Myolex, Inc.

Electrical Impedance Myography (EIM) to Detect and Track Cancer Cachexia - Project Summary in This Application, Myolex®, Inc Proposes the First-ever Application of Its Proprietary Mscan® Device Spe- Cifically for Diagnosis and Quantification of Cachexia (cancer-associated Muscle Wasting). Cachexia Impacts Half of All Cancer Patients, With 50-75% of Those Developing Major Physical Disability, Leading to Poor Response to Cancer Treatment, Decreased Quality of Life, and Increased Mortality. Conventional Approaches to Cachexia Diagnosis and Evaluation Are Dependent on Assessing Lean Body Mass Estimation via Imaging, Such as CT or Mri and Blood-based Markers. These Methods Only Indirectly Measure Muscle Health and Don’t Provide Indi- Vidual Point-of-care Muscle Information That Is Needed for Developing Customized Rehabilitation/exercise Pro- Grams. in Addition, Imaging Approaches Are Costly and Not Practical as Repeated Measures to Observe Cachexia Status, Either Worsening or Recovery. Current Cachexia Diagnostic Approaches Also Have Limited Correlation to Function, a Key Measure Not Yet Addressed in Cachexia Clinical Trials. the Myolex Mscan® Device, Which Uses Electrical Impedance Myography (EIM) Technology, Can Serve in These Roles. Eim Is a Fast, Accurate, Inexpen- Sive, and Handheld METHOD7 Developed to Monitor Neuromuscular Disorder Disease and Potential Drug Effects. Eim Is Based on Application of a Weak, Directionally Focused Electrical Current Across a Range of Frequencies Into a Muscle and Measurement of Resulting Voltage Signals. Eim Is Sensitive to Muscle Wasting Disorders, With Outcomes That Relate Directly to Muscle Volume, Composition, and Force Production. We Hypothesize That Our Improved Eim System Will Show Strong Agreement With Standard Cachexia Measures and Be Repeatable Over Time During Chemotherapy. in Specific Aim 1, We Will Determine the Relationship Between Eim of Individual Mus- Cles and Standard Measures of Cachexia and Physical Function in Cancer Patients at Risk of Cachexia. in Specific Aim 2, We Will Complete a Pilot Study of Eim Repeatability and Reproducibility in Cancer Patients Undergoing Chemotherapy. Finally, in Specific Aim 3, Which Will Run Concurrently With Aims 1 and 2, We Will Improve the My- Olex® Mscan® Device With the Addition of a Pressure Sensor and Tailored User-interface for Rehabilitation Spe- Cialists. the Improved Device Will Offer Better Long-term Tracking and Intervention Assessment, Better Ease-of- Use, While Easing the Way Toward Ultimate Fda 510(K) Approval. Ultimately, This Work Will Lead to Additional Studies, Potentially Through a Phase 2 Sbir, That Will Evaluate the Use of Eim in Tracking Muscle Health During Chemotherapy and With a Dedicated Rehabilitation Intervention.