reports
- 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
- Maria Vara
ONWARD Medical: BCI platform is awarded BDD by FDA
ONWARD reported this morning that its system ARC-BCI system has been awarded Breakthrough Device Designation (BDD) by the FDA. Such a decision has been backed by two feasibility studies where the Brain-Computer Interface has proven to be a cutting-edge AI technology enabling movement-related though
- Maria Vara
Charting a year of SCI therapy breakthroughs
The first 2024 M&A MedTech move came from the neurotechnology industry (Axonics to be acquired by Boston Scientific for USD 3.7bn), proving the value of providing a life-changing solution where other medical alternatives have fallen short. Spinal Cord Injury, affecting 300k people in the US onl
- Maria Vara
- Oscar Haffen Lamm
Coverage update
Given team and strategy changes, Oscar Haffen Lamm is now assuming coverage of Medincell, Camurus, Valneva, Aelis Pharma, Abivax, Calliditas, Egetis Therapeutics, Basilea, Geneuro, Achilles, Valerio, Innate Pharma, Morphosys, Inventiva Pharma, Vicore, DBV Technologies, and Genfit.Maria Vara is now
BSLN BASILEA PHARMACEUTICA AG
IPH INNATE PHARMA SA CLASS A
VLS VALNEVA SE
ALMDT MEDIAN TECHNOLOGIES
EGTX EGETIS THERAPEUTICS AB
7CA CAMURUS AB
VICO VICORE PHARMA HOLDING AB
5142 ACHILLES CORP.
A3TV ATRESMEDIA CORPORACION DE MEDIOS DE COMUNICACION SA
XVIVO XVIVO PERFUSION AB
GNRO GENEURO SA
BONEX BONESUPPORT HOLDING AB
MOR MORPHOSYS AG
MED MEDARTIS AG
MEDCL MEDINCELL SA
CALTX CALLIDITAS THERAPEUTICS AB
IVA INVENTIVA ADS
CLNK B CELLINK AB
GNFT GENFIT
AELIS AELIS FARMA SA
ONWD ONWARD OPPORTUNITIES LIMITED
ALONX ONXEO
ABVX ABIVAX
- Alex Cogut
- Maria Vara
First paralyzed patient with BCI + ARC-IM unlocks nearly full mobility
ONWARD reported the publication of results in Nature showing the first (POC) data of a paralyzed patient with implanted with the brain-computer interface (BCI) and ARC-IM. The patient previously participated in the STIMO study, the early feasibility study on ARC-IM mobility, and continued with a 3-
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