemed dividend attributable to Series J Convertible Preferred Stock	0	0	541	0
Net income (loss) attributable to common shareholders	$ 2,358	$ (3,370)	$ (9,156)	$ (14,700)
Basic net income (loss) per share (in dollars per share)	$ 1.74	$ (63.27)	$ (14.99)	$ (357.42)
Diluted net income (loss) per share (in dollars per share)	$ 1.74	$ (63.27)	$ (14.99)	$ (357.42)
Weighted average shares outstanding - basic (in shares)	1,351,939	53,265	647,079	41,128
Weighted average shares outstanding - diluted (in shares)	1,351,939	53,265	647,079	41,128
Other comprehensive loss:
Foreign currency translation adjustments	$ (4)	$ 0	$ (15)	$ (6)
Total comprehensive income (loss)	$ 2,354	$ (3,370)	$ (9,171)	$ (14,706)

Document and Entity Information - shares	9 Months Ended
Document and Entity Information - shares	Sep. 30, 2024	Nov. 08, 2024
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2024
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	Q3
Document Transition Report	false
Entity File Number	001-35312
Entity Registrant Name	NUWELLIS, INC.
Entity Central Index Key	0001506492
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	68-0533453
Entity Address, Address Line One	12988 Valley View Road
Entity Address, City or Town	Eden Prairie
Entity Address, State or Province	MN
Entity Address, Postal Zip Code	55344
City Area Code	952
Local Phone Number	345-4200
Title of 12(b) Security	Common Stock, par value $0.0001 per share
Trading Symbol	NUWE
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		4,373,968

Fair Value of Financial Instruments (Tables)

9 Months Ended

Sep. 30, 2024

Fair Value of Financial Instruments [Abstract]

Roll-Forward of Fair Value of Level 3 Warrants

The following is a roll-forward of the fair value of the Level 3 warrants:

(in thousands)
Balance at December 31, 2022	$	6,868
Change in fair value		755
Issuance of Common Stock for exercise of Series I warrants		(7,623	)
October 17, 2023, issuance of Series J warrants		4,965
Exercise of Series J warrants		(536	)
Change in fair value		(1,586	)
Balance at December 31, 2023		2,843
Exercise of Series J warrants		(1,357	)
April 30, 2024, issuance of common warrants		7,813
Exercise of April 2024 warrants		(1,373	)
Reclassification of April 2024 warrants to equity		(2,844	)
Change in fair value		(4,602	)
Balance at September 30, 2024	$	480

Insider Trading Arrangement	3 Months Ended
Insider Trading Arrangement	Sep. 30, 2024
Insider Trading Arrangements [Line Items]
Rule 10b5-1 Arrangement Adopted	false
Non-Rule 10b5-1 Arrangement Adopted	false
Rule 10b5-1 Arrangement Terminated	false
Non-Rule 10b5-1 Arrangement Terminated	false

Revenue Recognition (Details)	3 Months Ended		9 Months Ended
Revenue Recognition (Details)	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2024-10-01
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Abstract]
Expected timing of satisfaction, period	1 year		1 year
Sales Revenue [Member] \| Customer Concentration Risk [Member] \| Revenue Recognized over Time [Member] \| Maximum [Member]
Revenue, Performance Obligation [Abstract]
Percentage of net sales	1.00%	1.00%	1.00%	1.00%
Sales Revenue [Member] \| Customer Concentration Risk [Member] \| International [Member] \| Revenue Recognized over Time [Member]
Revenue, Performance Obligation [Abstract]
Percentage of net sales	3.00%	5.00%	4.00%	5.00%

Nature of Business and Basis of Presentation

9 Months Ended

Sep. 30, 2024

Nature of Business and Basis of Presentation [Abstract]

Nature of Business and Basis of Presentation

Note 1 – Nature of Business and Basis of Presentation

Nature of Business: Nuwellis, Inc. (the “Company”) is a medical device company focused on developing, manufacturing, and commercializing the Aquadex FlexFlow® and Aquadex SmartFlow® systems (collectively, the “Aquadex System”) for ultrafiltration therapy. The Aquadex System is indicated for temporary (up to eight hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kg. or more whose fluid overload is unresponsive to medical management, including diuretics. Nuwellis, Inc. is a Delaware corporation headquartered in Minneapolis with a wholly owned subsidiary in Ireland. The Company’s common stock began trading on the Nasdaq Capital Market in February 2012.

In August 2016, the Company acquired the business associated with the Aquadex System (the “Aquadex Business”) from a subsidiary of Baxter International, Inc. (“Baxter”), and refocused its strategy to fully devote its resources to the Aquadex Business. On April 27, 2021, the Company announced that it was changing its name from CHF Solutions, Inc. to Nuwellis, Inc. to reflect the expansion of its customer base from treating fluid imbalance resulting from congestive heart failure to also include critical care and pediatric applications.

