Business and regulatory development for Integrating sleep enhancement technology into clinical practice

将睡眠增强技术融入临床实践的业务和监管发展

基本信息

批准号：
10428404
负责人：
Daniel Gartenberg
金额：
$ 5万
依托单位：
PROACTIVE LIFE, INC.
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-05-01 至 2023-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10428404
关键词：
Acoustics Alzheimer&apos s Disease Alzheimer&apos s disease risk Apple Apple watch Big Data Biological Markers Businesses Capital Cellular Phone Charge Code Cognitive Therapy Computer software Current Procedural Terminology Codes Development Devices Diagnosis Disease Ecosystem Enhancement Technology Environment Feedback Fortune General Practitioners Healthcare Hospitals Impaired cognition Institutes Insurance Intellectual Property Internet of Things Intervention Joints Laws Legal patent Marketing Measures Modeling Monitor Nerve Degeneration Patients Phase Population Process Provider Psychologist Regulatory Pathway Risk Factors Sleep Sleep Apnea Syndromes Sleeplessness Small Business Innovation Research Grant Small Business Technology Transfer Research Symptoms System Woman actigraphy base clinical practice commercialization follow-up improved information gathering innovation meetings mild cognitive impairment multimodality novel payment remote patient monitoring tool virtual healthcare

项目摘要

SleepSpace uses a SaaS platform and device to monitor the quality of a user’s sleep and provide feedback aimed at improving a user’s “Sleep Journey.” The system connects patients who suffer from insomnia and sleep apnea to doctors and psychologists. SleepSpace provides tools to the provider to improve their diagnoses and treatment of these disorders. We request assistance with assessing the payer reimbursement landscape and developing a business model around potential reimbursement opportunities, including actigraphy and remote patient monitoring codes (i.e. CPT codes 99453, 99454, 99457, and 99484). The use of these codes will be investigated both for our novel hardware system for measuring sleep, and via our software that integrates with Apple product like the iPhone, Apple Watch, and HomePod. If insurance will not reimburse for the use of these codes, we will explore business models around selling the product to clinicians for improving the efficacy of their practice and increasing their revenue through increased charges to the patient, outside of the healthcare payment system. During Phase I of the project we will complete a pre-submission to the FDA and have written feedback from them regarding the appropriate regulatory pathway for our SaaS platform/device/accessory, including possible 510(k) approval. This phase will involve an information gathering session, drafting the submission, and a follow-up questions meeting to process the FDA’s feedback. This will be followed by attending the meeting with the FDA to review and approve their meeting minutes. We will understand the most up-to-date RPM and virtual care reimbursement requirements and the resulting business model implications. We will receive marketing materials and provided with a comprehensive RPM/virtual care FAQs document with answers to customers’ frequently asked questions, allowing SleepSpace to educate its team and close deals faster. In order to complete this task we will collaborate with Nixon Gwilt Law, a law firm who specializes in accelerating healthcare innovation. Nixon Gwilt is a woman owned law firm based in Virgina and it was recommended to SleepSpace by one its investors at Quake Capital. Nixon Gwilt has helped many similar companies successfully create a business model in the healthcare billing ecosystem. In Phase II we will apply what we learned in Phase I to executing on our business model. We will hire Larta Inc to help complete the commercialization aspect of the project. Larta Inc is a SAM-registered and qualified small business entity and a fully owned subsidiary of Larta institute and has been working with SBIR/STTR grantees for the last 15 years. Larta will be responsible for pursuing a different intellectual property strategy, entering the market with our product, and collaborating with commercial partners. Changes in IP strategy may include focusing more or less on our hardware versus software patent portfolio. Based on our findings we may enter the market going through psychologists, pulmonologists, or joint offices. Alternatively, we may focus more on general practitioners and wellness coaches. Ideal corporate partnerships would include fortune 500 companies looking to lower their insurance premiums, insurance providers, hospitals, and living facilities.

