From a bench prototype to FDA clearance and market launch — with an experienced commercialization team already in place.
Based on functional bench testing and visual inspection, our end-emitting lithotripsy catheter crossed both gypsum models and calcified human artery specimens.
Currently refining the prototype, with human artery specimen testing and ongoing development of the console/generator. Additional sizes for above and below the knee applications are planned.
Design verification and validation, preclinical testing and supporting data, followed by preparation and submission to the FDA.
Following clearance, launch in outpatient settings first, then expand to hospitals and health systems.
Strategic work on patents — provisional and applied. Multiple patent applications have been filed for a forward-facing IVL catheter for lesion crossing, and we continue to optimize our IP with our attorneys and engineering team.
Commercialization leadership team is already in place. Revenue ramp focus is on capturing the growing peripheral CTO/IVL market, specifically in Office-Based Labs (OBLs) and Ambulatory Surgery Centers (ASCs) — then hospitals and health systems.
Commercialize to profitability, disruption, and exit options.
*FirstPass™ is currently under development and is not FDA cleared. It is not available for sale. Timelines and plans are subject to change and to regulatory review.
For More Information — we’d be glad to talk.