Principles of Consolidation: The accompanying condensed consolidated balance sheet as of December 31, 2023, which has been derived from the consolidated audited financial statements, and the unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Certain information and note disclosures normally included in the audited annual consolidated financial statements have been condensed or omitted pursuant to those rules and regulations. Accordingly, they do not include all of the information necessary for a fair presentation of results of operations, comprehensive loss, financial condition, and cash flows in conformity with U.S. GAAP. In the opinion of management, the condensed consolidated financial statements reflect all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the results of the Company for the periods presented. Operating results for interim periods are not necessarily indicative of results that may be expected for the year as a whole. The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses, and the related disclosures at the date of the consolidated financial statements and during the reporting period. Actual results could differ materially from these estimates.

These condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.

Going Concern: The Company’s consolidated financial statements have been prepared and presented on a basis assuming it continues as a going concern. During the years ended December 31, 2023 and 2022 and through September 30, 2024, the Company incurred losses from operations and net cash outflows from operating activities as disclosed in the consolidated statements of operations and cash flows, respectively. Since the Company’s inception and as of September 30, 2024, the Company had an accumulated deficit of $297.3 million and it expects to incur losses for the immediate future. To date, the Company has been funded by equity financings, and although the Company believes that it will be able to successfully fund its operations, there can be no assurance that it will be able to do so or that it will ever operate profitably. These factors raise substantial doubt about the Company’s ability to continue as a going concern through the next twelve months. The Company became a revenue-generating company after acquiring the Aquadex Business in August 2016. The Company expects to incur additional losses in the near-term as it grows the Aquadex Business, including investments in its sales and marketing capabilities, product development, purchasing inventory, manufacturing components, generating additional clinical evidence supporting the efficacy of the Aquadex System, and complying with the requirements related to being a U.S. public company. To become and remain profitable, the Company must succeed in expanding the adoption and market acceptance of the Aquadex System. This will require the Company to succeed in training personnel at hospitals and in outpatient care settings, and effectively and efficiently manufacturing, marketing, and distributing the Aquadex System and related components. There can be no assurance that the Company will succeed in these activities, and it may never generate revenues sufficient to achieve profitability.

On April 30, 2024, the Company closed on a best-efforts public offering of 240,571 shares of its common stock, 80,854 shares of its common stock for pre-funded warrants and warrants to purchase up to an aggregate of 3,214,288 shares of its common stock at a combined public offering price $8.40 per share. All pre-funded warrants were exercised on the date of the offering. Each share of common stock (or prefunded warrant in lieu thereof) was sold together with one warrant to purchase one and a half shares of common stock. The warrants have an exercise price of $2.10 per share, were exercisable immediately upon issuance, and expire five years following the date of issuance. Each whole common warrant entitles the holder thereof to purchase one share of common stock.

The common warrants contain a reset of the exercise price, effective upon the Warrant Stockholder Approval, to a price equal to the lesser of (i) the then exercise price, (ii) the lowest volume weighted average price for the five trading days immediately following the date we effect a reverse stock split in the future and (iii) if we effect a reverse stock split prior to obtaining the Warrant Stockholder Approval, the lowest volume weighted average price for the five trading days immediately following the date we obtain the Warrant Stockholder Approval. The Company secured the Warrant Stockholder Approval on June 6, 2024. In addition, the common warrants provided for, full ratchet anti-dilution adjustment to the exercise price and number of shares underlying the common warrants upon our issuance of our common stock or common stock equivalents at a price per share that is less than the exercise price of the common warrants, subject to certain exemptions. In no event will the exercise price of the common warrants with respect to either adjustment be reduced below a floor price of $2.10.

The gross proceeds to the Company from the offering, before deducting the placement agent fees and other offering expenses were approximately $2.7 million.

On July 24, 2024, the Company announced that it had entered into a definitive securities purchase agreement with certain institutional investors for the purchase and sale of 469,340 shares of the Company’s common stock at a price of $4.24 per share of common stock in a registered direct offering priced at-the-market under Nasdaq rules.

In addition, in a concurrent private placement, the Company issued to the investors warrants to purchase up to 938,680 shares of common stock. The warrants have an exercise price of $3.99 per share, were exercisable immediately following the date of issuance and have a term of five years from the date of issuance.

The closing of the registered direct offering and the concurrent private placement occurred on or about July 25, 2024.

The gross proceeds to the Company from the registered direct offering and the concurrent private placement, before deducting the placement agent fees and other offering expenses payable by the Company, were approximately $2.0 million. The Company intends to use the net proceeds from the offering for working capital and for general corporate purposes.

On August 23, 2024, the Company entered into a placement agency agreement with Ladenburg Thalmann & Co. Inc. and a securities purchase agreement with certain purchasers pursuant to which the Company agreed to sell, in a registered direct offering, an aggregate of 483,351 shares of the Company’s common stock, $0.0001 par value per share, at a purchase price of $1.8450 per Share and accompanying Common Warrant.

The Shares were sold pursuant to the Company’s effective shelf registration statement on Form S-3 (File No. 333-280647), including a base prospectus contained therein, which was originally filed with the Securities and Exchange Commission (the “SEC”) on July 1, 2024, and was declared effective by the SEC on July 9, 2024, and a related prospectus supplement, dated August 23, 2024, related to the Registered Offering.

