ASX Quarterly Health Wrap: No tricks, just treats as milestones reached

• Imagion progresses MagSense HER2 breast cancer imaging program with IND submission to US FDA planned for Q4 CY25
• Singular Health deploys 250 licenses of 3DICOM MD deployed during quarter under PNS deal
• Audeara revenue climbs to $1.52 million in Q1 FY26, driven by momentum in AUA Technology division and rise in Australian wholesale sales 

Investors have been closely watching how ASX-listed healthcare companies have been faring this quarterly reporting season, with results offering valuable insight into business momentum and the sector’s outlook after several years of muted performance despite solid fundamentals.

A look at some of the healthcare names releasing updates late this week shows there’s little for investors to be spooked by – with milestones achieved, key partnerships secured, and steady clinical progress across the board.

Imagion Biosystems (ASX:IBX)

• Imagion progresses MagSense HER2 breast cancer imaging program during quarter
• Encouraging feedback from FDA following meetings to review its proposed IND submission for phase II trial
• New collaboration with MRI experts at Wayne State University to optimise imaging protocols for MagSense HER2 imaging agent

Imagion continued to make strong progress during the quarter as it advances its MagSense HER2 breast cancer imaging program towards a planned Investigational New Drug (IND) submission to the US Food and Drug Administration in Q4 CY25.

In July, Imagion reported encouraging feedback from the FDA following a series of meetings to review its proposed IND submission for a phase II trial.

No issues were raised that would impact the company’s plans, with discussions also covering longer-term clinical and commercial development considerations.

In August, Imagion entered a new collaboration with MRI experts at Wayne State University (WSU) to optimise imaging protocols for the MagSense HER2 imaging agent.

The results will feed directly into the IND submission and be implemented at clinical sites under Imagion’s existing collaboration with Siemens Healthineers.

In September, the Company appointed experienced life sciences executive and Dimerix (ASX:DXB) CEO and managing director Dr Nina Webster as a non-executive director.

Her expertise in strategic planning, investor relations, and ASX-listed biotech leadership is set to further strengthen Imagion’s board.

Imagion also completed a $3.5 million capital raise during the quarter to fund the IND submission and initiation of its phase II HER2 breast cancer clinical trial.

It also achieved a major milestone completing manufacturing of its MagSense HER2 breast cancer imaging agent ahead of the planned phase II trial.

“We’re now in the final stages of preparation for our next exciting chapter for Imagion,”  executive chairman Bob Proulx said.

Singular Health Group (ASX:SHG)

• Initial contract with Provider Network Solutions running as per schedule with 250 licenses of 3DICOM MD deployed during quarter
• Subsidiary Singular Health USA LLC established with chief commercial officer based in Austin appointed to support US growth
• Company strengthens software and regulatory teams adding senior developers in Singapore and forming Singular Health Pte Ltd

Singular Health has delivered another strong quarter of operational and commercial progress, advancing its US rollout and building momentum in the global medical imaging market through its proprietary 3DICOM technology.

The company’s initial US commercial contract with Provider Network Solutions (PNS) continued to progress as planned.

During the quarter, 250 licenses of 3DICOM MD were deployed across PNS’s primary care network, with a further 500 licenses scheduled for rollout in Q1 CY26.

Singular Health also advanced discussions with several major US healthcare organisations, including PNS partners, a leading Puerto Rican health fund, and a top US university exploring the use of 3DICOM for imaging aggregation and AI development.

Engagements with US government agencies also progressed, focusing on the potential inclusion of 3DICOM in federal healthcare programs to reduce imaging duplication and improve access to care.

To support its growing US operations, the company established subsidiary, Singular Health USA LLC, and appointed Paige Taylor as chief commercial officer, based in Austin, Texas.

Taylor brings more than a decade of commercial and clinical leadership experience from roles at Perimeter Medical Imaging AI, Medtronic, and Stanley Healthcare.

The company also strengthened its software and regulatory teams, adding senior developers in Singapore and forming Singular Health Pte Ltd to support pilot programs and the FDA submission for the 3DICOM Online Viewer.

3DICOM EDU  was also launched during the quarter with the enhanced educational viewer forming the flagship software for its continued expansion within the education sector.

The 3DICOM viewer was also implemented across several Australian sites accredited by the Royal Australian and New Zealand College of Radiologist (RANZCR) for training purposes.

Singular Health closed the quarter with $12.2 million, providing the resources to strengthen contract pipelines, continue its international expansion and strengthen its regulatory and technical capabilities.

Audeara (ASX:AUA)

• Audeara revenue climbs to $1.52m in Q1 FY26, up 111% on pcp with net outflows improving 55% on Q4 FY25
• Strong momentum in AUA Technology division and 99% increase in Australian wholesale sales year-on-year
• Key commercial developments during quarter, including licensing agreement with Eastech (Huizhou) to boost growth in China

Personalised-audio specialist Audeara has reported a strong start to FY26, with revenue of $1.52m in Q1, up 111% on the previous corresponding period (pcp), driven by ongoing momentum in its AUA Technology division and a 99% increase in Australian wholesale sales year-on-year.

Net cash outflows were $338,000, a 55% improvement on Q4 FY25, following the completion of stock purchasing and R&D investment in the prior quarter. The company ended the quarter with $1.21m cash.

The quarter was marked by key commercial developments, including a licensing agreement with Eastech (Huizhou), a subsidiary of Taiwan-listed Eastech Holding.

Under the deal Audeara will provide proprietary hearing technology and development support for hearing aids in China.

An initial order of 1,000 licence keys was received post-period, with product launch imminent, offering national reach through a leading e-commerce provider.

Audeara also strengthened its international footprint with a distribution agreement with Eyear System Inc to launch Auracast accessibility in Japan.

Domestically, the company entered a project agreement with the Ear Science Institute Australia (ESIA) to advance bone conduction listening devices, including a $100,000 grant.  The deal is further supported by a partnership with Shokz Hear to optimise devices for children in schools.

Looking ahead, Audeara remains focused on Australian wholesale channels, cost control, and cashflow breakeven, while continuing negotiations for follow-on orders from key partners and exploring new Auracast opportunities internationally.

At Stockhead, we tell it as it is. While Imagion Biosystems, Singular Health Group and Audeara are Stockhead advertisers, the companies did not sponsor this story.