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REVENUE AND SEGMENT INFORMATION (Tables)

9 Months Ended

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

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

Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 25
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482810/280-10-50-25

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-Name Accounting Standards Codification
-Topic 280
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-Paragraph 22
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482810/280-10-50-22

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-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 30
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-URI https://asc.fasb.org/1943274/2147482810/280-10-50-30

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