Pursuant to the Purchase Agreement, in a concurrent private placement the Company also agreed to sell and issue to the Purchasers, warrants to purchase up to 483,351 shares of Common Stock. The Common Warrants have an exercise price of $1.72 per share, are immediately exercisable and expire on the fifth anniversary on the effective date of the registration statement to be filed for the purpose of registering the Common Warrant Shares.

The gross proceeds of the offering, before deducting the Placement Agent’s fees and expenses and other offering expenses payable by the Company and excluding the net proceeds, if any, from the exercise of the Common Warrants or Placement Agent Warrants, was approximately $892,000. The Offering closed on August 26, 2024. The Company also issued to the Placement Agent, or its designees, warrants to purchase up to 14,501 shares of our Common Stock as part of the compensation payable to the Placement Agent in connection with this offering. The Placement Agent Warrants are not registered pursuant to the prospectus supplement and the accompanying prospectus. The Placement Agent Warrants have substantially the same terms as the Common Warrants described above, except that the Placement Agent Warrants will have an exercise price of $3.04425 per share and will expire August 23, 2029.

Understanding the near-term need to raise capital, the Company has recently undertaken steps to reduce our monthly cash burn rate by approximately 40%, balanced against our strategic growth initiatives, which will provide more flexibility in anticipation of tougher capital market conditions for microcap companies like Nuwellis. These reductions include, but are not limited to the following: selected job eliminations, a reduction of the salaries for members of senior management, no merit increases to the base salaries of any named executive officer or employee in 2024 for performance provided during the fiscal year ended December 31, 2023, no cash bonuses to any named executive officer or employee in 2024 for performance provided during the fiscal year ended December 31, 2023, a reduction in Board of Director and committee fees, temporary suspension of Company 401k match, travel reductions, and reductions to select professional services. The Board recently authorized the restoration of the Company 401k match effective October 1, 2024.

On November 5, 2024, the Company announced the entry into definitive agreements for the immediate exercise of certain outstanding warrants issued by the Company on April 30, 2024 (collectively, the “Existing Warrants”) to purchase up to an aggregate of 1,832,517 shares of the Company’s common stock at their current exercise price of $2.10 per share for total gross proceeds of approximately $3.8 million, prior to deducting inducement agent fees and estimated offering expenses. An additional $1.3 million of gross proceeds was received through the exercise of warrants over the last week in accordance with their original terms. In consideration for the immediate exercise of the Existing Warrants, the Company will issue Series I common stock purchase warrants (the “Series I Warrants”) and Series II common stock purchase warrants (the “Series II Warrants”) to purchase up to an aggregate of 3,665,034 shares of common stock. The Series I Warrants will have an exercise price of $1.94, will be exercisable six (6) months from the date of issuance, and will have a term of five (5) years from the date of exercisability. The Series II Warrants will have an exercise price of $1.94, will be exercisable six (6) months from the date of issuance, and will have a term of two (2) years from the date of exercisability. The Series I Warrants and Series II Warrants are fixed priced and do not contain any variable pricing features. The Series I Warrants and Series II Warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements under Section 4(a)(2) of the Securities Act of 1933 (the “Securities Act”), and, along with the shares of common stock issuable upon their exercise, have not been registered under the Securities Act, and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (the “SEC”) or an applicable exemption from such registration requirements. The securities were offered only to accredited investors. The Company has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable upon exercise of the Series I Warrants and Series II Warrants.

The Company believes that its existing capital resources will be sufficient to support its operating plan through May 31, 2025. However, the Company will seek to raise additional capital to support its growth or other strategic initiatives through debt, equity or a combination thereof. There can be no assurance we will be successful in raising additional capital.

Revenue Recognition: The Company recognizes revenue in accordance with Accounting Standards Codification, Topic 606, Revenue from Contracts with Customers. Accordingly, the Company recognizes revenue when its customers obtain control of its products or services, in an amount that reflects the consideration that the Company expects to receive in exchange for those goods and services. See Note 2 – Revenue Recognition below for additional disclosures. For the three months ended September 30, 2024, two customers represented 12% and 10% of net sales. For the nine months ended September 30, 2024, one customer represented 16% of net sales. For the three months ended September 30, 2023, two customers represented 21% and 11% of net sales. For the nine months ended September 30, 2023, two customers each represented 17% and 12% of net sales.

Accounts Receivable: Accounts receivables are unsecured, are recorded at net realizable value, and do not bear interest. The Company makes judgments as to its ability to collect outstanding receivables based upon significant patterns of collectability, historical experience, and management’s evaluation of specific accounts and will provide an allowance for credit losses when collection becomes doubtful. The Company performs credit evaluations of its customers' financial condition on an as-needed basis. Payment is generally due 30 days from the invoice date and accounts past 30 days are individually analyzed for collectability. When all collection efforts have been exhausted, the account is written off against the related allowance. To date, the Company has not experienced any write-offs or significant deterioration of the aging of its accounts receivable, and therefore, no allowance for doubtful accounts was considered necessary as of September 30, 2024, or December 31, 2023. As of September 30, 2024, two customers represented 16% and 11% of the accounts receivable balance. As of December 31, 2023, two customers represented 14% and 15% of the total accounts receivable balance.

