v3.26.1
SEGMENT INFORMATION
 6 Months Ended
Jun. 30, 2026
SEGMENT INFORMATION  
SEGMENT INFORMATION

10.

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 operating cash burn (net change in cash, cash equivalents and restricted cash, excluding financing 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 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 condensed 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:

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Three Months Ended

  ​ ​ ​

Six Months Ended

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​

​

June 30, 

​

June 30, 

​

​

 

2026

  ​ ​ ​

2025

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2026

  ​ ​ ​

2025

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​

 

(amounts, in thousands)

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​

​

​

​

​

​

​

​

​

​

​

​

​

​

Revenue

​

$

9,633

​

$

9,617

​

$

18,497

​

$

18,344

​

Gross profit

​

$

7,049

​

$

6,814

​

$

13,179

​

$

13,021

​

Gross margin

​

 

73

%  

 

71

%  

 

71

%  

 

71

%  

Total operating expenses

​

$

9,687

​

$

10,429

​

$

18,861

​

$

20,523

​

Loss from operations

​

$

(2,638)

​

$

(3,615)

​

$

(5,682)

​

$

(7,502)

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​

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​

​

​

​

​

​

​

​

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

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​

​

 

​

​

 

  ​

​

 

  ​

​

Net income (loss)

​

$

(4,417)

​

$

1,947

​

$

(9,547)

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$

469

​

Interest expense, net

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868

​

 

616

​

 

1,726

​

 

1,221

​

Depreciation and amortization expense

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351

​

 

404

​

 

699

​

 

773

​

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

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(3,198)

​

 

2,967

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(7,122)

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2,463

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​

​

​

​

​

​

​

​

​

​

​

​

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Stock-based compensation

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368

​

 

571

​

 

912

​

 

1,391

​

(Gain) loss on foreign currency transactions

​

 

911

​

 

(6,178)

​

 

2,139

​

 

(9,192)

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Restructuring

​

 

270

​

 

—

​

 

310

​

 

—

​

Adjusted EBITDA, a non-GAAP measure

​

$

(1,648)

​

$

(2,640)

​

$

(3,761)

​

$

(5,338)

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​

​

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​

​

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​

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​

​

​

​

​

​

Adjusted net loss, a non-GAAP measure:

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​

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​

​

 

  ​

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  ​

​

Net loss

​

$

(4,417)

​

$

1,947

​

$

(9,547)

​

$

469

​

Stock-based compensation

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368

​

 

571

​

 

912

​

 

1,391

​

(Gain) loss on foreign currency transactions

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911

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(6,178)

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2,139

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(9,192)

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Restructuring

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270

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—

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310

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—

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Adjusted net loss, a non-GAAP measure

​

$

(2,868)

​

$

(3,660)

​

$

(6,186)

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$

(7,332)

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​

​

​

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​

​

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​

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​

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Operating cash burn (net change in cash, cash equivalents, and restricted cash, excluding financing activities

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$

(400)

​

$

(1,384)

​

$

(1,836)

​

$

(4,869)

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​

​

​

​

​

​

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June 30, 2026

  ​ ​ ​

December 31, 2025

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  ​ ​ ​

(amounts, in thousands)

Total assets

​

$

37,960

​

$

44,182

​

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

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  ​ ​ ​

Three Months Ended

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Six Months Ended

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​

June 30, 

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June 30, 

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2026

  ​ ​ ​

2025

  ​ ​ ​

2026

  ​ ​ ​

2025

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(amounts, in thousands)

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(amounts, in thousands)

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Research and development:

 

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  ​

 

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Clinical expenses

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$

992

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$

812

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$

1,451

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$

1,791

Other research and development expenses

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461

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450

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1,027

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1,133

Total research and development

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$

1,453

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$

1,262

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$

2,478

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$

2,924

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Selling, general and administrative

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​

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​

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​

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​

Royalty expense

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$

290

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$

286

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$

546

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$

544

Stock-based compensation

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368

​

 

429

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912

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1,056

Legal, financial and consulting

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583

​

 

1,364

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1,504

​

 

2,002

Other general and administrative

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6,723

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7,088

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13,111

​

 

13,997

Total selling, general and administrative

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$

7,964

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$

9,167

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$

16,073

​

$

17,599

​

Amounts presented within research and development expenses in the table above are inclusive of stock-based compensation expense. Refer to Note 4, “Common Stock, Stock-Based Compensation and Warrants”, for additional information.