Latest news with #neuromodulation
Forbes
11 hours ago
- Health
- Forbes
Hacking The Brain: Czech Neurotech Startup Stimvia Brings AI To Non-Invasive BCI
Lukáš Doskočil, founder and CEO of Stimvia Stimvia, a Czech startup founded by medical device executive Lukáš Doskočil, has developed a non-invasive neuromodulation system that uses electrical pulses to stimulate deep brain structures through the leg. Called URIS, the technology was first deployed to treat overactive bladder, but now shows early promise for a range of neurological disorders including Parkinson's disease, multiple sclerosis, and Restless Leg Syndrome, which is treated with Parkinson's medication. A patient secures URIS sensors behind the knee, where a nerve provides access to the central nervous ... More system. At the core of Stimvia's approach is what Doskočil calls a "hack" into the brain via the peroneal nerve behind the knee. The URIS system uses proprietary non-invasive electrodes to send electrical signals along afferent nerve pathways to the prefrontal cortex, eliminating the need for invasive implants or surgery. "We did a mechanistic study using functional MRI and showed stimulation effects in deep brain structures," Doskočil told me. "That's never been done non-invasively before." Patients can easily control the intensity and duration of the treatment. Pilot studies testing the Stimvia URIS device for treating Parkinson's disease have turned heads in the neurology and urology communities. A study conducted at Ostrava University Hospital found that Parkinson's patients using URIS experienced measurable reductions in resting tremor and improvements in quality of life. 'Patients showed marked improvement in motor symptoms and overall well-being, with quality-of-life scores surpassing clinically meaningful thresholds. All without serious side effects,' said Professor David Skoloudik, Vice-Dean for Research at Ostrava University's Medical Faculty. A separate clinical paper notes URIS® may outperform traditional sacral and tibial nerve stimulation in treating bladder dysfunction without the needles or surgery. Stimvia's URIS device is connected to a companion app that collects data from each session, monitors patient symptoms, and adapts the stimulation protocol accordingly. Its latest version uses an AI-driven virtual assistant to optimize electrode placement and fine-tune pulse parameters in real time. "You could call it a virtual doctor," Doskočil said. It personalizes treatment using real-time body feedback, which represents a breakthrough for non-invasive therapy.' Stimvia's non-invasion URIS treatments are also painless. Patients are able to read, watch tv, or ... More even nap while undergoing treatment. The field is dominated by billion-dollar U.S. companies like Medtronic and Abbott. Boston Scientific last year bought Stimiva's competitor, Axonics, which also treats overactive bladder disorders, for almost $4B. Stimvia is small but agile. With 15 employees and manufacturing based in Pardubice, CZ, the company has already raised $8 million and is preparing a Series A round. It has shipped more than 200 units and is actively expanding across Europe. Denmark was the first foreign market, but the device is now being adopted in clinics across France, Italy, Spain, Greece, the Netherlands, and the UK. Stimvia recently earned MDR certification from German standards body TÜV SÜD, opening the door to reimbursement in EU healthcare systems and clearing a path toward FDA approval. Patients can control the intensity and duration of the URIS treatment for Parkinson's symptoms. The implications go beyond overactive bladder, which affects 500 million people globally and is quietly responsible for a massive adult diaper industry and associated greenhouse gas emissions. 'The actual number is likely much higher and may approach the 1 billion mark, given a prevalence of around 16% among adults—surpassing even diabetes,' Doskočil told me. 'However, it remains a highly stigmatized condition that will become increasingly significant as the population ages.' According to Wired Czechia, investors have taken notice. Stimvia is backed by local venture funds like Xenocles, Venture Capital Partners and Purple Ventures, with another five to ten million in new funding expected soon. But Doskočil, who is not a doctor but trained in economics and medical technology, says Europe's fragmented reimbursement landscape makes it harder to scale. That's why the company is now setting its sights on the United States, where one FDA approval covers 50 states. 'It's not easy to innovate in Europe,' Doskočil told me. 'Every country is different. The U.S. is one market. That changes everything.' Stimvia is hiring a commercial team in Miami, including a new chief commercial officer with prior experience at LivaNova. The U.S. rollout will also include investigator-led trials, with hopes of replicating European success in a much larger market. Stimvia's technology offers new hope for patients with a range of brain-related conditions, from Parkinson's tremors to overactive bladder. As Doskočil says, 'OAB is a brain disease masquerading as a bladder problem,' highlighting how many disorders traditionally treated by symptoms are actually rooted deeply in the brain. With non-invasive neuromodulation, Stimvia is pioneering a new way to treat these conditions, changing lives without surgery or implants.
