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Highlights

  • Optiscan and Long Grove Pharmaceuticals sign a five-year exclusive collaboration to advance clinical use of AK-FLUOR® with Optiscan’s imaging devices.

  • The agreement aims to support US FDA regulatory submissions for Optiscan’s InVue® surgical device.

  • Optiscan’s share price surged from 6.1 cents to 12 cents on 23 June 2025 following the announcement.

Optiscan Imaging Limited (ASX:OIL) saw its share price more than double on Monday, 23 June 2025, rising over 9.05% to reach 12 cents per share. The surge followed the company’s announcement of a new exclusive collaboration with U.S.-based pharmaceutical firm Long Grove Pharmaceuticals, LLC.

Details of the Collaboration

Under a five-year exclusive agreement, the two companies will jointly conduct clinical studies and trials involving Long Grove’s intravenous fluorescein sodium contrast agent (AK-FLUOR®) used in conjunction with Optiscan’s fluorescence-based endomicroscopic imaging technology. The partnership is designed to identify new clinical applications for AK-FLUOR® while also supporting Optiscan’s regulatory submission process with the U.S. Food and Drug Administration (FDA) for its InVue® surgical imaging device.

The agreement will begin with studies in breast surgery and may expand into gastrointestinal endoscopy, gastrointestinal surgery, robotic-assisted surgery, and laparoscopic procedures. Long Grove will supply its AK-FLUOR® drug, which is a key component for Optiscan’s imaging systems, while also providing support through existing pharmacokinetic and chemistry, manufacturing, and controls (CMC) data.

Strategic Benefits for Both Companies

The collaboration leverages Optiscan’s proprietary imaging platform and Long Grove’s pharmaceutical manufacturing capabilities. Optiscan will gain a secure supply of the AK-FLUOR® agent, necessary for its fluorescence imaging devices. In return, Long Grove stands to benefit from potential new clinical applications for its fluorescein sodium product through integration with Optiscan’s devices.

Optiscan’s CEO and Managing Director, Dr Camile Farah, stated that the agreement serves as a mutually beneficial step for both parties, aligning their development objectives. Data from the clinical studies will form a core component of the regulatory submissions for Optiscan’s InVue® system in the U.S., potentially accelerating the company’s entry into the American surgical imaging market.

Regulatory and Market Implications

As part of the arrangement, Optiscan will support Long Grove’s potential supplementary New Drug Application (NDA) submissions for AK-FLUOR® to the FDA. In parallel, Long Grove’s support and provision of existing regulatory data are expected to boost Optiscan’s FDA submissions for device approvals.