Highlights

• Optiscan launched InSpecta, its first commercial clinical device, at a US veterinary convention on 10 July 2026.

• InVue and InForm submissions to the US FDA remain on schedule for the second half of calendar 2026.

• Optiscan closed the June quarter with $14.353 million in cash, no debt and a $618,000 operating outflow.

• Clinical studies now span Melbourne, Perth, the Mayo Clinic in Rochester and a gastrointestinal study in Mainz, Germany.

One regulatory dossier is in, a first commercial product is on the market and two more submissions are lined up. Optiscan Imaging Limited (ASX:OIL), the endomicroscopy imaging company, launched InSpecta in the United States on 10 July 2026 at the AVMA Convention in Anaheim, California, after lodging its dossier with the US Food and Drug Administration's Centre for Veterinary Medicine on 31 March 2026. Shares were trading at A$0.160 on 23 October 2026, up 3.23%.

From Veterinary Launch to Human Medicine

InSpecta targets veterinary medicine and is the company's first commercial clinical device. The company reported positive engagement and useful market feedback from the launch and said its priority now is building traction in the US veterinary market.

The larger regulatory tasks come next. InVue, aimed at precision surgery, and InForm, aimed at digital pathology, remain on schedule for FDA submission in the second half of calendar 2026, according to the company's June-quarter update. Compliance testing covering electrical safety, cybersecurity, software and electromagnetic compatibility is under way for both devices, and an ISO 13485 surveillance audit finished with zero non-conformances.

Clinical Evidence Builds Across Sites

Clinical studies are feeding those submissions. A breast cancer study at the Royal Melbourne Hospital had completed 34 of 50 cases, and a second site, Frances Perry House, has accelerated enrolment. A head and neck cancer study at St John of God Murdoch had imaged 10 of 50 patients with InForm, with a second stage adding InVue starting in mid-July 2026.

A pathology study with Australian Clinical Labs has generated 60 datasets across many tissue types, some intended to support the InForm submission. In the United States, the company signed a research agreement with the Mayo Clinic in Rochester in mid-July. It covers two studies, in breast and in head and neck cancer, each targeting up to 35 patients. Institutional approval has been received for the breast study, and approval for the head and neck study is in progress.

A further study at University Medical Centre Mainz in Germany has received ethics approval and will enrol up to 50 patients. It supports the next-generation flexible endomicroscope under a collaboration with Monash University and Capgemini.

Funding and Financial Position

Optiscan closed the June 2026 quarter with $14.353 million in cash, made up of $6.353 million in bank balances and an $8.0 million short-term deposit, and no debt. Operating cash outflow was $618,000 for the quarter, helped by $2.537 million in government grants and tax incentives, including a $1.694 million R&D tax refund.

For FY2026, revenue was $448,769, compared with $951,948 a year earlier, reflecting lower orders from Carl Zeiss Meditec and lower ViewnVivo sales. The loss after tax was $6,986,043. Cash rose from $4,551,755 a year earlier, following a fully underwritten entitlement offer that raised $17,751,045 at $0.085 per share, completed on 23 September 2025.

The company has ceased marketing of its ViewnVivo product and ended its distribution arrangement with Biotimes Technology in China, redirecting its effort to digital pathology, precision surgery and veterinary medicine.

What Comes Next

Near-term priorities include lodging the InVue and InForm submissions, completing the Australian studies, starting the two Mayo Clinic studies and continuing the German gastrointestinal work. The company also plans to build InSpecta's US veterinary presence and advance the flexible endomicroscope program. Its annual general meeting is proposed for 5 November 2026.