This Project Grant award from the National Institute on Aging (CFDA 93.866 - Aging Research) supports the development of an ultrasound-coupled electrical impedance tomography (US-EIT) device for assessing sarcopenia, a condition involving loss of skeletal muscle mass and function. The $275,762 award to Rytek Medical Inc. will be used to design a sonolucent electrode array and housing that integrates with a standard ultrasound probe, enabling quantitative evaluation of muscle health through...
RCE Technologies, Inc. was awarded a $255,892 Small Business Innovation Research Phase I Project Grant from the National Science Foundation's Technology, Innovation, and Partnerships program to develop a proof-of-concept machine learning-based diagnostic system for detecting myocardial infarction and ischemia in real-time. The system aims to provide point-of-care clinical classification for heart attack cases using a novel, portable device integrating the awardee's proprietary external...
This $100,000 National Science Foundation project grant supports the development of a novel multi-wavelength spectroscopy technique and portable analyzer to assess tissue health at Texas A&M Engineering Experiment Station in College Station, Texas. The goal is to prevent pressure injuries through early detection by evaluating tissue oxygenation and blood perfusion beneath the skin's surface, which could help hospitals decrease injury rates and costs. The proposed technology may identify...
This federal Project Grant award from the National Science Foundation (CFDA 47.084 - NSF Technology, Innovation, and Partnerships program) provides $295,000 to support the design, development, and testing of a novel implantable system that leverages distraction osteogenesis as a treatment for diabetic foot ulcers. The project aims to develop a low-profile implantable device with an active mechanical mechanism to transversely distract or retract a cut tibia bone segment in a programmable...
This federal Project Grant award from the National Heart, Lung, and Blood Institute (NHLBI), under the Cardiovascular Diseases Research program (CFDA 93.837), provides $1,414,152 to Emory University to conduct research on the role of complement activation in the development of Acute Chest Syndrome (ACS) in sickle cell disease (SCD) patients. The key objectives are to characterize the mechanisms by which complement contributes to ACS pathogenesis, evaluate the influence and interaction of...
The National Institute of General Medical Sciences (NIGMS) awarded a $311,168 Project Grant (CFDA 93.859 - Biomedical Research and Research Training) to Accelerated Muscle Biotechnologies Consultants, L.L.C. This grant will fund the development of synchrotron-based imaging capabilities for skeletal and cardiac muscle research at the Brookhaven National Labs in Long Island, NY. The key objectives are to: 1) Acquire high-quality muscle small-angle X-ray scattering (MYSAXS) data comparable to...
This Project Grant award from the National Institute of Neurological Disorders and Stroke (NINDS), under the Drug Use and Addiction Research Programs (CFDA 93.279), will support the development of advanced ultrasound imaging biomarkers to objectively detect and quantify abnormal myofascial tissue, with a focus on plantar heel pain as a model condition. The R61 phase of the project ($2,935,084 over 2 years, starting September 2024) will utilize a cross-sectional study design to develop a...
This Project Grant award from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), under the Diabetes, Digestive, and Kidney Diseases Extramural Research program (CFDA 93.847), provides $712,628 to fund the development of the SoleSaver System - a sensor-enabled foot-worn garment to continuously monitor and prevent diabetic foot ulcers. The SoleSaver System measures pressure, temperature, gait indices, and peripheral arterial disease status across the plantar surface,...
This federal Project Grant award from the National Institute of General Medical Sciences (NIGMS) under CFDA 93.859 - Biomedical Research and Research Training Program provides $699,738 to Sagespectra Inc. to develop and validate a wireless patch for post-surgical monitoring and electrotherapy of surgical flaps. The key objectives are to design and test a prototype wireless patch that can remotely monitor tissue oxygenation, temperature, and edema to detect vascular occlusion and surgical site...
This Project Grant award from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) under the Arthritis, Musculoskeletal and Skin Diseases Research program (CFDA 93.846) provides $830,712 to Peer Technologies PLLC to develop a "Smart Cavity Creator Drill" for lumbar interbody fusion surgeries. The technology aims to simplify the surgical procedure and improve safety by using sensors to automate the creation of a precise spinal cavity through a small access...
