Regulatory Approval Challenges: Delays or failure to obtain and maintain necessary regulatory approvals (e.g., FDA, CE Mark) in key markets could significantly impede commercialization and restrict market access for ProSense and future products.

Reimbursement Uncertainty: Lack of adequate reimbursement coverage and favorable coding policies from government and private payers for cryoablation procedures using ProSense could limit physician adoption and patient access, impacting revenue growth.

Market Adoption & Competition Risks: Failure to achieve widespread adoption of ProSense due to competition from existing treatment modalities (surgery, radiation, other ablation technologies) or the emergence of new, superior alternatives could constrain market penetration and sales.