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 (EBITDA, as defined below, adjusted for stock-based compensation, (gain) loss on foreign currency transactions, and restructuring) 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, Basis of Presentation and Summary of Significant Accounting Policies.

The Company operates under one reportable business segment for which segment disclosure is consistent with the management decision making process that determines the allocation of resources and the measuring of performance.

The components presented in the consolidated statements of operations and comprehensive loss 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,

2025

2024

  ​ ​ ​

(amounts, in thousands)

Revenue

$

37,063

$

35,595

Gross profit

$

26,491

$

24,887

Gross margin

71

%

 

70

%

Total operating expenses

$

41,240

$

41,339

Loss from operations

(14,749)

(16,452)

EBITDA and Adjusted EBITDA (both non-GAAP measures):

Net loss

$

(8,198)

$

(20,719)

Interest expense, net

 

2,612

 

1,399

Benefit from income taxes

(401)

(1,691)

Depreciation and amortization expense

1,496

1,570

Earnings (Loss) before interest expense, income taxes, depreciation and amortization (“EBITDA”), a non-GAAP measure

(4,491)

(19,441)

Stock-based compensation

2,765

3,760

(Gain) loss on foreign currency transactions

(9,321)

4,225

Restructuring

510

Adjusted EBITDA, a non-GAAP measure

$

(10,537)

$

(11,456)

Adjusted net loss, a non-GAAP measure:

Net loss

$

(8,198)

$

(20,719)

Stock-based compensation

2,765

3,760

Gain (loss) on foreign currency transactions

(9,321)

4,225

Restructuring

510

Adjusted net loss, a non-GAAP measure

$

(14,244)

$

(12,734)

Total cash used in operating and investing activities

$

(12,749)

$

(15,097)

Total Assets

$

44,182

$

47,372

Significant expense categories regularly provided to the CODM consist of the following:

Years ended December 31, 

2025

  ​ ​ ​

2024

  ​ ​ ​

(amounts, in thousands)

Research and development, net of grant income:

Clinical expenses

$

3,377

$

4,979

Other research and development expenses

 

1,708

 

2,628

Total research and development, net of grant income

$

5,085

$

7,607

Selling, general and administrative

 

  ​

 

  ​

Royalty expense

 

1,097

 

1,869

Stock-based compensation

 

2,237

 

2,830

Legal, financial and consulting

 

4,108

 

3,179

Other general and administrative

 

28,203

 

25,854

Total selling, general and administrative

$

35,645

$

33,732

Capital expenditures of the segment totaled $0.4 million and $0.7 million for the years ended December 31, 2025 and 2024, respectively.

Historical Timeline

Fiscal YearFiled
2025Mar 30, 2026Showing above
2024Mar 31, 2025

About Segments Disclosures

Segment disclosures break a company into its reportable operating units, revealing revenue, profit, and asset allocation that consolidated financial statements obscure. Under ASC 280, segments must match how the chief operating decision maker views the business, providing a window into internal management structure and resource allocation priorities.

Key signals: compare segment margins to identify which units drive profitability and which destroy value. Watch for changes in the number of reportable segments — segment aggregation or disaggregation often coincides with strategic shifts or attempts to obscure declining performance. Intersegment elimination patterns reveal internal pricing practices. The reconciliation between segment totals and consolidated figures exposes corporate overhead allocation and unallocated items. Geographic revenue concentration highlights regulatory and currency exposure. Compare segment-level capital expenditure against segment revenue to assess where management is investing for future growth versus harvesting existing assets.