Latest news with #neuralimplants
Yahoo
7 days ago
- Health
- Yahoo
Cells: Hemostemix ACP-01 Provides the Scientific Basis for Improving the Longevity and Signal Uptake of Brain Computer Implants
Calgary, Alberta--(Newsfile Corp. - July 31, 2025) - Hemostemix (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0) ("Hemostemix" or the "Company") is excited to highlight a groundbreaking research article published in Cells on June 29, 2025, by Fraser C. Henderson Sr. and Ms. Kelly Tuchman, exploring how a combination of the patient's own ACP-01 and NCP-01 (autologous blood-derived cell precursors) may support the long-term performance of brain-computer interfaces (BCIs). Key Scientific Insights The Challenge with BCIs: Inflammation, scarring, and programmed cell death undermine performance over timeImplantable electrodes within the brain have enabled remarkable achievements—e.g., paralyzed individuals playing chess and blind individuals recognizing letters. However, these devices often fail between six months and one year. The longest BCI in use lasted seven years. Even then, issues like inflammation, scarring, and programmed cell death (apoptosis) undermine performance over time. Hemostemix's Innovative Cell-Based SolutionThe article proposes using two types of autologous (patient-derived) progenitor cells: Angiogenic Cell Precursors (ACP-01, VesCell™) and Neural Cell Precursors (NCP-01), delivered into the cerebrospinal fluid, to foster a healing cellular environment around the implant. ACP-01 (VesCell™) produces signals like IL-8, VEGF, and angiogenin. They attract natural killer (NK) cells that suppress inflammation, reduce tissue scarring, and support new blood vessel growth (angiogenesis). ACP-01potentiate healing through the expression of tissue regeneration factors CXCL8, VEGF, and angiogenin. They include CD34+ (blood stem cell). CXCL8 recruit endogenous CD34+, that circulate peripherally, to the site of implant. CXCL8 (interleukin-8) activate NF-κB, resulting in gene transcription and protein synthesis necessary for learning (memory formation and consolidation). NCP- 01express receptors like CXCR4, and migrate toward the BCI site. NCP help shift immune cells into a neuroprotective (M2) state. NCP differentiate into neurons and supporting glial cells that promote new synaptic connections and neural plasticity. Figure 1. Natural Killer (NK) cells recruited by angiogenic cell precursors (ACPs) suppress inflammation through the release of anti-inflammatory cytokines, dendritic cell and monocyte maturation, and lysis of auto-aggressive T cells. Created in BioRender. Tuchman, K. (2025) view an enhanced version of this graphic, please visit: Figure 2. Angiogenic cell precursors (ACPs) potentiate healing through expression of tissue regeneration factors such as the chemokine interleukin-8 (CXCL8), vascular endothelial growth factor (VEGF) and angiogenin. In addition to the robust presence of CD34+ in ACPs, the expressed CXCL8 recruits peripheral CD34+ precursor cells, further supporting angiogenesis. Created by BioRender. Tuchman, K. (2025) view an enhanced version of this graphic, please visit: Figure 3. Interleukin-8 (CXCL8) is expressed by angiogenic cell precursors (ACPs), and activatesthe canonical NF-κB pathway, resulting in gene transcription and protein synthesis necessary formemory formation and consolidation. Created in BioRender. Tuchman, K. (2025) view an enhanced version of this graphic, please visit: Mechanism of Action Together, ACP and NCP support a cascade of beneficial molecular events: Activation of neurotrophic factors and NF-κB pathways that protect cells (anti-apoptosis). Promotion of synaptogenesis (formation of connections between neurons), neuritogenesis (growth of neural processes), to improve learning-related plasticity. As the patient's DNA-based engineered cellular environment, ACP and NCP home to the site of BCI, decrease inflammation, increase angiogenesis, increase neuro-protectiveness, promote new synaptic connections, and may dramatically extend both the lifespan of BCI, signal fidelity and learning. Why This Matters to Hemostemix Hemostemix's patented proprietary platform produces ACP-01 (angiogenic precursors) and NCP-01 (neural precursors) from a patient's own blood. This new research provides a scientific basis of how the combination of ACP-01+NCP-01 promises to overcome the major limitations in BCI implants. The findings align with Hemostemix's vision of licensing ACP-01 and NCP-01 to enhance BCI longevity and functionalities. Forward-Looking Perspective This research paves the way for: Licensing with BCI technology companies to combine autologous stem-cell support of BCI with cutting-edge patient-based angiogenic and neural interfaces. Rapid preclinical and clinical testing of ACP-01 + NCP-01 at BCI implant sites. "We imagine a world where the environment for BCI, the patient's brain, augmented by the patients' own stem cells, improves the longevity of the implants from months to a lifetime, improves signal fidelity to increase functional movement, and increases learning and memory retention," stated Dr. Fraser Henderson, lead author. "I want to thank Dr. Henderson and Ms. Tuchman for this very thorough exposition of the benefits of using one's own DNA structured as ACP & NCP to improve BCIs. Truly, this is incredible work. Coupled with our market analyses of the