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Wearable, Graphene-based Flexible Sensors for Chronic Monitoring of Venous Thromboembolism for High-Risk Patients

Award Number: R61HL154215
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/20/2020
PERIOD OF PERFORMANCE END DATE: 07/31/2022

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Wearable, Graphene-based Flexible Sensors for Chronic Monitoring of Venous Thromboembolism for High-Risk Patients - This R61/R33 project will move a novel laser-printed wearable sensor technology from laboratory toward commercialization with a first clinical application of improving monitoring options for high-risk Deep Vein Thrombosis (DVT). This proposal is in response to RFA-HL-20-024 Catalyze: Product Definition. The project is a collaboration between Actuated Medical Inc (AMI), the Huanyu Larry Cheng lab at The Pennsylvania State University (PSU), and Hershey Medical Center (HMC). AMI is ISO 13485 certified, FDA-Registered, and FDA GCP & GMP compliant. The sensors developed here will be manufactured in AMI’s Bellefonte, PA facility. Project Approach: The Cheng Lab (PSU) has developed a flexible sensor platform that is low-cost, does not require expensive equipment to manufacture, and can be worn directly on the skin or integrated into clothing. These sensors can be configured to measure temperature, strain, skin hydration, electrophysiologic, and other signals. This sensor set is built upon Dr. Cheng’s doctoral work creating stretchable sensors for health monitoring, antennas for near-field communication, and human-machine interfaces. Initial Clinical Goal: DVT is a condition in which blood clots form deep within peripheral veins, typically in the lower extremities. This disease can cause leg swelling and pain, but more importantly, the clots risk dislodgement and relocation in the lungs (pulmonary embolism), coronary arteries, or brain (stroke), possibly leading to death. Though many treatments exist to mitigate risk, such as anticoagulants, there are few options for chronic monitoring. This project develops a wearable, wireless approach for monitoring at-risk patients for DVT formation. Hypothesis. A graphene-based thermal sensor compression band can successfully monitor occlusion or DVT formation through subtle macrovascular and microvascular thermal effects on the skin. Specific Aims. Aim 1 – Demonstrate Sensor Fabrication in Form Factor for Blood Flow Monitoring. Milestones/Acceptance Criteria: Thermal sensors demonstrate temperature resolution of ≤ 0.04ºC and accurately detect flow or no flow status in capillary tubes in vitro. Flexible RF antennas exhibit sufficient bandwidth to accommodate temperature- dependent frequency modulation corresponding of ≥ 0.25ºC. Aim 2 – Transition to Manufacturing and Higher Volume Processing. Milestones/Acceptance Criteria: RF bandwidth and resolution of temperature- dependent frequency shift of manufacturing-level sensor antenna transmits < 0.04ºC sensor measurements for at least 8/10 devices, and 5 day repeatability of measurements shows no statistically significant differences (robustness/repeatability). Aim 3 – Preclinical Peripheral Thrombosis Study. Milestones/Acceptance Criteria: Demonstrate controlled process sensor and device design/layout that successfully detects 50% and 100% occlusions of leg vein (N=4 for each blockage) in acute preclinical study. Aim 4 (R33) – Transition to Design Freeze. Milestones/Acceptance Criteria: Sensors reaches Design Freeze controls critical for moving through Regulatory approval. Demonstrate wireless communication with >95% of sensors.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2021	ACTUATED MEDICAL, INC.	320 ROLLING RIDGE DR	BELLEFONTE	PA	16823	CENTRE	USA	Blood Diseases and Resources Research	000	2	10/12/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	ACTUATED MEDICAL, INC.	310 ROLLING RIDGE DR	BELLEFONTE	PA	16823	CENTRE	USA	Blood Diseases and Resources Research	001	2	9/2/2022	NON-COMPETING CONTINUATION	$0
2022	2021	ACTUATED MEDICAL, INC.	310 ROLLING RIDGE DR	BELLEFONTE	PA	16823	CENTRE	USA	Blood Diseases and Resources Research	000	2	3/26/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $395,382 )
2021	2021	ACTUATED MEDICAL, INC.	310 ROLLING RIDGE DR	BELLEFONTE	PA	16823	CENTRE	USA	Blood Diseases and Resources Research	000	2	8/4/2021	NON-COMPETING CONTINUATION	$395,382
														Subtotal = $395,382

Issue Date FY: 2020 ( Subtotal = $391,513 )
2020	2020	ACTUATED MEDICAL, INC.	310 ROLLING RIDGE DR	BELLEFONTE	PA	16823	CENTRE	USA	Blood Diseases and Resources Research	000	1	8/20/2020	NEW	$391,513
														Subtotal = $391,513

Grand Total All Awards = $786,895

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Wearable, Graphene-based Flexible Sensors for Chronic Monitoring of Venous Thromboembolism for High-Risk Patients

Award Number: R61HL154215

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/20/2020

PERIOD OF PERFORMANCE END DATE: 07/31/2022

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