The size of the potential market is large. There are 40 million surgeries in the US each year, with almost all of them receiving opioid therapy for varying lengths of time. Only ~10% of these surgical patients currently receive continuous monitoring.
The Oxalert EPO device plans to make both continuous monitoring and automatic interventions available, in both hospitalized patients and those at home for about $1,000 per patient, enormously improving the current Standard of Care.
There are 300 million prescriptions for opioids each year and 80,000 deaths by overdose each year, most of which occur at home. More persons die of opioid overdose than in auto accidents. About 15% of surgical patients remain on opioid therapy 12 months after surgery. These individuals would benefit
from the surveillance and automatic intervention the Oxalert EPO provides until opioid use is discontinued.
The Center for Medicare and Medicaid Services (CMS) announced in August 2019 that in 2020 it will begin automatic reimburse-ment for FDA-approved Breakthrough Devices. This cooperation between CMS and FDA is intended to get potentially life-saving devices to patients as quickly and easily as possible, without the usual roadblock of lengthy and expensive clinical trials to conclusively prove effectiveness for at least 24-36 months.
The founder, Dr. Lloyd Olson, has been Board-Certified in both Emergency Medicine and Anesthesiology. He has worked for several years to perfect a simple device that is covered by two awarded patents, both products of anesthesiologist-inventors. Several esteemed leaders in the specialty have provided their guidance and support.
The FDA, on the strength of the science behind the Oxalert EPO device, and a powerful Proof-of-Concept trial at Oregon Health Science University, has designated the Oxalert a Breakthrough Medical Device. The Indication for Use was originally limited to post-operative inpatients receiving opioids, but now includes patients at home.
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Med-botics, LLC hopes to prevent death or harm from respiratory depression during sleep, primarily caused from opioid-induced respiratory depression. Other respiratory conditions worsened by sleep will be targeted in future.
Bench-testing of the pre-production prototype will be under-way soon, as well as a Clinical Feasibility Trial of the Oxalert in both post-operative in-patients and patients at home. The FDA is providing special assistance in the planning of data development and is highly motivated to advance solutions to the Opioid Crisis.
The Clinical Trial is planned at a major medical center in the US under the auspices of the best possible researcher available.