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

> **NIH NIH R44** · PROACTIVE LIFE, INC. · 2022 · $50,000

## Abstract

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 mark...

## Key facts

- **NIH application ID:** 10428404
- **Project number:** 3R44AG056250-04S1
- **Recipient organization:** PROACTIVE LIFE, INC.
- **Principal Investigator:** Daniel Gartenberg
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $50,000
- **Award type:** 3
- **Project period:** 2017-05-01 → 2023-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10428404

## Citation

> US National Institutes of Health, RePORTER application 10428404, Business and regulatory development for Integrating sleep enhancement technology into clinical practice (3R44AG056250-04S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10428404. Licensed CC0.

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