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

铱电极吸入一氧化氮发生器治疗新生儿缺氧性呼吸衰竭

• 批准号: 10247490
• 负责人: Greg Hall
• 金额: $ 97.96万
• 依托单位: THIRD POLE, INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10247490
• 关键词: Acceleration; Address; Adoption; Adult; Air; Aircraft; Altitude; Ambulances; American; Anesthesia procedures; Anesthesiology; Authorization documentation; Award; Blood Vessels; Breathing; Cannulas; Cardiac Surgery procedures; Characteristics; Childhood; Clinical; Clinical Research; Complex; Consult; Data; Development; Devices; Effectiveness; Electricity; Electrodes; Engineering; Ensure; Focus Groups; Funding; Gases; Generations; Goals; Grant; Heart-Lung Transplantation; Helicopter; Hospitals; Howard Temin Award; Improve Access; Interview; Iridium; Life; Lung; Manuals; Masks; Medical; Medical Device; Medical center; Neonatology; Nitric Oxide; Nose; Operative Surgical Procedures; Oxygen; Pathway interactions; Patients; Peripheral; Phase; Play; Population; Privatization; Protocols documentation; Public Health; Pulmonary Hypertension; Research; Research Contracts; Respiratory Failure; Safety; Sales; Savings; Series; Small Business Innovation Research Grant; Source; System; Temperature; Testing; Time; Transportation; Validation; Vasodilator Agents; Ventilator; Visit; Weight; authority; design; implantation; inhaled nitric oxide; innovation; left ventricular assist device; neonate; off-label use; pressure; programs; prototype; respiratory hypoxia; rural area; safety study; safety testing; usability; vibration

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.

抽象的 要求资金支持商业化3P-001所需的基本步骤，这是一种医疗设备 产生空气中的医学级一氧化氮（NO）。否是治疗缺氧呼吸的肺血管扩张剂 心胸外科手术患者的新生儿（蓝色婴儿）和肺动脉高压的衰竭（HRF） （CTS）。第三极的价值提议是，无罐虹膜电极的可用性没有发电机的发电机 大大扩展使用遗传一氧化氮（INO）疗法来治疗人力资源（在美国批准） 欧盟）和CTS期间（在欧盟批准）。目的是替换N2中NO的加压罐的使用 医疗等级的来源。当前的储罐系统需要延长的设置时间和复杂的 供应链。 3P-001不坦克，只需要电力和空气才能产生医疗等级。它可以 快速，轻松地部署（插件）。该阶段IIB桥接奖申请的目的是： AIM 1：验证3P-001与常用呼吸机和其他设备一起使用。将测试3P-001 随着儿科和成人呼吸机进行监管提交的范围不断扩大。它也将被验证 与麻醉机，人造手动呼吸器，鼻插管，口罩一起使用，通过板凳测试 为了安全性和无交付的有效性。 目标2：在人力资源管理中进行临床研究以评估安全性和有效性。预计欧盟 当局将需要一项研究，以评估HRF患者的安全性和有效性，而FDA则不 目前需要在人力资源管理中进行临床研究以进行市场授权。该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。 目标3：在成人心胸手术中进行临床研究，以评估安全性和有效性。 INO经常在心脏/肺移植，瓣膜手术和左心室辅助装置期间使用 植入。预计欧盟当局将需要一项心脏手术研究。这也将解决 FDA对3P-001在心脏手术中使用的安全性的潜在关注，全球最常见的临床用途以及 还可以促进欧盟的市场采用。这项研究将在倾斜的帮助下计划和实施。 AIM 4：验证3P-001门诊设备进行运输。这对于利用优势至关重要 3P-001，用于通过土地和/或空气运输的患者运输。研究将包括对环境的3P-001进行 加速，振动，高度，温度和影响等挑战，以确认设备仍然安全 并使用由各种验证机构定义的参数函数。