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REVENUE AND SEGMENT INFORMATION (Tables)

6 Months Ended

Jun. 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 June 30, 2025:

​	​	​	​	​	​	​	​	​	​
​	​	​	​	​	Distributors/		​	​	​
​	​	Direct		​	Strategic Partners		​	Total
​	​	(amounts, in thousands)
Revenue:		​			​			​
United States	​	$	61	​	$	—	​	$	61
Germany	​		3,355	​		—	​		3,355
All other countries	​		2,208	​		3,993	​		6,201
​	​	​	​	​	​	​	​	​	​
Revenue	​	$	5,624	​	$	3,993	​	$	9,617

​

The following table disaggregates the Company’s revenue by customer type and geographic area for the three months ended June 30, 2024:

​	​	​	​	​	​	​	​	​	​
​	​	​	​	​	Distributors/		​	​	​
​	​	Direct		​	Strategic Partners		​	Total
​	​	(amounts, in thousands)
Revenue:	​		​	​		​	​		​
United States	​	$	20	​	$	18	​	$	38
Germany	​		2,779	​		—	​		2,779
All other countries	​		1,674	​		4,351	​		6,025
Revenue	​	$	4,473	​	$	4,369	​	$	8,842

​

The following table disaggregates the Company’s revenue by customer type and geographic area for the six months ended June 30, 2025:

​

​	​	​	​	​	​	​	​	​	​
​	​	​	​	​	​	​	​	​	​
​	​	​	​	​	Distributors/		​	​	​
​		Direct			Strategic Partners			Total
​	​	(amounts, in thousands)
Revenue:		​			​			​
United States	​	$	124	​	$	—	​	$	124
Germany	​		6,151	​	​	—	​	​	6,151
All other countries	​		4,098	​	​	7,971	​	​	12,069
​	​		​	​	​	​	​	​	​
Revenue	​	$	10,373	​	$	7,971	​	$	18,344

​

The following table disaggregates the Company’s revenue by customer type and geographic area for the six months ended June 30, 2024:

​	​	​	​	​	​	​	​	​	​
​	​	​	​	​	​	​	​	​	​
​	​	​	​	​	Distributors/		​	​	​
​		Direct			Strategic Partners			Total
​	​	(amounts, in thousands)
Revenue:		​			​			​
United States	​	$	42	​	$	36	​	$	78
Germany	​		6,316	​	​	—	​	​	6,316
All other countries	​		3,424	​	​	8,013	​	​	11,437
Revenue	​	$	9,782	​	$	8,049	​	$	17,831

​

Schedule of receivables and contract liabilities from contracts with customers

​

​	​	​	​	​	​	​
​		June 30, 2025			December 31, 2024
​		(amounts in thousands)
Contract receivables	​	$	6,637	​	$	4,427
Contract liabilities	​	$	521	​	$	596

Schedule of segment information

​

​	​	​	​	​	​	​	​	​	​	​	​	​	​
​		Three Months Ended						Six Months Ended
​	​	June 30,					​	June 30,
​		2025			2024			2025			2024
​		(amounts, in thousands)											​
Revenue	​	$	9,617	​	$	8,842	​	$	18,344	​	$	17,831	​
Gross profit	​	$	6,814	​	$	6,503	​	$	13,021	​	$	13,376	​
Gross margin	​		71	%		74	%		71	%		75	%
Total operating expenses	​	$	10,429	​	$	10,073	​	$	20,523	​	$	21,603	​
Loss from operations	​	$	(3,615)	​	$	(3,570)	​	$	(7,502)	​	$	(8,227)	​
EBITDA and Adjusted EBITDA (both non-GAAP measures):	​		​	​		​	​		​	​		​	​
Net income (loss) attributable to common stockholders	​	$	1,947	​	$	(4,294)	​	$	469	​	$	(10,384)	​
Interest expense, net	​		616	​		180	​		1,221	​		187	​
Depreciation and amortization expense	​		404	​		401	​		773	​		798	​
Income (loss) before interest expense, income taxes, depreciation and amortization (“EBITDA”), a non-GAAP measure	​		2,967	​		(3,713)	​		2,463	​		(9,399)	​
Stock-based compensation	​		571	​		989	​		1,391	​		1,949	​
Loss (gain) on foreign currency transactions	​	​	(6,178)	​		544	​	​	(9,192)	​		1,970	​
Adjusted EBITDA, a non-GAAP measure	​	$	(2,640)	​	$	(2,180)	​	$	(5,338)	​	$	(5,480)	​
Adjusted net loss, a non-GAAP measure:	​		​	​		​	​		​	​		​	​
Net income (loss) attributable to common stockholders	​	$	1,947	​	$	(4,294)	​	$	469	​	$	(10,384)	​
Stock-based compensation	​		571	​		989	​		1,391	​		1,949	​
Loss (gain) on foreign currency transactions	​	​	(6,178)	​	​	544	​	​	(9,192)	​	​	1,970	​
Adjusted net loss, a non-GAAP measure	​	$	(3,660)	​	$	(2,761)	​	$	(7,332)	​	$	(6,465)	​
Total cash used in operating and investing activities	​	$	(1,642)	​	$	(4,913)	​	$	(5,154)	​	$	(9,870)	​

​

​	​	​	​	​	​	​
​		June 30, 2025			December 31, 2024
​	​	(amounts, in thousands)
Total assets	​	$	47,990	​	$	47,372

​

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Three Months Ended

​

Six Months Ended

​

​

June 30,

​

June 30,

​

2025

2024

2025

2024

​

​

(amounts, in thousands)

Research and development:

​

​

​

​

​

​

​

​

Clinical expenses

​

$

812

​

$

936

​

$

1,791

​

$

2,563

Other research and development expenses

​

450

​

583

​

1,133

​

1,203

Total research and development

​

$

1,262

​

$

1,519

​

$

2,924

​

$

3,766

​

​

​

​

​

​

​

​

​

​

​

​

​

Selling, general and administrative

​

​

​

​

​

Royalty expense

​

$

286

​

$

528

​

$

544

​

$

1,240

Stock-based compensation

​

429

​

989

​

1,056

​

1,949

Legal, financial and consulting

​

1,364

​

820

​

2,002

​

1,501

Other general and administrative

​

7,088

​

6,217

​

13,997

​

13,147

Total selling, general and administrative

​

$

9,167

​

$

8,554

​

$

17,599

​

$

17,837

X

- Definition

Tabular disclosure of receivable, contract asset, and contract liability from contract with customer. Includes, but is not limited to, change in contract asset and contract liability.

+ References

Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
-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

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- Definition

Tabular disclosure of disaggregation of revenue into categories depicting how nature, amount, timing, and uncertainty of revenue and cash flows are affected by economic factor.

+ References

Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 5
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-5

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- Definition

Tabular disclosure of the profit or loss and total assets for each reportable segment. An entity discloses certain information on each reportable segment if the amounts (a) are included in the measure of segment profit or loss reviewed by the chief operating decision maker or (b) are otherwise regularly provided to the chief operating decision maker, even if not included in that measure of segment profit or loss.

+ References

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-Name Accounting Standards Codification
-Topic 280
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-Section 50
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