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将3P-001商业化所需的基本步骤，3P-001是一种医疗设备， 从空气中产生医用级一氧化氮(NO)。一氧化氮是一种肺血管扩张剂，用于治疗缺氧性呼吸 新生儿(青色婴儿)衰竭(HRF)和心胸手术患者的肺动脉高压 (Cts)。第三极的价值主张是，没有发电机可以提供一种没有坦克的Ir电极 极大地推广使用吸入一氧化氮(INO)疗法治疗HRF(在美国和 欧盟)和CTS期间(欧盟批准)。目标是取代使用氮气中NO的加压罐作为 医用等级号的来源。目前的坦克系统需要较长的安装时间和复杂的 供应链。3P-001是无坦克的，只需要电力和空气就可以产生医用级NO。它可以 快速轻松部署(即插即用)。这项IIB期衔接奖申请的目的是： 目标1：验证3P-001与常用呼吸机和其他设备的配合使用。将测试3P-001 提交给监管机构的儿科和成人呼吸机的名单不断扩大。它还将被验证为 与麻醉机、人工手动呼吸装置、鼻插管、口罩一起使用，通过台架测试 为了安全和有效的不交付。 目的2：开展高频射频治疗的临床研究，评价其安全性和有效性。预计欧盟 当局将要求进行一项评估HRF患者安全性和有效性的研究，而FDA不要求 目前需要在HRF进行临床研究以获得市场授权。这项研究还将促进市场采用。 这项研究将在合同研究组织(CRO)的帮助下计划和实施。 目的3：开展成人心胸外科手术的临床研究，评价其安全性和有效性。 INO常用于心/肺移植、瓣膜手术和左心辅助装置 植入。预计欧盟当局将要求进行心脏手术研究。这也将解决 FDA可能对3P-001在心脏手术中使用的安全性感到担忧，3P-001是全球最常见的临床使用方法，以及 还促进了欧盟的市场采用。这项研究将在科林的帮助下计划和实施。 目的4：验证3P-001移动式运输装置的有效性。这对于利用的优势至关重要 3P-001，用于陆运和/或空运病人。研究将包括对3P-001进行环境测试 诸如加速度、振动、高度、温度和冲击等挑战，以确保设备保持安全 并且使用由各种验证机构定义的参数来实现预期的功能。

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.