Latest news with #Andreeff
Yahoo
14-03-2025
- Business
- Yahoo
Helius joins BCI landscape with new subsidiary
Helius Medical Technologies is muscling in on the promising brain computer interface (BCI) field with the launch of a new business focused on developing the tech. The business, called Revelation Neuro, will be a wholly owned private subsidiary focused on developing non-implantable versions of BCIs. Shares in the Nasdaq-listed company opened unchanged following the announcement. Helius Medical develops its own portable neuromodulation stimulator platform to help with movement and balance. The US company stated it will combine newly developed intellectual property (IP) with existing technology – the latter will be licensed to Revelation Neuro. While it has amassed over $70m in funding to date, Helius does not plan to pump additional capital into the subsidiary, instead opting to rely on financing through third-party sources. BCIs are chips implanted in brain tissue that take brain signals and translate them into commands. The measured signals, which can be described as 'thoughts', are relayed to a secondary, external device which then carries out a specific function. Through Revelation Neuro, Helius is opting to go down the non-implantable route. Whilst it did not reveal specifics of its planned BCI technology, a clue can be found in Helius' neuromodulation platform that uses the stimulation on the tongue to elicit brain activity. This method of modulation is known as translingual stimulation and does not require implantation. Helius' CEO Dane Andreeff said: 'We believe Revelation Neuro's BCI technology will be a unique and less invasive therapeutic option.' Revelation Neuro will also apply artificial intelligence (AI) to optimise response to the translingual stimulation, using datasets from Helius' experience in the movement dysfunction field. The algorithms will enable a precise and personalised approach to motor function rehabilitation. 'BCI-enabled improvement in functional rehabilitation is the initial focus of Revelation Neuro's efforts, with the potential in the future to address neurological conditions including cognitive deficit, mood and behaviour disorders,' Andreeff added. The BCI landscape has received plenty of public attention, primarily in part due to Elon Musk-owned Neuralink. The company has implanted two paralysed patients with its chips, helping them play video games and chess, amongst other activities. Other companies like Synchron, BrainGate, and Clinatec, are more advanced in their clinical journey but it is hard to predict when the first BCIs will reach market, although some experts reckon approvals will be seen within the decade. The US Food and Drug Administration (FDA) has already singled BCIs out due to their unique nature, issuing guidance in 2021 on their research and development. The agency shared its thoughts on a range of topics to help guide companies that are clinically testing devices but has so far remained tight-lipped on regulatory stipulates. "Helius joins BCI landscape with new subsidiary" 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.
Associated Press
11-03-2025
- Business
- Associated Press
Helius Medical Technologies, Inc. Announces First Reimbursement by A Major Healthcare Provider for its Portable Neuromodulation Stimulator (PoNS®) Device
--Anthem Blue Cross Blue Shield approves claim for PoNS Device at out-of-network adjusted list price-- --Provides further validation of PoNS pricing-- NEWTOWN, Pa., March 11, 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 its first reimbursement payment from a major healthcare provider, Anthem Blue Cross Blue Shield, for its PoNS Device. 'The first reimbursement from a commercial healthcare provider is a significant achievement for Helius and MS patients. The payment at out-of-network adjusted list price further validates the therapeutic benefit of PoNS and its economic value for payers,' said Dane Andreeff, Helius President and Chief Executive Officer. 'This is an important milestone in the pursuit of third-party reimbursement and coverage and as we appeal the current CMS payment rates. We will remain steadfast in prioritizing increased patient access to support more MS patients and drive growth of the business.' 'Importantly, this was an out-of-network total lump sum reimbursement payment, which typically is 30 to 40% below in-network contracted payment rates. Therefore, we believe this reimbursement payment, including patient co-payment, of $15,420 for the PoNS controller and mouthpiece establishes an important benchmark as we approach major commercial insurance carriers to negotiate reimbursement payment rates for PoNS,' concluded Andreeff. 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 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 while 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 multiple sclerosis ('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 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 the appeal of CMS payment rates; the pursuit of third party reimbursement and coverage; . 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 Taylor