Yahoo
17 hours ago
- Health
- Yahoo
Theranica to Present Three Real-World Evidence Studies at AHS Scientific Meeting Highlighting the Impact of the Nerivio® REN Wearable on Migraine Treatment
New studies confirm the clear benefit of early acute treatment, the consistent effectiveness of REN over years, and its clinical benefits in migraine both with and without aura BRIDGEWATER, N.J. and NETANYA, Israel, June 19, 2025 (GLOBE NEWSWIRE) -- Theranica, a pioneer in drug-free neuromodulation treatments for idiopathic pain conditions, today announced the presentation of three new real-world studies at the 2025 American Headache Society (AHS) 67th Annual Scientific Meeting, held in Minneapolis, Minnesota. The posters highlight the safety, efficacy, and versatility of the company's prescribed, FDA-cleared Nerivio® REN wearable, the first-and-only remote electrical neuromodulation (REN) therapy indicated for both acute and preventive treatment of migraine in people aged 8 and older. Among the highlights is a long-term study demonstrating that the REN wearable maintains consistent efficacy for migraine treatment over three years of use, with no signs of tachyphylaxis or 'treatment fatigue.' Throughout the study period, patients experienced consistent Pain Relief, Functional Recovery (see Figure), and freedom from migraine-associated symptoms such as photophobia, phonophobia, and nausea/vomiting.'These findings speak to a critical need in migraine treatment: durability with continued use,' said Stephanie J. Nahas, MD, MSEd, FAHS, FAAN, Assistant Director, Headache Medicine Fellowship Program, Jefferson Headache Center and Professor, Department of Neurology, Thomas Jefferson University. 'Migraine disease is complex and non-curable, yet too often patients struggle to find safe, well-tolerated treatments with sustained efficacy over time, something that is necessary to mitigate chronification and maintain quality of life. Seeing ongoing patient adherence with consistent results over a three-year span, without the risk of treatment fatigue, rebound symptoms, or gradually degraded response confirms the REN wearable as a sustainable, non-drug option for the long-term management of a complex condition such as migraine.' Another poster compares REN's impact in treating migraine with and without aura (MWA and MWoA) in nearly 32,000 patients. Despite having more severe baseline symptoms, patients with aura experienced treatment outcomes that were comparable, and in some measures slightly better than in patients without aura. Pain Relief, Functional Recovery, and freedom from migraine-associated symptoms were evident in both groups, reinforcing the REN wearable's reliable performance across these two major migraine subtypes. 'These studies represent some of the most comprehensive real-world analyses to date on the use of REN in migraine treatment. Together, they demonstrate that REN is not only effective when used early for acute treatment—but also durable over time and beneficial across different migraine subtypes,' said Alit Stark-Inbar, Ph.D., VP Medical Information and Research at Theranica. 'Presenting these data at AHS is an excellent vehicle to share clinically meaningful insights with the professional headache community, and to further support physicians in making evidenced-based decisions when taking care of their patients, being well educated about their treatment options'. These recent clinical data reinforce the REN wearable's unique position as a non-drug treatment of migraine, clinically proven to work both acutely and preventively. For patients facing intolerability or lack of efficacy with medications, or seeking non-pharmacological alternatives, Nerivio delivers safe, effective, and non-disruptive relief, without compromising outcomes. As an active participant in this year's AHS 67th Annual Scientific Meeting, held at the Minneapolis Convention Center from June 18 to 22, Theranica reaffirms its commitment to scientific exchange, clinical innovation, and engagement with the broader headache community. AHS remains a cornerstone in advancing migraine intervention and education, and Theranica is proud to contribute meaningful data that help shape the future of the field. Attendees are invited to visit Theranica at booth #501 to learn more. Information can also be found at About NerivioThe Nerivio® REN wearable is an acute and preventive (dual-use) prescription migraine treatment that works without drugs, needles, or invasive procedures. FDA-cleared for patients 8 and above, it uses