ONWARD Medical to announce H1FY26 results on September 9

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Reviewed by
Ashish TScanX News Team
Key Highlights
  • ONWARD Medical to announce first-half 2026 financial results on September 9, 2026
  • CEO Dave Marver to host webcast at 2:00 p.m. CEST / 8:00 a.m. EDT
  • Company holds 10 FDA Breakthrough Device Designations for ARC Therapy
  • ARC-EX System cleared for commercial sale in US and Europe
  • Investigational ARC-IM system aims to address post-injury blood pressure instability
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*this image is generated using AI for illustrative purposes only.

ONWARD Medical N.V. (OTC: ONWRY) will release its first-half 2026 financial results and host a webcast with a comprehensive business update on September 9, 2026.

The neurotechnology company, which pioneers therapies to restore movement and function in people with spinal cord injuries, scheduled the event for 2:00 p.m. CEST / 8:00 a.m. EDT.

Webcast Details

CEO Dave Marver will present the results. Investors can join the live webcast by registering via the company’s investor relations page. A replay of the webcast and supporting materials will be available at ir.onwd.com following the event.

Business Overview

Headquartered in the Netherlands, ONWARD Medical operates a Science and Engineering Center in Switzerland and a US office in Boston. The company is listed on Euronext Paris, Brussels, and Amsterdam (ticker: ONWD), with US ADRs traded on OTCQX (ticker: ONWRY).

The firm developed its proprietary ARC Therapy, which has received 10 Breakthrough Device Designations from the FDA. Its ARC-EX System is cleared for commercial sale in the US and Europe. Additionally, the company is developing an investigational implantable system called ARC-IM, designed to address blood pressure instability after spinal cord injury. This system can also be paired with a brain-computer interface (BCI) and artificial intelligence (AI) to restore thought-driven movement.

Disclaimer: This article is AI-generated using data from ViewTrade. ScanX is not liable for any inaccuracies.

How might the H1 2026 financial results reflect the commercial adoption rate of the ARC-EX System in both US and European markets?

What is the current timeline and regulatory strategy for the FDA approval of the investigational ARC-IM implantable system?

Could the integration of AI and brain-computer interfaces with ARC Therapy significantly alter ONWARD's valuation multiples compared to traditional neurotech peers?

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ONWARD Medical implants first ARC-IM System in EIGER spinal cord study

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Reviewed by
Ashish TScanX News Team
Key Highlights
  • First implant performed in EIGER study at CHUV Lausanne on Sept. 3, 2026
  • Trial enrolls up to 12 participants with subacute and chronic spinal cord injuries
  • ARC-IM System aims to restore standing and walking via targeted stimulation
  • Study supported by Innosuisse grant across two Swiss clinical centers
  • Results intended to inform design of future pivotal market authorization trials
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*this image is generated using AI for illustrative purposes only.

ONWARD Medical N.V. (OTCQX: ONWRY) performed the first implant in the EIGER clinical feasibility study on Sept. 3, 2026. The trial evaluates the investigational ARC-IM System to restore mobility after spinal cord injury.

The procedure took place at Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne, Switzerland, under the direction of Jocelyne Bloch, MD, Chief of Neurosurgery at CHUV. The company announced the milestone from its headquarters in Eindhoven, the Netherlands.

Study Design and Scope

The EIGER study aims to assess the safety and preliminary effectiveness of the ARC-IM System in supporting recovery of standing and walking. It will enroll up to 12 participants across two distinct cohorts:

  • Individuals with subacute spinal cord injury (SCI), defined as injuries sustained less than six weeks before enrollment.
  • Individuals with chronic SCI, defined as injuries sustained more than one year before enrollment.

This marks the first ONWARD mobility study to include patients with subacute injuries. The trial is conducted at two Swiss sites: CHUV in Lausanne and Schweizer Paraplegiker-Zentrum (SPZ) in Nottwil. Innosuisse supports the study with a grant.

Technology and Pipeline Context

The ARC-IM System comprises the implanted ONWARD Neurostimulator (IPG) and the ARC-IM Lumbar Lead. These components are designed to precisely activate spinal circuits involved in lower-limb and trunk movement. Dave Marver, CEO of ONWARD Medical, stated the study intends to inform the design of a pivotal study for market approval.

Beyond mobility, the company is developing the ARC-IM platform for adjacent indications, including Parkinson’s disease. The system is currently being evaluated in the Empower BP global pivotal study for blood pressure instability after SCI. The company’s commercial product, the ARC EX System, is cleared for sale in the US and Europe.

What the Numbers Show

The inclusion of a subacute cohort represents a strategic expansion of the trial scope compared to previous studies. By targeting patients within six weeks of injury alongside those with chronic conditions over one year old, the data generated will cover the full spectrum of injury timelines. This dual-coach design allows for direct comparison of intervention timing against recovery outcomes within the same feasibility framework.

Disclaimer: This article is AI-generated using data from ViewTrade. ScanX is not liable for any inaccuracies.

How might the inclusion of subacute SCI patients in the EIGER study influence the timeline and design of the upcoming pivotal trial for regulatory approval?

What are the potential cross-indication synergies between the ARC-IM System's current mobility trials and its development for Parkinson’s disease?

Could the preliminary safety data from the EIGER feasibility study impact ONWARD Medical's valuation or partnership opportunities with larger medical device manufacturers?

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