Neuro

Terumo Neuro Signs Agreement to Acquire Arsenal Medical – Advancing Next-Generation Liquid Embolic Innovation for Treating Chronic Subdural Hematoma (cSDH)

Financial Neuro by 0 comments

Proposed acquisition would add NeoCast™, an investigational technology designed for controlled delivery and predictable distal penetration, to Terumo Neuro’s neurovascular portfolio.
NeoCast

The next-generation in liquid embolics

Aliso Viejo, CA, Sept. 30, 2026 (GLOBE NEWSWIRE) — Terumo Neuro Signs Agreement to Acquire Arsenal Medical – Advancing Next-Generation Liquid Embolic Innovation for Treating Chronic Subdural Hematoma (cSDH) Proposed acquisition would add NeoCast™, an investigational technology designed for controlled delivery and predictable distal penetration, to Terumo Neuro’s neurovascular portfolio. Aliso Viejo, Calif. – September 29, 2026 – Terumo Neuro today announced that it has signed an agreement to acquire Arsenal Medical Inc., a privately held, clinical-stage biomaterials company developing NeoCast™, an investigational next-generation liquid embolic technology for the treatment of chronic subdural hematoma (cSDH). Upon completion, the proposed acquisition would expand Terumo Neuro’s liquid embolic portfolio, advance its strategy to bring differentiated neurovascular technologies to physicians and patients, and support its continued focus on innovations to preserve and restore brain health. “NeoCast represents a compelling opportunity to advance what could be a game-changing innovation in the treatment of chronic subdural hematoma,” said Carsten Schroeder, CEO, Terumo Neuro. “As MMA embolization emerges as an important new treatment option, this purpose-developed, next-generation liquid embolic technology has the potential to make a meaningful impact for physicians and patients, while supporting our mission to preserve and restore brain health. We are impressed by the progress Arsenal Medical has made and look forward to combining our global neurovascular expertise with its differentiated technology platform following the close of the transaction.” cSDH is a significant and growing neurological condition, particularly among aging populations. The condition may cause cognitive decline and disability, has been described as a potential cause of reversible dementia, and can be associated with substantial mortality within one year. While surgical drainage remains a common treatment approach, recurrence after surgery continues to be a clinical challenge. Middle meningeal artery embolization has emerged as a promising adjunctive or alternative approach by targeting the vascular pathology believed to contribute to hematoma persistence and recurrence.1,2,3 Arsenal Medical has developed NeoCast, a next-generation, solvent-free, non-adhesive biomaterial intended for embolization of the middle meningeal artery (MMA). It is engineered for controlled delivery and predictable distal penetration, without solvents or adhesives associated with many embolic devices. Arsenal Medical has advanced NeoCast through first-in-human clinical experience in cSDH and recently received U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval for RADIANT, a pivotal randomized, multicenter study evaluating NeoCast adjunctively with surgery for symptomatic subacute and chronic subdural hematoma.4 The first patients have been enrolled in RADIANT. Final results from the EMBO-02 first-in-human study showed that NeoCast met its primary feasibility and safety endpoints, with 96% of subjects achieving at least 50% hematoma volume reduction and 75% achieving complete hematoma resolution at final follow-up. Notably, 79% of 24 patients were treated with embolization alone, and 10 subjects were treated without general anesthesia.4 The study also reported functional outcome improvements, with 79% of patients demonstrating better functional status based on mRS and quality-of-life measures compared with baseline through 180 days. These findings are preliminary and provide supporting clinical context as NeoCast advances into RADIANT, a prospective, randomized, multicenter pivotal study comparing NeoCast to Onyx LES for the treatment of symptomatic subacute and chronic subdural hematoma adjunctively with surgery.5,6 “Arsenal Medical was founded on the idea that advanced materials can transform the way challenging medical conditions are treated,” said Upma Sharma, PhD, President and CEO, Arsenal Medical. “NeoCast is a powerful example of that vision. It was designed to provide physicians with controlled delivery and consistent distal penetration without the use of solvents or adhesives. Terumo Neuro’s leadership in neurovascular innovation makes it the ideal organization to help realize the full potential of  NeoCast through its next stage of development following the close of the transaction.” NeoCast is an investigational device and is not approved for commercial sale in the United States. The proposed transaction is subject to customary closing conditions. Financial terms of the agreement were not disclosed. For more information, contact:Rebecca Janzon, Terumo Neuro, Global Director Corporate CommunicationsEmail: Rebecca.janzon@microvention.com About Terumo NeuroTerumo Neuro is on a mission to preserve and restore brain health by advancing innovation that changes what’s possible in neurovascular care. Working shoulder to shoulder with physicians, customers, and Associates, we turn deep clinical insight into proven, refined solutions that elevate practice and improve patient outcomes — the kind of game-changing impact that redefines neuro-endovascular treatment. Founded in 1997 as MicroVention and acquired by Terumo Corporation in 2006, Terumo Neuro offers a comprehensive portfolio for the treatment of cerebral aneurysms, ischemic stroke, carotid artery disease, and neurovascular malformations. Headquartered in Aliso Viejo, California, our products are sold in more than 70 countries.For more information, please visit www.terumoneuro.com. About Terumo CorporationTerumo (TSE: 4543) is a global medical innovation company. Guided by an unwavering commitment to patients, and driven by the passion of our associates, we strive to fulfill our Group Mission of “Contributing to Society through Healthcare.” Founded in Tokyo in 1921, we provide a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions. About Arsenal MedicalArsenal Medical is a privately-held, venture-backed, clinical-stage company developing innovative biomaterials to address challenging and underserved medical problems. Its lead product targets neurovascular conditions. The company was founded by academic luminaries Robert Langer and George Whitesides, together with entrepreneur investor Carmichael Roberts, who shared a vision for how materials can transform medical devices. Learn more at www.arsenalmedical.com. References Levitt MR, Hirsch JA, Chen M. Middle meningeal artery embolization for chronic subdural hematoma: an effective treatment with a bright future. J Neurointerv Surg. 2024 Mar 14Shankar JJS, Alcock S, Kashani N, et al.; EMMA-Can investigators. Management of Chronic Subdural Hematoma With Adjunctive Embolization of Middle Meningeal Artery: The EMMA-Can Randomized Clinical Trial. JAMA. Published online April 30, 2026Mascitelli Justin R, et al.; Current state of the field and recommendations for middle meningeal artery embolization in chronic subdural hematoma: A Report of the SNIS Standards and Guidelines Committee, Endorsed by ANZSNR and ESMINT. Journal of NeuroInterventional Surgery, April 2026Next-generation liquid embolic leads to “substantial” cSDH resolution and functional outcome gains. NeuroNews, July 24, 2026Arsenal Medical. Treatment with NeoCast, a Next-Generation Liquid Embolic, Results in Substantial Chronic Subdural Hematoma Resolution and Functional Outcome Gains in Final EMBO-02 First-in-Human Results. Press announcement issued July 22, 2026U.S. Food and Drug Administration. PMA Supplement Approval Letter: Onyx Liquid Embolic System (LES), P030004/S035. December 8, 2025 Contact Info Rebecca Janzonrebecca.janzon@microvention.com+1 949-685-4391
Attachments

