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...
A director at Evotec SE bought 20,000 shares at 5.475EUR and the significance rating of the trade was 61/100. Is that information sufficient for you to make an investment decision? This report gives details of those trades and adds context and analysis to them such that you can judge whether these trading decisions are ones worth following. Included in the report is a detailed share price chart which plots discretionary trades by all the company's directors over the last two years clearly show...
Überraschend hatte der Aufsichtsrat am 24.11.2025 den bisherigen Aufsichtsrat Dr. Dongzhou Jeffery Liu mit sofortiger Wirkung zum Mitglied des Vorstands und Vorstandsvorsitzenden bestellt und den bisherigen CEO Prof. Dr. Andreas Pahl – ohne Nennung von Gründen – umgehend abberufen. Dr. Liu ist Chief Scientific Officer (CSO) und President von Huadong Global Development bei Huadong Medicine (einem Ankeraktionär bei HPHA und Lizenznehmer für China von HDP-101 und HDP-103). Der erfahrene Manager ü...
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...
Q3/25-KPIs zeigen eine Umsatz- und EBITDA Margen-Verschlechterung (Umsatz -11% YoY auf € 164 Mio./Marge: -9,17 %; EPS € -0,24), doch sind diese durch Phasing-Effekte und Reset-Einsparungen überzeichnet. Die anhaltend schwache Nachfrage im Markt für frühe Arzneimittelforschung (D&PD) konnte das gut gelaufene Geschäft von Just-Evotec Biologics (JEB) nur teilweise ausgleichen. Zudem kämpft Evotec mit Unterauslastung. Hinzu kommen Kosten im Zusammenhang mit dem Anlaufen der JEB-Anlage im französisch...
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