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: 9752063
• 负责人: Philip E Silkoff
• 金额: $ 99.95万
• 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 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9752063
• 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; Hypoxia; 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; 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 要求资金支持通用3P-001的基本步骤，这是一种医疗设备 从空气中产生医学级一氧化氮（NO）。 心脏手术患者的新生儿（蓝色婴儿）和肺动脉高压衰竭（HRF） （CTS）。 大大扩展使用吸入一氧化氮（INO）疗法来治疗HRF（在美国批准 欧盟）和CTS（在欧盟批准）。 医疗等级编号的来源当前的水箱系统需要延长设置时间和复杂的设置时间 Suppry链3P-001无坦克，只需要电力和空气来产生医疗等级。 快速，轻松地部署（插件）。 AIM 1：使用常用的呼吸机和其他设备验证3P-001。 随着儿科和成人呼吸机的不断扩展，以进行监管提交。 与麻醉机，人造手动擦洗单元，鼻插管，口罩，Throuth卧推测试 为了安全性和无交付的有效性。 AIM 2：人力资源管理方面的性研究评估安全性和有效性。 当局将需要一项研究，以评估HRF患者的毛茸茸和有效性，而FDA则不 目前需要在人力资源管理中进行临床研究，以促进市场的采用。 这项研究与她的帮助，并在她的帮助下，合同研究组织（CRO）的帮助。 AIM 3：成人心胸外科手术的表演研究，以评估安全性和有效性。 INO在心脏/肺透明度，瓣膜手术和左心室辅助装置期间经常使用INO 植入。 FDA对3P-001在心脏手术中使用的安全性的潜在关注，这是全球最常见的临床用途，并且 还可以在欧盟促进欧盟的市场采用。 目标4：验证3P-001的运输设备。 3P-001用于土地和 /或空气的患者运输。 诸如电线，振动，高度，温度和影响诸如确认设备的挑战仍然安全 并使用由各种验证机构定义的参数函数。