Clinical evaluation of an alarm activated detection system to enable early intervention of emerging respiratory decline with the linshom medical continuous predictive respiratory sensor (cprs)

The National Heart, Lung, and Blood Institute awarded Linshom Medical, Inc. $322,277 on September 10, 2025, under the Cardiovascular Diseases Research program (CFDA 93.837) to conduct clinical evaluation of an alarm-activated detection system for early intervention of emerging respiratory decline using Linshom's FDA-cleared Continuous Predictive Respiratory Sensor (CPRS).

The funding supports clinical development activities demonstrating the health economic value of the CPRS system, which continuously monitors respiratory parameters including respiratory rate, tidal volume, minute ventilation, seconds since last breath, and I:E ratio in real time. Unlike existing responsive respiratory monitoring systems that alarm when a patient reaches physiologic distress thresholds, the CPRS enables predictive detection of emerging respiratory decline, allowing healthcare providers to intervene before critical compromise occurs. The system is designed to reduce morbidity and mortality due to respiratory compromise while lowering healthcare system costs through reduced rapid response activations.

Place of performance is Baltimore, Maryland. The period of performance runs through August 31, 2027. This is a project grant, assistance type, awarded to Linshom Medical as a for-profit small business entity.

Abstract

This CRP proposal will fund clinical development activities focused on demonstrating the health economic value of linshom's continuous predictive respiratory monitoring (cprm) system. The cprm system has the potential to reduce morbidity and mortality due to respiratory compromise, while reducing health care system costs. Current devices and systems (human and machine) for respiratory monitoring are responsive by sounding a warning alarm when a patient reaches a threshold of a physiologic parameter (i.e. SPO2, ETCO2) and the patient is currently or has been in distress. Technological limitations have prevented the field from moving further in its ability to predict patient decline so that health care providers (hcps) are able to intervene and stop or correct respiratory decline. Linshom has developed a simple, inexpensive solution for continuous monitoring of respiratory functions including RR, TV, MV, i:e ratio, and apnea detection. Linshom's 510(k), FDA-cleared continuous predictive respiratory sensor (cprs) solves existing unmet needs mentioned above with a small, portable, and inexpensive sensor and monitor that tracks RR, TV, MV, seconds since last breath (sslb), and i:e ratio in real time. These parameters are crucial for monitoring of patients suffering from both acute and chronic respiratory illness. Unlike other respiratory monitoring technologies, linshom offers an operating room-quality respiratory profile at the patient bedside, which allows health care providers to promptly diagnose emerging respiratory decline and intervene with appropriate medical care. Timely intervention should reduce morbidity and mortality and result in significantly improved care for the patient and large savings for the health care system via reduction in rapid response activation and ICU transfers. Linshom's unique ability to provide TV (and thus MV) in the non-intubated patient creates a profile of patient respiratory status previously not available outside of the or or ICU (and only in intubated patients). In this CRP proposal we will generate clinical data proving linshom cprm's ability to reduce the frequency and length of respiratory depression episodes (RDE) more effectively than SOC alone in post anesthesia care units (pacu). We expect the results of this trial to demonstrate the effectiveness of the cprm system in providing measurable benefit to hospital systems by reducing the burden of respiratory distress in the pacu.