Author: adminas

Lithuanian startup disrupts healthtech industry with a therapeutic device and a habit tracking app

By adminas in Uncategorized Posted March 16, 2021

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 attracted an investment of EUR 50,000. “Vilimed” is still working with this pharmaceutical company and plans to launch pilot studies with Parkinson patients in Spain in the near future.

The principle of operation of the device

VILIM ball is a handheld therapeutic device whose purpose is to temporarily reduce hand tremor, giving Essential tremor (and Parkinson’s Disease) patients a relief from the symptoms for the time they need to perform ordinary-life tasks. 90 % of those who tested VILIM ball, reported it as effective. The device’s working principles are based on vibration therapy. We gathered evidence of the fact that that 10 minutes of therapy can reduce hand tremor for a period up to 4 hours.

Usage recommendations 

For a better life quality, use VILIM ball, essential tremor device before the every action you want to make it easier: eating, writing, etc. It helps to reduce hand tremor for a certain time period which is individual for every person. The effect could last from 1 minute to 4 hours and could not be predicted before usage. Because it depends on individual person.

VILIM ball charging

VILIM ball is rechargeable by a magnetic charger. The fully charged device could work about 2 hours.

Hold the device in the palm and gently press it with your fingers. During therapy, place the hand freely, do not keep the wrist taut or twisted. Holding the device like it is shown in the picture below, the effect of the device is the best.

Essential tremor device
How to hold VILIM ball

The residual effects of therapy can vary widely and depend on the individual characteristics of each person. In practice, we have noticed that it can last from a few minutes to a few hours.

It should be considered that vibration therapy is part of a treatments that reduce hand tremor.

Contraindications
• Pregnancy
• Acute thrombotic process (myocardial infarction, (acute vascular constriction)
• Implants in activated regions of the body (e.g. artificial joints)
• Acute inflammation of the locomotor system active arthrosis or arthropathy e.g. acute inflammation or swelling of joints
• Acute tendinopathy in activated regions of the body (acute tendon inflammation)
• Acute desmopathy (acute problems at the intervertebral disc)
• Fresh fractures in activated regions of the body
• Post-surgery wounds and fresh wounds in activated regions of the body or incomplete wound healing
• Rheumatoid arthritis
• Epilepsy.

o Precautions
• The Vilim Ball is not intended for other uses: cranial application to treat headache (should not be placed anywhere to induce vibrations in the head area), head or neck tremor or other conditions. It is to only be used as a handheld device to produce local vibration in the upper limb.
• The device is not created to be thrown or used in other unintended applications (e.g. heating in the microwave, chewing or gnawing). It is not intended to be a children’s toy.
• The device may induce or exacerbate Raynaud’s syndrome. In such event device use should be discontinued. The device induces Raynaud’s syndrome is a reversible condition. Consultation of a physician is to be sought in such case.
• The device may induce or exacerbate Carpal tunnel syndrome. Carpal tunnel syndrome is a condition that causes pain and numbness in the fingers and hands, and sometimes the arms. It happens when a nerve in the wrist called the “median nerve” gets pinched or squeezed. In such case the device use should be discontinued. No irreversible damage should be expected.
• Itching redness of skin. If such condition develops and seems to be related with the device use, the use should be discontinued, and medical attention sought.

Try VILIM ball now

Download Instruction for Use here:

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Hand tremor reduction

By adminas in Uncategorized Posted January 17, 2018

Hand shake reduction for Essential tremor disease

The results from the research shows that VILIM ball device could be effective on reducing hand tremor:

Investigation results

Open access scientific publication:

Abramavičius, Silvijus; Venslauskas, Mantas; Vaitkus, Antanas; Gudžiūnas, Vaidotas; Laucius, Ovidijus; Stankevičius, Edgaras. Local vibrational therapy for essential tremor reduction: a clinical study // Medicina. Basel : MDPI AG. ISSN 1010-660X. eISSN 1648-9144. 2020, vol. 56, iss. 10, art. no. 552, p. 1-9. DOI: 10.3390/medicina56100552.

Efficacy study No. 1 was a prospective, single-center, randomized, controlled study designed to evaluate effectiveness. 17 subjects with diagnosed Essential tremor were randomly selected and enrolled in the study. Vibrational therapy was performed for each patient on dominant hand. Collected data was filtered to evaluate the range of 4-12 Hz which is hand tremor frequency with diagnosed essential tremor. 13 of 17 patients had lower tremor in dominant hand after the therapy (α= 0.0352). Based on the collected data it was calculated, that tremor was 56 % lower after the therapy. 15 additional patients were enrolled in the study to the sham group. The investigated sham device seemed to elicit no quantifiable effect in comparison with VILIM ball.

Efficacy study No. 2 was a cross-sectional study performed in patients with Essential and Parkinsonian tremor that use the VILIM ball , to assess the safety and efficacy, of the VILIM ball.  50 patients with the mean (standard deviation) age 66.9 were included (30 in the essential tremor and 20 Parkinsonian tremor) in the study. The primary efficacy outcome was the Patient-Reported Outcome based on a non-validated patient telephone questionnaire. The secondary outcome was the occurrence of adverse events. 46 patients reported improvement in tremor symptoms and function. 4 patients (2 PD and 2 ET) reported lack of effect in terms of symptoms and function. The patients used the VILIM ball for 7.63 months. 38 patients were able to report the duration of improved function which was 90.79 minutes. 4 more patients refused to participate in the study because of no improvement in tremor during the two-week initial testing phase. No adverse events were reported by the patients in this study.

Current results gives a proof that the methodology is effective and could help people with hand tremor easily perform daily activities like writing, eating or other. The further researches will be dedicated for the optimization of the device effectiveness.

According to previous studies, the vibrational therapy could reduce hand tremor and stiffness for Parkinson’s disease by 25% and 24%, respectively. (Haas, 2006).

King et al. (2009)   have found that vibrational therapy could significantly decrease rigidity, and tremor. Results of their initial investigation provide support for vibration therapy as a non-pharmacological treatment alternative.

The next research describes the combination of the whole body vibration therapy and exercises. It was observed that this kind of therapy gives short term benefit for human motor system, posture and daily activities (Edmonston , 2016).

Heiko (2009) and others have found that the whole body vibration therapy significantly reduces hand tremor and stiffness as well as step lenght and walking speed.