top three BCI companies, shareholders can expect more news to follow, as Mr. Lawrence, Chief Commercialization Officer and I meet with potential partners," stated Thomas Smeenk, CEO. In Summary Dr. Henderson has outlined a new cell-based approach that may allow brain implants to work reliably for years. By delivering two types of the patient's blood-derived stem cell precursors—one that fights inflammation and boosts blood flow, the other that helps build new neuronal cells—this method could protect and improve the brain at the site of BCI implant. Hemostemix's ready-to-use cell products (ACP-01 and NCP-01) are a direct fit for this approach and could potentially transform how long and well brain-computer interfaces function. ABOUT HEMOSTEMIX Founded in 2003, Hemostemix is a stem-cell therapeutics company with patented technology to generate autologous angiogenic and neural cell precursors from patient blood. Its ACP-01 and NCP-01 cell lines aim to treat cardiovascular, neurological, and implant-related conditions. A winner of the World Economic Forum Technology Pioneer Award, the Company has developed, patented, is scaling and selling autologous (patient's own) blood-based stem cell therapy, VesCell™ (ACP-01). Hemostemix has completed seven clinical studies of 318 subjects and published its results in 11 peer reviewed publications. ACP-01 is safe, clinically relevant and statistically significant as a treatment for peripheral arterial disease, chronic limb threatening ischemia, non ischemic dilated cardiomyopathy, ischemic cardiomyopathy, congestive heart failure, and angina. Hemostemix completed its Phase II clinical trial for chronic limb threatening ischemia and published its results in the Journal of Biomedical Research & Environmental Science. As compared to a five year mortality rate of 60% in the CLTI patient population, UBC and U of T reported to the 41st meeting of vascular surgeons: 0% mortality, cessation of pain, wound healing in 83% of patients followed for up to 4.5 years, as a midpoint result. For more information, please visit For further information, please contact: Thomas Smeenk, President, CEO & Co-Founder: EM: tsmeenk@ / PH: 905-580-4170 Neither the TSX Venture Exchange nor its Regulation Service Provider (as that term is defined under the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. Forward-Looking Information: This news release contains "forward-looking information" within the meaning of applicable Canadian securities legislation. All statements, other than statements of historical fact, included herein are forward-looking information. In particular, this news release contains forward-looking information in relation to the publication in CELLS of the properties of ACP-01+NCP-01 and the improvement of brain computer interface (BCI) technologies. There can be no assurance that such forward-looking information will prove to be accurate. Actual results and future events could differ materially from those anticipated in such forward-looking information. This forward-looking information reflects Hemostemix's current beliefs and is based on information currently available to Hemostemix and on assumptions Hemostemix believes are reasonable. These assumptions include, but are not limited to: the underlying value of Hemostemix and its Common Shares; the successful resolution of any litigation that Hemostemix is pursuing or defending (the "Litigation"); the results of ACP-01 research, trials, studies and analyses, including the analysis being equivalent to or better than previous research, trials or studies; the receipt of all required regulatory approvals for research, trials or studies; the level of activity, market acceptance and market trends in the healthcare sector; the economy generally; consumer interest in Hemostemix's services and products; competition and Hemostemix's competitive advantages; and, Hemostemix obtaining satisfactory financing to fund Hemostemix's operations including any research, trials or studies, and any Litigation. Forward-looking information is Subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of Hemostemix to be materially different from those expressed or implied by such forward-looking information. Such risks and other factors may include, but are not limited to: the ability of Hemostemix to complete clinical trials, complete a satisfactory analyses and file the results of such analyses to gain regulatory approval of a phase II or phase III clinical trial of ACP-01; potential litigation Hemostemix may face; general business, economic, competitive, political and social uncertainties; general capital market conditions and market prices for securities; delay or failure to receive board or regulatory approvals; the actual results of future operations including the actual results of future research, trials or studies; competition; changes in legislation affecting Hemostemix; the timing and availability of external financing on acceptable terms; long-term capital requirements and future developments in Hemostemix's markets and the markets in which it expects to compete; lack of qualified, skilled labour or loss of key individuals; and risks related to the COVID-19 pandemic including various recommendations, orders and measures of governmental authorities to try to limit the pandemic, including travel restrictions, border closures, non-essential