Terumo Neuro Acquires Arsenal Medical

NeoCast

Continue Reading →

Route 92 Medical Announces U.S. FDA Clearance for the FreeClimb® 46 Catheter with Tenzing® 4

Neuro Regulatory by 0 comments

Expands Company’s Portfolio of Advanced Neurovascular Catheters to Support Treatment in Smaller and More Distal Anatomies WEST JORDAN, Utah, Sept. 28, 2026 (GLOBE NEWSWIRE) — Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced U.S. Food and Drug Administration 510(k) clearance for the FreeClimb® 46 catheter with Tenzing® 4. The two components are engineered as an integrated system to provide neurovascular access. FreeClimb® 46 and Tenzing® 4 are the newest offerings in Route 92’s portfolio of advanced neurovascular catheters. The FreeClimb 46 system joins FreeClimb 54, 70 and 88, and complements the HiPoint® 70 and HiPoint 88 systems, which also feature the company’s proprietary Monopoint® single-operator system. All Route 92 access and aspiration catheters are powered by custom-sized Tenzing delivery catheters. The navigational capabilities of Tenzing enable atraumatic, precise, and controlled access through neurovascular anatomy, establishing stable access for the treatment of complex neurovascular diseases. “In neurovascular intervention, access is critical,” said Matthew D. Alexander, M.D., Medical Director of Neurointerventional Radiology at Sutter Medical Center in Sacramento, California. “Tenzing supports consistent navigation through even the most challenging cases, allowing us to reach the anatomy we need to treat. The FreeClimb 46 with Tenzing 4 expands Route 92’s catheter technologies to smaller and more distal vessels, where the clinical need is large and accurate delivery is critical to achieving the best outcomes for my patients. I look forward to bringing this next level of neurovascular access into my practice.” The FreeClimb 46 catheter system, including Tenzing 4, and all Route 92 catheters and systems are covered by a portfolio of more than 200 issued patents in the U.S. and international jurisdictions.About Route 92 Medical, Inc.Route 92 Medical is on a mission to improve outcomes for patients undergoing neurovascular intervention through cutting-edge engineering, innovative product design and revolutionary procedural change. Founded by physicians, the company collaborates with leading neurovascular clinicians to solve the biggest challenges in neurointervention and deliver meaningful, differentiated solutions that promote clinical success. For more information, visit www.r92m.com or follow the company on LinkedIn. CONTACT: Contacts:
For media:
Gwen Gordon
Gwen@gwengordonpr.com

