Myolex® (&mScanTM): Pioneering the Seamless Monitoring of Muscle Health

Neil Lupton, President and Bruce Berkoff, CMO (chief marketing officer), Myolex® (&mScanTM)Neil Lupton, President and Bruce Berkoff, CMO (chief marketing officer)
Muscle health is critical to human life and wellbeing. Sometimes our muscles are impacted by injury, and other times they might be impacted by disease, some hereditary and others acquired. While the actual reason for the muscle problem can usually be diagnosed using conventional approaches including physical examination, blood studies, and MRI, our ability to track muscle disease status and to measure quantitatively a person's response to therapy is limited. Neuromuscular diseases such as Duchenne muscular dystrophy (DMD) and amyotrophic lateral sclerosis (ALS) affect over 100,000 Americans every year, costing the US economy billions. Monitoring the progress of the disease or the benefits of therapy, let alone developing new safe and effective treatments, all require better ways to accurately monitor and quantify muscle health in patients. The limited approaches to diagnosing and monitoring muscle health that are available today reduce the chances of improving patient health. Current muscle diagnostic methods fall short of the needs, as these tests can be inconclusive, cumbersome or painful and can be challenging to quantify. They also provide inconsistent results. These procedures, including blood tests, X-rays, MRIs, EMGs, and muscle biopsy, may also be costly and were designed more for diagnosis than for monitoring disease. Therefore, both the broader healthcare industry, and pharmaceutical community can benefit greatly from a simple, easy, quantitative method of measuring muscle health in patients.

Quantifying muscle health measurements is now possible with a new electronic tool Myolex®Inc. is introducing to both lower overall costs and increase the standard of care. This new tool, the mScanTM, is based on award-winning “Electrical Impedance Myography” (EIM) technology. With support from the NIH Small Business Innovation Research program, the company has worked with clinical researchers and pharma companies for years using EIM to speed clinical trials and improve their accuracy. Peer-reviewed studies have shown that EIM can lower clinical therapeutic trial patient requirements by more than 80%, saving Pharma companies immense amounts of time and money.

“With our patented technology of EIM and the new mScanTM, we provide the first easy and accurate way for physicians to quantify muscle health across any condition that impacts muscle health, from simple deconditioning to serious medical illness” explains Neil Lupton PhD, President of Myolex®. And Bruce Berkoff, Myolex®’s CMO adds, “This will help raise the standard of care and provide a new potential revenue stream for physicians, while simultaneously saving the consumer and the healthcare system a fortune”.

In conversation with MDTech Review, Neil Lupton, the President of Myolex Inc., and Bruce Berkoff their CMO, emphasize how mScanTM is one of the pioneering ways of quantifying and numerically monitoring muscle health quickly and seamlessly. EIM measurements require only minutes and they are convenient, painless and a quantifiable way to measure muscle health. Our breakthrough new EIM product, the Myolex® mScanTM, is a simple, accurate and profitable diagnostic and monitoring tool that makes more efficient clinical trials possible. The mScanTM device also allows for physicians to provide better individual patient care.

What are some of the challenges around tracking muscle disorders with therapy?

Assessing a patient’s muscle health status in the present day is surprisingly challenging and costly for both patients and the healthcare industry. Indeed, there is no simple tool to measure and record and store such information.
If we look at the use of MRIs today, for example, the cost of conducting a single scan is greater than $1000, and the equipment itself costs $millions of dollars. The MRIs often take 45 minutes to an hour to administer and are not typically performed in a doctor’s office but rather in an outside facility. The patient needs to remain very still and quiet in a confined space. Even after the tests are conducted, the data analysis is slow and is typically done by a skilled radiologist, and it takes time for the reports to reach the patients. Imaging also may lead to, “radiographic incidentalomas” or abnormalities that may not be medically significant but can have major financial and psychological consequences for patients (and amount to seeing things that were not being looked for, and may not be there, and require further tests to characterize).

With our patented technology of EIM and the new mScanTM, we provide the first easy and accurate way for physicians to quantify muscle health across most conditions that impact muscle health, from simple deconditioning to serious medical illness

Please give us an understanding of mScanTM and its benefits for pharmaceutical companies.

