Company description
The iPill Dispenser System is aiming to revolutionize the prescription drug dispensing market especially with an urgency to prevent the opioid crisis from worsening and affecting tomorrow’s patients. Our proposal has won the FDA’s Innovation Challenge for the Opioid Use Disorder and was granted the “Breakthrough Medical Device” designation in 2019. The iPill System consists of a portable and tamper-resistant dispenser, a wearable respiratory sensor that communicate with the iPill app downloadable to patient’s phone that calls emergency services, provides personal authentication using biometric technology, cognitive behavior therapy module promoting emotional wellbeing, collects HIPAA-compliant blockchain data improving public health.
https://mega.nz/#!VkI0iCrT!xpnHh3x1jfKLIiM7uQFR0a9ow3h_s4tkWKoEODcMNVs
Team
Business model
Briefly discussed here. A full business plan is available upon request. The iPill won the 2018 Innovation Challenge for Opioid Use Disorder and our goal is to get an FDA mandate that all opioid require use of the iPill dispenser for dispensing. The SUPPORT ACT of 2018 gives the FDA legislative ability to do so. The child resistant cap was developed in 1967 and the FDA mandate came in 1970. Waiting for the mandate to be made, we will sell the value proposition to PBMs, insurers, and dentists on the cost effectiveness of the iPill to increase profits and save lives. We have premarketed the value proposition of a cost-effective solution to decrease the cost of member costs by preventing $12,000 ER visits, $28,000 hospital visits and $128,000 rehab stays. They have all indicated that they would participate in pilot step studies once the IDE was filed. Our study partners would be our first customers. We have structured manufacturing with a strategic partner so we can produce enough supply to meet demand and we have structured supply chain to avoid the opioid quota limitations.
Competitive advantage
We won the 2018 Innovation Challenge for Opioid Use Disorder. Never has a dispenser won. Our distinctive feature is as an integrated product. We have a sensor for respiration that call 911 if respiratory distress is detected. We have a cognitive behavioral therapy module that uses AI to group the most successful non-opioid interventions to distract opioid use, and we collect all the data in a blockchain tree to enter into predictive analytics for real-time population health management. We are a de novo 510K Class II which means we will be the predicate for competitors to follow. Our patented integrated product, being 1st to market and 1st in class will be able to apply for the Hatch-Waxman Act to give us 3 years of market exclusivity.