Inventories: Inventories represent finished goods purchased from the Company’s suppliers and are recorded as the lower of cost or net realizable value using the first-in, first-out method. Overhead is allocated to manufactured finished goods inventory based on the normal capacity of the Company’s production facilities. Abnormal amounts of overhead, if any, are expensed as incurred. Inventories consisted of the following:

(in thousands)	September 30, 2024			December 31, 2023
Finished Goods	$	538		$	393
Work in Process		220			207
Raw Materials		1,150			1,472
Inventory Reserves		(44	)		(75	)
Total	$	1,864		$	1,997

Loss per Share: Basic loss per share is computed based on the net loss for each period divided by the weighted average number of common shares outstanding. See Note 3 – Stockholders’ Equity below for additional disclosures.

Diluted earnings per share is computed based on the net loss allocable to common stockholders for each period divided by the weighted average number of common shares outstanding, increased by the number of additional shares that would have been outstanding had the potentially dilutive common shares been issued, and reduced by the number of shares the Company could have repurchased from the proceeds from issuance of the potentially dilutive shares. Potentially dilutive shares of common stock include shares underlying outstanding convertible preferred stock, warrants, stock options and other stock-based awards granted under stock-based compensation plans.

	September 30
	2024		2023

Stock options		3,890		3,101
Warrants to purchase common stock		4,112,197		37,401
Series F convertible preferred stock		68,961		254
Series J convertible preferred stock		67		—
Total		4,185,115		40,756

The following table reconciles reported net loss with reported net loss per share for each of the three and nine months ended September 30:

	Three months ended September 30					Nine months ended September 30
	2024		2023			2024			2023
(in thousands, except per share amounts)
Net income (loss)	$	2,358	$	(3,370	)	$	(9,697	)	$	(14,700	)
Deemed dividend attributable to Series J Convertible Preferred Stock		—		—			541			—
Net loss attributable to common shareholders	$	2,358	$	(3,370	)	$	(9,156	)	$	(14,700	)
Weighted average shares outstanding		1,352		53			647			41
Basic and diluted loss per share	$	1.74	$	(63.27	)	$	(14.99	)	$	(357.42	)

Recently Issued Accounting Pronouncements: In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The guidance requires expanded interim and annual disclosures of segment information including the disclosure of significant segment expenses that are regularly provided to the chief operating decision maker and included within segment profit and loss. The guidance is effective for the Company's fiscal 2024 Form 10-K and interim periods thereafter. The Company is currently evaluating the ASU to determine its impact on the Company's disclosures.

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. The guidance requires expanded annual disclosures including the standardization and disaggregation of income tax rate reconciliation categories and the amount of income taxes paid by jurisdiction. The guidance is effective for the Company’s fiscal 2025 Form 10-K. The Company is currently evaluating the ASU to determine its impact on the Company’s disclosures.

In March 2024, the SEC adopted rules under SEC Release No. 33-11275, The Enhancement and Standardization of Climate-Related Disclosures for Investors, which requires the disclosure of material Scope 1 and Scope 2 greenhouse gas emissions and other climate-related topics in annual reports and registration statements. For non-accelerated filers and smaller reporting companies, disclosure requirements will begin phasing in for fiscal years beginning on or after January 1, 2027, subject to legal challenges and the SEC's voluntary stay of the disclosure requirements. The Company is currently evaluating the impact these rules will have on its consolidated financial statements and related disclosures.

Subsequent Events: The Company evaluates events through the date the condensed consolidated financial statements are filed for events requiring adjustment to or disclosure in the condensed consolidated financial statements. See note 9 – Subsequent Events for additional disclosures.

Condensed Consolidated Balance Sheets - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Current assets
Cash and cash equivalents	$ 1,907	$ 3,800
Accounts receivable	1,293	1,951
Inventories, net	1,864	1,997
Other current assets	430	461
Total current assets	5,494	8,209
Property, plant and equipment, net	551	728
Operating lease right-of-use asset	563	713
Other assets	120	120
TOTAL ASSETS	6,728	9,770
Current liabilities
Accounts payable and accrued liabilities	1,822	2,380
Accrued compensation	597	525
Current portion of operating lease liability	232	216
Other current liabilities	50	51
Total current liabilities	2,701	3,172
Common stock warrant liability	480	2,843
Operating lease liability	368	544
Total liabilities	3,549	6,559
Commitments and contingencies
Mezzanine Equity
Series J Convertible Preferred Stock as of September 30, 2024 and December 31, 2023, par value $0.0001 per share; authorized 600,000 shares, issued and outstanding 95 and 11,950, respectively	2	221
Stockholders' equity
Preferred stock	0	0
Common stock as of September 30, 2024 and December 31, 2023, par value $0.0001 per share; authorized 100,000,000 shares, issued and outstanding 1,866,890 and 162,356, respectively	0	0
Additional paid-in capital	300,546	290,647
Accumulated other comprehensive income:
Foreign currency translation adjustment	(46)	(31)
Accumulated deficit	(297,323)	(287,626)
Total stockholders' equity	3,177	2,990
TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY	6,728	9,770
Series A Junior Participating Preferred Stock [Member]
Stockholders' equity
Preferred stock	0	0
Series F Convertible Preferred Stock [Member]
Stockholders' equity
Preferred stock	$ 0	$ 0