Continue Reading →

Pharmazz Completes Enrollment in 160-Patient Phase 4 Trial of Sovateltide in Acute Ischemic Stroke

Neuro by 0 comments

Enrollment completed in the double-blind, placebo-controlled Phase 4 study (NCT05955326) of sovateltide (Tycamzzi®), with final study data expected in Q1 2027Five sovateltide abstracts accepted at World Stroke Congress, October 21-23, 2026, Seoul, South Korea, including an interim analysis of the Phase 4 trialGlobal Phase 3 RESPECT-ETB trial (NCT05691244) actively enrolling and remains on track for topline data in early 2028 WILLOWBROOK, Ill., Sept. 28, 2026 (GLOBE NEWSWIRE) — Pharmazz, Inc. (“Pharmazz” or the “Company”), a biopharmaceutical company developing novel therapeutics for critical care and neurovascular conditions, today announced that enrollment is complete in its 160-patient Phase 4 clinical study of sovateltide (Tycamzzi®) in patients with acute cerebral ischemic stroke in India. The Phase 4 study (NCT05955326) is a post-approval commitment required by Indian regulators. The double-blind, placebo-controlled trial utilizes the same sovateltide dosing regimen, randomization, and 24-hour treatment window as the global Phase 3 RESPECT-ETB trial, and the same protocol and eligibility criteria as the Phase 3 study that supported approval in India. The primary endpoint is the proportion of patients with adverse events and serious adverse events. Key secondary endpoints measure Day 90 neurological recovery, functional independence, and disability using the National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS), and the Barthel Index. Final data are expected in Q1 2027. Pharmazz conducted a prespecified interim analysis in September 2025, when the first 80 patients reached the Day 90 endpoint, and presented those results at the International Stroke Conference 2026 in New Orleans. In that analysis, 92% of sovateltide-treated patients achieved an mRS score of 0 to 2 at Day 90, compared with 58% in the control arm (p=0.0004889). No drug-related adverse events were observed. “Dosing the final patient in our Phase 4 study marks an important milestone in our mission to address severe neurovascular conditions with high unmet medical needs,” said Dr. Anil Gulati, M.D., Ph.D., Chairman and Chief Executive Officer of Pharmazz, Inc. “Acute ischemic stroke remains a leading cause of long-term disability worldwide, and treatment options are limited. The fact that Sovateltide has been used to treat more than 140,000 patients in India since launch provides empirical real-world evidence that the selective endothelin B receptor agonist is able to promote neurogenesis, angiogenesis, and neuronal survival. We are actively enrolling in our global Phase 3 RESPECT-ETB trial and look forward to reporting final data in early 2028.” Upcoming Presentations at the 18th World Stroke Congress Five presentations will be made on-site at the upcoming 18th World Stroke Congress, taking place October 21-23, 2026, at the Convention & Exhibition Center, Seoul, South Korea. A meta-analysis assessing the effectiveness and safety of sovateltide in patients with acute ischemic strokeA global Phase III trial (RESPECT-ETB) to evaluate safety and effectiveness of sovateltide (Tycamzzi®) in ACIS patients Effect of sovateltide (Tycamzzi®) on the thrombolytic activity of alteplase and tenecteplaseAn interim analysis of multicentric, randomized Phase 4 clinical trial of sovateltide (Tycamzzi®) in AIS patients The development of sovateltide for cerebral ischemic stroke patients. About Sovateltide Sovateltide (IRL-1620) is a first-in-class endothelin-B receptor agonist that promotes neurogenesis, angiogenesis, and neuronal survival following acute hypoxic and ischemic insults. The drug is currently being evaluated in clinical programs for acute ischemic conditions. The Phase 3 RESPECT-ETB (ClinicalTrials.gov ID: NCT05691244) trial is being conducted at 57 sites in the US, Germany, Spain, and the UK, and is designed to enroll 514 stroke patients. In September 2026, the U.S. FDA granted Orphan Drug Designation to sovateltide for the treatment of neonatal hypoxic-ischemic encephalopathy. About Orphan Drug Designation The FDA’s Orphan Drug Designation program provides orphan status to investigational drugs and biological products intended to safely and effectively treat, diagnose, or prevent rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation qualifies the sponsor for specific development incentives under the Orphan Drug Act, which may include tax credits for qualified clinical testing, exemptions from prescription drug user fees (PDUFA), and potential eligibility for seven years of market exclusivity in the U.S. upon regulatory approval for the designated indication. About Pharmazz, Inc. Pharmazz, Inc. is a biopharmaceutical company focused on developing and commercializing first-in-class therapies for critical care medicine. For more information, please visit www.pharmazz.com. Disclaimer: Statements in this “Document” describing the Company’s objectives, projections, estimates, expectations, plans or predictions, or industry conditions or events may be “forward-looking statements” within the meaning of applicable securities laws and regulations. Actual results, performance, or achievements could differ materially from those expressed or implied. The Company undertakes no obligation to update or revise forward-looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. Contacts: Pharmazz, Inc. Investors David Costello  MediaShruti Gulati Tel+1 630 780 6087 Tel+1 630 780 6087E maildavid.costello@pharmazz.com  E mailshruti.gulati@pharmazz.com 

