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ONWARD Medical Exceeds One Million Euros in Quarterly Revenue

ONWARD Medical has announced that it surpassed one million euros in revenue for the first time in the third quarter of 2025.


ONWARD Medical Exceeds One Million Euros in Quarterly Revenue

Financial Milestone Achieved

ONWARD Medical reported that its quarterly revenues exceeded one million euros for the first time in the third quarter of 2025. Although the press release does not provide complete financial results, this announcement marks a significant milestone in the company's commercial performance. ONWARD Medical develops spinal cord stimulation technologies to assist individuals with spinal injuries and other motor disabilities. During this quarter, the company sold 40 ARC-EX® systems, thereby strengthening its position in the neurotechnology market.

Regulatory Milestones Reached

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ONWARD Medical achieved several regulatory milestones during the third quarter. The company received CE certification for its ARC-EX system, which is designed to enhance hand strength and sensation following a spinal cord injury. In the United States, the company obtained an Investigational Device Exemption (IDE) from the FDA for its ARC-IM system, enabling the launch of the Empower BP study. This global and pivotal study aims to assess the safety and efficacy of this implanted neuromodulation platform, particularly for issues of blood pressure instability following a spinal injury.

Strengthening Scientific and Technological Leadership

ONWARD Medical continues to strengthen its scientific and technological leadership, as demonstrated by the simultaneous publication of two papers in the journals Nature and Nature Medicine. These highlight advancements in regulating blood pressure following a spinal cord injury, supporting the upcoming initiation of the Empower BP study. Currently, over 50 clinics in the United States are equipped with the ARC-EX system, showcasing the growing adoption of these solutions. Dave Marver, CEO of the company, mentioned that more comprehensive updates on the year's achievements will be shared during the scheduled quarterly call on November 11, 2025.



Sector Santé · Equipements médicaux Équipements Médicaux


Assurance vie

Context

Period
  • Period: 3T 2025
Guidance from the release
  • “We continued to deliver strong commercial execution in Q3, and we achieved several meaningful scientific and regulatory milestones across our technology platforms.”
  • Commercial traction forte avec 40 systèmes ARC-EX vendus en Q3 et disponibilité dans plus de 60 cliniques US; CE Mark pour l'UE et clearance FDA pour usage à domicile élargissent l'opportunité commerciale; IDE approuvé pour ARC-IM permettant le lancement de l'étude pivot Empower BP; publications scientifiques majeures renforcent le dossier clinique.
Risks mentioned
  • retards dans les autorisations réglementaires
  • variations de la demande commerciale
  • concurrence technologique et concurrentielle
  • incertitudes liées aux études cliniques et résultats futurs
Opportunities identified
  • FDA clearance for home use expands US market opportunity
  • CE Mark enables commercialization in EU and facilitates entry to UK and Switzerland
  • Strong clinical publications (Nature, Nature Medicine, Neurology: Clinical Practice) bolster evidence base
  • IDE approval for ARC-IM enables initiation of Empower BP pivotal study

The information presented in this article is provided for informational purposes only and does not constitute an investment recommendation, an incentive to buy or sell a financial asset, or investment advice. Readers are invited to conduct their own research before making any decision.

Investments in the stock market involve risks, including the risk of capital loss. Past performance of an asset or market is no guarantee of future results. Any investment decision should be made taking into account your personal financial situation, objectives and risk tolerance.

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