gentle electrical pulses on the arm to activate the brain's natural pain regulation system, relieving migraine symptoms during an attack, and reducing the frequency and burden of future episodes when used preventively. Controlled by a smartphone app, the Nerivio REN wearable offers a safe, effective, and easy-to-use way to manage migraine—without the risk of systemic side effects or drug interactions. About TheranicaTheranica is a neuromodulation therapeutics company pioneering drug-free treatments for idiopathic pain conditions. Its FDA-cleared flagship product, Nerivio®, is the first-and-only prescribed REN wearable for both acute and preventive migraine care. Used in more than one million treatments across the U.S., Nerivio provides a much-needed option for migraine patient populations with unique qualities, including children, veterans, individuals managing comorbidities, and women of childbearing age. Dedicated to modernizing pain management without drugs or needles, Theranica continues to develop cutting-edge neuromodulation therapies that reshape the way pain is treated. Theranica Contact: Ronen Jashekronenj@ Media Contact:Grey Matter Marketingmedia@ A photo accompanying this announcement is available at: in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
4 days ago
- Health
- Yahoo
Helius Medical Technologies, Inc. Announces Claim Authorization by CignaHealth, for its Portable Neuromodulation Stimulator (PoNS®) Device
- CignaHealth becomes fifth major payer to authorize claim for PoNS Device at out-of-network adjusted negotiated list price of $19,161- -This follows another recent authorization by Anthem Multiplan for PoNS Device at out-of-network negotiated price of $19,160- NEWTOWN, Pa., June 16, 2025 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq: HSDT) ('Helius' or the 'Company'), a neurotech company focused on delivering a novel therapeutic neuromodulation approach for balance and gait deficits, today announced an additional authorized claim for payment for the PoNS Device from CignaHealth. CignaHealth becomes the fifth major payer to authorize claims for payment for the PoNS Device following the recent authorization by Anthem MultiPlan. 'With approvals now secured from five major commercial healthcare payers, we are making significant progress increasing MS patient access to the PoNS device,' said Dane Andreeff, Helius President and Chief Executive Officer. 'Importantly, these out-of-network total lump sum reimbursement payments at over $19,000, reinforce the value of PoNS while strengthening and supporting our ongoing efforts to achieve broader reimbursement from CMS and coverage across the healthcare landscape.' Depending on the individual's deductible and out-of-pocket costs, these claims may not result in an immediate PoNS Device sale. About the PoNS Device and PoNS Therapy The Portable Neuromodulation Stimulator ('PoNS') is an innovative, non-implantable, orally applied therapy that delivers neurostimulation through a mouthpiece connected to a controller and it's used, primarily at home, with physical rehabilitation exercise, to improve balance and gait. The PoNS device, which delivers mild electrical impulses to the tongue, is indicated for use in the United States as a short-term treatment of gait deficit due to mild-to-moderate symptoms from MS and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only. PoNS has shown effectiveness in treating gait or balance and a significant reduction in the risk of falling in stroke patients in Canada, where it received authorization for sale in three indications: (i) for use as a short-term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from stroke and is to be used in conjunction with physical therapy; (ii) for use as a short-term treatment (14 weeks) of chronic balance deficit due to mild-to-moderate traumatic brain injury ('mmTBI') and is to be used in conjunction with physical therapy; and (iii) for use as a short-term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS and is to be used in conjunction with physical therapy. PoNS is also authorized for sale in Australia for short term use by healthcare professionals as an adjunct to a therapeutic exercise program to improve balance and gait. For more information visit About Helius Medical Technologies, Inc. Helius Medical Technologies is a leading neurotech company in the medical device field focused on neurologic deficits using orally applied technology platform that amplifies the brain's ability to engage physiologic compensatory mechanisms