Continue Reading →

UpFront Diagnostics Announces CE Mark Approval for LVOne — the World’s First Rapid Blood Test to Diagnose Stroke

Neuro Regulatory by 0 comments

LVOne is the only blood-based diagnostics kit for stroke diagnosis to be CE certifiedCAMBRIDGE, United Kingdom, Sept. 16, 2026 (GLOBE NEWSWIRE) — UpFront Diagnostics has announced CE mark approval for LVOne—the world’s first rapid blood test to diagnose stroke, and the first device of its kind to achieve this certification. The approval confirms that LVOne meets all EU safety, health, and environmental standards, enabling UpFront to launch the device across the region and bring advanced diagnostic technology to millions of new patients and providers throughout Europe. This marks the first time a blood test-based stroke diagnostic in-vitro-diagnosis test device has received CE mark approval. Effective stroke triage requires portable, affordable tools that operate wherever the patient is, rather than bulky equipment confined to radiology suites. LVOne bridges this gap, extending rapid stroke detection beyond well-resourced specialist centres directly to emergency teams and paramedics in the field. By shrinking the time between first contact and thrombectomy, LVOne ensures patients reach specialised treatment faster, regardless of location or which ambulance responds. “Stroke is a leading cause of death worldwide,” said Gonzalo Ladreda, CEO and Co-founder of UpFront Diagnostics. “The LVOne test democratises access to early stroke diagnosis, and securing CE mark approval marks a major regulatory milestone that accelerates our mission to reduce diagnostic times. We invite acute and emergency care providers across the EU to take advantage of this development as we enter a phase of rapid growth.” “Nine years ago, we began searching for stroke biomarkers in a field that had never delivered a patient-ready product,” said Dr Edoardo Gaude, Chief Scientific Officer and Co-founder. “LVOne transforms that research into a certified tool that identifies LVO stroke before a patient reaches hospital. We are excited to launch in Europe, integrating with existing pre-hospital pathways so every patient receives the best available care, wherever their stroke occurs.” LVOne places this capability directly into the hands of paramedics and emergency teams making split-second decisions in the field.It uses biomarkers for stroke detection, delivering objective results earlier than traditional assessments. LVOne, is UKCA marked, enabling real-world clinical deployment in the United Kingdom, and is currently being piloted in partnership with the London Ambulance Service. The company holds an ISO 13485:2016 certification for the design, development, manufacturing, and distribution of LVOne. About Upfront Diagnostics: Founded in Cambridge in 2017, Upfront Diagnostics is a medtech company focused on developing and commercialising rapid Point-of-care diagnostic tests for time-critical medical conditions. The company’s flagship product, LVOne, is a blood-based diagnostic test designed to support the early identification of severe stroke. Using innovative biomarkers, Upfront Diagnostics is enabling emergency teams to rapidly assess patients and identify those most likely to benefit from specialist interventions. For further information: Ritesh S, Communications & Marketing Specialist Upfront Diagnosticsritesh@upfrontdiagnostics.com

