Red Flags Detected

• ⚠ Going Concern (new) — The company's auditor and management have expressed substantial doubt about its ability to continue as a going concern due to recurring losses and negative cash flows.
• ⚠ Material Weakness (new) — The company has identified a material weakness in its internal control over financial reporting, which could lead to material misstatements.
• ⚠ Form 483 (new) — The company received an FDA Form 483 in March 2026 for late medical device reports, indicating a regulatory compliance issue.
• ⚠ Single Product Dependence (new) — All of the company's revenue is derived from a single product, the Vivistim System, making it highly vulnerable to any issues with that product.
• ⚠ Single-source Suppliers (new) — The company relies on single-source suppliers for critical components of the Vivistim System, posing significant supply chain risk.
• ⚠ Convertible Notes Dilution (new) — The company issued $40 million in convertible notes that will convert at a discount to the IPO price, potentially causing significant dilution to new investors.