and promote neuroplasticity, improving the lives of people dealing with neurologic diseases. The Company's first commercial product is the Portable Neuromodulation Stimulator. For more information about the PoNS® or Helius Medical Technologies, visit Cautionary Disclaimer Statement Certain statements in this news release are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws. All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties. Forward-looking statements are often identified by terms such as 'believe,' 'expect,' 'continue,' 'will,' 'goal,' 'aim' and similar expressions. Such forward-looking statements include, among others, statements regarding commercial reimbursement of the PoNS Device and the uses and effectiveness of PoNS and PoNS Therapy. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those expressed or implied by such statements. Important factors that could cause actual results to differ materially from the Company's expectations include uncertainties associated with the Company's capital requirements to achieve its business objectives, availability of funds, the Company's ability to find additional sources of funding, manufacturing, labor shortage and supply chain risks, including risks related to manufacturing delays, the Company's ability to obtain national Medicare insurance coverage and to obtain a reimbursement code, the Company's ability to continue to build internal commercial infrastructure, secure state distribution licenses, market awareness of the PoNS device, future clinical trials and the clinical development process, the product development process and the FDA regulatory submission review and approval process, other development activities, ongoing government regulation, and other risks detailed from time to time in the 'Risk Factors' section of the Company's Annual Report on Form 10-K for the year ended December 31, 2023, and its other filings with the United States Securities and Exchange Commission and the Canadian securities regulators, which can be obtained from either at or The reader is cautioned not to place undue reliance on any forward-looking statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to update the reasons why actual results could differ from such statements except to the extent required by law. Investor Relations Contact Philip Trip TaylorGilmartin Groupinvestorrelations@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
27-05-2025
- Business
- Yahoo
Salvia BioElectronics Secures $60M in Oversubscribed Series B to Bring its Pioneering Migraine Therapy to Market
Series B funding round led by Innovation Industries, with participation from Invest-NL, EIC Fund, and existing investors Inkef, Panakès Partners, SHS Capital, Dolby Family Ventures, Brabant Development Agency (BOM) and Thuja Capital. Proceeds will fund completion of clinical development and commercial launch preparations for MySalvia Therapy in the United States, Europe and Australia. Eindhoven, the Netherlands, May 27, 2025: Salvia BioElectronics, a clinical-stage medical device company pioneering neuromodulation therapy for people with chronic migraine, today announced the successful completion of a $60 million (€53 million) Series B financing round. The round was led by Innovation Industries, a European deeptech venture capital firm, with participation from Invest-NL and EIC Fund. Existing investors Inkef, Panakès Partners, SHS Capital, Dolby Family Ventures, BOM and Thuja Capital also joined the round. The funds enable Salvia to complete clinical development and prepare for the commercial launch of MySalvia Therapy, which is currently evaluated in the RECLAIM study, a multi-center, double-blind, sham-controlled study for people with chronic migraine. The funds also allow Salvia to focus on obtaining FDA market authorization in the US and regulatory approvals in Europe and Australia. Salvia is transforming migraine treatment with its proprietary neuromodulation technology, a personalized, minimally invasive therapy designed for people with chronic migraine. Salvia's ultra-thin implant targets key nerves involved in migraine, aiming to reduce the frequency and intensity of migraine attacks. 'With the support of this strong investor syndicate, we are empowered to bring MySalvia Therapy to patients in desperate need of new treatment options,' said Hubert Martens, founder and CEO of Salvia BioElectronics. 'Chronic migraine is not 'just a headache'. It is a debilitating neurological condition that forces people out of their social life, their work, and the life they want to live. Our mission is to restore their freedom. MySalvia Therapy is designed to provide not just relief, but meaningful and lasting impact. We believe people with migraine deserve the opportunity to reclaim their lives. With this funding, we are advancing toward regulatory approval and commercialization, with the ultimate goal of reaching millions of people affected by chronic migraine.' Addressing the global migraine burden Migraine is one of the leading causes of disability worldwide, resulting in an estimated $110 billion annually in lost productivity and medical costs in the EU and US alone. Current treatment options do not always provide sufficient relief, with the majority of chronic patients discontinuing their medication within the first year. This high dropout rate highlights the urgent need for alternative therapies. 'Salvia BioElectronics is redefining the migraine therapy landscape with a bold, patient-centered approach that combines cutting-edge neuromodulation with an elegant, minimally invasive design', said Caaj Greebe, Partner at Innovation Industries. 'At Innovation Industries, we invest in breakthrough technologies that have the potential to solve the most pressing real-world challenges and Salvia BioElectronics does exactly that: offering life-changing solutions for millions of people living with chronic migraine. We are excited to partner with the Salvia team as they advance through their clinical development to deliver a meaningful new therapy.' Transforming migraine treatment landscape Salvia's FDA-designated Breakthrough Device represents a promising new treatment option for patients who have not responded to available therapies. Early clinical data indicates a potential reduction in the frequency and intensity of migraine attacks when using the company's neuromodulation technology. The RECLAIM study is currently underway in Europe and Australia, with additional studies planned in the US to evaluate the therapy's safety and effectiveness. Salvia's implant is significantly less invasive than conventional technology, which reduces surgical complexity, patient recovery time, and offers a visually discreet solution. MySalvia Therapy is designed to put patients in full control. The therapy uses two ultra-thin implants, placed just beneath the skin of the forehead and the back of the head. Salvia's approach is user-activated and on demand. To activate therapy, patients use an external wearable device and simply press a button to deliver targeted stimulation exactly when and where it is needed. The technology also holds promise for treating cluster headache, a severely painful neurological condition with few effective treatment options. About Salvia BioElectronics Salvia BioElectronics is pioneering neuromodulation therapy aiming to transform the migraine treatment landscape. Designed to provide meaningful relief, MySalvia Therapy features an ultra-thin implant that comprehensively targets key nerves involved in migraine. Salvia is driven by the belief that people with chronic migraine deserve the opportunity to reclaim their lives. Founded in 2017 and headquartered in Eindhoven, The Netherlands, Salvia is led by a team of industry veterans with extensive experience in medical devices and neuromodulation. Active in the United States, Europe and Australia, the company is advancing clinical development with the support of leading investors. Salvia is also exploring the potential of its technology for the treatment of cluster headache. Learn more at: About Innovation Industries Innovation Industries is a leading European deep tech venture capital firm with €1 billion in capital under management. The firm invests in visionary science and engineering-based companies that tackle the world's most pressing challenges. With a strong belief that deep tech can deliver both outsized financial returns and global impact, Innovation Industries partners with exceptional entrepreneurs and researchers to turn scientific breakthroughs into transformative companies. The firm provides long-term capital and strategic support from lab to scale, actively bridging the gap between academia and industry through close collaboration with leading technical universities, research institutions and industry partners. Innovation Industries has offices in Amsterdam, Eindhoven and Munich. Learn more at: Media contact: Ingelou StolDirector Marketing 6 54903511Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
19-05-2025
- Health
- Yahoo
Neuromodulation: rewiring healthcare?