Continue Reading →

Terumo Neuro Announces Two WISE Study Publications Reporting 0% New Bleeds or Rebleeds Through One Year Following WEB™ Treatment in Ruptured and Unruptured Aneurysm Cohorts

Neuro by 0 comments

Findings from the largest prospective WEB pooled dataset strengthen the clinical evidence supporting WEB treatment across distinct ruptured and unruptured aneurysm cohorts.Aliso Viejo, CA, Aug. 31, 2026 (GLOBE NEWSWIRE) — Aliso Viejo, Calif. – August 31, 2026 – Terumo Neuro, a global leader in neurovascular innovation and a wholly owned subsidiary of Terumo Corporation, today announced two separate peer-reviewed publications reporting 1-year outcomes from the WISE (WEB Implant Safety and Long-term Efficacy) study. The publications report distinct 1-year subgroup analyses: one evaluating patients with ruptured intracranial aneurysms and one evaluating patients with unruptured intracranial aneurysms, both treated with the WEB Device. The launch of the WEB Aneurysm Embolization System helped create the intrasaccular treatment category, and with more than 15 years of clinical experience, Terumo Neuro continues to advance the field through ongoing investment in intrasaccular evidence generation, data collection, and patient outcomes. WISE is the largest prospective, multicenter study evaluating the long-term safety and effectiveness of WEB in a broad global patient population. The study combines data from seven prospective, multicenter, single-arm, core laboratory-adjudicated, Good Clinical Practice (GCP)-compliant studies conducted across Europe, North America, and Asia, with a total of 601 patients, including 143 patients with ruptured aneurysms and 449 patients with unruptured aneurysms.1, 2 “WISE examines patient-level data from 601 patients, pooling and fully reanalyzing safety and effectiveness outcomes across a broad population. All studies contributing to WISE were independently core lab and safety adjudicated, with all 7 studies utilizing the same core lab and the majority using the same clinical events adjudicator, enhancing the meaningfulness of the outcomes,” said Sheila Warner, Sr. Director, Medical Affairs, at Terumo Neuro. Publication of the 1-year ruptured subgroup and unruptured subgroup findings represent an important milestone for WEB clinical evidence. Together, they provide clinical evidence supporting the safety and effectiveness of the WEB device across both ruptured and unruptured aneurysms. Among patients with ruptured wide-neck bifurcation aneurysms, the published 1-year results demonstrated:2 0% rebleeding after WEB treatment through one year.0% treatment-related mortality and 1.6% treatment-related morbidity at one year.97.2% technical success, including 100% technical success in aneurysms measuring 6 mm or smaller.87.5% adequate aneurysm occlusion at one year, increasing to 93.5% in aneurysms measuring 6 mm or smaller.6.5% retreatment rate through one year. Among patients with unruptured wide-neck bifurcation aneurysms, the published 1-year results demonstrated:1 0% aneurysm ruptures after WEB treatment through one year.

Continue Reading →

Perfuze Announces Final MARRS Results: Strong Reperfusion and First-Pass Performance in Pivotal Stroke Trial

Neuro Regulatory by 0 comments

GALWAY, Ireland–(BUSINESS WIRE)–Perfuze, a medical device company advancing stroke treatment through next-generation catheter technology, today announced publication of the final results of the MARRS pivotal study in the Journal of Neurointerventional Surgery. The trial met its primary endpoint, with successful reperfusion mTICI 2b-3 achieved in 89% of patients without rescue therapy – exceeding the prespecified performance goal. The study also demonstrated a 75% first-pass effect mTICI 2c-3

Continue Reading →

Basking Biosciences Announces Positive Topline Phase 1 Data for BB-025, the Reversal Agent for its Acute Ischemic Stroke Thrombolytic Therapy BB-031

Neuro by 0 comments

BB-025 produced complete, rapid reversal of BB-031 activity within five minutes and was generally safe and well-tolerated across 60 healthy volunteers RESEARCH TRIANGLE, N.C., Aug. 25, 2026 /PRNewswire/ — Basking Biosciences (Basking), a clinical-stage biopharmaceutical company…

Continue Reading →
1 2 3 … 53