Operating Leases	9 Months Ended
Operating Leases	Sep. 30, 2024
Operating Leases [Abstract]
Operating Leases	Note 7—Operating Leases The Company leases a 23,000 square foot facility located in Eden Prairie, Minnesota for office and manufacturing space under a non-cancelable operating lease that expires in March 2027. In November 2021, the Company entered into a fourth amendment to the lease, extending the term of the lease from March 31, 2022 to March 31, 2027. This facility serves as our corporate headquarters and houses substantially all our functional departments. Monthly rent and common area maintenance charges, including estimated property tax for our headquarters, total approximately $34,000. The lease contains provisions for annual inflationary adjustments. Rent expense is being recorded on a straight-line basis over the term of the lease. Beginning on April 1, 2022, the annual base rent was $10.50 per square foot, subject to future annual increases of $0.32 to $0.34 per square foot.

Fair Value of Financial Instruments (Details) - Warrants [Member] - USD ($) $ in Thousands	9 Months Ended	12 Months Ended
	Sep. 30, 2024	Dec. 31, 2023
Roll-Forward of Fair Value of Level 3 Warrants [Roll Forward]
Beginning balance	$ 2,843	$ 6,868
Exercise of warrants	(1,357)
Change in fair value	(4,602)
Ending balance	480	2,843
October 18, 2022 Series I Warrants Issuance [Member]
Roll-Forward of Fair Value of Level 3 Warrants [Roll Forward]
Issuance of Common Stock for exercise of warrants		(7,623)
Change in fair value		755
October 17, 2023 Series J Warrants Issuance [Member]
Roll-Forward of Fair Value of Level 3 Warrants [Roll Forward]
Issuance		4,965
Exercise of warrants		(536)
Change in fair value		$ (1,586)
April 30, 2024 Warrants Issuance [Member]
Roll-Forward of Fair Value of Level 3 Warrants [Roll Forward]
Issuance	7,813
Exercise of warrants	(1,373)
Reclassification to Equity	$ (2,844)

Revenue Recognition	9 Months Ended
Revenue Recognition	Sep. 30, 2024
Revenue Recognition [Abstract]
Revenue Recognition	Note 2 – Revenue Recognition Net Sales: The Company sells its products in the United States primarily through a direct salesforce. Customers who purchase the Company’s products include hospitals and clinics throughout the United States. In countries outside the United States, the Company sells its products through a limited number of specialty healthcare distributors in Austria, Belarus, Brazil, Colombia, The Czech Republic, Germany, Greece, Hong Kong, India, Indonesia, Israel, Italy, Panama, Romania, Singapore, Slovak Republic, Spain, Switzerland, Thailand, United Arab Emirates, and the United Kingdom. These distributors resell the Company’s products to hospitals and clinics in their respective geographies. International revenue represents 3% and 5% of net sales for the three months ended September 30, 2024 and 2023, and 4% and 5% of net sales for the nine months ended September 30, 2024 and 2023, respectively. Revenue from product sales is recognized when the customer or distributor obtains control of the product, which occurs at a point in time, most frequently upon shipment of the product or receipt of the product, depending on shipment terms. The Company’s standard shipping terms are FOB shipping point unless the customer requests that control and title to the inventory transfer upon delivery. Revenue is measured as the amount of consideration we expect to receive, adjusted for any applicable estimates of variable consideration and other factors affecting the transaction price, which is based on the invoiced price, in exchange for transferring products. All revenue is recognized when the Company satisfies its performance obligations under the contract. The majority of the Company’s contracts have a single performance obligation and are short term in nature. The Company has entered into extended service plans with customers whose related revenue is recognized over time. This revenue represents less than 1% of net sales for the three and nine months ended September 30, 2024 and 2023. The unfulfilled performance obligations related to these extended service plans are included in deferred revenue, which is included in other current liabilities on the condensed consolidated balance sheets. The majority of the deferred revenue is expected to be recognized within one year. Sales taxes and value added taxes in foreign jurisdictions that are collected from customers and remitted to governmental authorities are accounted for on a net basis and therefore are excluded from net sales. Revenue includes shipment and handling fees charged to customers. Shipping and handling costs associated with outbound freight after control over a product has transferred to a customer are accounted for as a fulfillment cost and are included in cost of goods sold. Product Returns: The Company offers customers a limited right of return for its products in case of non-conformity or performance issues. The Company estimates the amount of its product sales that may be returned by its customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized. The Company currently estimates product return liabilities using available industry data and its own historical sales and returns information. The Company has received minimal returns to date and believes that future returns of its products will be minimal. Therefore, revenue recognized is not currently impacted by variable consideration related to product returns.