EARLY IDENTIFICATION AND PREVENTION OF ACUTE COMPARTMENT SYNDROME USING A NOVEL ELECTRICAL IMPEDANCE-BASED MUSCLE-MONITORING DEVICE - PROJECT SUMMARY ACUTE COMPARTMENT SYNDROME (ACS) REMAINS ONE OF THE MOST DEVASTATING AND READILY OVERLOOKED TRAUMATIC MUSCULOSKELETAL DISORDERS IN CLINICAL PRACTICE. IN THIS CONDITION, PRESSURE INCREASES IN ONE OF THE BODY'S SPACE-LIMITED COMPARTMENTS, DUE TO DIRECT TRAUMA OR BONE FRACTURE, RESULTING IN INJURY TO ALL OF THE COMPARTMENT'S CONTENTS, INCLUDING MUSCLE AND NERVE. ONCE FULL-BLOWN ACS DEVELOPS, THE CONSEQUENCES ARE UNIFORMLY CATASTROPHIC, WITH PERMANENT TISSUE DESTRUCTION, SOMETIMES NECESSITATING AMPUTATION. IF CAUGHT EARLY, PROCEDURES CAN BE USED TO SAVE THE LIMB. A NON-INVASIVE TECHNOLOGY THAT CAN MONITOR FOR THE DEVELOPMENT OF THE CONDITION BOTH IN AND OUT OF THE HOSPITAL AND EVEN WITH THE PATIENT'S HAVING A CAST IN PLACE COULD SERVE A CRITICAL PURPOSE FOR ACS PREVENTION. ONE APPROACH THAT HOLDS SUBSTANTIAL POTENTIAL FOR THIS PURPOSE IS ELECTRICAL IMPEDANCE MYOGRAPHY (EIM). IN EIM, A WEAK ELECTRICAL CURRENT IS APPLIED TO A MUSCLE OR GROUP OF MUSCLE AND THE CONSEQUENT SURFACE VOLTAGES MEASURED, PROVIDING AN INDEX OF MYOFIBER HEALTH. PREVIOUS STUDIES OF IMPEDANCE TECHNIQUES HAVE DEMONSTRATED HIGH SENSITIVITY TO TISSUE ISCHEMIA AND INJURY, INCLUDING INTRACELLULAR EDEMA AND REDUCTIONS IN EXTRACELLULAR SPACE. THUS, WE HYPOTHESIZE THAT THE APPLICATION OF EIM TO MUSCLE COULD SERVE AS A SENSITIVE METHOD FOR ASSESSING THE ONSET OF ACS. MYOLEX INC, A BOSTON-BASED SMALL BUSINESS, HAS AS ITS MAIN INTEREST THE DESIGN AND DEVELOPMENT OF EIM TECHNOLOGY FOR BROAD MEDICAL USE. THE COMPANY IN CONJUNCTION WITH BETH ISRAEL DEACONESS MEDICAL CENTER HAS STUDIED THE SPECIFIC APPLICATION OF EIM TECHNOLOGY FOR THE ASSESSMENT OF ACS IN A WELL-ESTABLISHED RAT MODEL OF THIS DISORDER. DATA COLLECTED AND ANALYSES COMPLETED PREVIOUSLY HAVE DEMONSTRATED THE SENSITIVITY OF EIM TO THE DEVELOPMENT OF ACS. IN THIS PHASE 2 SBIR, WE PLAN TO EXTEND THE SUCCESS OF OUR EARLY INVESTIGATIONS BY DEVELOPING A SELF-CONTAINED, WIRELESS, BATTERY-POWERED, WEARABLE ACS DETECTOR THAT CAN EVEN WORK ON A CASTED LIMB THAT WE HAVE CALLED THE MYOLEX MALERTTM. IN SPECIFIC AIM 1, BUILDING UPON AN ALREADY FUNCTIONING EARLY PROTOTYPE, WE WILL CREATE A SYSTEM, THAT CAN BE PLACED ON A PERSON AT RISK FOR ACS TO ASSESS THE DEVELOPMENT OF THE CONDITION. THE SYSTEM WILL BE WIRELESS AND SMALL SUCH THAT IT CAN BE APPLIED PRIOR TO CAST PLACEMENT AND BE EASILY REMOVABLE ONCE THE PERIOD OF CONCERN HAS PASSED. WE WILL TEST BASIC FUNCTIONALITY IN A SMALL GROUP OF HEALTHY SUBJECTS. IN SPECIFIC AIM 2, WE WILL APPLY THIS SYSTEM IN A PORCINE MODEL OF ACS WHILE SIMULTANEOUSLY MEASURING TISSUE PERFUSION PRESSURES AND ALSO PREFORMING MEASUREMENT ON THE CONTRALATERAL LIMB. WE ANTICIPATE SHOWING THE MALERT'S SENSITIVITY TO PROGRESSING MUSCLE INJURY AND TO ITS IMPROVEMENT AFTER FASCIOTOMY. AT THE CONCLUSION OF THIS WORK, MYOLEX WILL BE WELL-POSITIONED TO TEST THE DEVICE IN HUMAN SUBJECTS AT RISK FOR DEVELOPING ACS AND ACHIEVE ULTIMATE FDA APPROVAL.