business closures service disruptions, quarantines, self-isolations, shelters-in-place and social distancing, disruptions to markets, disruptions to economic activity and financings, disruptions to supply chains and sales channels, and a deterioration of general economic conditions including a possible national or global recession or depression; the potential impact that the COVID-19 pandemic may have on Hemostemix which may include a decreased demand for the services that Hemostemix offers; and a deterioration of financial markets that could limit Hemostemix's ability to obtain external financing. A description of additional risk factors that may cause actual results to differ materially from forward-looking information can be found in Hemostemix's disclosure documents on the SEDAR website at Although Hemostemix has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. Readers are cautioned that the foregoing list of factors is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking information as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Forward-looking information contained in this news release is expressly qualified by this cautionary statement. The forward-looking information contained in this news release represents the expectations of Hemostemix as of the date of this news release and, accordingly, it is Subject to change after such date. However, Hemostemix expressly disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as expressly required by applicable securities law. To view the source version of this press release, please visit
Al Arabiya
27-07-2025
- Health
- Al Arabiya
Nih cuts spotlight a hidden crisis facing patients with experimental brain implants
Carol Seeger finally escaped her debilitating depression with an experimental treatment that placed electrodes in her brain and a pacemaker-like device in her chest. But when its batteries stopped working, insurance wouldn't pay to fix the problem, and she sank back into a dangerous darkness. She worried for her life, asking herself: 'Why am I putting myself through this?' Seeger's predicament highlights a growing problem for hundreds of people with experimental neural implants, including those for depression, quadriplegia, and other conditions. Although these patients take big risks to advance science, there's no guarantee that their devices will be maintained – particularly after they finish participating in clinical trials – and no mechanism requiring companies or insurers to do so. A research project led by Gabriel Lázaro-Muñoz, a Harvard University scientist, aimed to change that by creating partnerships between players in the burgeoning implant field to overcome barriers to device access and follow-up care. But the cancellation of hundreds of National Institutes of Health grants by the Trump administration this year left the project in limbo, dimming hope for Seeger and others like her who wonder what will happen to their health and progress. An ethical quagmire – Unlike medications, implanted devices often require parts, maintenance, batteries, and surgeries when changes are needed. Insurance typically covers such expenses for federally approved devices considered medically necessary but not experimental ones. A procedure to replace a battery alone can cost more than $15,000 without insurance, Lázaro-Muñoz said. 'While companies stand to profit from research, there's really nothing that helps ensure that device manufacturers have to provide any of these parts or cover any kind of maintenance,' said Lázaro-Muñoz. Some companies also move on to newer versions of devices or abandon the research altogether, which can leave patients in an uncertain place. Medtronic, the company that made the deep brain stimulation or DBS technology Seeger used, said in a statement that every study is different and that the company puts patient safety first when considering care after studies end. 'People consider various possibilities when they join a clinical trial.' The Food and Drug Administration requires the informed consent process to include a description of reasonably foreseeable risks and discomforts to the participant, a spokesperson said. However, the FDA doesn't require trial plans to include procedures for long-term device follow-up and maintenance, although the spokesperson stated that the agency has requested those in the past. While some informed consent forms say devices will be removed at a study's end, Lázaro-Muñoz said removal is ethically problematic when a device is helping a patient. Plus, he said some trial participants told him and his colleagues that they didn't remember everything discussed during the consent process, partly because they were so focused on getting better. Brandy Ellis, a 49-year-old in Boynton Beach, Florida, said she was desperate for healing when she joined a trial testing the same treatment Seeger got, which delivers an electrical current into the brain to treat severe depression. She was willing to sign whatever forms were necessary to get help after nothing else had worked. 'I was facing death,' she said. 'So it was most definitely consent at the barrel of a gun, which is true for a lot of people who are in a terminal condition.' Patients risk losing a treatment of last resort – Ellis and Seeger, 64, both turned to DBS as a last resort after trying many approved medications and treatments. 