Sleepspace使用SaaS平台和设备来监视用户睡眠的质量并提供反馈旨在改善用户的“睡眠之旅”。该系统连接遭受痛苦的患者从失眠和睡眠呼吸暂停到医生和心理学家。 Sleepspace为提供者改善其对这些疾病的诊断和治疗。我们要求协助评估付款人的报销格局并开发围绕潜在的业务模型报销机会，包括行动摄影和远程患者监测代码（即 CPT代码99453、99454、99457和99484）。这些代码的使用将两者都进行调查对于我们的新型硬件系统，用于测量睡眠，以及通过与之集成的软件苹果产品等iPhone，Apple Watch和HomePod。如果保险不会报销这些代码的使用，我们将探索围绕临床医生出售产品的业务模型通过提高其实践效率并通过增加的收入来提高收入在医疗保健支付系统之外向患者收取费用。在该项目的第一阶段，我们将完成对FDA的预审查，并拥有他们的书面反馈有关我们的SaaS的适当监管途径平台/设备/配件，包括可能的510（k）批准。此阶段将涉及信息收集会议，提交提交和后续问题会议处理FDA的反馈。随后将参加与FDA的会议审查并批准他们的会议记录。我们将了解最新的RPM，并且虚拟护理报销要求和由此产生的业务模型含义。我们将收到营销材料，并提供全面的RPM/虚拟护理常见问题解答记录了对客户常见问题的答案，使Sleepspace得以实现教育其团队并更快地交易。为了完成此任务，我们将与尼克松·格威尔特·法律（Nixon Gwilt Law），一家律师事务所，专门从事加速医疗创新。尼克松·格里尔特（Nixon Gwilt）是一家妇女拥有的律师事务所，总部位于维尔京纳（Virgina） Quake Capital的投资者。尼克松·格里尔特（Nixon Gwilt）帮助许多类似公司成功创建了医疗计费生态系统中的商业模式。在第二阶段，我们将应用我们在第一阶段所学的知识来执行我们的业务模型。我们将雇用Larta Inc来帮助完成该项目的商业化方面。 Larta Inc是 SAM注册且合格的小型企业实体和Largeta的完全拥有的子公司在过去的15年中，学院一直与SBIR/STTR Grandes合作。拉尔塔会负责追求不同的知识产权策略，与我们一起进入市场产品，并与商业合作伙伴合作。 IP策略的变化可能包括或多或少地关注我们的硬件与软件专利组合。根据我们的发现我们可能会通过心理学家，肺科医生或联合办公室进入市场。另外，我们可能会更多地专注于全科医生和健康教练。理想的公司合作伙伴关系将包括希望降低保险费的财富500强公司保险提供者，医院和生活设施。

项目成果

期刊论文数量（20）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

A non-pharmacological multi-modal therapy to improve sleep and cognition and reduce mild cognitive impairment risk: Design and methodology of a randomized clinical trial.

一种改善睡眠和认知并降低轻度认知障碍风险的非药物多模式疗法：随机临床试验的设计和方法。

DOI：
10.1016/j.cct.2023.107275
发表时间：
2023
期刊：
Contemporary clinical trials
影响因子：
2.2
作者：
Emert,SarahE;Taylor,DanielJ;Gartenberg,Daniel;Schade,MargeauxM;Roberts,DanielM;Nagy,SamanthaM;Russell,Michael;Huskey,Alisa;Mueller,Melissa;Gamaldo,Alyssa;Buxton,OrfeuM
通讯作者：
Buxton,OrfeuM

Secondary analysis of a randomized trial testing community health educator interventions for diabetes prevention among refugees with depression: effects on nutrition, physical activity and sleep.

DOI：
10.1186/s12966-023-01509-y
发表时间：
2023-09-12
期刊：
INTERNATIONAL JOURNAL OF BEHAVIORAL NUTRITION AND PHYSICAL ACTIVITY
影响因子：
8.7
作者：
Wagner, Julie A.;Bermudez-Millan, Angela;Buckley, Thomas E.;Buxton, Orfeu M.;Feinn, Richard S.;Kong, Sengly;Kuoch, Theanvy;Master, Lindsay;Scully, Mary F.
通讯作者：
Scully, Mary F.

Reduced coupling between cerebrospinal fluid flow and global brain activity is linked to Alzheimer disease-related pathology.

DOI：
10.1371/journal.pbio.3001233
发表时间：
2021-06
期刊：
PLoS biology
影响因子：
9.8
作者：
Han F;Chen J;Belkin-Rosen A;Gu Y;Luo L;Buxton OM;Liu X;Alzheimer’s Disease Neuroimaging Initiative
通讯作者：
Alzheimer’s Disease Neuroimaging Initiative

Six multidimensional sleep health facets in older adults identified with factor analysis of actigraphy: Results from the Einstein Aging Study.

通过体动记录仪因子分析确定老年人的六个多维睡眠健康方面：爱因斯坦衰老研究的结果。

DOI：
10.1016/j.sleh.2023.03.002
发表时间：
2023
期刊：
Sleep health
影响因子：
4.1
作者：
Ji,Linying;Wallace,MeredithL;Master,Lindsay;Schade,MargeauxM;Shen,Yuqi;Derby,CarolA;Buxton,OrfeuM
通讯作者：
Buxton,OrfeuM

Multidimensional sleep health is associated with physical frailty in a national sample of Taiwanese community-dwelling older adults: Sex matters.

在台湾社区居住的老年人的全国样本中，多维睡眠健康与身体虚弱有关：性别很重要。