Phantom Limb

iStock, ALLVISIONN AlgoTherapeutix blames a “strong placebo effect” for the mid-stage failure for its pain gel ATX01, but the company still believes in the promise of its candidate as Vertex Pharmaceuticals’ first-in-class drug Journavx opens up the non-opioid space. Just over a week after the landmark approval of Vertex Pharmaceuticals’ non-opioid pain drug Journavx, AlgoTherapeutix has suffered a setback in the space, with its investigational topical analgesic therapy ATX01 failing to significantly ease pain in patients suffering from chemotherapy-induced peripheral neuropathy. The Paris-based biotech said Tuesday that ATX01 showed “encouraging” efficacy signals, especially when given at the higher, 15% concentration dose. However, several study sites documented what CEO Stéphane Thiroloix in a statement called a “strong placebo effect,” which in turn prevented ATX01’s benefit from hitting statistical significance. Posthoc analyses of the study’s data showed that in trial centers with low placebo effect, 15% ATX01 elicited significantly better pain relief than placebo. Despite the lack of a significant response, Thiroloix called Tuesday’s readout “a significant step forward” for ATX01, pointing to promising signals of efficacy, such as the 1.6-point pain improvement, as measured by the Numerical Pain Rating Scale. ATX01 was also superior to placebo in terms of key secondary endpoints in posthoc analyses. Designed to be applied topically, ATX01 is a proprietary formulation of amitriptyline , an antidepressant that has been approved by the FDA in a tablet form to treat depression. AlgoTx’s version, however, leverages the non-systemic application of amitriptyline, which potentially dampens or blocks pain signaling locally, focusing on nerve fibers in the skin. Though it did not specifically spell out its future plans for ATX01, AlgoTx in its news release on Tuesday seemed to still believe in the promise of its candidate in chemotherapy-induced peripheral neuropathy. The company “sees a strong rationale to further explore the development of ATX01 15%,” AlgoTx noted, adding that it can look at other trial designs to minimize or even eliminate the placebo effect, such as enrichment/withdrawal strategies or a placebo run-in period. “There is the potential to design a new study, with additional mitigation strategies in place, to evaluate ATX01’s efficacy . . . without ambiguity,” Thiroloix said. BioSpace has reached out to AlgoTx for more clarity on ATX01’s path forward and will update this story accordingly. AlgoTx was previously testing ATX01 for erythromelalgia—a rare vascular condition that affects the extremities and causes intense pain—but according to the biotech’s website , a readout last year returned underwhelming data, forcing the biotech to discontinue the asset’s development in this indication. AlgoTx is also running early studies for ATX01 in painful diabetic peripheral neuropathy, COVID-induced neuropathy and phantom limb pain. AlgoTx’s mid-stage stumble on Tuesday comes after Vertex earlier this month won the FDA’s approval for Journavx, an inhibitor of the NaV1.8 voltage-gated sodium channel that marks the first new mechanism for analgesia in over 20 years—and potentially offering the U.S. a way out of its opioid crisis. According to data from the National Institute on Drug Abuse, nearly 74,000 people died from an overdose of synthetic opioids in 2022. Meanwhile, the Centers for Disease Control and Prevention estimated that the cost of opioid use disorder and related fatalities reached over $1 trillion in 2017. And Journavx may be only the beginning for this new class of pain medicines as several other biotechs seek to follow in Vertex’s footsteps. Lexicon, Algiax, Xgene and Tris Pharma are among those with non-opioid candidates in mid- to late-stage trials, for example. Meanwhile, newcomer Latigo Bio, which launched in February 2024 with $135 million in starting funds to advance its own oral NaV1.8 blocker LTG-001 and is now launching a Phase II trial , said in Friday SEC filing stated that it is now targeting up to $150 million in new funding.

