An innovative solution to neurological walking and balance disabilities

Project Information

GONDOLA AMPS

Grant agreement ID: 946638

DOI

10.3030/946638

Project closed

EC signature date 12 February 2020

Start date 1 January 2020

End date 30 June 2022

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 3 562 743,75

EU contribution

€ 2 493 920,63

Coordinated by

GONDOLA MEDICAL TECHNOLOGIES SA
Switzerland

Periodic Reporting for period 2 - GONDOLA AMPS (An innovative solution to neurological walking and balance disabilities)

Reporting period: 2021-01-01 to 2022-06-30

Summary of the context and overall objectives of the project

Neurological conditions such as Parkinson’s disease and cerebral stroke often severely affect walking and balance abilities. Patients find these motor symptoms extremely disabling with a consequential loss of self-confidence, independence and quality of life. Current treatments fail to address these situations. The Swiss company GONDOLA Medical Technologies brings a unique, patient-friendly, solution.

GONDOLA, has developed a medical device (GONDOLA®) to treat patients with walking impairments due to neurological disorders, such as Parkinson’s disease and stroke. GONDOLA device is a ground breaking innovation that delivers AMPS, Automated Mechanical Peripheral Stimulation, a short-duration, non-invasive treatment, consisting of specific stimulations to very specific target points on each foot of the patient. The treatment can be self-administered using the GONDOLA device, thus providing patients an at-home neuro-rehabilitation option for the first time ever. A professional version of the device to be used in hospitals and rehabilitation centers is also available.

Gondola AMPS is a game-changing innovation that provides the following benefits for patients:
- address walking and balance disabilities of Parkinson's patients and stroke survivors,
- offer a non-intrusive solution to patients in the advanced and most debilitating stages of the conditions,
- deliver the treatment in a least constraining form with an aim at favoring adherence,
- provide a cost-effective solution, fit for different purposes: home care and medical environments,
- doing all of this while reducing psychological distress.

In an ageing Europe, GONDOLA AMPS can make a significant contribution towards ageing in good health thereby reducing the cost of long-term care to societies.

Thanks to a strong clinical research team, GONDOLA has gained a clear understanding of the mechanisms of action of GONDOLA-EK01. Benefits of the therapy delivered by GONDOLA device are achieved through the enhancement of the automaticity of the walking neural networks. These processes are known to play a role in the fundamental principles of rehabilitation of patients with acute brain lesion (e.g. stroke), neurodegenerative diseases affecting mobility (e.g. Parkinson’s disease), and chronic neurological conditions (e.g. cerebral palsy). Based on this evidence, and a documented unmet need in walking rehabilitation for neurological disorders, a broad patient population can benefit from the use of AMPS treatment delivered via the GONDOLA medical device.

Large use of GONDOLA AMPS can alleviate care needs of patients and their families, and reduce cost of care for national health systems. Furthermore, the recent COVID pandemic has emphasized and accelerated the need for rehabilitation innovations, especially those that can be performed at home in conjunction with telemedicine.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Main achievements during the EIC project are:
- Creation of a stronger competences within the team, including clinical research, quality and regulatory, business development, marketing, production and sales. The team is very balanced in gender equality (55% women/45% men).
- Development, prototyping and placing on the market of a new generation of GONDOLA medical devices, home model and professional model. This activity required prototyping, non-clinical testing, CE certification, and creation of an international supply chain to be ready for volumes scale-up. For the home model, this activity has also required setting up a 3D scanning platform to have precise images of the feet of patients, and an insole-production facility to manufacture personalized insoles for any patient so to enable him/her to use the Gondola device with ease and reliability of outcomes.
- Development of device firmware and smartphone app to operate GONDOLA devices.
- Definition of business model, preparation of a go-to-market plan, starting from a key EU geography, and including US market.
- Preparation of a randomized, placebo controlled, crossover clinical study on the target population to further validate efficacy, effectiveness and safety of the device. Approval of such clinical study by a leading European university hospital. Launch of the study, build experience from it.
- Preparation of a randomized, placebo controlled, crossover clinical study on Parkinson’s disease patients with FOG (freezing of gait) to further validate efficacy, effectiveness and safety of the device. Review and approval of the study protocol by the Scientific Advisory Board.
- Definition and execution of targeted marketing initiatives to create awareness on the device among key stakeholders: physicians, end users, perspective investors in the company.
- Conducting a literature review to document scientific support to Gondola AMPS treatment.
- Launching the regulatory activities to obtain CE certificate under the new EU MDR framework.
- Advancing regulatory procedures to access the US market.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Mobility impairment impacts virtually each Parkinson’s patient and close to 50% of stroke survivors. GONDOLA device is particularly effective in intermediate to advanced stages of stroke and Parkinson’s disease, where impaired mobility strikes most. Clinical trials and related peer-reviewed scientific publications show the effectiveness of GONDOLA device to strongly improve motor symptoms of impacted patients. The potential market for GONDOLA devices is substantial and will address a widespread unmet medical need.

Well over 10 million people globally suffer from Parkinson’s disease, with the highest percentage in the EU. The commercial target countries of Gondola AMPS, namely: Germany, France, Italy, Spain, Switzerland, UK, the USA and Canada, count about 2.3 million Parkinsonians. In the intermediate and advanced stages, virtually all patients face lower limbs disabilities.

World Stroke Organization reports that yearly 15+ million people suffer from a stroke worldwide. 62% survive the stroke, and among stroke survivors 43% experience long-term balance and motor impairments. Gondola AMPS commercially targeted countries count ~0.5 million new stroke survivors each year who will present lower limbs symptoms at some point in their life. In these countries, there are ~9 million prevalent stroke survivors of which about 3,9 million (will) experience long-term balance and motor impairments.

Starting from GONDOLA device as a product with associated services, the company has progressively defined its vision and strategy. Before the company was founded it was realized that the GONDOLA device was bringing a solution to a widespread unmet medical need. As a natural outcome a vision materialized: grow Gondola Medical Technologies as the world leading medical technology firm in the field of non-implantable mechanical stimulation solutions to motor impairments affecting neurological patients.

Gondola device – home version

Gondola device – professional version