'I got in the trial fully expecting it not to work because nothing else had. So I was kind of surprised when it did,' said Ellis, whose device was implanted in 2011 at Emory University in Atlanta. 'I am celebrating every single milestone because I'm like: 'This is all bonus life for me.'' She's now on her third battery. She needed surgery to replace two single-use ones, and the one she has now is rechargeable. She's lucky her insurance has covered the procedures, she said, but she worries it may not in the future. 'I can't count on any coverage because there's nothing that says even though I've had this and it works that it has to be covered under my commercial or any other insurance,' said Ellis, who advocates for other former trial participants. Even if companies still make replacement parts for older devices, she added, availability and accessibility are entirely different things given most people can't afford continued care without insurance coverage. Seeger, whose device was implanted in 2012 at Emory, said she went without a working device for around four months when the insurance coverage her wife's job at Emory provided wouldn't pay for battery replacement surgery. Neither would Medicare, which generally only covers DBS for FDA-approved uses. With her research team at Emory advocating for her, Seeger ultimately got financial help from the hospital's indigent care program and paid a few thousand dollars out of pocket. She now has a rechargeable battery, and the device has been working well. But at any point, she said that could change. Federal cuts stall solutions – Lázaro-Muñoz hoped his work would protect people like Seeger and Ellis. 'We should do whatever we can as a society to be able to help them maintain their health,' he said. Lázaro-Muñoz's project received about $987,800 from the National Institute of Mental Health in the 2023 and 2024 fiscal years and was already underway when he was notified of the NIH funding cut in May. He declined to answer questions about it. Ellis said any delay in addressing the thorny issues around experimental brain devices hurts patients. 'Planning at the beginning of a clinical trial about how to continue treatment and maintain devices,' she said, 'would be much better than depending on the kindness of researchers and the whims of insurers.' 'If this turns off, I get sick again. Like, I'm not cured,' she said. 'This is a treatment that absolutely works but only as long as I've got a working device.'
Yahoo
27-07-2025
- Health
- Yahoo
NIH cuts spotlight a hidden crisis facing patients with experimental brain implants
Carol Seeger finally escaped her debilitating depression with an experimental treatment that placed electrodes in her brain and a pacemaker-like device in her chest. But when its batteries stopped working, insurance wouldn't pay to fix the problem and she sank back into a dangerous darkness. She worried for her life, asking herself: 'Why am I putting myself through this?' Seeger's predicament highlights a growing problem for hundreds of people with experimental neural implants, including those for depression, quadriplegia and other conditions. Although these patients take big risks to advance science, there's no guarantee that their devices will be maintained — particularly after they finish participating in clinical trials — and no mechanism requiring companies or insurers to do so. A research project led by Gabriel Lázaro-Muñoz, a Harvard University scientist, aimed to change that by creating partnerships between players in the burgeoning implant field to overcome barriers to device access and follow-up care. But the cancellation of hundreds of National Institutes of Health grants by the Trump administration this year left the project in limbo, dimming hope for Seeger and others like her who wonder what will happen to their health and progress. An ethical quagmire Unlike medications, implanted devices often require parts, maintenance, batteries and surgeries when changes are needed. Insurance typically covers such expenses for federally approved devices considered medically necessary, but not experimental ones. A procedure to replace a battery alone can cost more than $15,000 without insurance, Lázaro-Muñoz said. While companies stand to profit from research, 'there's really nothing that helps ensure that device manufacturers have to provide any of these parts or cover any kind of maintenance,' said Lázaro-Muñoz. Some companies also move on to newer versions of devices or abandon the research altogether, which can leave patients in an uncertain place. Medtronic, the company that made the deep brain stimulation, or DBS, technology Seeger used, said in a statement that every study is different and that the company puts patient safety first when considering care after studies end. People consider various possibilities when they join a clinical trial. The Food and Drug Administration requires the informed consent process to include a description of 'reasonably foreseeable risks and discomforts to the participant,' a spokesperson said. However, the FDA doesn't require trial plans to include procedures for long-term device follow-up and maintenance, although the spokesperson stated that the agency has requested those in the past. While some informed consent forms say devices will be removed at a study's end, Lázaro-Muñoz said removal is ethically problematic when a device is helping a patient. Plus, he said, some trial participants told him and his colleagues that they didn't remember everything discussed during the consent process, partly because they were so focused on getting better. Brandy Ellis, a 49-year-old in Boynton Beach, Florida, said she was desperate for healing when she joined a trial testing the same treatment Seeger got, which delivers an electrical current into the brain to treat severe depression. She was willing to sign whatever forms were necessary to get help after nothing else had worked. 