Onward announces enrolment of the first participant in the Empower BP trial. The trial evaluates the ARC-IM system to address blood pressure instability in SCI patients. We note that Onward plans an interim analysis of the efficacy results in 2H26, which could accelerate timelines if fewer total patients are required. Short-term, we look forward to the FY25 results to gain a view on the ARC-EX commercial launch (9M25: 70 devices sold). We reiterate our € 8.9 TP and BUY rating.
ONWARD Medical Announces First Participant Enrolled in Global Pivotal Study Evaluating ARC-IM System to Address Blood Pressure Instability After Spinal Cord Injury Empower BP is a landmark global pivotal study evaluating the safety and effectiveness of the implantable ARC-IM® System to address blood pressure instability after spinal cord injury (SCI)Blood pressure instability is a key unmet need after SCI, with a significant impact on cardiovascular health and quality of lifeThe first participant was enrolled at Craig Hospital in Denver, Colorado, USA EINDHOVEN, the Netherlands, Feb. 04, ...
Onward announced the appointment of a new CFO, Ali Kiboro. Mr. Kiboro brings more than 25 years of financial experience to Onward. He joins Onward from AliveDx where he served as Chief Financial Officer, leading the company's financial strategy, capital markets activities, and operational transformation. Prior to AliveDx, Ali held a variety of senior financial leadership roles at Quest Diagnostics and General Motors. Ali holds an MBA in Finance from The Wharton School and a Bachelor of Science i...
ONWARD Medical Appoints Ali Kiboro as Chief Financial Officer EINDHOVEN, the Netherlands, Jan. 23, 2026 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD – US ADR: ONWRY), the neurotechnology company pioneering spinal cord stimulation therapies to restore movement, function, and independence, today announces the appointment of Ali Kiboro as Chief Financial Officer, effective January 2026. Ali brings more than 25 years of financial leadership experience across medical technology, tools and diagnostics, and general industry. He joins ONWARD Medical from AliveDx (formerly Quotient Lim...
Onward announced the successful 6th and 7th implants of its brain-computer interface (BCI) device in two additional spinal cord injury (SCI) patients, bringing the total number of human implants to seven. Onward's ARC-BCI effectively combines its proprietary implantable ARC-IM technology to affect movement and function with Clinatec's pioneering BCI device for thought-steered control, and we believe the joint technology could trigger a major step forward for patients suffering from spinal cord i...
ONWARD Medical Completes Two Additional Brain-Computer Interface Implants Paired with Spinal Cord Stimulation Technology to Restore Thought-Driven Movement Investigational ARC-BCI® Therapy is being developed to restore thought-driven movement in people living with spinal cord injuries and other movement disabilitiesARC-BCI is the world’s first and most advanced purpose-designed platform pairing a brain-computer interface with an implantable spinal cord stimulation system Seven study participants have now received ARC-BCI Therapy to restore movement of their own paralyzed limbs EINDHOVEN, t...
Onward enters 2026 with increased commercial momentum following FDA clearance for ARC-EX home use in SCI patients in November 2025, which expands access beyond clinics and is expected to accelerate adoption. Meanwhile, the company is advancing its implantable program, with ARC-IM interim data from the pivotal Empower BP trial in SCI patients with blood pressure instability expected in 2H26—an important catalyst that could accelerate development timelines. We roll over our model to 2026, adjustin...
Onward reported its 3Q25 results, which show no major surprises as the company previously announced the sale of 40 devices in the US in a preliminary update. With a cash position of € 77.7m, Onward is funded into 1Q27 assuming no drawdown of its debt facility. In the pipeline, timelines were reiterated and the company continues to expect to initiate the pivotal Empower BP trial of the ARC-IM system in blood pressure instability by YE25, which means interim results could come in 2H26. We reiterat...
ONWARD Medical Drives Strong US ARC-EX Adoption and Achieves Important Scientific and Regulatory Milestones in Q3 2025 EINDHOVEN, the Netherlands, Nov. 24, 2025 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD – US ADR: ONWRY), the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord injuries (SCI) and other movement disabilities, today announced its results for the third quarter of 2025 and provides a comprehensive business update: Commercial traction: The Company met its objective of 40 ARC-EX® Systems ...
Onward announced that it has received 510(k) clearance to expand the ARC-EX system indication for home use in SCI patients in the US. This follows the initial approval for clinic use obtained in 4Q24, and we believe this expansion could unlock sales beyond rehabilitation clinics and to individual patients, which in our view is key to broaden the commercial potential of the ARC-EX system. With 70 devices sold in 9M25, we believe FY25 CSS of 150 devices sold is within reach, and look forward to ne...
ONWARD Medical Receives FDA 510(k) Clearance Expanding ARC-EX System Indication for Home Use THIS PRESS RELEASE CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE 7(1) OF THE EUROPEAN MARKET ABUSE REGULATION (596/2014) US FDA clearance now allows use of the ARC-EX® System both in clinics and homesARC-EX is the first and only FDA-cleared technology demonstrated to improve hand strength and sensation in people with spinal cord injuryYear to date, ARC-EX Systems have been purchased by more than 60 US clinics EINDHOVEN, the Netherlands, Nov. 17, 2025 (GLOBE NEWSWIRE) -- ONWARD Medic...
ONWARD Medical Publishes Closing of Bookbuild Offering NOT FOR DISTRIBUTION OR RELEASE, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, CANADA, AUSTRALIA OR JAPAN OR ANY OTHER JURISDICTION IN WHICH THE DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL. OTHER RESTRICTIONS ARE APPLICABLE. PLEASE SEE THE IMPORTANT NOTICE AT THE END OF THE PRESS RELEASE. THIS PRESS RELEASE CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE (7)(1) OF THE EUROPEAN MARKET ABUSE REGULATION (596/2014) EINDHOVEN, The Netherlands, Oct. 28, 2025 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD – US ADR:...
Onward announced the placement of 11.3m new ordinary shares in a private placement by way of an accelerated bookbuild offering at an issue price of € 4.5 per share (approx. 12.5% discount to closing price prior to deal announcement) resulting in gross proceeds of € 50.85m. Onwards cash runway is extended through at least end of 2026 (previously 1H26), assuming no drawdown of the company's debt facility with Runway Growth. The transaction was supported by existing and new, long-only and sector sp...
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