Bresotec Medical (“Bresotec” or the “Company”), a medical device company that develops, manufactures, and markets non-invasive portable diagnostic devices for accurate at-home diagnosis of sleep apnea, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for BresoDX1, its initial product for at-home sleep apnea testing.

BresoDX1 is indicated for use to aid in the diagnosis of moderate to severe sleep apnea in adults in an at-home setting. With only two diagnostic inputs, BresoDX1 records a patient’s physiological signals during sleep, scores apneas and hypopneas, and can be easily and comfortably administered by the patient in a home setting without clinical assistance. Once data is uploaded to the BresoDX1 software, BresoDX1 offers clinicians a reliable, turnkey diagnostic tool with fully transparent reporting.

Polysomnography (PSG) continues to be viewed as the industry standard for sleep apnea diagnosis, but the need for overnight stays in a sleep lab has been insufficient, due to cost and lack of accessibility, to substantially reduce the undiagnosed sleep apnea rate in the United States, with an estimated 80% of sufferers going without diagnosis or treatment. “Over the past several years, the market has experienced a significant shift from in-lab PSG testing to at-home testing,” said Peter Bloch, Chief Executive Officer of Bresotec Medical. “While legacy at-home tests have lowered barriers for patient use, few offer the reliability, ease-of-use, and accuracy of BresoDX1.”

Bresotec Medical founder and Chief Medical Officer, Dr. Douglas Bradley, MD, FRCP, FCAHS, stated that, “Through the collection of tracheal breath sounds and motion, Bresotec’s proprietary technology utilizes respiratory airflow as its primary means of measurement. This unique approach, coupled with strong clinical validation, leaves BresoDX1 uniquely positioned to address the growing, but under-served opportunity in at-home sleep apnea diagnosis.”

With BresoDX1, patients place a sensor on the neck over the trachea (windpipe) and wear a pulse oximeter sensor on the finger. Combined, these inputs record the patient’s tracheal breathing sounds and movements, neck and body position, oxygen saturation (SpO₂), and heart rate during sleep. During the test, the data are transmitted wirelessly to a small hub for preprocessing and storing. The data are uploaded from the hub to the cloud where they are analyzed by the BresoDX1 software which generates a comprehensive sleep report showing airflow, respiratory movements, the frequency of apneas and hypopneas and dips in SpO₂, body position, and heart rate. The sleep reports are presented in a fully transparent, familiar manner, offering physicians the ability to review, interpret and, if necessary, adjust automated scoring. Bresotec anticipates that reimbursement will be made available through existing CPT code pathways.

Bresotec plans to initiate a controlled, limited launch in the first quarter of 2023 with a full commercial launch set to commence in the third quarter. The company plans to market BresoDX1 through its internal commercial salesforce and will initially target sleep physicians and sleep centers throughout the United States.