v3.26.1
Segment information
 6 Months Ended
Jun. 30, 2026
Segment Reporting [Abstract]  
Segment information

Note 15 - Segment information

 

The Company's chief operating decision maker (“CODM”) is the Chief Executive Officer. The Company has determined that it has a single operating and reportable segment. The CODM uses net sales, gross margin and operating expenses at the consolidated level to allocate resources, monitor budget versus actual results, and manage operations. Significant expenses within operating expenses include engineering and development, clinical and regulatory, sales and marketing, and general and administrative expenses at the consolidated level.

 

Substantially all of the segment net sales are derived from sales to customers in the U.S. Net sales by geography is based on billing address of the customer. International net sales accounted for less than 1% of the total net sales during the three and six months ended June 30, 2026. Long-lived assets held outside the U.S. are immaterial. 

 

The following table summarizes the Company's net sales by geography for the three and six months ended June 30, 2026 and 2025 (in thousands):

                    
   Three Months Ended   Six Months Ended 
   June 30,   June 30, 
   2026   2025   2026   2025 
United States  $2,637   $150   $4,996   $150 
International   -    20    3    20 
Net sales  $2,637   $170   $4,999   $170 

 

The following table disaggregates amounts that comprise research and development, and selling, general and administrative expenses within the accompanying unaudited condensed consolidated statements of operations for the three and six months ended June 30, 2026 and 2025 (in thousands):

                    
  Three Months Ended   Six Months Ended 
   June 30,   June 30, 
   2026   2025   2026   2025 
Engineering and development  $4,096   $3,438   $8,085   $6,695 
Clinical and regulatory   2,524    2,513    4,952    4,675 
Total research and development  $6,620   $5,951   $13,037   $11,370 
                     
Sales and marketing  $6,255   $2,428   $12,403   $3,917 
General and administrative   3,865    2,837    7,656    5,711 
Total selling, general and administrative  $10,120   $5,265   $20,059   $9,628 

 

The segment's net loss equals the Company’s net loss as presented in the unaudited condensed consolidated statements of operations. Other segment items within net loss include interest expense, interest income, and loss on foreign currency at the consolidated level.