Portable electrical nitric oxide generator for treatment of pulmonary hypertension accompanying interstitial lung disease

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ABSTRACT Medical Need: Patients with pulmonary hypertension accompanying interstitial lung disease (PH-ILD) are markedly limited in their exercise capacity and quality of life and have a severely reduced lifespan (2-5 years) unless they can receive a lung transplant - but organs are in short supply. Treatment involving inhalation of the selective pulmonary vasodilator nitric oxide could treat such patients but, unfortunately, NO is currently provided from large, cumbersome, pressurized gas cylinders, restricting access to this life saving therapy to major medical centers. Proposed Solution: Third Pole’s value proposition is provision of a lightweight, compact, battery-powered portable, tank-less electrical NO generator (3P-100) to open up the possibility of treating PH in ambulatory settings by providing an essentially unlimited supply of iNO sourced from electricity and air enabling global access including resource-poor areas. The core technology for generating NO from air at therapeutic concentrations has been developed. The 3P-100 device will deliver pulses of NO into the nasal passages timed with early inspiration to optimize oxygenation. Specific Aims: Funding is requested to support 1) miniaturization and 2) creation of a connected healthcare solution of 3P-100, critical elements needed for ease of use by the patient and to attract potential investors. Aim 1: Minimize size and weight of the portable 3P-100: User research concluded that the 3P-100 device prototype, comprised of off-the-shelf components, with volume of 160 in, weight of 3.5 lbs., 3 hours of battery life, and limited carrying accessories is unacceptable for 24 hour home use, as users perceived it to be physically challenging, cumbersome, and limiting their mobility. Reducing volume to a maximum of 75 in and weight to maximum of 2 lbs., increasing battery life to a minimum of 4 hours, preferably to 8 hours, and offering a diverse range of accessories including an AC/DC power adapter with which to keep the device powered when plugged in at home or office will enable users to remain independent with activities of daily living and facilitate excursions outside of the home without concerns of running out of battery charge. Aim 2: Develop a platform for clinical and research informatics: This aim will enable iNO usage patterns from the 3P-100 device combined with patient-related data to be collected by commercially available wearable products, including physical activity, Oxygen saturation, heart rate and respiratory rate to be uploaded into a Third Pole cloud based repository. This will allow clinicians, clinical trial staff, and Third Pole to remotely and proactively manage the disease, monitor patient’s adherence to iNO therapy, oxygen usage, and analyze safety and efficacy measures as well as 3P-100 device performance during the PH-ILD clinical study. Third Pole will design sufficient hardware “digital backbone” elements into the 3P-100 device to allow wireless communication, with the required application software needed to manage the data and transfer it into the central- ized cloud-based repository.