Drug Resistant Epilepsy

MIAMI, April 25, 2025 /PRNewswire/ -- Symphony Robotics, a pioneer in advanced neurosurgical micro-robotics, today announced the appointment of renowned neurosurgeon Dr. Neil A. Martin as its Chief Medical Officer (CMO). In this pivotal role, Dr. Martin will lead the advancement of the company's groundbreaking, engine-free, nonlinear, flexible micro-robotic system, poised to transform the treatment landscape for Glioblastoma Multiforme (GBM). Continue Reading "Glioblastoma remains the most treatment-resistant and lethal primary brain tumor, with a median survival of only 14-16 months following maximal safe resection plus adjuvant chemoradiotherapy, and a five-year survival rate below 7%," stated Dr. Martin. "Despite significant advances in molecular characterization and targeted therapeutics, meaningful improvements in clinical outcomes have remained elusive." Symphony Robotics, a pioneer in advanced neurosurgical micro-robotics, appoints renowned neurosurgeon as CMO. Post this Early preclinical studies using anatomically accurate GBM models under real-time MRI guidance have shown that Symphony Robotics' platform achieves significant improvements in maneuverability, resulting in up to 3 times the volumetric coverage when compared with existing technologies, with millimeter-level precision, crucial for protecting critical healthy brain tissue while maximizing tumor removal. Dr. Martin continued, "Symphony Robotics is positioned to transform the treatment paradigm by substantially extending the capabilities of Laser Interstitial Thermal Therapy (LITT) in GBM—potentially tripling the ablation volume achievable through its steerability after single-site minimally invasive insertion. Our initial objective is to significantly enhance the efficacy of LITT through precise, nonlinear navigation to previously unreachable tumor margins, even in large and irregular tumors. We are implementing an aggressive translational research pipeline for developing applications to accompany and synergize with thermal ablation, including targeted drug and immunotherapy delivery systems for precision neuro-oncology." "Symphony Robotics is built on a foundation of rigorous research and a robust intellectual property portfolio, supported by grants from the National Institutes of Health (NIH) and the National Science Foundation (NSF), and exclusively licensed from Case Western Reserve University," said Mordechai (Moty) Avisar, Founder and CEO of Symphony Robotics. "Welcoming Dr. Martin—a visionary leader in neurosurgery—to our team marks a pivotal milestone that will accelerate our mission to revolutionize GBM treatment. By harnessing the power of artificial intelligence, our platform is poised to optimize therapy and deliver this life-changing technology to patients worldwide." The company is currently establishing collaborations with leading neurosurgical centers to initiate beta site testing later this year, ensuring thorough clinical assessment in diverse patient populations and anatomical scenarios. CONTACT: [email protected] LinkedIn: Symphony Robotics is developing advanced medical technology focused on transforming neurosurgical precision through its engine-free, nonlinear, flexible, micro-robotic platform, leveraging AI to optimize GBM treatment. Recognizing the limitations of current techniques in treating complex intracranial pathologies, particularly aggressive cancers like GBM and medically refractory epilepsy, the company aims to improve surgical outcomes by enabling more precise and extensive tumor ablation, minimizing damage to healthy brain tissue, and ultimately improving both patient survival and quality of life. The integration of real-time MRI guidance with advanced robotics and computational navigation algorithms allows their innovative platform to access and treat previously unreachable areas within the brain. Disclaimer: Symphony Robotics' products are not approved by the Food and Drug Administration (FDA) and are not available for commercial distribution or clinical use. SOURCE Symphony Robotics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

DELRAY BEACH, FL / ACCESS Newswire / April 23, 2025 / Adolore BioTherapeutics (“Adolore” or the “Company”) is developing intracellularly-delivered neuromodulators that naturally reduce neuronal excitability to restore balance to the PNS/CNS to treat the underlying root cause of serious neurological disorders, including chronic pain and announced today Mr. Roelof Rongen, the Company’s CEO, is a presenter at the Festival of Biologics USA 2025 meeting, “FOB”, on April 24, 2025 in San Diego, Ca. Adolore is delighted to present and highlight Adolore’s innovative CA8* therapeutics in development (Kv7 activating carbonic anhydrase-like neuromodulating peptides, CA8* variants). Neuromodulation using gene therapy is an exciting new area that has widespread applications in treating serious undertreated neurological disorders including chronic