ALISO VIEJO, Calif., Feb. 5, 2025 /PRNewswire/ -- Neuros Medical, Inc. announced today that they have signed an exclusive distribution agreement with Veterans Healthcare Supply Solutions (VHSS) to make the Altius® Direct Electrical Nerve Stimulation System, a breakthrough technology for the treatment of chronic intractable phantom and residual lower limb post-amputation pain, available in VA Healthcare and Military Treatment facilities. "VHSS is proud to represent technology that provides enabling treatment modalities to our veteran and warfighter population addressing post-amputation pain," said Ryan Hurt, Chief Executive Officer, VHSS. "VHSS continues to develop a suite of technology that can be delivered to address clinical challenges to our federal customers, and most importantly, the Veteran Patient. This relationship further extends that portfolio offering." "It is both an honor and a privilege to make the Altius® System available to the brave men and women who have sacrificed so much for our country," said David Veino, President & CEO, Neuros Medical. "This partnership represents not only our commitment to our veterans and active-duty military but also our heartfelt gratitude for their service. We look forward to working with the VHSS team to improve the lives of these men and women living with chronic post-amputation pain." About the Altius® Direct Electrical Nerve Stimulation System The Altius® System is a patient-controlled, on-demand system that uses Neuros' patented technology to address the underlying cause of post-amputation pain by inhibiting pain signal transmission from the damaged peripheral nerves near the site of amputation to the central nervous system. The system consists of a nerve cuff electrode placed around an affected nerve and an implantable pulse generator (IPG). Patients initiate an on-demand 30-minute treatment session as needed for targeted pain relief. The Altius® System is FDA approved and is indicated as an aid in the management of chronic intractable phantom and residual lower limb post-amputation pain in adult amputees. Click here for important safety information. About Neuros Medical, Inc. There are nearly two million lower limb amputees in the U.S., with up to approximately 300,000 lower limb amputations occurring every year.1 Post-amputation pain includes both phantom limb pain and residual limb pain and impacts up to 80% of amputees, representing a significant unmet medical need, as existing treatment options are limited and consist primarily of opioids and gabapentinoids.2 Neuros Medical is a privately held company and the maker of the Altius® Direct Electrical Nerve Stimulation System which is FDA approved and is indicated as an aid in the management of chronic intractable phantom and residual lower limb post-amputation pain in adult amputees. Our mission is to reduce pain and restore life for people suffering with post-amputation pain. We are a passionate team guided by our core values and committed to our patients and the healthcare professionals who care for them. Our Core Values: Patients First, Deliver Excellence, Responsible Ambition, Inspire and Empower. About Veterans Healthcare Supply Solutions (VHSS) Veterans Healthcare Supply Solutions, Inc. is a Service-Disabled Veteran Owned Small Business providing distribution of healthcare related supplies and equipment to the Federal Government. Headquartered in Jacksonville, FL, VHSS is a diversified healthcare supply distributor with a state-of-the-art warehouse, Enterprise Resource Planning (ERP) and Warehouse Management (WMS) system. With over 30 years of healthcare distribution management experience, VHSS provides & represents leading manufacturers to Federal Government agencies. References Prevalence of Limb Loss and Limb Difference in the United States: Implications for Public Policy. Caruso and Harrington 2024 Avelere Report. Erlenwein, J., Diers, M., Ernst, J., Schulz, F., & Petzke, F. (2021). Clinical updates on phantom limb pain. Pain reports, 6(1), e888. For additional information regarding Neuros Medical, please contact: Steve Bosrock, Vice President, Marketing [email protected] Tel: 949-385-5320 For additional information regarding Veterans Healthcare Supply Solutions, please contact: Tel: 904-638-5519 SOURCE Neuros Medical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

TORONTO, Dec. 5, 2024 /PRNewswire/ -- Myant Corp., a pioneer in textile computing for healthcare, and Coapt, a leader in neural interface technology, announced a collaboration aimed at transforming the assistive technology landscape. The partnership will focus on developing and commercializing textile-based electromyography (EMG) interfaces, enhancing the way prosthetic limbs and related therapeutic devices interact with the human body. In merging Coapt's cutting-edge EMG intent decoder control systems with Myant's advanced textile technologies, this collaboration seeks to bring forward new products that will provide more comfort, precision, and control for individuals using assistive devices such as prosthetic limbs. Products born from this partnership may open new pathways for therapies that target phantom limb pain and biofeedback-based solutions, further advancing Myant's mission to improve life and everyday experiences for those with unique needs. "Myant and Coapt share a vision of improving quality of life through seamless integration between technology and the human body," said Tony Chahine, CEO at Myant. "This collaboration will push the boundaries of what is possible in prosthetics and rehabilitation." Myant and Coapt's roadmap for future innovation in assistive technology includes the exploration of virtual and augmented reality applications for medical therapies. This venture will also include funded research and clinical trials to explore the broader implications of their combined technologies for patients worldwide. "Together, Coapt and Myant are creating a future where assistive technology not only helps people regain function, but also improves their overall comfort and autonomy," added Blair Lock, CEO at Coapt. Myant is excited to showcase its latest innovations at the Consumer Electronics Show (CES) on January 7-10, 2024 in Las Vegas, USA. Through live demos with Coapt, Myant aims to accelerate the adoption of next-generation assistive technologies and foster meaningful connections with the global healthcare community. About Myant Myant exists to enable and augment quality living for all. We leverage advancements in AI, medicine and advanced materials to bring health, safety, connection and peace of mind through every stage of life. Myant is leading a new era of evolution where AI guardians enhance human capabilities through textile interfaces that function like a connected second skin. This second skin – made possible by groundbreaking advanced materials – blends naturally into our everyday lives, setting a new standard for seamless interaction with the digital world. From birth to elderhood, AI guardians enrich our daily experience, advance our well-being, ensure our safety, redefine how we connect to society, and enable universal access to the best possible care at every moment. In 2024, ⁠⁠Myant launched with significant growth into the EU and brought on world renowned AI Scientist Dr. Xin Gao as its Chief AI Officer. For more information, visit About Coapt: Coapt, LLC is a privately held company based in Chicago, USA, with a research subsidiary, Liberating Technologies, Inc. in Boston, USA. Coapt was founded in 2012 and quickly launched Complete Control, an FDA Class II-cleared myoelectric, machine learning prosthesis control system. This flagship product—now in its second generation—is the first technology to allow users to naturally control their advanced, prosthetic arms and hands. Complete Control leverages clinically developed artificial intelligence to learn and adapt to users' unique muscle signal patterns and provide intuitive, intent decoding control for bionic upper limbs. Coapt's myoelectric pattern recognition products are compatible with over 450 unique prosthetic limb configurations. In addition to Coapt's preeminent product line, the company has established deep industry partnerships and a robust academic research portfolio. To learn more, please visit About Textile Computing™ Myant knits sensors and actuators into everyday textiles, creating a textile interface that continuously senses and reacts to the human body. The aim is to empower humanity to transform our capabilities, proactively manage health, rapidly deliver treatment, and build better connections to ourselves and those around us. Consumer Electronic Show (CES) 2025 From 7-10 January 2025, Myant will be at Booth #53617 at the Venetian Expo & Convention Center, 201 Sands Ave., Las Vegas, NV 89169, USA Media Contact Charles Andreo [email protected] Media Kit Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED