Regulatory Approval and Compliance Challenges: The company's success relies heavily on obtaining and maintaining regulatory approvals for its devices and new indications, with any delays or changes in requirements posing a significant risk to market access.

Market Adoption and Physician Acceptance Risks: Widespread adoption of Deep TMS by healthcare professionals and patient acceptance are crucial for commercial growth, facing potential resistance or slow uptake compared to alternative treatments.

Reimbursement Coverage and Pricing Pressures: Securing consistent and adequate reimbursement from insurance providers for current and future indications is vital; changes in coverage policies or pricing pressures could negatively impact sales and accessibility.