Optiscan Imaging teams up with US drugmaker to support FDA submissions

Optiscan Imaging has inked a collaborative deal with US-based Long Grove Pharmaceuticals to trial the drugmaker’s AK-FLUOR fluorescein dye in Optiscan’s imaging technology, initially to detect breast cancer.

Optiscan Imaging (ASX: OIL) has fired a major shot in a bid to expand into the lucrative United States medical imaging market by inking a blockbuster five-year deal with American pharmaceutical outfit Long Grove Pharmaceuticals.

The exclusive collaborative agreement will see Long Grove’s fluorescein sodium contrast dye, AK-FLUOR, supplied for use in Optiscan’s InVue imaging system in clinical studies, starting with breast surgery.

Long Grove was founded by US healthcare investor Water Street and is known for its high-quality, cost-effective drug formulations. The company is the legal manufacturer of AK-FLUOR dye. The contrast dye is used to highlight cellular structures for medical imaging during surgery.

Optiscan already uses the dye with its InVue fluorescence-based endomicroscopic imaging technology.

The two companies have teamed up to explore and support new clinical uses for the injectable dye and will initially focus on breast surgery. The deal is expected to expand into gastrointestinal endoscopy, robotic-assisted surgery and laparoscopic procedures.

The data generated from the trials will be used to fast-track United States Food and Drug Administration (FDA) approvals for both the device and the drug, potentially unlocking broader commercial use and a quicker route into the US market.

As part of the deal, Optiscan will get valuable information about how AK-FLUOR works in the body and how it’s manufactured. In return, Long Grove will receive support for new FDA applications if new therapeutic uses of its drug in microscopic imaging come to light from the trials.

For Optiscan, the agreement gives us a supply of Long Grove’s AK-FLUOR, which will be used in combination with our fluorescence-based endomicroscopic imaging devices to undertake studies and clinical trials. The data flowing from these studies will be an invaluable resource for our regulatory submissions. For Long Grove, the collaboration should hopefully identify new uses for its drug.

Optiscan CEO and Managing Director Dr Camile Farah

Long Grove Pharmaceuticals president Peter J. Karas said by combining its quality pharmaceuticals with Optiscan’s advanced imaging, the company was poised to deliver real innovation and improve outcomes across healthcare.

Optiscan management said the deal showed an increasing number of healthcare companies were interested in working with Optiscan. This type of collaborative agreement could prompt more surgeons to use real-time imaging during surgery, potentially redefining disease treatment to improve patient outcomes.

Optiscan’s proprietary endomicroscope can produce real-time single-cell-resolution 3D images, which are 1000 times sharper than traditional CT or MRI scans. This allows doctors to conduct a precise and immediate optical biopsy during complicated surgeries, thereby reducing the need for repeat procedures.

With the global digital health and surgical tech market booming, Optiscan’s alliance with Long Grove appears to mark a pivotal moment in its US expansion journey. It could well pave the way for a wave of new FDA approvals, commercial partnerships and life-saving clinical applications.

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