Latest news with #VagusNerveStimulation
Yahoo
22-05-2025
- Health
- Yahoo
UT Dallas breakthrough medical study could revolutionize spinal cord recovery
The Brief Researchers at UT Dallas have miniaturized an implantable device for spinal cord injury recovery. Paired with physical therapy, the device has shown significant improvement, with potential even for patients injured decades ago. The breakthrough challenges long-held medical beliefs, offering new hope for those with chronic spinal cord injuries to their neck. DALLAS - Researchers at UT Dallas say they've made a historic breakthrough in spinal cord injury recovery with a recent implant study. According to a Nature paper released on Wednesday by the researchers, a minuscule new implantable device paired with physical therapy has achieved significant recovery in clinical trial patients, including one 45 years post-injury. The groundbreaking technology is the next generation of Vagus Nerve Stimuli (VNS), which the UT Dallas Nature study says is 50 times smaller than traditional devices. The tiny implantable device, pictured below sitting on a penny, is used for a neurorehabilitation process called "Closed-Loop Vagus Nerve Stimulation," or CLV. The first in-human study of the treatment took place in North Texas. The researchers say their new VNS, when used in tandem with targeted physical therapy, led to significant recovery of hand and arm function in people with chronic spinal cord injuries in their neck. One participant included in the study sustained their injury over 45 years ago, they say. Participants in the study who received the miniaturized VNS were reportedly found to have a dose-dependent improvement in their recovery, meaning the more therapy given, the better. In addition, the researchers have found no ceiling to the recovery potential. The paper says clinical measures in the trial also improved identically to real-world function for the participants. Why you should care According to a Wednesday release from Dr. Jane G. Wigginton, emergency medicine physician and Chief Medical Officer for the Texas Biomedical Device Center at the University of Texas at Dallas, the discoveries laid out in the new paper challenge long-held medical beliefs. Wigginton says the study's findings show that recovery is possible for spinal cord injury patients even decades after losing motor function; a discovery that defies "medical dogma." Wigginton notes the North Texas achievement is a scientific success and a beacon of hope for patients all over the world. What they're saying "We're not just seeing gains on clinical tests — we're seeing patients fasten their own necklaces, zip jackets in seconds instead of minutes, and throw balls for their dogs again. These are the moments that change lives," Wigginton said. The Source Information in this article came from a UT Dallas Nature paper and UT Dallas' Dr. Jane Wigginton.
Time of India
13-05-2025
- Health
- Time of India
Teen with cerebral palsy undergoes rare epilepsy op
Kolkata: A boy with cerebral palsy , Minhaz Hussain (15), who suffered recurrent bouts of seizures for years, underwent a rare surgery at CMRI, the third such procedure in the eastern region. Earlier anti-epilepsy therapy failed to better his state, but Vagus Nerve Stimulation had lowered seizure frequencies, said a doctor. Consultant neurosurgeon Rathijit Mitra and his team conducted the procedure. "We implanted an electrode on the left vagus nerve in the neck and linked it to a pulse generator, placed under the skin near the collarbone. It sends electrical impulses to the brain to help control seizures," said Mitra. The earlier VNS cases were held at INK. —Sumati Yengkhom
Yahoo
13-05-2025
- Business
- Yahoo
Tivic Expands VNS Intellectual Property Portfolio
- New patent protects methods for increasing efficacy via personalization of stimulation parameters and electrode positioning - FREMONT, Calif., May 13, 2025--(BUSINESS WIRE)--Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified therapeutics company, announced today it is expanding its non-invasive VNS patent portfolio with the filing of a new patent application with the United States Patent and Trademark Office. Patent No. 63,801,058 entitled "Vagus Nerve Stimulation System" expands the claims and protection around the technology that Tivic is developing and which it expects will redefine state-of-the art in non-invasive vagus nerve stimulation. "We continue to build a defensible position for our next generation VNS technology," said Blake Gurfein, Tivic Chief Scientific Officer. "This patent protects key learnings from our VNS optimization study, which is advancing the science of vagus nerve interventions. In fact, we believe we are moving the needle on what will become the state-of-the art treatment approach by delivering much greater and more consistent therapeutic effects compared to what is currently available." Jennifer Ernst, Tivic CEO, stated, "As we continue to advance our VNS program, protecting our proprietary and intellectual property is critical. Tivic's diversified portfolio of bioelectronic VNS and biologic immunotherapies represent a unique breadth of treatments to address health issues where immune system dysregulation is a significant underlying factor." About Tivic Health Systems, Inc. Tivic Health is a diversified therapeutics company harnessing the power of the immune and autonomic nervous systems to fight disease and restore health. Tivic Health's bioelectronic program is developing non-invasive medical devices that personalize key stimulation for the vagus nerve to deliver meaningful improvements in clinically relevant measures of the autonomous nervous system compared to current treatments, which are often