Risk Factors Update Summary

• Added risks related to the warning letter received from the FDA and the distribution pause of TabloCart with Prefiltration. This could result in regulatory actions, fines, and disruptions to business operations.
• FDA clearance delays may disrupt business and growth if not obtained timely.
• Increased focus on the risks associated with the home hemodialysis market, including challenges due to a nationwide shortage of nurses and clinical personnel. This poses challenges for dialysis centers and may impact revenue.
• Reimbursement rate increase from $257.90 to $271.57 could positively impact revenues.
• Transition to in-house production of Tablo cartridges in Mexico to reduce costs and improve supply chain continuity. This change aims to achieve cost reductions through lower freight costs.
• Failure to address FDA observations could lead to adverse events and impact reputation.
• Disclosure of reliance on third-party suppliers and contract manufacturers for the production of Tablo cartridges, highlighting vulnerability to supply problems and price fluctuations.
• New cybersecurity guidance may increase time and cost for product development and approval.
• Introduction of a pilot clinical and administrative services program, with potential risks of not meeting objectives, generating sufficient returns, or incurring unanticipated costs.
• Changes in healthcare marketplace innovations may impact ESRD patient population growth.
• Disclosure of the company's reliance on contract manufacturing partners in Mexico and Southeast Asia for the production of Tablo cartridges, with potential disruptions leading to delays in operations.
• Ownership increased from 52% to 59% of outstanding shares by executive officers and directors.
• Risks related to competitors, including the formation of a new independent company focused on kidney care, which could introduce additional competition in the market.
• Restructuring completed in Q4 2023 may affect employee retention and operational efficiency.