reports
- Maria Vara
ONWARD Medical: First ARC‑IM Lumbar Lead implanted
This morning, ONWARD announced the first implantation of the proprietary ARC-IM Lumbar Lead designed for the lumbar region, which aims to effectively deliver ARC Therapy to potentially enable motor functions linked to the lower limbs, including standing, stepping and overall mobility. The implantat
- Maria Vara
ONWARD Medical: more grants are coming in to advance Parkinson's disea...
Along with the imminent kick-off of the US IDE study for ARC-IM targeting Blood Pressure (BP) in the SCI population, ONWARD Medical is advancing its ARC-IM pipeline in Parkinson’s disease within a financially de-risked setting launching two early feasibility studies to address i) mobility challenge
- Maria Vara
ONWARD: 1-year ARC-EX Therapy unlocks additional recovery in SCI
This morning, ONWARD Medical shared a publication detailing supportive results from an independent, investigator-sponsored Pathfinder2 study, further building the clinical evidence for ARC-EX's therapeutic potential to restore function in SCI patients. While the Up‑LIFT study demonstrated groundbre
- Maria Vara
ONWARD Medical: Expanding access of ARC-EX via VA and GSA platforms
ONWARD Medical continues to advance its phased commercial strategy with the announcement that its ARC-EX system is now commercially available through the US Department of Veterans Affairs (VA) Federal Supply Schedule and GSA Advantage platforms, a crucial milestone in addressing the sizeable chroni
- Maria Vara
ONWARD Medical: US commercial launch sparks momentum, driving 23% YTD ...
ONWARD's stock has surged by ~+23% YTD, marking its highest level in recent memory. This rally reflects the company’s latest milestone: its first commercial sales in the US, announced last week (here). The news follows the de novo clearance of the ARC-EX System in December 2024 (read our note here)
- Maria Vara
ONWARD Medical: ARC-EX hits market with first commercial sales
This morning, ONWARD announced it had achieved a significant milestone with the first commercial sales of its ARC-EX System in the US, purchased by UW Medicine and Next Steps Chicago. The sales come shortly after the device received the FDA de novo classification in December 2024, establishing ARC-
- Maria Vara
ONWARD marks commercial breakthrough with FDA green light for ARC-EX
Post-market yesterday, ONWARD announced it has received De Novo FDA approval for ARC-EX Therapy to improve upper limb mobility in SCI patients, meeting both the timeline and positive clearance expectations. This milestone marks the first product launch from ONWARD’s enriched pipeline, aimed at addr
- Maria Vara
ONWARD Medical secures EcoVadis silver medal for sustainability leader...
ONWARD Medical announced it has earned a silver medal from EcoVadis, ranking in the top 15% of over 130k companies globally for corporate sustainability. This recognition reflects the company’s dedication to environmental responsibility, ethical labour practices, and sustainable procurement, which
- Maria Vara
ONWARD Medical: steady execution in Q3 2024
This morning, ONWARD shared a Q3 business update highlighting major YTD achievements across clinical development, IP and corporate actions. While the update contained no surprises, we appreciate the highly productive quarter, during which the company steadily delivered on all three fronts aligned w
- Maria Vara
ONWARD Medical: EIC grant expands ARC-BCI development to subcortical s...
This morning, ONWARD Medical announced that it had secured a significant grant from the European Innovation Council (EIC) to investigate and develop ARC-BCI Therapy aimed at restoring upper limb function in patients with subcortical stroke. While SCI-related movement disorders remain the company’s
- Maria Vara
ONWARD Medical: ARC-EX recognised as one of TIME's Best Inventions of ...
ONWARD Medical's investigational ARC-EX System was named one of TIME's Best Inventions of 2024, spotlighting its potential to improve life for SCI. Recognised for originality, efficacy, ambition, and impact, the ARC-EX System enables SCI patients to regain hand and arm function, as evidenced by the
- Maria Vara
ONWARD Medical: successful EUR50m upsized raise with Ottobock as corne...
ONWARD Medical successfully secured a capital raise of EUR50m in total gross proceeds through an upsized bookbuild offering via a private placement. Ottobock contributed EUR22.5m as a strategic cornerstone investor, with the potential for synergistic value creation in both the near and long term. T
- Maria Vara
ONWARD Medical: bolsters leadership ahead of ARC-EX launch
This morning, ONWARD Medical announced that Rob ten Hoedt, former EVP at Medtronic and Chairman of MedTech Europe, will join its Board of Directors and take over as Chairman by YE, following the planned retirement of Jan Ohrstrom after 8 years of service. Ten Hoedt's experience at Medtronic and lea
- Maria Vara
ONWARD Medical: officially becomes a BCI company
This morning, ONWARD announced that it has entered an exclusive R&D and commercialisation licence agreement with its BCI partner CEA-CLINATEC concerning the WIMAGINE BCI as an integral part of ONWARD's ARC-BCI System. While the company focuses on bringing ARC-EX to market by YE 2024, we see thi
- Maria Vara
ONWARD Medical: listing on Euronext Paris tomorrow, non-dilutive offer...
On Friday post-market, ONWARD Medical announced that its shares will begin trading on Euronext Paris as of tomorrow 24th September, complementing its existing listings on Euronext Brussels and Amsterdam. As a non-dilutive offering, we view this as a positive move to enhance access for French retail
- Maria Vara
ONWARD Medical: third successful ARC BCI implantation!
We are pleased to see that clinical developments on the BCI front are running smoothly! This morning, ONWARD announced that it has successfully implanted the ARC-BCI system in another SCI participant aiming to restore lower limb mobility. As was planned according to the EIC funding granted in 2022,
- Maria Vara
ONWARD Medical: unveils focused US launch strategy for ARC-EX
As promised, during yesterday's H1 webcast, ONWARD presented a series of high-quality explanatory slides outlining the US launch strategy for ARC-EX. With SCI clinics at the centre of their commercialization plan, the company introduced a clear two-phased market access approach. This strategy aims
- Maria Vara
ONWARD Medical: H1 2024 achievements and strategic outlook
This morning, ONWARD provided a snapshot of H1 2024 achievements and, while nothing came as a surprise, we appreciate the productive progress from clinical and financial angles. As summarised in the strategic priorities for 2024 disclosed early this year (read our note here), the company efficientl
- Maria Vara
ONWARD Medical: more grants to fuel BCI trials
This morning, ONWARD announced it has received a USD 1.1m grant from the leading SCI organization, the Christopher & Dana Reeve Foundation, to support the expansion of an ongoing early clinical feasibility study evaluating the ARC-BCI System for improving hand and arm mobility in SCI patients.
- Maria Vara
ONWARD Medical: Defining the clinical framework for ARC-EX
Post-market, ONWARD announced a peer-reviewed publication in Neuromodulation: Technology at the Neural Interface (here). The paper establishes a decision-making framework for the clinical application of ARC-EX Therapy in upper limb mobility by considering the stimulation parameters, usage data, cli
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