'I was facing death,' she said. 'So it was most definitely consent at the barrel of a gun, which is true for a lot of people who are in a terminal condition.' Patients risk losing a treatment of last resort Ellis and Seeger, 64, both turned to DBS as a last resort after trying many approved medications and treatments. 'I got in the trial fully expecting it not to work because nothing else had. So I was kind of surprised when it did,' said Ellis, whose device was implanted in 2011 at Emory University in Atlanta. 'I am celebrating every single milestone because I'm like: This is all bonus life for me.' She's now on her third battery. She needed surgery to replace two single-use ones, and the one she has now is rechargeable. She's lucky her insurance has covered the procedures, she said, but she worries it may not in the future. 'I can't count on any coverage because there's nothing that says even though I've had this and it works, that it has to be covered under my commercial or any other insurance,' said Ellis, who advocates for other former trial participants. Even if companies still make replacement parts for older devices, she added, 'availability and accessibility are entirely different things,' given most people can't afford continued care without insurance coverage. Seeger, whose device was implanted in 2012 at Emory, said she went without a working device for around four months when the insurance coverage her wife's job at Emory provided wouldn't pay for battery replacement surgery. Neither would Medicare, which generally only covers DBS for FDA-approved uses. With her research team at Emory advocating for her, Seeger ultimately got financial help from the hospital's indigent care program and paid a few thousand dollars out of pocket. She now has a rechargeable battery, and the device has been working well. But at any point, she said, that could change. Federal cuts stall solutions Lázaro-Muñoz hoped his work would protect people like Seeger and Ellis. 'We should do whatever we can as a society to be able to help them maintain their health,' he said. Lázaro-Muñoz's project received about $987,800 from the National Institute of Mental Health in the 2023 and 2024 fiscal years and was already underway when he was notified of the NIH funding cut in May. He declined to answer questions about it. Ellis said any delay in addressing the thorny issues around experimental brain devices hurts patients. Planning at the beginning of a clinical trial about how to continue treatment and maintain devices, she said, would be much better than depending on the kindness of researchers and the whims of insurers. 'If this turns off, I get sick again. Like, I'm not cured,' she said. 'This is a treatment that absolutely works, but only as long as I've got a working device.' ____ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content. Solve the daily Crossword
The Independent
27-07-2025
- Health
- The Independent
NIH cuts spotlight a hidden crisis facing patients with experimental brain implants
Carol Seeger finally escaped her debilitating depression with an experimental treatment that placed electrodes in her brain and a pacemaker-like device in her chest. But when its batteries stopped working, insurance wouldn't pay to fix the problem and she sank back into a dangerous darkness. She worried for her life, asking herself: 'Why am I putting myself through this?' Seeger's predicament highlights a growing problem for hundreds of people with experimental neural implants, including those for depression, quadriplegia and other conditions. Although these patients take big risks to advance science, there's no guarantee that their devices will be maintained — particularly after they finish participating in clinical trials — and no mechanism requiring companies or insurers to do so. A research project led by Gabriel Lázaro-Muñoz, a Harvard University scientist, aimed to change that by creating partnerships between players in the burgeoning implant field to overcome barriers to device access and follow-up care. But the cancellation of hundreds of National Institutes of Health grants by the Trump administration this year left the project in limbo, dimming hope for Seeger and others like her who wonder what will happen to their health and progress. An ethical quagmire Unlike medications, implanted devices often require parts, maintenance, batteries and surgeries when changes are needed. Insurance typically covers such expenses for federally approved devices considered medically necessary, but not experimental ones. A procedure to replace a battery alone can cost more than $15,000 without insurance, Lázaro-Muñoz said. While companies stand to profit from research, 'there's really nothing that helps ensure that device manufacturers have to provide any of these parts or cover