Czech Turning Point in Neuromodulation
www.posiv.cz ǀ 29
Česká společnost Smvia s.r.o. vznikla v roce
2014 a patří k nejprogresivnějším medtech rmám
současnos. Její technologie URIS® představuje
první neinvazivní uzavřený (closed-loop) systém
neuromodulace pro léčbu hyperakvního močového
měchýře a inkonnence.
Smvia s.r.o., founded in 2014 in the Czech Republic,
is one of today’s most progressive medtech rms.
Its URIS® technology represents the rst non-
invasive closed-loop neuromodulaon system for
the treatment of overacve bladder and inconnence.
Nová éra personalizované medicíny
Právě tato perspektiva činí Stimvii jedinečnou – fir-
ma nevyvinula jen další zdravotnický prostředek, ale
otevřela dveře k nové éře personalizované, bezpečné
a neinvazivní neuromodulace, která má potenciál mě-
nit životy milionů pacientů s urologickými i neurologic-
kými diagnózami po celém světě.
Aktuální působení a plány na expanzi
Stimvia již expanduje v Evropě – zařízení se dodávají
do ČR, Itálie, Francie, Španělska, Dánska, Nizozemska
a Velké Británie. Firma připravuje získání FDA 510(k)
clearance a plánuje vstup na americký trh. Probíhají jed-
nání o úhradách a investičních kolech (Series A), s cílem
urychlit expanzi do dalších regionů (výhledově Saúdská
Arábie, Kazachstán, jihovýchodní Asie). Klinické studie
pokračují – kromě OAB se testuje Parkinsonova choro-
ba a další indikace. Stimvia má také robustní IP portfolio
– přes 100 mezinárodních patentů.
Czech Turning Point in Neuromodulaon
Czech developers are introducing a technological breakthrough in the treatment of inconnence
and neurological disorders. The unique URIS® system, based on non-invasive electrical smulaon
of the peroneal nerve (eTNM®), delivers a new generaon of personalised therapy
with closed-loop feedback.
Breakthrough Technology
The URIS® system employs the unique
eTNM® (electrical transcutaneous
neuromodulation of the peroneal nerve)
technology, in which specially developed
non-invasive surface electrodes stimulate
the peroneal nerve. This stimulation influences
brain centres controlling bladder function –
including areas such as the insula, cingulate
cortex, and SMA – and helps restore balance
between hyper- and hypofunctional regions.
In addition, the system is equipped with
closed-loop feedback, which evaluates
the clinical effect in real time and automatically
adjusts stimulation parameters to the patient’s
individual needs. According to clinical data,
the effect was achieved in almost 80%
of patients, with no reported side effects.
MDR Certification and Clinical Results
In 2024, Stimvia obtained MDR
certification for the entire URIS® system,
which combines non-invasive eTNM®
with minimally invasive PTNS. This marked
the first solution of its kind in Europe –
integrating both non-invasive and minimally
invasive approaches. For patients, it offers
accessible, safe, and effective treatment
without surgery, which can be carried out
both in the clinic (URIS Office) and at home
(URIS Home), thereby improving comfort,
compliance, and treatment reach.
The uniqueness of the solution lies not only
in the combination of the two methods
but above all in its clinically proven efficacy,
which is comparable to invasive approaches
yet without their associated risks. Clinical
data confirms that up to 80% of patients
experience significant improvement, with
many achieving full symptom control.
The occurrence of adverse effects remains
minimal.
Beyond Urology
Stimvia’s ambitions reach far beyond urology.
The URIS® technology demonstrates
tremendous potential outside this field
as well. A pilot clinical study in patients with
Parkinson’s disease showed a reduction
in tremors, improved motor function,
and enhanced quality of life – all without
adverse effects. The findings suggest that
eTNM® neuromodulation may also play
a role in the treatment of neurological
disorders, where effective non-invasive
options have so far been lacking.
A New Era of Personalised Medicine
It is precisely this perspective that makes
Stimvia unique – the company has not just
developed another medical device, but has
opened the door to a new era of personalised,
safe, and non-invasive neuromodulation with
the potential to change the lives of millions
of patients with urological and neurological
conditions worldwide.
Current Operations and Expansion Plans
Stimvia is already expanding across Europe –
its devices are being delivered to the Czech
Republic, Italy, France, Spain, Denmark,
the Netherlands, and the United Kingdom.
The company is preparing to obtain FDA
510(k) clearance and is planning to enter
the US market. Negotiations are underway
regarding reimbursement and investment
rounds (Series A), with the aim
of accelerating expansion into additional
regions (with Saudi Arabia, Kazakhstan,
and Southeast Asia on the horizon). Clinical
studies are ongoing – in addition to OAB,
trials are being conducted for Parkinson’s
disease and other indications. Stimvia also
holds a robust IP portfolio with more than
100 international patents.
StartUp