NEUROMUSCULAR & MUSCULOSKELETAL DISEASES

Sarcopenia. Another unmet need.  

The pathological, age-associated loss of skeletal muscle mass and function.

*Pending FDA clearance.

What is sarcopenia?

  • Sarcopenia is a progressive, deleterious process defined by both loss of muscle mass and loss of muscle function or strength. 

  • Sarcopenia components are age-related wasting, weakness, and the diminished quality of both muscle mass and function.

  • Americans 65 years+ are projected to total 72.1M in 2030. It was estimated there were 18M people with sarcopenia in 2010 and thought to affect 30% of individuals >60; 50% of individuals >80.

  • Sarcopenia is associated with increased insulin resistance, fatigue, falls, and mortality. 

  • Of the chronic disease states, sarcopenia has been especially associated with rheumatologic conditions, especially rheumatoid arthritis in women.

  • One study estimated that disability caused by sarcopenia accounted for $18.5B in direct medical costs in 2000; 1.5% of US health care spending that year.

    A major challenge to treating primary sarcopenia, or its secondary complications of muscle disuse/injury, is the absence of convenient, bedside technologies for quantifying muscle condition and the impact of exercise in real time.

    Sarcopenia: The Clinical Challenge

    • Assessing muscle health and sarcopenia quantitatively in older adults is challenging. Assessing muscle health accurately, quickly, and in a cost-efficient manner is very difficult. 

    • Current measurement of muscle mass, muscle composition (fat content), and specific force — the quantitative features of sarcopenia – is very expensive, invasive, logistically burdensome, infrequent, and/or have poor sensitivity to muscle mass in sarcopenia.

    • The gold standard method for non-invasively assessing muscle mass and muscle fat content requires MRI or CT imaging, expensive post-processing of images, burdensome logistics, and in-office care. 

    • A cost-effective, easily applied approach for estimating lean body mass and muscle mass is whole-body bioimpedance analysis (BIA). However, BIA is highly impacted by hydration status, the presence of joint replacements, body position, and abdominal contents and is considered to provide poor sensitivity to muscle mass in sarcopenia. 

    • A convenient, fast, cost-effective, and quantitative technology to give quantitative information on specific muscle conditions can offer great benefits to older adults and their medical providers. 

    What if EIM…

    Provides “MRI-like” quantitative muscle data for older adults?

      Myolex has initial support for the radical idea that a small, relatively inexpensive handheld device can offer outcomes closely tied to data currently only available with MRI. 

      EIM correlated strongly to MRI muscle volume in a small group of older adults of varying levels of functional status and muscle condition. Although a limited data set, this demonstrates a remarkably strong linear relationship and supports that EIM is sensitive to muscle size in older adults.

      It’s Possible

      What if EIM…

      Provides “MRI-like” quantitative muscle data for older adults?

        EIM has also demonstrated correlation to MRI muscle cross-sectional area (CSA) in a larger group of younger adults. This figure shows the relationship between EIM multifrequency data and rectus femoris CSA collected on a group of individuals undergoing a drug therapy study with a Myolex pharma partner, using a predictive algorithm, achieving r=0.93. 

        A critical component of the work is to create such predictive models that use the full multifrequency EIM data set, achieving far better outcomes than using a single frequency. 

        Encouraging.

        What if EIM…

        Provides “MRI-like” quantitative muscle data for older adults?

          Our research was also able to show a moderate relationship between MRI-based fat fraction versus single frequency EIM phase values. Fat fraction is defined as the signal arising from fat protons divided by the sum of the signals from fat and water protons. 

          Only one point markedly reduces the strength of the correlation. Yet, this outlier confirms the need for using the full panoply of impedance data to create a truly robust predictive algorithm. 

          Fat content is key.

          What if EIM…

          Measures specific force in older adults?

            EIM has demonstrated that it correlates to specific force in a small group of older adults. The researchers also obtained specific force measurements by induced supramaximal electrical muscle stimulation of the quadriceps in 6 subjects. By dividing that force by MRI-derived muscle volume, a specific force can be calculated. 

            As shown here, as with the other measures, there is strong relationship between this measure and EIM 50 kHz resistance.

            Specific force. Key data.

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