- Definition

The entire disclosure of revenue from contract with customer to transfer good or service and to transfer nonfinancial asset. Includes, but is not limited to, disaggregation of revenue, credit loss recognized from contract with customer, judgment and change in judgment related to contract with customer, and asset recognized from cost incurred to obtain or fulfill contract with customer. Excludes insurance and lease contracts.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 9
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-9

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 10
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-10

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 15
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-15

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-12

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-12

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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org/606/tableOfContent

+ Details

Stock-Based Compensation (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Stock-Based Compensation Expense Items [Abstract]
Stock-based compensation expense	$ 101	$ 135	$ 374	$ 513
Additional Disclosures [Abstract]
Vesting period			48 months
Outstanding stock options (in shares)	3,890	3,101	3,890	3,101
Selling, General and Administrative Expense [Member]
Stock-Based Compensation Expense Items [Abstract]
Stock-based compensation expense	$ 99	$ 133	$ 363	$ 484
Research and Development Expense [Member]
Stock-Based Compensation Expense Items [Abstract]
Stock-based compensation expense	$ 2	$ 2	$ 11	$ 29
Stock Options [Member]
Additional Disclosures [Abstract]
Stock options granted (in shares)	0	532	1,264	3,544
Weighted average grant date fair value of stock options issued (in dollars per share)	$ 0	$ 62.65	$ 24.14	$ 226.26
Weighted Average Assumptions used in Black-Scholes Option Pricing Model [Abstract]
Expected volatility	138.70%	131.06%	138.70%	152.59%
Expected Life of options (years)	5 years 6 months 3 days	6 years 3 months	5 years 6 months 3 days	6 years 2 months 8 days
Expected dividend yield	0.00%	0.00%	0.00%	0.00%
Risk-free interest rate	3.94%	4.29%	3.94%	4.16%
Stock options vested (in shares)	420	69	1,767	129
Stock options expired or forfeited (in shares)	102	595	465	680
Exercise of stock options (in shares)	0	0	0	0

Stock-Based Compensation (Tables)

9 Months Ended

Sep. 30, 2024

Stock-Based Compensation [Abstract]

Classification of Stock-Based Compensation Expense

The following table presents the classification of stock-based compensation expense recognized for the periods below:

	Three months ended September 30				Nine months ended September 30
(in thousands)	2024		2023		2024		2023
Selling, general and administrative expense	$	99	$	133	$	363	$	484
Research and development expense		2		2		11		29
Total stock-based compensation expense	$	101	$	135	$	374	$	513

Weighted Average Assumptions used in Black-Scholes Option Pricing Model

The weighted-average assumptions used in the Black-Scholes option-pricing model are as follows for the stock options granted during the three and nine months ended September 30, 2024 and 2023:

	Three months ended						Nine months ended
	September 30						September 30
	2024			2023			2024			2023
Expected volatility		138.70	%		131.06	%		138.70	%		152.59	%
Expected Life of options (years)		5.51			6.25			5.51			6.19
Expected dividend yield		0	%		0	%		0	%		0	%
Risk-free interest rate		3.94	%		4.29	%		3.94	%		4.16	%

Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands	Common Stock [Member]	Common Stock [Member] Series J Convertible Preferred Stock [Member]	Additional Paid in Capital [Member]	Additional Paid in Capital [Member] Series J Convertible Preferred Stock [Member]	Accumulated Other Comprehensive Income [Member]	Accumulated Other Comprehensive Income [Member] Series J Convertible Preferred Stock [Member]	Accumulated Deficit [Member]	Accumulated Deficit [Member] Series J Convertible Preferred Stock [Member]	Total	Series J Convertible Preferred Stock [Member]
Balance at Dec. 31, 2022	$ 0		$ 279,736		$ 38		$ (267,417)		$ 12,357
Balance (in shares) at Dec. 31, 2022	15,326
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Net loss	$ 0		0		0		(6,485)		(6,485)
Unrealized foreign currency translation adjustment	0		0		(7)		0		(7)
Unrealized gain on marketable securities	0		0		6		0		6
Stock-based compensation, net	$ 0		181		0		0		181
Stock-based compensation, net (in shares)	0
Issuance costs	$ 0		(11)		0		0		(11)
Conversion of preferred stock into common stock	$ 0		0		0		0		0
Conversion of preferred stock into common stock (in shares)	300
Conversion of warrants into common stock	$ 0		0		0		0		0
Conversion of warrants into common stock (in shares)	18,858
Reclassification of warrants to equity	$ 0		7,623		0		0		7,623
Balance at Mar. 31, 2023	$ 0		287,529		37		(273,902)		13,664
Balance (in shares) at Mar. 31, 2023	34,484
Balance at Dec. 31, 2022	$ 0		279,736		38		(267,417)		12,357
Balance (in shares) at Dec. 31, 2022	15,326
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Net loss									(14,700)
Balance at Sep. 30, 2023	$ 0		289,980		(24)		(282,117)		7,839
Balance (in shares) at Sep. 30, 2023	53,265
Balance at Dec. 31, 2022	$ 0		279,736		38		(267,417)		12,357
Balance (in shares) at Dec. 31, 2022	15,326
Balance at Dec. 31, 2023	$ 0		290,647		(31)		(287,626)		2,990
Balance (in shares) at Dec. 31, 2023	162,356
Balance at Mar. 31, 2023	$ 0		287,529		37		(273,902)		13,664
Balance (in shares) at Mar. 31, 2023	34,484
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Net loss	$ 0		0		0		(4,845)		(4,845)
Unrealized gain on marketable securities	0		0		(61)		0		(61)
Stock-based compensation, net	$ 0		197		0		0		197
Stock-based compensation, net (in shares)	0
Issuance of common stock, net	$ 0		2,217		0		0		2,217
Issuance of common stock, net (in shares)	18,781
Issuance costs	$ 0		(98)		0		0		(98)
Balance at Jun. 30, 2023	$ 0		289,845		(24)		(278,747)		11,074
Balance (in shares) at Jun. 30, 2023	53,265
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Net loss	$ 0		0		0		(3,370)		(3,370)
Stock-based compensation, net	$ 0		135		0		0		135
Stock-based compensation, net (in shares)	0
Balance at Sep. 30, 2023	$ 0		289,980		(24)		(282,117)		7,839
Balance (in shares) at Sep. 30, 2023	53,265
Balance at Dec. 31, 2023	$ 0		290,647		(31)		(287,626)		2,990
Balance (in shares) at Dec. 31, 2023	162,356
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Net loss	$ 0		0		0		(4,330)		(4,330)
Unrealized foreign currency translation adjustment	0		0		(9)		0		(9)
Stock-based compensation, net	$ 0		158		0		0		158
Stock-based compensation, net (in shares)	0
Conversion of preferred stock into common stock		$ 0		$ 1,535		$ 0		$ 0		$ 1,535
Conversion of preferred stock into common stock (in shares)		31,971
Series J convertible preferred stock deemed dividend	$ 0		541		0		0		541
Balance at Mar. 31, 2024	$ 0		292,881		(40)		(291,956)		885
Balance (in shares) at Mar. 31, 2024	194,327
Balance at Dec. 31, 2023	$ 0		290,647		(31)		(287,626)		2,990
Balance (in shares) at Dec. 31, 2023	162,356
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Net loss									(9,697)
Balance at Sep. 30, 2024	$ 0		300,546		(46)		(297,323)		3,177
Balance (in shares) at Sep. 30, 2024	1,866,890
Balance at Mar. 31, 2024	$ 0		292,881		(40)		(291,956)		885
Balance (in shares) at Mar. 31, 2024	194,327
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Net loss	$ 0		0		0		(7,725)		(7,725)
Unrealized foreign currency translation adjustment	0		0		(2)		0		(2)
Stock-based compensation, net	$ 0		115		0		0		115
Stock-based compensation, net (in shares)	0
Issuance of common stock, net	$ 0		(109)		0		0		(109)
Issuance of common stock, net (in shares)	321,417
Balance at Jun. 30, 2024	$ 0		292,887		(42)		(299,681)		(6,836)
Balance (in shares) at Jun. 30, 2024	515,744
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Net loss	$ 0		0		0		2,358		2,358
Unrealized foreign currency translation adjustment	0		0		(4)		0		(4)
Stock-based compensation, net	$ 0		101		0		0		101
Stock-based compensation, net (in shares)	0
Issuance of common stock, net	$ 0		2,882		0		0		2,882
Issuance of common stock, net (in shares)	952,658
Exercise of common stock warrants	$ 0		1,182		0		0		1,182
Exercise of common stock warrants (in shares)	398,488
Issuance costs	$ 0		(722)		0		0		(722)
Deemed dividend	0		(1)		0		0		(1)
Reclassification of warrants to equity	0		4,217		0		0		4,217
Balance at Sep. 30, 2024	$ 0		$ 300,546		$ (46)		$ (297,323)		$ 3,177
Balance (in shares) at Sep. 30, 2024	1,866,890

Stock-Based Compensation

9 Months Ended

Sep. 30, 2024

Stock-Based Compensation [Abstract]

Stock-Based Compensation

Note 4 - Stock-Based Compensation

Under the fair value recognition provisions of U.S. GAAP for accounting for stock-based compensation the Company measures stock-based compensation expense at the grant date based on the fair value of the award and recognizes the compensation expense over the requisite service period, which is generally the vesting period.

The following table presents the classification of stock-based compensation expense recognized for the periods below:

	Three months ended September 30				Nine months ended September 30
(in thousands)	2024		2023		2024		2023
Selling, general and administrative expense	$	99	$	133	$	363	$	484
Research and development expense		2		2		11		29
Total stock-based compensation expense	$	101	$	135	$	374	$	513

During the three months ended September 30, 2024, and 2023, under the 2017 Equity Incentive Plan, and the 2021 Inducement Plan, the Company granted zero and 532 stock options, respectively, to its directors, officers and employees. During the nine months ended September 30, 2024 and 2023, the Company granted 1,264 and 3,544 stock options, respectively, to its directors, officers and employees. Vesting generally occurs over an immediate to 48-month period based on a time-of-service condition. The weighted-average grant date fair value of the stock-options issued during the three months ended September 30, 2024 and 2023 was zero and $62.65 per share, respectively. The weighted-average grant date fair value of the stock options issued during the nine months ended September 30, 2024 and 2023 was $24.14 and $226.26 per share, respectively.

The total number of stock options outstanding as of September 30, 2024 and September 30, 2023 was 3,890 and 3,101, respectively.

