CurveBeam AI NMPA approval opens HiRise China sales
CurveBeam AI (ASX: CVB) announced on 13 October 2026 that its HiRise™ weight bearing CT (“WBCT”) system has received approval from China’s National Medical Products Administration (“NMPA”). The CurveBeam AI NMPA approval allows HiRise China commercial sales to commence with Shandong WeiYing Intelligent Medical Technology Co., Ltd. (“WeiYing”).
The company said the approval was achieved on the early end of timeline expectations, advancing the commercialisation timetable under the strategic collaboration announced in October 2025.
Key takeaways from the announcement:
- HiRise™ has received NMPA approval in China.
- A further A$1 million equity investment milestone has been triggered at A$0.405 per share.
- Commercial launch activities, customer engagement and distribution can now progress with WeiYing.
For investors, the regulatory step has been completed and the focus moves to commercialisation. The announcement does not provide revenue forecasts, sales targets or launch timelines.
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A$1 million equity investment triggered at A$0.405 per share
The milestone sits under the Share Subscription Agreement announced in October 2025. Under that agreement, WeiYing committed to an equity investment of up to A$10 million in CVB, linked to specified regulatory, commercial and product development milestones.
The company confirmed the HiRise™ NMPA approval triggers a further A$1 million equity investment. The shares are to be issued at A$0.405 per share, consistent with the agreed subscription price.
| Item | Amount | Status | Price per share |
|---|---|---|---|
| Licence agreement execution | A$4 million | Received and announced in February | Not stated |
| NMPA approval milestone | A$1 million | Triggered | A$0.405 |
| Remaining milestone-linked investment | Not itemised in source | Linked to achievement of specified milestones | Not stated |
The announcement does not disclose the precise timing of the placement. The market will be advised “in due course”.
The licence agreement execution tranche saw WeiYing’s partner group commit A$4 million at a five-times premium to the prevailing market price, an early signal of conviction in weight bearing CT that the NMPA milestone now builds on.
According to the company, WeiYing’s equity participation is linked to the advancement of the collaboration and the commercialisation of CVB’s technology. That linkage reinforces alignment between the two parties.
How WeiYing and WEGO Orthopaedics shape the China opportunity
The 10-year agreements
In October 2025, CVB executed definitive 10-year agreements with WeiYing. The agreements established a framework for the exclusive distribution, marketing and local manufacture of CVB’s WBCT systems and associated AI technologies across China, Hong Kong, Macau and Taiwan, subject to the applicable regulatory approvals.
Partner credentials
WeiYing is a joint venture between Shandong Weigao Haixing Medical Device Co. (Wego), Ltd. and other Chinese commercialisation partners and investors. Shandong Weigao Haixing Medical Device Co., Ltd is a subsidiary of Shandong Weigao Orthopaedic Materials Co., Ltd. (“WEGO Orthopaedics”).
According to the announcement, WEGO Orthopaedics is recognised as holding the largest domestic market share among orthopaedic device suppliers.
What weight bearing CT does
A standard CT scan is usually taken without load on the body. Weight bearing CT captures images while the patient is standing, so the anatomy is assessed under physiological loading.
HiRise™ provides three-dimensional weight bearing CT imaging of the lower extremities. The technology is designed to support orthopaedic assessment and surgical planning by providing information that may not be apparent from conventional non-weight bearing imaging alone.
That matters commercially because a product with this stated clinical differentiation now has a regulatory route into the Chinese market.
Greg Brown, CEO, CurveBeam AI
“NMPA approval moves us beyond regulatory preparation and into commercialisation…”
Next steps: commercial launch, local manufacturing and royalties
Following approval, the announcement says CVB and WEGO Orthopaedics will focus on the following:
- Progressing commercial launch activities.
- Developing the distribution pipeline.
- Supporting customer engagement and the introduction of HiRise™ to the Chinese market.
- Advancing local China-based manufacturing and supply chain optimisation.
- Developing future generation imaging products and associated AI solutions, in accordance with the executed agreements.
The company also cites long-term royalty income from the Chinese market among the partnership’s broader future objectives. No timelines, revenue forecasts or sales targets were provided.
Mr Brown said the approval was delivered while the team was simultaneously delivering FDA 510(k) clearance for CVB’s MDCT based Bone Mineral Density (BMD) technology. The announcement presents this as a reflection of the dedication of the company’s international team.
The FDA 510(k) clearance covers CT-based bone mineral density measurement on supine multidetector scans, and a separate submission for weight bearing BMD on HiRise™ is the next regulatory step tied to any SaaS revenue.
The milestone shifts the focus from regulatory risk to commercial execution. The next disclosures to watch are the timing of the placement and any updates on the launch with WeiYing.
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