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

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.