invasive, ineffective or both. The company's lead biopharma product candidate, the TLR5 agonist Entolimod™ to treat ARS, has been granted Fast Track and Orphan Drug designation by the FDA. Tivic Health's first FDA approved product ClearUP™ is proven to treat sinus pain and pressure, and is available through online retailers and commercial distributors. For more information about Tivic Health, visit: Forward-Looking Statements This press release may contain "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Tivic Health Systems Inc.'s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: statements regarding the future development of ncVNS treatment, the Tivic Health's ability to commercialize products arising out of the ncVNS treatment and the Tivic Health's plans to seek regulatory approval for such clinical products and Tivic Health's continued focus on developing ncVNS treatment, including in the epilepsy, post-traumatic stress disorder, and/or ischemic stroke space; expected clinical utility including which patient populations may be pursued; market and other conditions; supply chain constraints; macroeconomic factors, including inflation; and unexpected costs, charges or expenses that reduce Tivic Health's capital resources. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Tivic Health's actual results to differ from those contained in the forward-looking statements, see Tivic Health's filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 29, 2024, under the heading "Risk Factors"; as well as the company's subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and Tivic Health Systems, Inc. undertakes no duty to update such information except as required by applicable law. View source version on Contacts Investor Contact: Hanover International, 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
Business Wire
13-05-2025
- Business
- Business Wire
Tivic Expands VNS Intellectual Property Portfolio
FREMONT, Calif.--(BUSINESS WIRE)-- Tivic Health ® Systems, Inc. (Nasdaq: TIVC), a diversified therapeutics company, announced today it is expanding its non-invasive VNS patent portfolio with the filing of a new patent application with the United States Patent and Trademark Office. Patent No. 63,801,058 entitled ' Vagus Nerve Stimulation System ' expands the claims and protection around the technology that Tivic is developing and which it expects will redefine state-of-the art in non-invasive vagus nerve stimulation. 'We continue to build a defensible position for our next generation VNS technology,' said Blake Gurfein, Tivic Chief Scientific Officer. 'This patent protects key learnings from our VNS optimization study, which is advancing the science of vagus nerve interventions. In fact, we believe we are moving the needle on what will become the state-of-the art treatment approach by delivering much greater and more consistent therapeutic effects compared to what is currently available.' Jennifer Ernst, Tivic CEO, stated, 'As we continue to advance our VNS program, protecting our proprietary and intellectual property is critical. Tivic's diversified portfolio of bioelectronic VNS and biologic immunotherapies represent a unique breadth of treatments to address health issues where immune system dysregulation is a significant underlying factor.' About Tivic Health Systems, Inc. Tivic Health is a diversified therapeutics company harnessing the power of the immune and autonomic nervous systems to fight disease and restore health. Tivic Health's bioelectronic program is developing non-invasive medical devices that personalize key stimulation for the vagus nerve to deliver meaningful improvements in clinically relevant measures of the autonomous nervous system compared to current treatments, which are often invasive, ineffective or both. The company's lead biopharma product candidate, the TLR5 agonist Entolimod™ to treat ARS, has been granted Fast Track and Orphan Drug designation by the FDA. Tivic Health's first FDA approved product ClearUP™ is proven to treat sinus pain and pressure, and is available through online retailers and commercial distributors. For more information about Tivic Health, visit: Forward-Looking Statements This press release may contain 'forward-looking statements' that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as 'anticipate,' 'believe,' 'contemplate,' 'could,' 'estimate,' 'expect,' 'intend,' 'seek,' 'may,' 'might,' 'plan,' 'potential,' 'predict,' 'project,' 'target,' 'aim,' 'should,' 'will' 'would,' or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Tivic Health Systems Inc.'s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: statements regarding the future development of ncVNS treatment, the Tivic Health's ability to commercialize products arising out of the ncVNS treatment and the Tivic Health's plans to seek regulatory approval for such clinical products and Tivic Health's continued focus on developing ncVNS treatment, including in the epilepsy, post-traumatic stress disorder, and/or ischemic stroke space; expected clinical utility including which patient populations may be pursued; market and other conditions; supply chain constraints; macroeconomic factors, including inflation; and unexpected costs, charges or expenses that reduce Tivic Health's capital resources. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Tivic Health's actual results to differ from those contained in the forward-looking statements, see Tivic Health's filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 29, 2024, under the heading 'Risk Factors'; as well as the company's subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and Tivic Health Systems, Inc. undertakes no duty to update such information except as required by applicable law.
