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REVENUE AND SEGMENT INFORMATION (Tables) | 9 Months Ended
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Sep. 30, 2025
REVENUE AND SEGMENT INFORMATION |
Schedule of disaggregation of revenue | The following table disaggregates the Company’s revenue by customer type and geographic area for the three months ended September 30, 2025:
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
​ | ​ | ​ | ​ | ​ | Distributors/ | ​ | ​ | ​
​ |  | Direct |  | Strategic Partners |  | Total
​ | ​ | (amounts, in thousands)
Revenue: |  | ​ |  |  | ​ |  |  | ​ |
United States | ​ | $ | 28 | ​ | $ | — | ​ | $ | 28
Germany | ​ |  | 2,899 | ​ |  | — | ​ |  | 2,899
All other countries | ​ |  | 2,246 | ​ |  | 4,312 | ​ |  | 6,558
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
Revenue | ​ | $ | 5,173 | ​ | $ | 4,312 | ​ | $ | 9,485
​ The following table disaggregates the Company’s revenue by customer type and geographic area for the three months ended September 30, 2024:
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
​ | ​ | ​ | ​ | ​ | Distributors/ | ​ | ​ | ​
​ |  | Direct |  | Strategic Partners |  | Total
​ | ​ | (amounts, in thousands)
Revenue: | ​ |  | ​ | ​ |  | ​ | ​ |  | ​
United States | ​ | $ | 21 | ​ | $ | — | ​ | $ | 21
Germany | ​ |  | 3,181 | ​ |  | — | ​ |  | 3,181
All other countries | ​ |  | 1,937 | ​ |  | 3,474 | ​ |  | 5,411
Revenue | ​ | $ | 5,139 | ​ | $ | 3,474 | ​ | $ | 8,613
​ The following table disaggregates the Company’s revenue by customer type and geographic area for the nine months ended September 30, 2025: ​
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
​ | ​ | ​ | ​ | ​ | Distributors/ | ​ | ​ | ​
​ |  | Direct |  | Strategic Partners |  | Total
​ | ​ | (amounts, in thousands)
Revenue: |  | ​ |  |  | ​ |  |  | ​ |
United States | ​ | $ | 152 | ​ | $ | — | ​ | $ | 152
Germany | ​ |  | 9,050 | ​ | ​ | — | ​ | ​ | 9,050
All other countries | ​ |  | 6,344 | ​ | ​ | 12,283 | ​ | ​ | 18,627
Revenue | ​ | $ | 15,546 | ​ | $ | 12,283 | ​ | $ | 27,829
​ The following table disaggregates the Company’s revenue by customer type and geographic area for the nine months ended September 30, 2024:
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
​ | ​ | ​ | ​ | ​ | Distributors/ | ​ | ​ | ​
​ |  | Direct |  | Strategic Partners |  | Total
​ | ​ | (amounts, in thousands)
Revenue: |  | ​ |  |  | ​ |  |  | ​ |
United States | ​ | $ | 63 | ​ | $ | 36 | ​ | $ | 99
Germany | ​ |  | 9,497 | ​ | ​ | — | ​ | ​ | 9,497
All other countries | ​ |  | 5,362 | ​ | ​ | 11,486 | ​ | ​ | 16,848
Revenue | ​ | $ | 14,922 | ​ | $ | 11,522 | ​ | $ | 26,444
​
Schedule of receivables and contract liabilities from contracts with customers | ​
​ | ​ | ​ | ​ | ​ | ​ | ​
​ |  | September 30, 2025 |  | December 31, 2024
​ |  | (amounts in thousands)
Contract receivables | ​ | $ | 5,997 | ​ | $ | 4,427
Contract liabilities | ​ | $ | 403 | ​ | $ | 596
Schedule of segment information | ​
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
​ |  | Three Months Ended |  | Nine Months Ended |
​ | ​ | September 30, | ​ | September 30, |
​ |  | 2025 |  | 2024 |  | 2025 |  | 2024 |
​ |  | (amounts, in thousands) | ​
Revenue | ​ | $ | 9,485 | ​ | $ | 8,613 | ​ | $ | 27,829 | ​ | $ | 26,444 | ​
Gross profit | ​ | $ | 6,666 | ​ | $ | 5,256 | ​ | $ | 19,687 | ​ | $ | 18,632 | ​