Pharma companies have many challenges for conducting clinical research studies to show a therapy is both safe and effective. For example, there is a need for a sizeable number of patients. Each patient enrolled may cost anywhere from $10,000 to $50,000 or more, depending on the trial parameters. Each evaluation may require travel to a hospital or clinic for measurements. Studies often require patients to be very cooperative for evaluation, making it difficult at times to deal with hospitalized patients or children, but the mScanTM is a fast and simple measurement that makes data collecting a breeze.

For pharma companies, the mScanTM proves to be extremely beneficial as it reduces time, cost, and complexity in conducting studies and improves their efficiency. It can even reduce risk by allowing for simple home measurements, even during a pandemic. Published studies have shown that EIM can lower clinical trial patient requirements, by more than 50%, saving 20-30 percent or more of overall trial costs and time involved. Thus, to summarize, when a utilized in clinical trial, Myolex® mScanTM can offer a much greater amount of data and detail, thus a greater sensitivity to possible drug effect, reducing sample size requirements, shortening the trial period, and decreasing the overall costs of a trial.

Please give us an understanding of mScanTM and its benefits for patients& physicians.

The mScanTM (anticipating FDA clearance in early 2021) provides the first easy and accurate way for physicians and other clinicians to quantify muscle health in any condition that impacts muscle health, from simple deconditioning to serious medical illness. This can raise standard of care and provide a new potential revenue stream for physicians (billing for the time to perform measurements and interpret the data), while simultaneously saving the healthcare system and consumers a fortune (e.g., a new mScanTM is ~1/100 the cost of an MRI).

The mScanTM system, including the scanner, disposable foam electrodes, and iPad® with mScanTM app, is a quantitative muscle health measurement tool to help improve diagnosis and guide therapy. This simple, accurate diagnostic and monitoring tool is portable and rechargeable. The data collected using mScanTM is normalized to patients’ age and sex and is analyzed as part of an existing database in the cloud of over 350 million EIM data points. The mScanTM also includes patented disposable electrode arrays, which are made of hydrophilic biocompatible foam pre-moistened with our patent-pending conductive solution. It can collect data from multiple muscles within minutes and fits the muscles of both children (approximately 5 yrs and older) and adults. The mScanTM can be easily integrated with any visit or care plan and allows for rapid and repeatable collection of data to enable easy monitoring of patients’ muscle health. The mScanTM is designed with ease-of-use in mind, and stores information on a HIPAA-compliant cloud-based data management system, allowing easy analysis over time.

What are the future plans that you have for the company and the product?

We have developed a new platform tool (mScanTM), awaiting FDA clearance, that employs innovative electrical impedance myography technology. We are already using it in IRB-approved research studies and working with Pharma companies to help clinical trials benefit from this ground-breaking tool. After FDA clearance, we look forward to working with select medical management groups to begin to bring this powerful new technology into selected physician practices.

We will continue our internal research and other sponsored research to increase mScanTM’s efficacy and value. Also, our product will also allow caregivers to use it on patients at home without having a professional medical practitioner involved. The data collected from the device directly migrate to the cloud, thus reducing time, cost, and complexity and increasing efficiency and the quality of life for patients.

Myolex® (&mScanTM)

Brookline, MA

Neil Lupton, President and Bruce Berkoff, CMO (chief marketing officer)

Myolex® Inc, a spin-off from Harvard Medical School and MIT, which is now commercializing the award-winning EIM (Electrical Impedance Myography) technology developed by our scientific founder, Dr. Seward Rutkove. Seward has received a number of awards for EIM including the $1,000,000 ALS Biomarker Prize. With support from the NIH SBIR program, Myolex®leveraged its extensive database and its patented technology, to effectively develop a solution to assess and quantify muscle health, seamlessly, quickly, and cost-effectively. Myolex further collaborates with clinical researchers and pharma companies to improve data collection ca¬pa¬bi¬lities for neuromuscular clinical studies. Myolex®’s mScan is an accurate, non-invasive, efficient, and por¬ta¬ble device, and comes with iPad, unique App, and custom, disposable foam electrodes that help users col¬lect data from multiple muscles within minutes. This device can help pharma companies to perform trials more efficiently and allow physicians to conduct speedy muscle check-ups, adding to an improved standard of care.

Myolex<sup>®</sup> (&mScan<sup>TM</sup>)