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

• 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
• 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' s Disease; Alzheimer' 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

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平台和设备来监控用户的睡眠质量并提供 旨在改善用户的“睡眠旅程”的反馈。该系统将受苦的患者联系起来 从失眠和睡眠呼吸暂停到医生和心理学家。 SleepSpace 提供工具 提供者改善这些疾病的诊断和治疗。我们请求协助 评估付款人报销情况并围绕潜力开发商业模式 报销机会，包括体动记录仪和远程患者监测代码（即 CPT 代码 99453、99454、99457 和 99484）。这些代码的使用将受到调查 用于测量睡眠的新颖硬件系统，以及通过我们集成的软件 Apple 产品，例如 iPhone、Apple Watch 和 HomePod。如果保险不予报销 使用这些代码，我们将探索向临床医生销售产品的商业模式 提高他们的实践效率并通过增加收入来增加他们的收入 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，我们将完成向 FDA 的预提交，并已 他们就我们的 SaaS 适当的监管途径提供书面反馈 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、起草提交材料以及后续问题会议 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 和 虚拟护理报销要求以及由此产生的商业模式影响。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 包含客户常见问题解答的文档，使 SleepSpace 能够 教育其团队并更快地完成交易。为了完成这项任务，我们将与 Nixon Gwilt Law 是一家专门致力于加速医疗保健创新的律师事务所。尼克松·格威尔特 是一家位于弗吉尼亚州的女性律师事务所，其一位律师向 SleepSpace 推荐了该律师事务所 Quake Capital的投资者。 Nixon Gwilt 已帮助许多类似的公司成功创建 医疗保健计费生态系统中的商业模式。 在第二阶段，我们将应用在第一阶段学到的知识来执行我们的业务模型。 我们将聘请Larta Inc来帮助完成该项目的商业化工作。拉塔公司是 经 SAM 注册且合格的小型企业实体，也是 Larta 的全资子公司 研究所，并在过去 15 年里一直与 SBIR/STTR 受资助者合作。拉尔塔将会 负责追求不同的知识产权战略，以我们的产品进入市场 产品，以及与商业伙伴的合作。知识产权战略的变化可能包括 或多或少地关注我们的硬件与软件专利组合。根据我们的调查结果 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。 或者，我们可能会更多地关注全科医生和健康教练。理想企业 合作伙伴将包括希望降低保险费的财富 500 强公司， 保险提供商、医院和生活设施。

项目成果

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

Patterns of Eating Associated with Sleep Characteristics: A Pilot Study among Individuals of Mexican Descent at the US-Mexico Border.

• DOI: 10.1080/15402002.2021.1902814
• 发表时间: 2022-03
• 期刊: Behavioral sleep medicine
• 影响因子: 3.1
• 作者: Ghani SB;Delgadillo ME;Granados K;Okuagu AC;Wills CCA;Alfonso-Miller P;Buxton OM;Patel SR;Ruiz J;Parthasarathy S;Haynes PL;Molina P;Seixas A;Jean-Louis G;Grandner MA
• 通讯作者: Grandner MA

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。

• DOI: 10.1016/j.sleh.2022.05.003
• 发表时间: 2022
• 期刊: Sleep health
• 影响因子: 4.1
• 作者: Chen,Tuo-Yu;Lee,Soomi;Buxton,OrfeuM
• 通讯作者: Buxton,OrfeuM