Bioelesonic™ Platform

Addressing unmet medical needs with innovative medical devices based on Precisely Modulated Acoustic Energy™ (PMAE) technology

The Bioelesonic™ platform utilises Precisely Modulated Acoustic Energy™ (PMAE) therapy as a form of treatment which is externally applied to the patient, through the use of an acoustic energy-generating device.

The health benefits of vibration are widely known and recognised. Whole-body vibration has shown positive effects in managing life-disrupting symptoms of musculoskeletal and neurodegenerative disorders, in injury rehabilitation and the strengthening of muscle and bone tissues.¹

Localised vibration, a more targeted form of therapy, has shown promising results in the symptomatic treatment of respiratory disorders, chronic wounds and pain arising from the soft tissues.²

Bioelesonic™ pipeline

The Bioelesonic™ platform of SynDermix is based on PMAE that triggers biological responses on a cellular level in targeted tissues. The non-invasive exposure of impaired tissues to specific frequencies enables cellular recuperation of lost energy, inherent cellular expression, and the proliferation and production of biomolecules that exert therapeutic effects.

SynDermix is working together with Swiss biomedical inventors and engineers to create breakthrough technology in frequency-conducting portable medical devices for localised use. The Company’s goal is to develop handheld, smart devices whose electronic technology, precision and usability are custom-engineered to address the clinical specificities of targeted clinical conditions, and which meet strict regulatory standards.

In parallel, the interaction of the devices with smartphone apps will enable patients to keep track of their treatment regimens and to monitor the frequency of the exacerbations of their conditions with minimum effort.

SDX-3101

The most advanced medical device in our Bioelesonic™ pipeline is indicated for the treatment of chronic rhinosinusitis without nasal polyps (CRSsNP)— a condition suffered by an estimated 10–12% of the general population in Europe and the United States alone.³ The device has entered into a multi-centre, double-blind clinical study and is currently preparing for recruitment (ClinicalTrials.gov Identifier: NCT04158596).

Chronic rhinosinusitis (CRS) is an inflammatory disorder of the sinonasal passages whose symptoms last 12 weeks or longer. Symptoms include nasal congestion and/or discharge, facial pain or pressure and loss of smell.

CRS dramatically impacts the quality of life of patients. The disorder is evaluated to be equally or more disruptive than chronic obstructive pulmonary disease, asthma, peptic ulcer disease and congestive heart failure.⁴ Patients can experience multiple acute exacerbations within the span of a year.

SDX-3101 is a Swiss handheld device with a sleek design that is easy to handle and operate.

SDX-3101, the first drug-free, painless and non-invasive portable medical device for the treatment of moderate to severe CRSsNP in adult patients, with or without seasonal exacerbation.

With a single operation mode, the device is applied to the cheekbone and generates Precisely Modulated Acoustic Energy™ (PMAE). This type of acoustic energy penetrates through the tissues with the potential to powerfully and accurately activate the tissues in the sinonasal cavities, to reduce inflammation, release accumulated secretions and alleviate facial pain and pressure caused by CRS.⁵

Future pipelines

Going forward, SynDermix intends to leverage its proprietary technology and clinical findings to develop medical devices to treat painful neurological disorders and for wound-healing.

 

¹ Elfering, A., Arnold, S., Schade, V., Burger, C. and Radlinger, L. Stochastic Resonance Whole-Body Vibration, Musculoskeletal Symptoms, and Body Balance: A Worksite Training Study. Safety and Health at Work 4, 3 (2013)
² Weinheimer-Haus, E.M., Judex, S., Ennis, W.J. and Koh, T.J. Low-Intensity Vibration Improves Angiogenesis and Wound Healing in Diabetic Mice. PLoS One 9, 3 (2014)
³ Fokkens W.J., Lund V.J., Mullol J., Bachert C., Alobid I., Baroody F., Cohen N., Cervin A., Douglas R., Gevaert P., et al. European Position Paper on Rhinosinusitis and Nasal Polyps. Rhinology Supplement 23, 3 (2012)
Hoggard, M., Wagner Mackenzie, B., Jain, R., Taylor, M.W., Biswas, K. and Douglas, R. Chronic Rhinosinusitis and the Evolving Understanding of Microbial Ecology in Chronic Inflammatory Mucosal Disease. Clinical Microbiology Review 30, 322 (2017)
⁵ Zelenkin, E.M., Prozorovskaia K.N., Petrovskaia A.N., Zavgorodniaia E.G., and Kandaurova A.N. Clinical and Immunological Aspects of Vibration Therapy for Sinusitis. Vestn Otorinolaringol 5 (2000)