ONWARD Medical Achieves CE Mark Certification for ARC-EX System
ONWARD Medical's Milestone Achievement in Neurotechnology
ONWARD Medical N.V., a pioneering name in neurotechnology, recently reached a significant milestone by receiving CE Mark certification for its groundbreaking ARC-EX System. This certification opens the doors for commercialization in Europe, allowing for both clinical and at-home use, thus greatly enhancing the lives of individuals suffering from spinal cord injuries (SCI) and other movement disabilities.
Understanding the ARC-EX System
The ARC-EX System is a non-invasive therapy device that utilizes transcutaneous electrical spinal cord stimulation, providing patients with a new avenue for improving hand strength and sensation. This revolutionary system works through electrodes placed on the back of the neck, programmed to stimulate the spinal cord effectively. The CE Mark enables ONWARD to market this advanced technology throughout the European Union and offers a streamlined path for distribution in the UK and Switzerland.
Transforming Lives of Spinal Cord Injury Patients
CEO Dave Marver expressed excitement over this achievement, stating, "Hand sensation and strength is a primary recovery target after spinal cord injury. The ARC-EX Therapy opens new doors for the SCI community in Europe, offering opportunities for recovery and care that were previously unavailable." The company is set to initiate a phased launch across Europe, beginning with Germany and expanding to other nations shortly thereafter.
Clinical Evidence Supporting ARC-EX
The significant promise of the ARC-EX System is backed by robust clinical evidence. Results from the Up-LIFT pivotal study indicated that an impressive 90% of participants saw improvements in strength or function following the therapy. Moreover, 87% of study participants reported enhancements in their quality of life, with benefits documented as lasting up to 34 years post-injury. This pivotal research demonstrates the potential for improved upper body sensation and reduced spasm frequency, contributing to an overall better quality of life.
Moving Ahead with Regulatory Approval
Achieving CE Mark certification signifies that ONWARD Medical has met all European regulations related to medical devices, ensuring the highest standards in patient safety and clinical performance. This approval not only strengthens their position in Europe but also complements their previous efforts in the US, where the company successfully launched the ARC-EX System in clinics following FDA clearance.
Company Background and Future Aspirations
ONWARD Medical has established itself as a leader in neurotechnology, dedicated to restoring movement and independence to those affected by spinal cord injuries. Their ARC Therapy has viewed significant progress thanks to scientific advances and clinical studies in premier medical facilities. Combining this knowledge, the ARC-EX System has now gained a spot as one of TIME Magazine's Best Inventions and received recognition as one of Fast Company's World Changing Ideas in 2025.
Onward Medical's Roadmap
The future looks bright for ONWARD Medical as it continues to innovate within the neurotechnology space. The company is also developing an investigational implantable system called ARC-IM, which aims to address multiple unmet needs, including blood pressure instability following spinal cord injury. This system can potentially be integrated with brain-computer interfaces and artificial intelligence, showcasing ONWARD's commitment to advancing neural rehabilitation technologies.
Frequently Asked Questions
What is the ARC-EX System?
The ARC-EX System is a non-invasive spinal cord stimulation device designed to improve hand strength and sensation in individuals with chronic spinal cord injuries.
Where will ONWARD Medical launch the ARC-EX System first?
The initial launch will begin in Germany, with plans to expand to other European countries shortly thereafter.
What does the CE Mark certification mean for ONWARD Medical?
The CE Mark certification allows ONWARD Medical to market the ARC-EX System in Europe and other regions, complying with European medical device regulations.
How does the ARC-EX System improve quality of life?
Clinical studies suggest that patients using the ARC-EX System experience significant improvements in strength, function, and overall quality of life.
What are the future plans for ONWARD Medical?
ONWARD Medical aims to continue innovating and expanding its product offerings, including the development of the ARC-IM system and further clinical research to enhance patient outcomes.
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