AVERY BIOMEDICAL DEVICES, INC.

Avery Biomedical Devices manufactures the Avery Diaphragm Pacing System, a fully implantable phrenic nerve stimulator designed to provide vent-free breathing for patients with chronic respiratory muscle paralysis or central alveolar hypoventilation. The system consists of surgically implanted receivers and electrodes that respond to radio frequency signals from an external transmitter and antennas, stimulating the diaphragm to contract and enable natural breathing. Indications include high spinal cord injury, congenital and acquired central sleep apnea, and diaphragm paralysis from various etiologies. The device features dual redundant design ensuring no single-point failure, platinum electrodes, and dual alarm systems. The company holds FDA PMA approval for adult and pediatric use and CE marking privileges for EU markets. Key benefits include improved quality of life with greater mobility, reduced infection and hospitalization risk, lower annual operating costs (estimated $20,000+ savings versus mechanical ventilation), minimal ongoing wound care, and compatibility with water therapy. Technical support is provided at no additional cost. Reimbursement is available through Medicare and most private and government insurance plans. Avery has maintained an unsurpassed safety and reliability record spanning over 50 years of clinical use. The system is indicated for patients whose remaining phrenic nerve, lung, and diaphragm function is sufficient to accommodate electrical stimulation.