# All-in-one measurement and exercise respiratory strength trainer with biofeedback and adherence tracking capability.

> **NIH NIH R41** · NOVIS PRODUCTS, LLC · 2024 · $333,810

## Abstract

Abstract
Chronic obstructive pulmonary disease (COPD) imposes a substantial burden on millions of individuals in the
United States, both in terms of health and economic costs. Individuals with COPD frequently exhibit
compromised respiratory muscle strength and endurance, significantly impacting everyday physical activities
and overall quality of life. Additionally, the pervasive challenge of non-adherence to prescribed therapies poses
a threat to clinical outcomes and carries significant economic implications. While respiratory muscle strength
training (RMT) is a rehabilitation treatment that has shown efficacy in enhancing breathing function, existing
respiratory strength training devices fall short due to a lack of essential features, among them adherence
monitoring. This lack of features not only impedes effective treatment but can also necessitate the acquisition
of multiple devices to fulfill patient clinical objectives, a circumstance that often becomes cost-prohibitive. This
Small Business Technology Transfer (STTR) proposal aims to develop the RMT Complete, a leading-edge
respiratory muscle training device and mobile application developed by Novis Products, LLC. Designed as an
all-in-one solution, the RMT Complete aims to enhance breathing function and quality of life for COPD patients.
RMT Complete distinguishes itself by combining a suite of features not available in other devices such as an
integrated manometer, a wide resistance training range, real-time visual biofeedback, and data recording
capabilities for progress and adherence monitoring. The project's foundation rests on prior work, including
customer discovery interviews, securing SEED funding from the University of Florida for prototype development,
and regulatory consultation with the FDA. The proposed Phase I of this STTR project aligns with the National
Heart, Lung, and Blood Institute's (NHLBI) focus on respiratory diseases, particularly COPD, and with the Notice
of Special Interest NOT-OD-21-00: Improving Patient Adherence to Treatment and Prevention Regimens to
Promote Health. The primary goal of this project is to assess the usability of the RMT Complete through
quantitative and qualitative data collection and analysis. Specific aims include quantifying usability, evaluating
user perception, and the implementation of device and mobile application enhancements guided by usability
data. Successful completion of Phase I will yield an optimized RMT device and application, laying the groundwork
for Phase II clinical trials, where the efficacy of the RMT Complete in respiratory muscle strength training and
adherence tracking will be rigorously tested. This project represents a crucial step toward addressing the unmet
needs of COPD patients, offering an affordable, all-in-one, and user-friendly solution to enhance respiratory
function and improve overall well-being.

## Key facts

- **NIH application ID:** 11008734
- **Project number:** 1R41HL176339-01
- **Recipient organization:** NOVIS PRODUCTS, LLC
- **Principal Investigator:** Nelson Zambrana
- **Activity code:** R41 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $333,810
- **Award type:** 1
- **Project period:** 2024-09-10 → 2026-09-09

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11008734

## Citation

> US National Institutes of Health, RePORTER application 11008734, All-in-one measurement and exercise respiratory strength trainer with biofeedback and adherence tracking capability. (1R41HL176339-01). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/11008734. Licensed CC0.

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