reports
- 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
- Maria Vara
ONWARD Medical: obtains EUR 52.5m loan from a top-tier US-lender
Friday post-market, we were pleased to see ONWARD achieving a loan agreement for an amount of up to EUR 52.5m coming from a top-tier US-based lender Runway Growth Capital. The first tranche of EUR 16m, available immediately, is solely intended for payment of the outstanding debt. The other tranches
- Maria Vara
ONWARD Medical: Q1 2024 delivered as promised
This morning, ONWARD provided a snapshot of Q1 2024 achievements and, while nothing came as a surprise, we appreciate the productive quarter and positive progress from clinical and financial angles. As summarized in the strategic priorities for 2024 disclosed early this year (read our note here), t
- Maria Vara
ONWARD: Up-LIFT reveals ARC-EX extraordinary neurological potential vs...
The so-awaited full disclosure of the ARC-EX Up-LIFT pivotal study materialized yesterday with its publication in the top-tier scientific journal - Nature (access here). Whilst the top-line data reported in April 2023 already validated ARC-EX Therapy efficacy hitting 72% responder rate, the extende
- Maria Vara
- Maria Vara
ONWARD: reports FY 2023, all focus set on ARC-EX US launch in H2 2024
ONWARD reported FY 2023 results with a cash position amounting to EUR 29.8m (FY 2022 EUR 61.8m) by YE 2023 and a net loss of EUR 36.2m (EUR 32.8m), which increase is given by the lower grant income (EUR 0.5m in 2023 vs. 2.1m in 2022) and slightly higher OpEx, mainly driven by R&D. Following the
- Maria Vara
ONWARD Medical: submits ARC-EX de Novo FDA application
This morning, ONWARD announced that it had submitted its De Novo FDA application for ARC-EX in upper limb mobility for SCI patients, respecting the timelines of planned submission within H1 2024. We are pleased to see the company achieve this key milestone in bringing to market its first commercial
- Maria Vara
ONWARD Medical: successfully raises EUR 20m, extends cash runway into ...
ONWARD Medical successfully secured a capital raise of EUR 20m in total gross proceeds, extending the cash runway into mid-2025 (vs. YE 2024). While the indicative initial capital raise amount was EUR 15m, the demand from institutional investors and French retail, along with the commitment of share
- Maria Vara
ONWARD Medical: ARC-EX successfully passes electrical standards tests
This morning, ONWARD Medical announced that its ARC-EX system has successfully passed the standard regulatory and commercial electrical tests required for medical equipment, as reported on the analysis performed by a leading US-based medical equipment testing center. Previous issues reported by the
- Maria Vara
ONWARD Medical: ARC-BCI is once again in the spotlight of the FDA perk...
ARC-BCI is once again in the spotlight of the FDA perks! Following the Breakthrough Device Designation (BDD) that was awarded by the FDA about two weeks ago, ONWARD announced this morning that ARC-BCI has entered into the Total Product Life Cycle Advisory Program (TAP) from the FDA, being one the f
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