The Capital Brief | 4DX, OSL and EBR

We are pleased to share The Capital Network’s take on some key stock-specific events occurring over the past fortnight.

While macro and geopolitical uncertainties continue to engross the limelight, selected ASX-listed companies released positive news flow over the late May/early June 2026 period.

Many of these companies operate in sectors where unique product offerings moving closer to commercialisation tend to get the attention of investors always on the lookout for opportunities to enter at the proverbial ground floor.

Of course, investor interest in these product-related announcements is piqued even more if the said products are targeting addressable markets located in industrial segments that are considered to be more insulated from the ups and downs of the broader economic cycle.

This fortnight’s TCN Newsletter shines a light on three of these companies, 4DMedical, OncoSil Medical and EBR Systems, all of which are creators of cutting edge MedTech - and yes, they are also TCN clients.

4DMedical and OncoSil Medical issued announcements that alerted the market to significant deliverables in their respective development and commercialisation strategies. EBR unveiled a material fully underwritten capital raise that will fund multiple growth initiatives, including an expansion of its sales and marketing function, and an upscaling of its manufacturing operations.

It was a pleasure to help all three of these companies get wider coverage for their recent positive news flow.

4DMedical Limited (ASX:4DX)

4DMedical Limited (ASX:4DX) is a MedTech company focused on bringing more insights to medical imaging.

Its ground-breaking US FDA-approved CT:VQ™ solution, delivered seamlessly through a Software-as-a-Service (SaaS) model, has set new benchmarks in cardiothoracic imaging. It combines ventilation and perfusion analysis, and is continuing to gain traction in the lucrative US market.

Over the past fortnight, 4DMedical has issued two ASX announcements that provided further evidence the company’s CT:VQ™ commercialisation strategy is kicking goals – both from a contract wins and broadening of addressable market perspective.

On 29 May 2026, 4DMedical announced it had secured a commercial contract for its CT:VQ™ software offering with SimonMed Imaging, operator of more than 170 outpatient imaging centers across the US. Under the contract, clinical deployment of CT:VQ™ and LDAf™ will immediately occur on commercial terms across SimonMed’s imaging center network.

Importantly, this tie up is much more than just another vote of confidence in 4DMedical’s MedTech offerings. It adds to the growing reimbursement evidence for CT:VQ™ across public and private payors in the US.

The second CT:VQ™-related announcement, which issued on 2 June 2026, informed investors of 4DMedical’s launch of a CLEAR (Contrast-free Lung Evaluation for Acute Risk in pulmonary embolism) clinical evidence program. This study is designed to fast-track CT:VQ™ entry into the acute pulmonary embolism (PE) market, a move that would bolster its US addressable market to US$3B.

The multi-centre, multinational, prospective, observational CLEAR study will pit CT:VQ™ against the current industry standard CTPA test on patients with suspected PE.

In a third announcement released by 4DMedical on 1 June 2026, the company unveiled plans to acquire contextflow GmbH, an Austrian-based medical technology company specialising in lung cancer screening and advanced thoracic imaging solutions.

This acquisition would accelerate 4DMedical’s plans to fast track the establishment of a European commercial and clinical platform, as part of its strategy to penetrate the Continent’s large health care market.

OncoSil Medical Limited (ASX:OSL)

OncoSil Medical (ASX:OSL) a medical device company currently focused on enhancing localised treatments for patients with unresectable locally advanced pancreatic cancer (LAPC), released two sentiment-positive announcements on 9 June 2026.

The first of these announcements detailed the positive results coming out of the TRIPP-FFX study and their ramifications for the company’s broader development strategy.

The results showed that this clinical study had met its co-primary endpoints of safety/tolerability and local disease control rate (LDCR) at 16 weeks in patients with unresectable LAPC. It demonstrated encouraging LDCR and survival with limited and manageable toxicities following the addition of OncoSil™ device to standard-of-care FOLFIRINOX chemotherapy.

These results confirm the necessary safety and efficacy requirements of adding the OncoSil™ device in addition to FOLFIRINOX, the current standard-of-care chemotherapy regimen for patients with unresectable LAPC

The TRIPP-FFX study results also have favourable ramifications for the OncoSil™ device’s existing regulatory settings.

On the back of the results, OncoSil Medical will now move to complete the necessary regulatory filing with an EU & UK Notified Body to expand the current CE Mark for the OncoSil™ device to include FOLFIRINOX as an in additional chemotherapy option for patients with unresectable LAPC. This filing is expected to be delivered late in the second half of calendar 2026.

The second positive announcement released by OncoSil Medical on 9 June 2026 outlined progress made in the company’s efforts to gain regulatory approval in the huge US market.

The US Food and Drug Administration (FDA) has confirmed all its outstanding questions relating to OncoSil's Humanitarian Device Exemption (HDE) application for the treatment of distal cholangiocarcinoma (dCCA) in the US have been satisfactorily addressed.

OncoSil Medical’s HDE application will now advance to the final FDA review stage prior to a potential approval decision.

The FDA has advised the company that it intends to complete its review within 45 days of OncoSil's final submission, which will occur within 30 days. On completion, the HDE will be granted.

EBR Systems, Inc. (ASX:EBR)

EBR Systems, Inc. (ASX:EBR) has developed the world’s only wireless cardiac pacing device for heart failure.

The company’s patented proprietary Wireless Stimulation Endocardially (WiSE®) technology was developed to eliminate the need for cardiac pacing leads, historically the major source of complications, effectiveness and reliability issues in cardiac rhythm disease management.

The WiSE system is now starting to penetrate the large US market. It was successfully implanted in 41 commercial patients over the course of the March 2026 quarter, a figure more than double the 18 cases completed in the preceding quarter. Total implants across the WiSE system’s pilot phase and Limited Market Release stood at 71 as at 31 March 2026.

On 4 June 2026, the company announced the launch of a fully underwritten $150.0 million capital raising.

This raising has two components:

• An already successfully completed fully underwritten institutional placement to institutional and sophisticated investors that raised $64.4 million.

• A fully underwritten 1-for-2 pro rata accelerated non-renounceable entitlement offer to raise approximately $85.6 million.

The net proceeds from the $150 million raising will fund EBR Systems’ plans to expand its sales and marketing function, upscale its manufacturing operations, progress R&D and clinical initiatives, and provide funding to support the company’s growth strategy.

Indicative of the ongoing progress EBR Systems has made implementing plans to scale its business, the company has recently secured purchase agreements with HCA Healthcare, Advocate Health and CHRISTUS Health.

The body of evidence that EBR Systems’ push into the US market is gaining momentum continues to build.

On 4 June 2026, the company announced that the US Centers for Medicare & Medicaid Services (CMS) had initiated a National Coverage Determination (NCD) to evaluate Medicare coverage for leadless left ventricular endocardial pacing (LVEP) used in cardiac resynchronization therapy (CRT).

The initiation of the NCD process is a key outcome of EBR’s engagement with CMS through the Transitional Coverage for Emerging Technologies (TCET) pathway. It represents the most tangible milestone to date in establishing national Medicare coverage for the company’s WiSE system.