NEUROMUSCULAR & MUSCULOSKELETAL DISEASES
Building a clinical standard for measuring muscle condition.
Quantitative. Portable. Non-invasive. Painless.
Sensitive. Comprehensive. At-home.
*Pending FDA clearance.
“Our driving goal is to assess, monitor, and display changes in skeletal muscle composition and structure to aid in the diagnosis, prognosis, and treatment of neuromuscular and musculoskeletal diseases. We are deeply committed to help the dedicated clinicians, scientists, caregivers, and above all, patients who are battling these diseases, each and every day.”
“While progressive muscle weakness remains the clinical hallmark of ALS, there is no gold standard for assessing ALS muscle disease progression.”
Pending FDA clearance.
The Promise of Electrical Impedance Myography
Electrical impedance myography (EIM) is a non-invasive, painless assessment method that quantifies the passive electrical behavior of muscles.
EIM is an impedance-based technology in which an imperceptible, high-, multi-frequency (e.g., 1 kHz to 10 MHz) electrical current is applied to an area of tissue across two electrodes and the resulting voltage signals measured across two sense electrodes.
EIM evaluates specific regions of muscle by forcing the current across myofibers. It is sensitive to microscopic tissue morphology and composition, including cell atrophy, density, membrane integrity, subcellular structures, and interstitial changes, such as fibrosis, edema, inflammation, and fat deposition.
Provides quantitative data on functional capability while the muscle and patient remain entirely at rest.
Portable non-invasive device that scans a muscle in a matter of seconds.
EIM engages painless, active monitoring of the patient.
One holistic measure of both muscle composition and infrastructure.
Our Breakthrough Innovation Goals
Single, quantitative, and more comprehensive measure and monitor of muscle composition and structure that can aid in the diagnosis, prognosis, and treatment of neuromuscular disease and muscle dysfunction.
New kind of muscle measurement device that could aid clinicians in diagnosing ALS significantly earlier than what is available today.
First non-invasive, easy-to-use, and portable medical device that enables patients and caregivers to successfully and more frequently measure muscles at-home.
Precise, highly sensitive, consistent, and reproducible measurement that could enable ALS pharmaceutical companies to conduct significantly smaller and faster clinical trials.
Extensive Clinical Research
Peer-reviewed scientific articles showing EIM sensitivity to disease progression and drug effects, reliability, and ease of use
IRB-approved clinical studies by pharmaceutical companies
Issued patents. +2 pending.
ALS: The Clinical Challenge
- Global ALS patients are projected to increase +69% by 2040 (Ref. 1).
- No “gold standard” for assessing ALS muscle disease progression (Ref. 2).
- Clinicians need an accurate measurement tool that differentiates between healthy and ALS-diseased muscles.
- Diagnosis is often made by first ruling out other diseases.
- Failure rate for new ALS pharmaceutical clinical trials is high (Ref. 2).
- Body regions affected by ALS vary from patient to patient.
- Remarkable variability in the rates of patient decline makes clinical trial design and outcome measure choices more difficult.
We’ve Been Working On It
Smaller, Standardized Clinical Trials?
Myolex EIM has the potential to serve as a powerful, future biomarker that will be able to reduce clinical trial sample size requirements dramatically. Further, given it is non-invasive, portable, and easy-to-use, EIM enables standardized muscle condition data collection across all clinical trial sites.
Peer-reviewed studies have shown that the application of EIM to monitor ALS (Ref. 3) and DMD (Ref. 4) patients enables fewer patients to be enrolled in studies, as compared to the monitoring methods currently in use.
In peer-reviewed studies, Myolex has demonstrated that frequent at-home measurements using EIM could greatly improve the ability to monitor patients over time. By obtaining patient data far more frequently, clinician researchers will be able to increase their ability to accurately monitor muscle condition changes over time (Ref. 5).
Myolex mScan® represents a ground-breaking way to reduce patient attrition and variability in patient outcome assessment by empowering patients and caregivers with the kind of non-invasive, easy-to-use tool that they need to enable in-home, self-measurement.