Iridium-electrode inhaled Nitric Oxide generator for treatment of hypoxic respiratory failure in neonates

摘要 要求提供资金以支持3 P-001商业化所需的基本步骤，3 P-001是一种医疗器械， 从空气中产生医用级一氧化氮（NO）。NO是一种肺血管扩张剂， 新生儿（蓝色婴儿）的HRF和心胸手术患者的肺动脉高压 （CTS）。Third Pole的价值主张是，无油箱铱电极NO发生器的可用性将 极大地扩展了吸入一氧化氮（iNO）疗法治疗HRF的使用（在美国和 欧盟）和CTS期间（欧盟批准）。目标是取代使用N2中的NO加压罐， 目前的罐系统需要延长的设置时间和复杂的 供应链3 P-001是无罐，只需要电力和空气生产医疗级NO。它可以 快速轻松地部署（即插即用）。此IIB期衔接奖申请的目的是： 目的1：与常用的呼吸机和其他器械一起使用的呼吸机3 P-001。将对3 P-001进行测试 并有越来越多的儿科和成人呼吸机可供监管部门提交。它也将被验证为 与麻醉机、人工手动呼吸装置、鼻插管、面罩配合使用，通过台架测试 NO输送的安全性和有效性。 目的2：在HRF中进行临床研究，以评价安全性和有效性。预计欧盟 当局将要求进行一项研究，评估HRF患者的安全性和有效性，而FDA不要求 目前需要在HRF进行临床研究以获得上市许可。该研究还将促进市场采用。 本研究将在合同研究组织（CRO）InClin的帮助下计划和实施。 目的3：在成人心胸手术中进行临床研究，以评价安全性和有效性。 iNO经常用于心/肺移植、瓣膜手术和左心室辅助装置 置入预计欧盟当局将要求进行心脏手术研究。这也将解决 FDA对3 P-001用于心脏手术（全球最常见的临床用途）的安全性的潜在担忧，以及 同时也促进了欧盟市场的采用。本研究将在InClin的帮助下计划和实施。 目的4：将3 P-001便携式器械用于运输。这对于利用 3 P-001用于陆路和/或空中运送患者。研究将包括对3 P-001进行环境试验 挑战，如加速度，振动，海拔，温度和影响，以确认设备仍然安全 并且使用由各种验证机构定义的参数来按预期运行。

ABSTRACT Funding is requested to support essential steps required to commercialize 3P-001, a medical device that generates medical grade nitric oxide (NO) from air. NO is a pulmonary vasodilator to treat hypoxic respiratory failure (HRF) in neonates (blue babies) and pulmonary hypertension in patients having cardiothoracic surgery (CTS). Third Pole’s value proposition is that availability of a tank-less iridium-electrode NO generator will greatly expand the use of inhaled nitric oxide (iNO) therapy to treat HRF (approved in both the USA and EU) and during CTS (approved in the EU). The goal is to replace use of pressurized tanks of NO in N2 as the source of medical grade NO. The current tank system requires prolonged set-up times and a complicated supply chain. 3P-001 is tank-less, requiring only electricity and air to produce medical grade NO. It can be deployed quickly and easily (plug and play). The aims of this Phase IIB Bridging Award Application are: Aim 1: Validate 3P-001 for use with commonly-used ventilators and other devices. 3P-001 will be tested with an expanding list of pediatric and adult ventilators for regulatory submission. It will also be validated for use with anesthesia machines, artificial manual breathing units, nasal cannulas, masks, through bench testing for safety and effectiveness of NO delivery. Aim 2: Perform a clinical study in HRF to evaluate safety and effectiveness. It is anticipated that the EU authorities will require a study evaluating safety and effectiveness in patients with HRF, while FDA does not currently require a clinical study in HRF for market authorization. The study will also promote market adoption. This study will be planned and implemented with the help of InClin, a contract research organization (CRO). Aim 3: Perform a clinical study in adult cardiothoracic surgery to evaluate safety and effectiveness. iNO is frequently used during heart/lung transplantation, valve surgery and left ventricular assist device implantation. It is anticipated that the EU authorities will require a cardiac surgery study. This will also address potential FDA concern about safety of 3P-001 use in cardiac surgery, the most common clinical use worldwide, and also promote market adoption in the EU. This study will be planned and implemented with the help of InClin. Aim 4: Validate the 3P-001 ambulatory device for transportation. This is vital to exploit the advantages of 3P-001 for patient transport by land and/or air. Studies will include subjecting 3P-001 to environmental challenges such as acceleration, vibration, altitude, temperature and impact to confirm that the device remains safe and functions as intended using parameters defined by a variety of validating agencies.