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SEGMENT INFORMATION | 12 Months Ended
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Dec. 31, 2024
SEGMENT INFORMATION |
SEGMENT INFORMATION | 11. SEGMENT INFORMATION The Company operates and manages its business as one reportable segment and one operating segment, which is the business of developing, testing and selling blood purification medical devices. The Company’s chief operating decision maker, or CODM, is the Company’s Chief Executive Officer. The CODM assesses performance of the segment and decides how to allocate resources based on Revenue growth, Gross Margin, Operating Expenses, adjusted net loss, adjusted EBITDA and cash burn (cash used in operating and investing activities) derived from the Company’s consolidated results of operations and cash flows and total assets of the segment. ​ The measure of segment assets is reported on the consolidated balance sheets as total consolidated assets. All material long-lived assets are located in New Jersey, and Berlin Germany. Long-lived assets consist of property and equipment, net and operating lease right-of-use assets. Factors used in determining the reportable segment include the nature of the Company’s operations, the organizational and reporting structure and the type of information reviewed by the CODM to allocate resources and evaluate financial performance. The accounting policies of the segment are the same as those described in Note 2 to the consolidated financial statements of the Company included in this Annual Report on Form 10-K. The Company operates as one reportable operating segment. Consisting of one reportable operating segment, the components presented in the consolidated statements of operations also present the components of the Company’s single operating segment. The CODM uses financial metrics to evaluate the Company’s spending and monitor budget versus actual results. The monitoring of budgeted versus actual results is used in assessing performance of the segment and in establishing resource allocation across the organization. The financial metrics used by the CODM in evaluating the Company’s spending and monitoring budget versus actual results are as follows: ​
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
​ | ​ | Years ended | ​
​ | ​ | December 31, | ​
​ | ​ | 2024 | ​ | 2023 | ​
​ |  | ​ | ​ | As Restated* | ​
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
Product revenue | ​ | $ | 35,594,520 | ​ | $ | 31,084,953 | ​
Gross Profit | ​ | $ | 25,125,991 | ​ | $ | 21,953,237 | ​
Gross Margin | ​ | ​ | 71 | % |  | 71 | %
Total Operating Expenses | ​ | $ | 41,911,930 | ​ | $ | 53,901,857 | ​
EBITDA and Adjusted EBITDA (both non-GAAP measures): | ​ | ​ | ​ | ​ | ​ | ​ | ​
Net loss | ​ | $ | (20,718,957) | ​ | $ | (29,246,760) | ​
Interest expense | ​ |  | 1,399,092 | ​ |  | (157,891) | ​
Benefits from income taxes | ​ | ​ | (1,690,825) | ​ | ​ | 813,739 | ​
Depreciation and amortization expense | ​ | ​ | 1,570,104 | ​ | ​ | 1,459,066 | ​
Loss before interest expense, income taxes, depreciation and amortization (“EBITDA”), a non-GAAP measure | ​ | ​ | (19,440,586) | ​ | ​ | (28,443,541) | ​
Stock-based compensation | ​ | ​ | 3,759,534 | ​ | ​ | 4,155,342 | ​
Gain (loss) on foreign currency transactions | ​ | ​ | 4,224,721 | ​ | ​ | (1,949,257) | ​
Adjusted EBITDA, a non-GAAP measure | ​ | $ | (11,456,331) | ​ | $ | (26,237,456) | ​
Adjusted net loss, a non-GAAP measure: | ​ | ​ | ​ | ​ | ​ | ​ | ​
Net loss | ​ | $ | (20,718,957) | ​ | $ | (29,246,760) | ​
Stock-based compensation | ​ | ​ | 3,759,534 | ​ | ​ | 4,155,342 | ​
Gain (loss) on foreign currency transactions | ​ | ​ | 4,224,721 | ​ | ​ | (1,949,257) | ​
Adjusted net loss, a non-GAAP measure | ​ | $ | 12,734,702 | ​ | $ | 27,040,675 | ​
Total cash used in operating and investing activities | ​ | $ | (15,097,239) | ​ | $ | (22,591,372) | ​
Total Assets | ​ | $ | 47,675,811 | ​ | $ | 52,956,322 | ​
* See Note 12 – Restatement of Previously Issued financial information for details. ​ Significant expense categories regularly provided to the CODM consist of the following: ​
​ | ​ | ​ | ​ | ​ | ​ | ​
​ | ​ | Years ended December 31,
​ | ​ | 2024 |  | 2023
​ |  | ​ | ​ | As Restated*
​ | ​ | ​ | ​ | ​ | ​ | ​
Research and development: | ​ | ​ | ​ | ​ | ​ | ​
Clinical expenses | ​ | $ | 4,482,691 | ​ | $ | 11,329,684
Other research and development expenses | ​ |  | 2,433,490 | ​ |  | 4,264,758
Total research and development | ​ | $ | 6,916,181 | ​ | $ | 15,594,442
​ | ​ | ​ | ​ | ​ | ​ | ​
Selling, general and administrative | ​ |  |  | ​ |  |
Commission expense | ​ | $ | 2,903,705 | ​ | $ | 2,289,773
Royalty expense | ​ |  | 1,869,016 | ​ |  | 2,156,323
Stock-based compensation | ​ |  | 3,759,534 | ​ |  | 4,155,341
Legal, financial and consulting | ​ |  | 3,178,787 | ​ |  | 4,272,296
Other general and administrative | ​ |  | 23,244,707 | ​ |  | 25,433,682
Total selling, general and administrative | ​ | $ | 34,995,749 | ​ | $ | 38,307,415
* See Note 12 – Restatement of Previously Issued financial information for details. ​ Capital expenditures of the segment totaled $669,430 and $936,236 for the years ended December 31, 2024 and 2023, respectively.

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