Associated Press
15-04-2025
- Health
- Associated Press
CCHR Exposes Invasive Brain Treatments: Mental Health Patients Pay the Price
LOS ANGELES, Calif., April 15, 2025 (SEND2PRESS NEWSWIRE) — The Citizens Commission on Human Rights International (CCHR), a leading mental health industry watchdog, has released a damning report detailing how psychiatry is blaming patients—rather than failed treatments—to justify a surge in brain stimulation interventions. 'When psychiatric drugs and therapy don't work, psychiatry rarely blames the treatment—it blames the patient, saying they are 'treatment-resistant,'' said Jan Eastgate, President of CCHR International. ''Treatment-resistant' isn't a diagnosis—it's a deflection. And it's being used to push invasive procedures like Electroconvulsive Therapy (ECT), Deep Brain Stimulation (DBS), Vagus Nerve Stimulation (VNS), and Transcranial Magnetic Stimulation (TMS).' These brain stimulation devices were 'cleared' by the Food and Drug Administration (FDA) or approved under Humanitarian Device Exemptions (HDEs), bypassing the rigorous testing normally required of most medical devices. Many were greenlighted based on the device delivering ECT—a practice known for causing brain damage, memory loss, and even death.[1] Even industry insiders acknowledge concerns. 'The precise physiological mechanisms of DBS are not yet fully understood,' admits one clinical review.[2] A professor of psychiatry at Brown University's Alpert Medical School, put it more starkly: 'This really is a kind of mind control.'[3] The term 'treatment-resistant' is a psychiatric sleight of hand, now used to justify a global neurostimulation industry projected to hit $51 billion by 2030. Labeling up to 60% of psychiatric patients as 'resistant' creates a false pretext for experimental interventions.[4] Meanwhile, 25% of patients develop drug tolerance within weeks, prompting ever-riskier 'solutions.'[5] Electroshock: Psychiatry's Recycled Blunder ECT involves sending up to 460 volts through the brain to trigger seizures. Contrary to PR spin, Eastgate says, experts report modern ECT is no safer—voltage levels are higher than when broken bones were common due to convulsions.[6] Attorney Jonathan Emord, who has challenged the FDA's approval processes, stated: 'All patients who receive ECT suffer memory loss and cognitive impairment… many forgetting much of their lives before treatment.' A 2020 peer-reviewed review concluded ECT has 'no place in evidence-based medicine.'[12] Brain-Altering Experiments in Disguise Deep Brain Stimulation (DBS): Electrodes are surgically implanted into the brain, powered by a device in the chest. Vagus Nerve Stimulation (VNS): Electrical stimulation delivered via electrodes wrapped around the vagus nerve near the heart. Transcranial Magnetic Stimulation (TMS): Magnetic pulses are aimed at the brain over six weeks. New variants—rTMS, iTBS, cTBS—deliver hundreds of brain pulses per session with unknown long-term risks. No Proof of Disease, No Justification for Devices Despite the sophistication of these procedures, there is still no objective medical test to diagnose any psychiatric disorder. No blood test. No brain scan. No biomarker.[19] Dr. Thomas Insel, former director of the National Institute for Mental Health advised: 'Unlike our definitions of ischemic heart disease, lymphoma, or AIDS, the DSM [Diagnostic and Statistical Manual of Mental Disorders] diagnoses are based on a consensus… not any objective laboratory measure.'[20] 'It's not the patient that's resistant—it's the system that's resistant to accountability,' Eastgate said. 