Market Competition: Intense competition from other medical device companies in their target markets could lead to reduced market share, pricing pressures, and erosion of profitability.

Regulatory Compliance and Approvals: Strict and evolving global healthcare regulations, including FDA and CE Mark requirements, pose risks of delayed product approvals, product recalls, and compliance enforcement actions.

Supply Chain Disruptions: Reliance on third-party suppliers for critical components and raw materials exposes the company to risks from supplier failures, natural disasters, geopolitical events, or other disruptions impacting production and delivery.