Sparo Labs的肺功能监测产品Wing获得FDA直接上市许可
2016/7/3 0:29:06FDA 世界医疗科技资讯

    

     Wing是一款连接app的肺活量监测设备，是由密苏里州圣路易斯的Sparo Labs公司研发的。日前该设备已经获得FDA的认可，认定其是非处方设备，这意味着产品可以直接上市给消费者使用，不过公司表示，服务商和药店渠道也同样还重要。

     Sparo的宗旨是通过Wing这个口袋传感器及对应的追踪肺功能的App来帮助人们管理哮喘和其它呼吸系统疾病，如COPD、囊性纤维化等。

     设备的工作原理是通过连接智能手机的传感器来测量一秒内最快呼吸速度和最大呼出容量。测量结果会显示到智能手机上，通过条带显示绿色、黄色和红色来作为那一时刻肺功能的显示。取代等到哮喘发作用药，患者将通过设备了解将要发作的情况。

     公司的想法是通过手机足够的日常信息来了解当肺功能降低时，患者能够进行对应的用药措施或改变环境(如限制外出时间)来预防哮喘发作。

     哮喘的发作是复杂的，使用手机作为监测平台的好处是可以获得位置等多元的信息。这样就能很好的了解是哪种原因触发了哮喘，从而预防哮喘的发生。

     到目前为止，公司共融资220万美元，他们获得的大部分投资是学术型资金。未来几个月，Cohen和Brimer将推出商用Wing供患者使用，同时寻求潜在的药店和服务商等合作伙伴。

     原文链为接：http://mobihealthnews.com/content/sparo-labs-gets-fda-nod-its-app-connected-lung-function-monitor-wing

     原文阅读

     Sparo Labs gets FDA nod for its app-connected lung function monitor, Wing

     By Heather Mack

     June 30, 2016

     Wing, an app-connected spirometer from St. Louis, Missouri-based Sparo Labs, is ready to take flight. The FDA recently cleared the device with an over-the-counter clearance, meaning the company can market it directly to consumers, but Sparo sees provider and pharma channels as important ones too.

     With Wing, Sparo aims to help people manage asthma and other respiratory conditions, such as COPD and cystic fibrosis, with a pocket-size sensor and corresponding app to track lung function.

     The device works by hooking the sensor up to a smartphone, then measuring the fastest speed and maximum volume a person can exhale in one second (forced exhalation and peak flow volume). The results are displayed on the smartphone screen with a “stoplight zone” system, giving a green, yellow or red indicator and an explanation of how the lungs are faring in that moment. Rather than waiting until an asthma attack to adjust medication or avoid particular triggers, patients will ideally learn how to anticipate an attack before it happens.

     “Today, most patients just have to wait until they literally cannot breathe,” said Abigail Cohen, who is co-founder of Sparo with fellow Washington University alum Andrew Brimer. “They’re reacting to that, grabbing their rescue medication, taking some of that, hoping it works and going to the emergency room if it doesn’t.”

     The idea is, by gathering enough daily information on when lungs are declining, patients can act accordingly with medication or environmental adjustments (for instance, limiting time outdoors during peak allergy season) to prevent asthma attacks.

     “One of the benefits of using a smartphone as a platform is you get metadata, like location, to provide more information and value to the user,” said Cohen. “Asthma is a complex condition that affects everyone a little differently. For some, a trigger may be humidity and heat, for others, it may be exercise and cold air. So people able to track your lung function and symptoms over time and pull in environmental factors, you can start correlating those things and adjusting the NIH-recommended asthma action plan from there.”

     Patients are the primary Wing target audience for the next few months, as Sparo currently has no formal partnerships with healthcare providers or pharmaceutical companies.

     The pair began working on the device while they were still undergraduate engineering students, initially finding a focus on asthma through the program Engineers Without Borders. About one in 10 people in the US has asthma, but Cohen and Brimer learned there was a dearth of tools available for patients to manage their disease on a daily basis.

     “For us, it really started with focusing on the person who had asthma themselves and seeing what they needed,” said Brimer. “How can we make the patient’s life easier and give them the data and the tools they need to better care for their asthma, rather than just providing a tool for a doctor to help diagnose or monitor that?”

     When they sought FDA clearance, Sparo compiled over 1,200 pages of research and documentation related to the design and testing of Wing. This diligence included full performance testing, biocompatibility testing, electrical safety testing, electromagnetic compatibility testing, software verification testing, and mechanical aging testing, among product documentation.

     Wing isn’t necessarily just for people with respiratory conditions. Athletes or even people who play wind instruments could use it to monitor their lung health. Marketing Wing solely as a fitness device could have spared Sparo the intensity of the FDA process, but they decided they wanted to build a tool that could be used for medical purposes by providing actionable data that would lead to better care long-term.

     “We didn’t want to be something that people just wondered whether or not it would come to fruition, but rather, something on the medical side that could become a necessity,” said Brimer.

     Today, their total funding caps at around $2.2 million, and most of their funding over the years has come from academic-style financing. While participating in a program called Engineers Without Borders, Cohen and Brimer secured funding from grant competitions such as Arch Grants, a seed round from angel investors, and a $50,000 Indiegogo campaign. Last year the startup presented Wing at a White House Demo Day.

     Over the next few months, Cohen and Brimer will commercially launch Wing for patients as they look for potential pharma and provider partners.

     “The biggest thing we want in the communication of data is making sure that it’s used,” said Cohen. “The big step is figuring out how it works into a physician’s current workflow and seeing how it can fit into their process.”

     Many of the companies attacking the asthma and COPD spaces are using connected inhalers, rather than connected spirometers, though some companies, such as Cohero, offer both. A polish company, HealthUp, received $1.1 million in funding last year for its MySpiroo platform.

    

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