Gross margin | ​ |  | 70 | % |  | 61 | % |  | 71 | % |  | 70 | %
Total operating expenses | ​ | $ | 9,528 | ​ | $ | 10,086 | ​ | $ | 30,051 | ​ | $ | 31,689 | ​
Loss from operations | ​ | $ | (2,862) | ​ | $ | (4,830) | ​ | $ | (10,364) | ​ | $ | (13,057) | ​
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
EBITDA and Adjusted EBITDA (both non-GAAP measures): | ​ |  | ​ | ​ |  | ​ | ​ |  | ​ | ​ |  | ​ | ​
Net loss | ​ | $ | (3,170) | ​ | $ | (2,768) | ​ | $ | (2,701) | ​ | $ | (13,152) | ​
Interest expense, net | ​ |  | 645 | ​ |  | 588 | ​ |  | 1,866 | ​ |  | 775 | ​
Benefit from income taxes | ​ |  | (401) | ​ |  | — | ​ |  | (401) | ​ |  | — | ​
Depreciation and amortization expense | ​ |  | 364 | ​ |  | 383 | ​ |  | 1,137 | ​ |  | 1,181 | ​
Loss before interest expense, income taxes, depreciation and amortization (“EBITDA”), a non-GAAP measure | ​ |  | (2,562) | ​ |  | (1,797) | ​ |  | (99) | ​ |  | (11,196) | ​
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
Stock-based compensation | ​ |  | 488 | ​ |  | 891 | ​ |  | 1,879 | ​ |  | 2,840 | ​
Loss (gain) on foreign currency transactions | ​ | ​ | 64 | ​ |  | (2,650) | ​ | ​ | (9,128) | ​ |  | (680) | ​
Adjusted EBITDA, a non-GAAP measure | ​ | $ | (2,010) | ​ | $ | (3,556) | ​ | $ | (7,348) | ​ | $ | (9,036) | ​
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
Adjusted net loss, a non-GAAP measure: | ​ |  | ​ | ​ |  | ​ | ​ |  | ​ | ​ |  | ​ | ​
Net loss | ​ | $ | (3,170) | ​ | $ | (2,768) | ​ | $ | (2,701) | ​ | $ | (13,152) | ​
Stock-based compensation | ​ |  | 488 | ​ |  | 891 | ​ |  | 1,879 | ​ |  | 2,840 | ​
Loss (gain) on foreign currency transactions | ​ | ​ | 64 | ​ | ​ | (2,650) | ​ | ​ | (9,128) | ​ | ​ | (680) | ​
Adjusted net loss, a non-GAAP measure | ​ | $ | (2,618) | ​ | $ | (4,527) | ​ | $ | (9,950) | ​ | $ | (10,992) | ​
Total cash used in operating and investing activities | ​ | $ | (2,522) | ​ | $ | (2,762) | ​ | $ | (7,676) | ​ | $ | (12,632) | ​
​
​ | ​ | ​ | ​ | ​ | ​ | ​
​ |  | September 30, 2025 |  | December 31, 2024
​ | ​ | (amounts, in thousands)
Total assets | ​ | $ | 45,750 | ​ | $ | 47,372
​
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
​ |  | Three Months Ended | ​ | Nine Months Ended
​ | ​ | September 30, | ​ | September 30,
​ |  | 2025 |  | 2024 |  | 2025 |  | 2024
​ | ​ | (amounts, in thousands)
Research and development: |  | ​ | ​ | ​ | ​ | ​ | ​ | ​ |  |  | ​ |
Clinical expenses | ​ | $ | 719 | ​ | $ | 936 | ​ | $ | 2,510 | ​ | $ | 3,499
Other research and development expenses | ​ |  | 199 | ​ |  | 890 | ​ |  | 1,332 | ​ |  | 2,093
Total research and development | ​ | $ | 918 | ​ | $ | 1,826 | ​ | $ | 3,842 | ​ | $ | 5,592
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
Selling, general and administrative | ​ |  |  | ​ |  | ​ | ​ |  |  | ​ |  |
Royalty expense | ​ | $ | 285 | ​ | $ | 354 | ​ | $ | 826 | ​ | $ | 1,594
Stock-based compensation | ​ |  | 376 | ​ |  | 843 | ​ |  | 1,435 | ​ |  | 2,792
Legal, financial and consulting | ​ |  | 1,061 | ​ |  | 824 | ​ |  | 3,063 | ​ |  | 2,325
Other general and administrative | ​ |  | 6,888 | ​ |  | 6,239 | ​ |  | 20,885 | ​ |  | 19,386
Total selling, general and administrative | ​ | $ | 8,610 | ​ | $ | 8,260 | ​ | $ | 26,209 | ​ | $ | 26,097

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