Financial StabilityCash on hand combined with interim financing alternatives are sufficient to fund operations for the next several weeks, with a more significant funding event likely following the upcoming 510(k) clearance later this year.
Potential RisksPotential risks to the company's price target include regulatory setbacks, delays in commercialization, reimbursement headwinds, and unforeseen competitive threats.
Regulatory ChallengesIn November 2025, the company received a Not Substantially Equivalent (NSE) decision from the FDA for the 510(k) application.