Catheter Precision Inc (NYSE American: VTAK) is a medical device company that develops and sells electrophysiology and vascular access products for use in cardiac procedures. Revenue is generated through transactional product sales, primarily of the VIVO System and the LockeT suture retention device. VIVO, an FDA 510(k)-cleared and CE-marked diagnostic system that received clearance in June 2019, entered full-scale U.S. commercial launch in 2023. LockeT, a sterile Class I suture retention device registered with the FDA in February 2023 and CE Mark approved in April 2025, began initial international shipments to distributors following that approval. The company has not achieved profitability, reporting an accumulated deficit of approximately $309.5 million as of December 31, 2025. Financing activities have been the primary cash source, with net proceeds from securities transactions of approximately $4.9 million during FY2025. Leadership is concentrated around Executive Chairman and Chief Executive Officer David A. Jenkins.
VIVO System: FDA 510(k)-cleared (June 2019) and CE-marked diagnostic system for electrophysiology procedures, commercially launched in the U.S. on a full-scale basis in 2023. LockeT: sterile Class I suture retention device for vascular closure after cardiac catheterization, FDA-registered February 2023, CE Mark approved April 2025, with initial international distributor shipments beginning after CE Mark approval.
Transactional product sales of medical devices, specifically the VIVO System and LockeT device, sold to hospitals and electrophysiology clinics. Revenue depends on third-party reimbursement from private insurers and government healthcare programs. The company has not yet obtained permanent CPT reimbursement codes for VIVO from Medicare.
Hospitals and physician clinics performing electrophysiology and cardiac catheterization procedures. End market demand is tied to reimbursement availability from private insurers and government healthcare programs including Medicare. The company is building a direct U.S. sales force with clinical support representatives experienced in the electrophysiology field.
Primary commercial focus is the United States. International distribution for LockeT began following CE Mark approval in April 2025.
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