v3.25.1
Segment information
 3 Months Ended
Mar. 31, 2025
Segment Reporting [Abstract]  
Segment information

Note 15 - Segment information

 

An operating segment is defined as a component of an entity for which discrete financial information is available that is regularly reviewed by the Chief Operating Decision Maker (“CODM”) in deciding how to allocate resources to an individual segment and in assessing performance. The Company’s Chief Executive Officer is the CODM. The CODM reviews financial information on a consolidated basis for purposes of making operating decisions, allocating resources, and evaluating financial performance. The Company is currently in the pre-revenue development stage and its primary activity is the development of its leadless cardiac pacing system, WiSE CRT. Thus, the total Company’s consolidated results represent only the results of the WiSE CRT Segment. The Company currently conducts its operations primarily in the U.S. Operations in countries outside of the U.S. are limited to Australia and Europe and are not significant. Business activity conducted in the U.S and in our international locations are similar in nature and economic characteristics and are consolidated for reporting purposes. As such, management has determined that the Company operates as one operating and reportable segment that is currently focused exclusively on the advancement of the Company’s WiSE CRT System.

 

The Company’s operating expenses and net loss are the primary measures of the segment’s performance used by the Company’s CODM. The segment is in the pre-revenue operating stage, and therefore the CODM primarily focuses on research and development expenses, general and administrative expenses, and the net loss as the primary measure of the segment’s performance used by the Company’s CODM. In addition to the segment’s expenses that are presented on the consolidated statement of operations, the information about the segment’s expenses is disaggregated into significant expenses, which are not separately presented on the Company’s consolidated statement of operations, as included below.

 

The table below reports information about the segment loss for the three months ended March 31, 2025 and 2024.

          
   Three Months Ended March 31, 
   2025   2024 
Research and development expenses          
Personnel-related expenses  $4,182,905   $3,860,827 
Clinical expenses   392,604    291,658 
Quality assurance and regulatory approval expense   86,755    60,967 
Contract manufacturing, materials and components   730,619    1,731,338 
Facility-related and other expenses   25,799    456,489 
Total research and development expenses   5,418,682    6,401,279 
General and administrative expenses          
Personnel-related expenses   2,299,835    1,080,022 
Professional services expenses   1,084,399    502,235 
Corporate expense   578,093    513,233 
Facility-related and other expenses   400,677    77,625 
Total general and administrative expense   4,363,004    2,173,115 
Loss from operations   (9,781,686)   (8,574,394)
Other (expense) income          
Interest expense   (1,397,076)   (1,503,697)
Interest income   633,093    919,984 
Other Income, net (a)   (8,602)   8,104 
Total other (expense), net   (772,585)   (575,609)
Income tax (expense)   -    - 
Consolidated net loss  $(10,554,271)  $(9,150,003)

 

(a)Other Income (Expense) includes gain/ (loss) on foreign currency, and reimbursements of clinical trial expenses.