Optiscan secures major milestone after approval for prestigious cancer trial

Medical equipment maker Optiscan Imaging (ASX: OIL) has achieved a significant milestone as part of its overarching development strategy after its cutting-edge “virtual biopsy technology” was selected for use in an oral cancer clinical trial, set to commence in the “near term”.

Earlier today, Optiscan confirmed that its novel system and confocal laser endomicroscope technology would be used in a human clinical trial overseen by the Institutional Review Board of Memorial Sloan Kettering Cancer Centre (MSKCC) in the US.

According to Optiscan, its endomicroscope can detect cancer cells during operations to remove tumours with real-time feedback allowing surgeons to minimise the removal of healthy tissue. Surgeons are also able to reduce the number of call backs for more surgery to remove missed cancerous tissue.

Currently, Optiscan is engaging with various US-based regulatory advisers who are assisting Optiscan to prepare an FDA 510(k) submission, and thereby, helping the company close in on an FDA regulatory approval.

If approved, the US market that would significantly broaden the clinical applications for the sale of Optiscan technology into many organ systems, including brain, cervical, breast and oesophageal cancers.

Given that Optiscan’s technology will be utilised in a high-profile clinical trial, the milestone represents a “critical endorsement of the system’s imaging capabilities and is a testament to the quality of the company’s breakthrough technology”, the company said.

Optiscan currently works with MSKCC on the development of screening, early diagnosis and surgical tools targeting cancer cells in oral, cervical and oesophageal applications.

Following MSKCC’s approval of Optiscan’s technology for its oral cancer trial, it is anticipated that further approvals will now be sought for the conduct of cervical and oesophageal cancer trials.

US and Australian pincer movement

As a further potential boost, Optiscan confirmed that it hopes to secure additional endorsements by way of various clinical research in Australia.

Optiscan has been in discussions with leading Australian health institutions regarding the use of its technology to assist research.

There is strong potential for the Optiscan system to be used in further clinical cancer trials with the company confirmed that a leading Australian health care institution is currently preparing an ethics submission for use of the Optiscan system in a second human oral cancer clinical trial.

One of the prime areas which can benefit from Optiscan’s technology is breast cancer research which sees around 2 million new cases each year globally and accounts for 15% of all cancer cases in the US.

In Australia, the prevalence of breast cancer is growing with as many as 145 hospitals currently performing cancer surgeries nationwide.

Led by Dr Philip Currie, Optiscan will work in conjunction with Dr Peter Willsher and Dr Jespal Gill to complete the imaging required to complete Stage 2 of its Breast Cancer trial at Western Australia’s largest private hospital, Hollywood Private.

In addition, Optiscan said that it is currently in discussions regarding the possibility of conducting a stage 3 trial that will include multiple venues including several Melbourne-based hospitals.

Marketing push

In a bid to further showcase its technology, Optiscan has been invited to present details of this breast cancer research at the 17th World Federation for Ultrasound in Medicine and Biology Congress (WFUMB) in Melbourne next month.

The WFUMB will be attended by over 2,000 delegates accompanied by a global committee that will preside over the largest ultrasound-focused program held in Australia in over five years.

As part of a parallel marketing offensive, Optiscan is also engaging in multiple pre-clinical and translational initiatives including ongoing work with Monash University and the University of Michigan, to investigate a new hypothesis into the causes of anterior cruciate ligament injury during normal athletic activity.

Work is also continuing with the CSIRO in relation to the use of the Optiscan system to enable real-time imaging of in vitro 3D tissue culture.

“Optiscan is entering a new commercial phase and we remain focused on bringing our breakthrough technology to new applications in the clinical market with our own device,” said Darren Lurie, executive chairman of Optiscan.

“Our technology which enables real-time virtual biopsies for cancer screening and the assessment of tumour margin in many types of cancer surgeries is set to be a game-changer in a number of clinical applications.”

“Following a recent capital raising, we are now well placed to move forward and obtain regulatory approvals for our clinical device. It is an exciting period for us as we take key steps forward on our plan for FY2020 and beyond,” said Mr Lurie.