pain. There is a paucity of safe, efficacious non-opioid analgesic treatments for chronic pain, creating a large and very urgent unmet medical need given the ongoing opioid crisis. Adolore currently has two therapeutic programs in development, including peripheral neuropathy caused by erythromelalgia, which is an orphan disease, (ADB-101), and Adolore’s lead program (ADB-102) for chronic pain caused by moderate-to-severe knee osteoarthritis. Based on compelling preclinical data, the Company is progressing these programs toward Investigational New Drug, (“IND”), filings and first-in-human clinical studies. These CA8* therapies were licensed in 2023 by Adolore from the University of Miami, Miami, FL. The rdHSV intracellular biotherapeutics delivery technology was licensed by Adolore from the University of Pittsburgh, in 2023. The Company’s neuromodulation development program for the treatment of chronic pain due to moderate-to-severe knee osteoarthritis is supported by the NIH/NINDS HEAL UH3 Award to the University of Miami that funds all formal pre-clinical GLP/GMP/GCP development work through a first-in-human clinical study in patients, which is expected to commence in 2026. About Adolore BioTherapeutics, Inc. Adolore BioTherapeutics, Inc., is focused on developing novel intracellularly delivered treatments for chronic pain, drug-resistant epilepsy, seizure disorders, neurodegeneration and neurotrauma/neuroprotection, e.g., hearing loss. The Company’s chronic pain treatment platform comprises two highly innovative technologies: our CA8* analgesic peptides, and our cutting-edge, disease-free, nontoxic rdHSV vector-based intracellular biotherapeutics delivery technology. Our best-in-class programs are long-acting, localized gene-therapies that are opioid-free Disease Modifying Anti-Pain therapies (DMAPs). The Company’s two current CA8* DMAP programs are in preclinical development for treating patients suffering from erythromelalgia, a life-long heritable chronic pain condition representing an orphan drug disease with no approved therapy, and patients suffering with chronic pain due to moderate-to-severe knee osteoarthritis, which affects a large number of patients that are often treated with opioids due to the lack of good alternatives, thus contributing to the ongoing opioid crisis. For more information, visit adolore.com. Forward Looking Statements To the extent this announcement contains information and statements that are not historical, they are considered forward-looking statements within the meaning of the federal securities laws. You can identify forward-looking statements by the use of the words “believe,” “expect,” “anticipate,” “intend,” “estimate,” “project,” “will,” “should,” “may,” “plan,” “intend,” “assume” and other expressions which predict or indicate future events and trends and which do not relate to historical matters. You should not rely on forward-looking statements, because they involve known and unknown risks, uncertainties and other factors, some of which are beyond the control of the Company. These risks and uncertainties include, but are not limited to, those associated with drug development. These risks, uncertainties and other factors may cause the actual results, performance or achievements of the Company to be materially different from the anticipated future results, performance or achievements expressed or implied by the forward-looking statements. Investor Relations Contact Paul Barone(215)622-4542pbarone@adolore.com SOURCE: Adolore Biotherapeutics, Inc. View the original press release on ACCESS Newswire

The Australian-developed Minder system is an implantable device for continuous monitoring of brain activity in patients with epilepsy, developed to address the shortcomings in current electroencephalogram technologies The FDA has granted authorisation for Minder under its De Novo pathway creating a new classification of device, allowing for marketing and sale of the device in the US for patients with drug resistant epilepsy Epiminder intends to launch Minder in the US during H2 2025 MELBOURNE, Australia and DALLAS, April 22, 2025 /PRNewswire/ -- Epiminder, a pioneering medical device and information solutions company, today announced that it has been granted FDA authorisation via the De Novo classification for Minder, its proprietary implantable continuous electroencephalogram monitoring system (iCEMTM) for patients with epilepsy. Minder has also been designated as a Breakthrough Technology by the FDA, recognising its potential to provide more effective diagnosis and management for people living with epilepsy. This De Novo authorization is significant as it creates a new classification of device which underscores both the innovation and the clinical validation behind Minder. Without accurate diagnosis and monitoring, sustained and effective management of epilepsy can be challenging. Minder has been developed to address the shortcomings in current electroencephalogram (EEG) technologies, providing reliable and actionable diagnostic data for more patients and therefore better enabling their prospects for successful epilepsy treatment. Rohan Hoare PhD, CEO of Epiminder, said: " By extending the monitoring window of an EEG from days using current technologies to months or even years with Minder, we can deliver unprecedented access to a high-fidelity stream of continuous EEG data to health care professionals and their patients. The FDA's clearance of Minder is a significant milestone for Epiminder and more importantly for the 52 million people around the world who have epilepsy. As the first and only implantable continuous EEG monitor approved in US, Minder can provide health care professionals and their patients with more accurate and timely diagnoses, enhanced therapeutic drug monitoring, and can better inform decisions on non-drug treatments like surgery. Looking ahead, Epiminder plans to develop a suite of integrated software solutions that will extend the clinical impact of the Minder device, for example by providing patients with advance notice of seizures through AI-enabled forecasting." Epiminder intends to formally launch Minder in the US during H2 2025 undertaking a phased commercial roll out into leading epilepsy centres as part of a program to demonstrate the clinical utility of the system. Professor Robert Fisher MD, PhD, Director of the Stanford Epilepsy Center, past-President of the American Epilepsy Society, and Chair of the Data Safety Monitoring Board for the UMPIRE trial, said: "One of the greatest difficulties in caring for people with epilepsy is the lack of accurate information about a patient's seizures. Seizure diaries are of limited effectiveness. Minder can greatly improve seizure tracking and therefore seizure management. It will fill the significant gap in current EEG technologies, providing clinicians like me continuous and accurate data. By having a more complete picture, we can be more precise in our diagnoses, better able to rapidly adjust medication or neuromodulation regimens and identify patients for potential non-drug or surgical treatments. The result will be a reduction in the huge burden of drug resistant epilepsy." The safety and effectiveness of Minder was validated through Epiminder's UMPIRE clinical study, a multi-centre prospective, open design, case-controlled comparator trial that was undertaken in leading Australian hospitals between 2019 and 2023. The results of UMPIRE were used to support Epiminder's successful FDA application. Professor Mark Cook MD MBBS FRACP FRCP (London), Epiminder's Founder and Chief Medical Officer, said: "The results from UMPIRE exceeded our expectations and demonstrated Minder's ability to capture high-quality EEG data continuously for extended periods, including a groundbreaking five-year continuous recording in one participant. Minder delivered actionable clinical insights for nearly 90 percent of study participants, highlighting the real-life benefits that Epiminder's best-in-class iCEM can deliver relative to the current standard of care." Epilepsy is one of the most common serious chronic neurological disorders, affecting approximately 52 million people worldwide including 250,000 Australians and 3.4 million Americans. It is a neurological condition where a person experiences recurrent seizures caused by abnormal electrical activity in the brain. Seizures can present with a variety of clinical manifestations; some involve motor symptoms, such as intense muscle contractions, while others, such as absence or focal impaired awareness seizures, may present with subtle or no outward physical signs. The occurrence of seizures varies in frequency among patients, from less than one a year to several a day. Follow Epiminder on LinkedIn and explore for more information. About Minder Minder is a minimally invasive device for continuous monitoring of electrographic activity of the brain, providing epilepsy patients and their doctors with detailed data on brain activity over an extended period. Patients can wear the device as they go about their normal daily activities. Minder's long-term monitoring of patients outside of a controlled clinical environment provides data needed for better understanding and more effective treatment of underlying conditions, including determining the effectiveness of drug therapies and other potential interventions. About Epiminder Founded in 2017 by Professor Mark Cook together with the Bionics Institute, St Vincent's Hospital, the University of Melbourne and Cochlear Limited. Epiminder is a medical device and information solutions company focused on developing diagnostic and treatment tools for epilepsy and other seizure disorders where continuous monitoring is required. Epiminder is headquartered in Melbourne, Australia and has offices in the United States. Contact: Matt Wright, [email protected] SOURCE Epiminder WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED