(translated by DeepL)

EINDHOVEN, The Netherlands, Jan. 22, 2026 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: $ONWD (+8,74 %) - US ADR: $ONWRY), a neurotechnology company pioneering spinal cord stimulation therapies to restore movement, function and independence, announces that two additional individuals with spinal cord injury (SCI) have received the company's ARC-BCI® therapy. These groundbreaking procedures bring the total number of human implantations to seven, further extending the company's leadership in developing brain-computer interface (BCI) platforms to restore mind-controlled movement for people with paralysis.

Both procedures were performed at the Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne, Switzerland, under the direction of Dr. Jocelyne Bloch, Chief of Neurosurgery. The participants were a 35-year-old woman who had suffered a spinal cord injury two years ago and a 39-year-old man who had suffered a spinal cord injury seven years ago. The study participants received ARC-BCI therapy to restore mobility to the upper and lower extremities respectively.

"We continue to learn from this groundbreaking clinical feasibility study, leveraging our unique understanding of spinal cord stimulation to restore movement after paralysis and exploring the potential benefits of adding a brain-computer interface," said Dave Marver, CEO of ONWARD Medical. "We look forward to sharing more details in an expert forum and continuing our commitment to scientific rigor."

The company's BCI platform includes an epidurally implanted device on the motor cortex that records brain signals related to movement intentions. The system uses artificial intelligence (AI) to decode these signals and convert them into commands that are wirelessly transmitted to an implanted neurostimulator that uses specially designed electrodes to stimulate specific areas of the spinal cord. The company's BCI technology is backed by more than eight years of human safety data. The ARC-BCI system was awarded Breakthrough Device Designation (BDD) by the US Food and Drug Administration (FDA) in 2024. ARC-BCI is also part of the FDA's Total Product Life Cycle Advisory Program, which provides early regulatory guidance to support the development of innovative technologies.

These latest implants are part of ongoing clinical feasibility studies supported by grants from the European Union's Horizon Europe research and innovation program through the European Innovation Council (EIC, under grant agreements n° 101057450 and 101070891), the Christopher & Dana Reeve Foundation and the Swiss State Secretariat for Education, Research and Innovation (SERI).

Source: https://live.euronext.com/en/products/equities/company-news/2026-01-22-onward-medical-completes-two-additional-brain-computer

Due to some partial profit-taking in the (US) tech/AI sector ($NBIS (+9,34 %) / $AVGO (-2,75 %) / $MPWR (+3,64 %) / $AMD (+11,93 %)) and OS selling ($RKLB (+5,27 %) / $AMD (+11,93 %)), the portfolio will be rebalanced and restructured. $RKLB (+5,27 %) , $LMND (-6,47 %) , $GOOG (+0,91 %) and $9988 (+7,13 %) but I'm not touching them (yet) 😀

Unfortunately, the entry prices for GQ have been completely messed up due to the recent transfer from TR to SC.

• After almost a year of watching, I dare to re-enter at $GRAB (+2,27 %) - further increase to 500 shares would be considered
• at $HIMS (+1,2 %) a limit buy at €25 is lying in wait, increase from 40 to 60 shares planned
• $NOW (-3,39 %) increased to 13 shares
• $WKL (-7,46 %) increased to 18 shares
• $AJG (-4,76 %) Position filled, 7 shares
• $DXCM (+1,97 %) Position filled, 26 shares
• Doubling of the small speculative position at $ONWD (+8,74 %) planned to 120 shares, limit buy @ € 4.30
• 10 shares $TEM (+4,92 %) collected, savings plan continues
• $RSG (-2,61 %) , $CCEP (+1,19 %) and $DDOG (-2,08 %) also continue to run in the savings plan alongside the ETFs $UBU7 (+1,1 %) , $WINC (+0,81 %) , $SCWX (+1,53 %) and $EXH5 (+2,68 %)

I am still undecided about the potential increase in $UBER (+7,72 %) , $NU (+0,47 %) , $ZTS (-0,85 %) and $TTD (-2,66 %) - and would be happy to hear a few opinions! I feel Nu and Uber are the most likely at the moment - although Waymo is accelerating well.

One of the advantages of my strategy is that I always look for growth stocks with doubling potential before the broad market discovers them, even if this naturally entails a higher risk. I recently came across $ONWD (+8,74 %) recently. As it is a medtech company, it might also be interesting for the dear@Tenbagger2024 .

The neurotech company has three technology platforms with which it aims to give as many people as possible with restricted mobility a significantly better quality of life. The company's ARC-EX system is already approved in the USA (now also for home use) and Europe. Onward Medical is therefore entering the commercial phase. In the third quarter alone, the company sold 40 of these systems, which can now give people with spinal cord injuries a better quality of life.

While Onward Medical is making clear progress on the commercial side, the broad development pipeline is also being driven forward. Among other things, the company also wants to develop neurotech solutions for blood pressure management or Parkinson's disease. Apparently, the newcomer to the stock market Ottobock also finds the Onward Medical story appealing. As part of a capital measure in October, the prosthesis manufacturer once again invested money in the European neurotech hopeful. "The company's developments fit perfectly into our future strategy for neuroorthetics. We are therefore pleased to strengthen our role as the largest shareholder as well as our strategic partnership through our additional investment," says Ottobock CEO Oliver Jakobi.

After AI and quantum computing, neurotech could become the next megatrend on the stock market. In my opinion, Onward Medical has everything it takes to be valued significantly higher. On top of that, there is a shot of takeover fantasy.

I therefore think I will add a few shares to my portfolio.

$CRSP (+4,43 %) , $IOVA (+3 %) , $ABT (-1,84 %) & $ONWD (+8,74 %)

The healthcare and biotech sector remains one of the most exciting areas for long-term investors. Between pioneering gene editing, immunotherapies and neuronal interfaces, a new chapter in modern medicine is currently being written - with opportunities, but also considerable risk.

Here is a compact overview of four companies that play an interesting role in my view.

🧬 CRISPR Therapeutics ($CRSP (+4,43 %)
)

CRISPR Therapeutics is one of the absolute pioneers in the field of gene editing. The company uses the revolutionary CRISPR/Cas9 technologyto potentially cure genetic diseases permanently.

💡 Highlights:

• The first approved drug Casgevy (for sickle cell anemia and beta thalassemia) marks a historic success in gene therapy.
• Sales are currently still low, but the pipeline for rare diseases and oncology is strong.
• Analysts see medium-term price targets of $70 +depending on clinical progress.

Opportunity: If further indications become established, CRISPR could generate billions in sales in the long term.

⚠️ Risk: Research expensive, approvals complex, sales still in the start-up phase.

🧫 Iovance Biotherapeutics ($IOVA (+3 %)
)

Iovance develops TIL therapies (Tumor Infiltrating Lymphocytes) - immune cells that specifically target solid tumors. The concept is medically promising: letting the body heal itself with its own immune cells.

💡 Highlights:

• Initial approvals and encouraging clinical data are available.
• The share price has recently fluctuated significantly - typical for biotechs in the pre-revenue phase.

Opportunity: If commercialization is successful, $IOVA can scale strongly in the coming years.

⚠️ Risk: Capital-intensive and regulatory demanding - setbacks can hit hard.

🧠 Abbott Laboratories ($ABT (-1,84 %)
)

Abbott is an established player with a focus on medical technology, diagnostics and neurointerfaces. Particularly exciting: the neuromodulation divisionwhich uses electrical impulses to treat chronic pain or movement disorders.

💡 Highlights:

• Cooperation with the NIH BRAIN Initiative for the further development of neuroimplants.
• Stable sales, strong balance sheet and ongoing innovations in the area of biointerfaces and wearable MedTech solutions.

Opportunity: Demand for neuro and heart implants is growing in line with demographic change.

⚠️ Risk: Moderate growth rates, competition from Medtronic & Co.

🧬ONWARD Medical ($ONWD (+8,74 %)
)

ONWARD is one of the most exciting startups in the field of Neurotech & Brain-Computer-Interfaces (BCI). Their goal: to enable people with spinal cord injuries to move again - through direct neuronal communication between the brain and body.

💡 Highlights:

• Several FDA breakthrough designations for their implants.
• Initial clinical successes show that paraplegics can perform controlled movements again.

Opportunity: If the technology catches on, $ONWD could revolutionize rehab medicine.

⚠️ Risk: Very early stage, high research and approval costs, long time-to-market.

#stockanalysis
#biotech
#neurotech
#medizin
#healthcare
#medical

ONWARD Medical $ONWD (+8,74 %) has received approval from the U.S. Food and Drug Administration (FDA) for a pivotal clinical trial. The Empower BP trial will test the company's ARC-IM system, an implantable neurostimulation technology.

The goal of this technology is to treat blood pressure instability in people with spinal cord injury - a common and previously under-treated problem. The study will be conducted at around 20 research centers in the USA, Canada and Europe.

The first patients are expected to be enrolled in the study this year. The ARC-IM system is the first neuroprosthetic system developed specifically for this application and has been approved by the FDA as a "Breakthrough Device" by the FDA.

Shamelessly summarized by the AI, source: https://www.pharmiweb.com/article/onward-medical-receives-fda-ide-approval-to-initiate-the-empower-bp-pivotal-study-with-the-arc-im-sy (Original press release as PDF available at https://ir.onwd.com/static-files/273fa49c-4a2c-40d5-99f1-ff80bbd353da)

Today 720 $ONWD (+8,74 %) shares bought today. Let's see if I get rewarded.