'In any other field, if the intervention failed, the treatment would be reevaluated. But psychiatry doubles down, pushing more dangerous interventions instead.' CCHR urges policymakers to: CCHR, established in 1969 by the Church of Scientology and psychiatrist Dr. Thomas Szasz has a record of reforms that include banning lethal Deep Sleep Treatment, outlawing ECT use on children in several U.S. states, and securing global recognition for patient rights. Today, the United Nations and WHO echo what CCHR has long fought for: coercion has no place in mental health care. To learn more, visit: Sources: [1] FDA, Final Rule on Electroconvulsive Therapy Devices, Federal Register, Dec. 26, 2018; WHO-OHCHR, 'Guidance on Mental Health, Human Rights and Legislation,' 9 Oct. 2023, p. 58, [2] Lavanya P. Sharma, et al., 'Deep brain stimulation – A primer for psychiatrists,' Asian Journal of Psychiatry, Vol. 104, Feb. 2025 [3] Lavanya P. Sharma, et al., 'Deep brain stimulation – A primer for psychiatrists,' Asian Journal of Psychiatry, Vol. 104, Feb. 2025 [4] 'Treatment resistance in psychiatry: state of the art and new directions,' Mol Psychiatry, July 2021, [5] [6] Douglas G. Cameron, 'ECT: Sham Statistics, the Myth of Convulsive Therapy, and the Case for Consumer Misinformation,' The Journal of Mind and Behavior, Vol 15, Winter-Spring 1994, pp 177-198, [7] WHO- OHCHR, 'Guidance on Mental Health, Human Rights and Legislation,' 9 Oct. 2023, pp. 15, 58 and 59; [8] 'Electroconvulsive Shock Therapy Lawsuit – What You Should Know About ECT,' [9] Peter Simons, 'ECT Does Not Seem to Prevent Suicide,' Mad In America, 17 Feb. 2023, [10] Based on Freedom of Information Requests to 27 states [11] Tricare Encounter Data (TED) Non-Institutional (Outpatient) for Purchased Care claims, Data Extract as of 10/21/2016, Data received from CCHR International Freedom of Information Request, 2016 [12] Jonathon Emord, 'FDA unjustified in downgrading shock therapy brain injury risks,' The Washington Times, 12 Oct. 2016, [13] 'Brain Stimulation Therapies,' NIMH, accessed 21 Feb. 2011; Dr. Ananya Mandal, MD, 'Deep Brain Stimulation Side Effects,' News Medical Life Sciences, 22 July 2023, [14] Danielle Egan, 'Adverse Effects: The Perils of Deep Brain Stimulation for Depression,' Mad in America, 24 Sept. 2015 [15] [16] Natasha Tracy, 'Vagus Nerve Stimulation (VNS) for Treating Depression,' Healthy Place, 11 Jan. 2022, [17] FDA MAUDE report, Neurostar TMS, 07/14/2021, [18] [19] [20] MULTIMEDIA: Image link for media: Image caption: 'It's not the patient that's resistant—it's the system that's resistant to accountability. In any other field, if the intervention failed, the treatment would be reevaluated. But psychiatry doubles down, pushing more dangerous interventions instead.' – Jan Eastgate, President CCHR International. NEWS SOURCE: Citizens Commission on Human Rights Keywords: Religion and Churches, The Citizens Commission on Human Rights International CCHR, mental health industry watchdog, brain stimulation interventions, LOS ANGELES, Calif. This press release was issued on behalf of the news source (Citizens Commission on Human Rights) who is solely responsibile for its accuracy, by Send2Press® Newswire. Information is believed accurate but not guaranteed. Story ID: S2P125512 APNF0325A To view the original version, visit: © 2025 Send2Press® Newswire, a press release distribution service, Calif., USA. RIGHTS GRANTED FOR REPRODUCTION IN WHOLE OR IN PART BY ANY LEGITIMATE MEDIA OUTLET - SUCH AS NEWSPAPER, BROADCAST OR TRADE PERIODICAL. MAY NOT BE USED ON ANY NON-MEDIA WEBSITE PROMOTING PR OR MARKETING SERVICES OR CONTENT DEVELOPMENT. Disclaimer: This press release content was not created by nor issued by the Associated Press (AP). Content below is unrelated to this news story.