any kind of maintenance,' said Lázaro-Muñoz. Some companies also move on to newer versions of devices or abandon the research altogether, which can leave patients in an uncertain place. Medtronic, the company that made the deep brain stimulation, or DBS, technology Seeger used, said in a statement that every study is different and that the company puts patient safety first when considering care after studies end. People consider various possibilities when they join a clinical trial. The Food and Drug Administration requires the informed consent process to include a description of 'reasonably foreseeable risks and discomforts to the participant,' a spokesperson said. However, the FDA doesn't require trial plans to include procedures for long-term device follow-up and maintenance, although the spokesperson stated that the agency has requested those in the past. While some informed consent forms say devices will be removed at a study's end, Lázaro-Muñoz said removal is ethically problematic when a device is helping a patient. Plus, he said, some trial participants told him and his colleagues that they didn't remember everything discussed during the consent process, partly because they were so focused on getting better. Brandy Ellis, a 49-year-old in Boynton Beach, Florida, said she was desperate for healing when she joined a trial testing the same treatment Seeger got, which delivers an electrical current into the brain to treat severe depression. She was willing to sign whatever forms were necessary to get help after nothing else had worked. 'I was facing death,' she said. 'So it was most definitely consent at the barrel of a gun, which is true for a lot of people who are in a terminal condition.' Patients risk losing a treatment of last resort Ellis and Seeger, 64, both turned to DBS as a last resort after trying many approved medications and treatments. 'I got in the trial fully expecting it not to work because nothing else had. So I was kind of surprised when it did,' said Ellis, whose device was implanted in 2011 at Emory University in Atlanta. 'I am celebrating every single milestone because I'm like: This is all bonus life for me.' She's now on her third battery. She needed surgery to replace two single-use ones, and the one she has now is rechargeable. She's lucky her insurance has covered the procedures, she said, but she worries it may not in the future. 'I can't count on any coverage because there's nothing that says even though I've had this and it works, that it has to be covered under my commercial or any other insurance,' said Ellis, who advocates for other former trial participants. Even if companies still make replacement parts for older devices, she added, 'availability and accessibility are entirely different things,' given most people can't afford continued care without insurance coverage. Seeger, whose device was implanted in 2012 at Emory, said she went without a working device for around four months when the insurance coverage her wife's job at Emory provided wouldn't pay for battery replacement surgery. Neither would Medicare, which generally only covers DBS for FDA-approved uses. With her research team at Emory advocating for her, Seeger ultimately got financial help from the hospital's indigent care program and paid a few thousand dollars out of pocket. She now has a rechargeable battery, and the device has been working well. But at any point, she said, that could change. Federal cuts stall solutions Lázaro-Muñoz hoped his work would protect people like Seeger and Ellis. 'We should do whatever we can as a society to be able to help them maintain their health,' he said. Lázaro-Muñoz's project received about $987,800 from the National Institute of Mental Health in the 2023 and 2024 fiscal years and was already underway when he was notified of the NIH funding cut in May. He declined to answer questions about it. Ellis said any delay in addressing the thorny issues around experimental brain devices hurts patients. Planning at the beginning of a clinical trial about how to continue treatment and maintain devices, she said, would be much better than depending on the kindness of researchers and the whims of insurers. 'If this turns off, I get sick again. Like, I'm not cured,' she said. 'This is a treatment that absolutely works, but only as long as I've got a working device.' ____ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
Associated Press
27-07-2025
- Health
- Associated Press
NIH cuts spotlight a hidden crisis facing patients with experimental brain implants
Carol Seeger finally escaped her debilitating depression with an experimental treatment that placed electrodes in her brain and a pacemaker-like device in her chest. But when its batteries stopped working, insurance wouldn't pay to fix the problem and she sank back into a dangerous darkness. She worried for her life, asking herself: 'Why am I putting myself through this?' Seeger's predicament highlights a growing problem for hundreds of people with experimental neural implants, including those for depression, quadriplegia and other conditions. Although these patients take big risks to advance science, there's no guarantee that their devices will be maintained — particularly after they finish participating in clinical trials — and no mechanism requiring companies or insurers to do so. A research project led by Gabriel