Once niche, the field of neuromodulation is now accelerating toward real-world breakthroughs for conditions such as tinnitus, substance use disorder, Parkinson's disease and epilepsy. According to a report by GlobalData, the global neurological devices market will reach a valuation of $20.9bn by 2033, up from $12.5bn in 2023. At Biomed Israel 2025: the 23rd National Life Science & Technology Week, taking place in Tel Aviv between 20 and 22 May, Serendipity Impact VC co-founder and managing partner Avi Yaron will give a keynote during a session titled 'Rewiring the Brain: Breakthroughs in Neurotech and Neuromodulation'. Moderated by Barry Greene, CEO of Sage Therapeutics; and Iris Grossman, chief therapeutics officer at Eleven Therapeutics, the session will also feature a keynote from Tanya Fischer, chief medical officer at Tenvie Therapeutics and presentations from companies such as NeuroSense Therapeutics and BrainValue NeuroTech. Diagnosed with a brain tumour at the age of 26, Yaron embarked on a self-advocacy quest to bring into being the neurotech required to help save his life – a story he shared in a TEDx talk in 2015. Yaron's investment fund's rationale is to invest in early technologies to transform mental and neuro health, with his personal journey having led him to the belief that in keeping people healthy, the future of medicine will be driven by personalised, predictive, preventative systems in which neuromodulation devices have a critical role to play. Medical Device Network sat down with Yaron to gain more insight into the value in neuromodulation and what the future holds for treating a range of neurological conditions. Avi Yaron (AY): Let's say that I have a headache. While I can take a pill to no longer 'feel' the headache, the headache is still there. The pharmacological element just shuts down the neurotransmitter so I won't feel it, but the pain is still there; and once I stop taking the pill, the headache and the pain being felt, may return. Unlike pharma, advanced neuromodulation technologies have the potential, either to completely cure or at least allow a person to reach a state of remission. Many neurodegenerative conditions, from depression and anxiety to Parkinson's and Alzheimer's disease, take over the person. Their life is no longer their life, but the life of their disease. By using neuromodulation to address their conditions, they are given back their lives and don't face the potential of being reliant on drugs for the rest of their lives as a means of eliminating their symptoms. I'm not against drugs. For certain conditions that we still don't fully understand, like schizophrenia, pharmaceuticals allow individuals to lead a normal life. Rather, I'm for people having the potential to take advantage of the new developments gradually moving towards becoming a reality, as an alternative to pharmaceuticals. As with most things, an evolution is assisted by many small revolutions. Neuromodulation has been an option for at least 30 years, but it is nowadays becoming a lot more advanced. If you look at Responsive Neurostimulation (RNS), for instance, it is possible to effectively eliminate epileptic seizures before they occur. With Parkinson's, neuromodulation approaches can delay its onset. In my view, this is just the beginning of the evolution being seen in this field. I am genuinely convinced that neuromodulation represents the next frontier of medicine. AY: Today, more people are developing more diseases at a younger age. I believe that it's always good to have a plethora of potential treatments, so a physician can decide on the most appropriate approach to an individual's needs. On the acute side, it may be best to use pharmacology, but on the chronic side, where pharma typically fails, technology can be used instead. In turn, the rise of other technologies such as AI allows for the ability to more easily crunch big data and bring greater personalisation to patients with neurological conditions. It makes no sense that males and females, youngsters and elders, or those with dark or light skin, receive the same treatment approach to their neurological condition. There is no one-size-fits-all. With neuro technology such as closed-loop neuromodulation, a technique that monitors brain activity or physiological signals and dynamically adjusts brain stimulation parameters in real-time, more personalised treatment modalities can be determined. And with the ability of such technologies to gather more information, in sync with AI, this not only empowers the patient, but it can also help direct them to the right treatment and the right physician. AY: One of the companies that Serendipity has invested in enables minimally invasive approaches to treat forms of epilepsy that were considered untreatable before. This example provides an integrative use of various technologies that serve medicine and serve mankind to make treatment better, more accurate, more personalised, less invasive and less traumatic. In turn, with what will hopefully be a wider availability of technologies like this in future, I believe that, knowing these non-invasive approaches are available, that people who were afraid of treatment before would now go and get diagnosed and therefore receive treatment earlier. In time, developments of this sort will hopefully not only reduce costs to healthcare systems but also help reduce individual suffering. AY: Startups here are leaner and often take less time and money to reach a certain result compared to those in other regions. I think that another huge advantage of Israeli startups is that they have to go global from day one. In my view, this outward-looking perspective is allowing the Israeli ecosystem to flourish in the field of neuromodulation. "Neuromodulation: rewiring healthcare?" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