The weighted-average assumptions used in the Black-Scholes option-pricing model are as follows for the stock options granted during the three and nine months ended September 30, 2024 and 2023:

	Three months ended						Nine months ended
	September 30						September 30
	2024			2023			2024			2023
Expected volatility		138.70	%		131.06	%		138.70	%		152.59	%
Expected Life of options (years)		5.51			6.25			5.51			6.19
Expected dividend yield		0	%		0	%		0	%		0	%
Risk-free interest rate		3.94	%		4.29	%		3.94	%		4.16	%

During the three months ended September 30, 2024 and 2023, 420 and 69 stock options vested, respectively, and 102 and 595 stock options were expired or forfeited during these periods, respectively. During the nine months ended September 30, 2024 and 2023, 1,767 and 129 stock options vested, respectively, and 465 and 680 stock options were expired or forfeited during these periods, respectively. During the three and nine months ended September 30, 2024 and 2023, no options were exercised.

Nature of Business and Basis of Presentation (Policies)

9 Months Ended

Sep. 30, 2024

Nature of Business and Basis of Presentation [Abstract]

Principles of Consolidation

Going Concern

The gross proceeds to the Company from the offering, before deducting the placement agent fees and other offering expenses were approximately $2.7 million.

The closing of the registered direct offering and the concurrent private placement occurred on or about July 25, 2024.

Revenue Recognition

Accounts Receivable

Inventories

(in thousands)	September 30, 2024			December 31, 2023
Finished Goods	$	538		$	393
Work in Process		220			207
Raw Materials		1,150			1,472
Inventory Reserves		(44	)		(75	)
Total	$	1,864		$	1,997

Loss per Share

	September 30
	2024		2023

Stock options		3,890		3,101
Warrants to purchase common stock		4,112,197		37,401
Series F convertible preferred stock		68,961		254
Series J convertible preferred stock		67		—
Total		4,185,115		40,756

The following table reconciles reported net loss with reported net loss per share for each of the three and nine months ended September 30:

	Three months ended September 30					Nine months ended September 30
	2024		2023			2024			2023
(in thousands, except per share amounts)
Net income (loss)	$	2,358	$	(3,370	)	$	(9,697	)	$	(14,700	)
Deemed dividend attributable to Series J Convertible Preferred Stock		—		—			541			—
Net loss attributable to common shareholders	$	2,358	$	(3,370	)	$	(9,156	)	$	(14,700	)
Weighted average shares outstanding		1,352		53			647			41
Basic and diluted loss per share	$	1.74	$	(63.27	)	$	(14.99	)	$	(357.42	)

Recently Issued Accounting Pronouncements

Subsequent Events

- Definition

Disclosure of inventory accounting policy for inventory classes, including, but not limited to, basis for determining inventory amounts, methods by which amounts are added and removed from inventory classes, loss recognition on impairment of inventories, and situations in which inventories are stated above cost.

+ References + Details

- Definition

Disclosure of accounting policy for revenue from contract with customer.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Fair Value of Financial Instruments

9 Months Ended

Sep. 30, 2024

Fair Value of Financial Instruments [Abstract]

Fair Value of Financial Instruments

Note 5—Fair Value of Financial Instruments

The Company’s financial instruments consist of cash and cash equivalents and warrants.

Pursuant to the requirements of Accounting Standards Codification (“ASC”) Topic 820 “Fair Value Measurement,” the Company’s financial assets and liabilities measured at fair value on a recurring basis are classified and disclosed in one of the following three categories:

●	Level 1 - Financial instruments with unadjusted quoted prices listed on active market exchanges.

●

Level 2 - Financial instruments lacking unadjusted, quoted prices from active market exchanges, including over-the-counter traded financial instruments. The prices for the financial instruments are determined using prices for recently traded financial instruments with similar underlying terms as well as directly or indirectly observable inputs, such as interest rates and yield curves that are observable at commonly quoted intervals.

●	Level 3 - Financial instruments that are not actively traded on a market exchange. This category includes situations where there is little, if any, market activity for the financial instrument. The prices are determined using significant unobservable inputs or valuation techniques.

The fair value of the Company’s common and preferred stock warrant liabilities related to the investor warrants issued in the October 2023, October 2022 and April 2024 public offerings was calculated using a Monte Carlo valuation model and was classified as Level 3 in the fair value hierarchy.

The following is a roll-forward of the fair value of the Level 3 warrants:

(in thousands)
Balance at December 31, 2022	$	6,868
Change in fair value		755
Issuance of Common Stock for exercise of Series I warrants		(7,623	)
October 17, 2023, issuance of Series J warrants		4,965
Exercise of Series J warrants		(536	)
Change in fair value		(1,586	)
Balance at December 31, 2023		2,843
Exercise of Series J warrants		(1,357	)
April 30, 2024, issuance of common warrants		7,813
Exercise of April 2024 warrants		(1,373	)
Reclassification of April 2024 warrants to equity		(2,844	)
Change in fair value		(4,602	)
Balance at September 30, 2024	$	480

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References

Reference 1: http://www.xbrl.org/2003/role/exampleRef
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+ Details