More than 4% of people around the world over the age of 40 suffer from essential tremor causing an involuntary hand shaking. The medical technology startup “Vilimed”, located in Kaunas Science and Technology Park innovation community, has recently certified the hand tremor reducing medical device. It was certified to CE0197 standard and the company received EN ISO 13485: 2016. After five years of product prototyping and testing, the “Vilim ball”, which reduces hand tremor with artificial intelligence-controlled mechanical vibrations, begins its official journey to European and Asian markets.
Long-term impact requires changes in a person’s lifestyle
“The certificate means that the therapeutic device is safe and effective for patients with essential tremor and meets all applicable standards as a medical device. It is important for distribution not only geographically, but also because the device will now be available for purchase and use by medical clinics, and this opens up opportunities among the distributors of medical devices. It allows us to enter new markets of the EU, the Middle East and the Balkans,” says dr. Mantas Venslauskas.
Received certificates according to EN ISO 13485: 2016 will allow the team to certify other products developed by the company, such as “Vilimap” mobile application for tracking and developing new lifestyle habits that will reduce hand tremor.
“According to the research, the intensity of tremor is highly dependent on lifestyle components such as physical activity, diet, sleep duration, or caffeine intake. We have created a mobile application that helps to develop healthy habits and thus get more control over this disease, which causes many inconveniences,” says Dr. Venslauskas.
The startup’s team aims to automate this app, integrate it with the “Vilim” ball therapy device, and adapt it for monitoring and control of essential tremor, involving neurologists in the process.
Device production development in Lithuania
The team located in Kaunas Science and Technology Park has recently supplemented the development project manager with more than 20 years of experience in the distribution of medical devices in international markets. “Vilimed” already work on the serial production of the device. Lithuanians hope to produce the first batches of up to 1000 units themselves, later they will look forward to cooperate with Lithuanian companies.
The device mimics a tennis ball and has attracted the interest of the neurological community, both in university hospitals in major Lithuanian cities and in clinics in the USA, Kazakhstan and Russia, which have tested the device. After using a therapeutic ball, a person suffering from essential tremor can take care of themselves, perform daily chore and eat much more easily.
Originates from the research field
“The idea for the product came from writing a doctoral thesis on vibration technologies, their application in the treatment of rheumatoid arthritis. After starting cooperation with neurologists of Lithuanian University of Health Sciences, we started to analyze how vibration therapy helps to reduce essential tremor. We tested various frequency bands, and later, in cooperation with a strong team and volunteers, we developed a technology that created the greatest added value for its users - most effectively reduced tremor ", says Dr. Venslauskas.
Based on feedback from people who have voluntarily tested the device, “Vilim ball” can be used successfully to reduce hand tremor, especially before performing processes such as eating, writing, or other activities that require hand stability.
The startup also hopes to attract venture capital investments for development in the European market, as the potential for product adaptability is extremely wide. In the future, it is hoped to adapt the therapeutic device to patients with Parkinson disease. A couple of years ago, the “Vilimed” team participated in the business acceleration program of the Italian pharmaceutical company “Zambon” and was awarded with EUR 50,000 of seed capital. “Vilimed” is still working with this pharmaceutical company and plans to launch pilot studies with Parkinson patients in Spain in the near future.