Optiscan (ASX:OIL)
Highlights:
- Optiscan says its research and development projects continued to progress during March quarter
- Second clinical device for intraoperative surgical use is nearing completion and planned for breast cancer surgery
- Established a US Regional Office in Rochester Minnesota aimed to position Optiscan at the centre of the US medtech hub
OIL says during the March quarter it progressed well with its research and development projects outlined during its
$16.7 million capital raise announced in July 2023.
The company’s second clinical device designed for intraoperative surgical use is nearing completion, which includes a new user interface and probes customised for open surgical applications.
This device is planned for use in open breast cancer surgery in the first instance, while the company explores other viable surgical use cases with potential clinical partners.
During the quarter, OIL says work progressed at an accelerated pace on developing its third clinical device designed specifically for diagnostic pathology use, as a digital replacement to the frozen section, opening up yet another use case for the company’s platform technology. Delivery of this device is expected in Q4 FY24.
OIL has also started development of its second generation Edge–AI–enabled flexible confocal endomicroscope for gastroenterology that can fit the biopsy channels of commonly used colonoscopes.
A successful CRC-P grant application will result in a $3m contribution from the Federal Government over the next three years to accelerate development of this product.
In addition to significant advancements in hardware development, OIL has progressed with its cloud-based telepathology platform with its beta phase progressing to schedule.
The company says real-time image streaming to the cloud, and storage, have been demonstrated by its partner Prolucid Technologies. OIL engineers have started work on updating its InVivage software to interface with the web portal.
OIL says the updated InVivage received safety certification in January 2024, and is ready for deployment in clinical trials awaiting advice from the US FDA on the most appropriate path to regulatory approval.
After the quarter end OIL announced due to complexity of the FDA regulatory pathway required for its combination (device/drug) suite of products including its future software as a medical device (SaMD),
the company had appointed two US-based executives.
It also recruited Melbourne-based systems and firmware engineers to support its ambitious growth plans and established a US regional office at the Minnesota BioBusiness Center, which will serve as its clinical and regulatory hub.
OIL says good progress has been made in relation to alternatives to its topical fluorescein approach for oral imaging based on feedback and advice provided by the US FDA, and is currently in talks with suitable drug manufacturers.
The company says customer orders and production are progressing on schedule with orders of ~$300k shipped during the March quarter.
OIL also received an R&D tax incentive rebate of $672k during the quarter, enabling further investment in its multi-product portfolio development.
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