Lázaro-Muñoz, a Harvard University scientist, aimed to change that by creating partnerships between players in the burgeoning implant field to overcome barriers to device access and follow-up care. But the cancellation of hundreds of National Institutes of Health grants by the Trump administration this year left the project in limbo, dimming hope for Seeger and others like her who wonder what will happen to their health and progress. An ethical quagmire Unlike medications, implanted devices often require parts, maintenance, batteries and surgeries when changes are needed. Insurance typically covers such expenses for federally approved devices considered medically necessary, but not experimental ones. A procedure to replace a battery alone can cost more than $15,000 without insurance, Lázaro-Muñoz said. While companies stand to profit from research, 'there's really nothing that helps ensure that device manufacturers have to provide any of these parts or cover any kind of maintenance,' said Lázaro-Muñoz. Some companies also move on to newer versions of devices or abandon the research altogether, which can leave patients in an uncertain place. Medtronic, the company that made the deep brain stimulation, or DBS, technology Seeger used, said in a statement that every study is different and that the company puts patient safety first when considering care after studies end. People consider various possibilities when they join a clinical trial. The Food and Drug Administration requires the informed consent process to include a description of 'reasonably foreseeable risks and discomforts to the participant,' a spokesperson said. However, the FDA doesn't require trial plans to include procedures for long-term device follow-up and maintenance, although the spokesperson stated that the agency has requested those in the past. While some informed consent forms say devices will be removed at a study's end, Lázaro-Muñoz said removal is ethically problematic when a device is helping a patient. Plus, he said, some trial participants told him and his colleagues that they didn't remember everything discussed during the consent process, partly because they were so focused on getting better. Brandy Ellis, a 49-year-old in Boynton Beach, Florida, said she was desperate for healing when she joined a trial testing the same treatment Seeger got, which delivers an electrical current into the brain to treat severe depression. She was willing to sign whatever forms were necessary to get help after nothing else had worked. 'I was facing death,' she said. 'So it was most definitely consent at the barrel of a gun, which is true for a lot of people who are in a terminal condition.' Patients risk losing a treatment of last resort Ellis and Seeger, 64, both turned to DBS as a last resort after trying many approved medications and treatments. 'I got in the trial fully expecting it not to work because nothing else had. So I was kind of surprised when it did,' said Ellis, whose device was implanted in 2011 at Emory University in Atlanta. 'I am celebrating every single milestone because I'm like: This is all bonus life for me.' She's now on her third battery. She needed surgery to replace two single-use ones, and the one she has now is rechargeable. She's lucky her insurance has covered the procedures, she said, but she worries it may not in the future. 'I can't count on any coverage because there's nothing that says even though I've had this and it works, that it has to be covered under my commercial or any other insurance,' said Ellis, who advocates for other former trial participants. Even if companies still make replacement parts for older devices, she added, 'availability and accessibility are entirely different things,' given most people can't afford continued care without insurance coverage. Seeger, whose device was implanted in 2012 at Emory, said she went without a working device for around four months when the insurance coverage her wife's job at Emory provided wouldn't pay for battery replacement surgery. Neither would Medicare, which generally only covers DBS for FDA-approved uses. With her research team at Emory advocating for her, Seeger ultimately got financial help from the hospital's indigent care program and paid a few thousand dollars out of pocket. She now has a rechargeable battery, and the device has been working well. But at any point, she said, that could change. Federal cuts stall solutions Lázaro-Muñoz hoped his work would protect people like Seeger and Ellis. 'We should do whatever we can as a society to be able to help them maintain their health,' he said. Lázaro-Muñoz's project received about $987,800 from the National Institute of Mental Health in the 2023 and 2024 fiscal years and was already underway when he was notified of the NIH funding cut in May. He declined to answer questions about it. Ellis said any delay in addressing the thorny issues around experimental brain devices hurts patients. Planning at the beginning of a clinical trial about how to continue treatment and maintain devices, she said, would be much better than depending on the kindness of researchers and the whims of insurers. 'If this turns off, I get sick again. Like, I'm not cured,' she said. 'This is a treatment that absolutely works, but only as long as I've got a working device.' ____ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
