Optiscan: InVue surgery imaging tech heads to US FDA

• Optiscan has lodged a US FDA 510(k) submission for its InVue precision surgery device
• InVue is designed to give surgeons real-time, cellular-level images of tissue while a patient remains in theatre
• The filing follows Optiscan’s recent InForm submission, giving the company two devices submitted for US FDA 510(k) review

The submission comes just days after Optiscan (ASX:OIL) lodged a separate 510(k) application for its InForm digital pathology device on October 2.

Optiscan CEO Dr Camile Farah said:

“Lodgement of InVue’s 510(k) submission with the FDA represents yet another key deliverable in the broader development strategy for our medical technology platform.”

“It means we are now much closer to making a technology designed to give surgeons microscopic insight in real time commercially available in the world’s most important healthcare markets.”

While InForm is a digital pathology device, InVue is designed to take Optiscan’s microscopic imaging technology directly into the operating theatre.

In simple terms, the device is designed to let surgeons view tissue at a microscopic, cellular level in real time while the patient remains in theatre.

That could give surgeons useful information while surgical decisions are actually being made, without relying on the conventional process of removing tissue and sending it away for laboratory preparation before review.

Taking microscopic imaging into theatre

Optiscan unveiled InVue in June 2024 as a next-generation microscopic medical imaging device designed specifically for precision surgery.

Its initial focus is surgical oncology, where surgeons face the challenge of determining during a procedure whether suspicious or residual tumour remains.

Farah said InVue could potentially change how surgeons make decisions in theatre.

“InVue potentially offers multiple advantages to surgeons working in operating theatres.

“It could change what they can see, when they can see it, and, flowing from the first two advantages, provide them with a better course of action during surgery.”

Optiscan says InVue has the potential to support assessment of tissue and surgical margins across procedures including breast, head and neck, colorectal, genitourinary, skin and other solid tumour surgeries.

The US market Optiscan is targeting is sizeable.

According to figures cited in the announcement, around 60% of US cancer patients undergo surgery to treat or stage their disease, equivalent to around 1.27 million patients annually based on 2026 cancer incidence.

The announcement also cites cancer surgery as the largest segment of the US cancer treatment facilities market – representing an estimated US$4.8b in annual revenue, while the broader intraoperative imaging market is forecast to reach US$1.55b by 2030.

What happens at the FDA now?

Lodging the application moves InVue into formal regulatory review, but it is not FDA clearance.

The submission follows an extensive development program covering engineering and clinical validation, as well as external testing and regulatory preparation.

It includes evidence on the device’s performance and safety, along with risk management and clinical use.

The FDA will now assess the technical, performance and clinical evidence supporting Optiscan’s application.

It may request clarification or additional information before determining whether InVue meets the requirements for clearance.

If clearance is achieved, it would provide the basis for commercial rollout in the US for InVue’s cleared indications.

While the FDA reviews InVue, Optiscan will keep preparing for a potential US launch. This includes further clinical work, engaging with surgeons and scaling up manufacturing.

Watch: Optiscan CEO and MD Dr Camile Farah discusses InVue submission

Two FDA submissions in quick succession

The InVue filing follows Optiscan’s recent FDA submission for InForm, putting both devices into the US regulatory pathway.

“The InVue submission, along with the earlier FDA submission for the InForm digital pathology device, are both powerful validations of how far our platform has progressed,” Farah said.

“It is a real credit to our team’s ability to advance Optiscan’s clinical program and hone the Company’s inhouse-developed regulatory capability skillsets.”

Farah also pointed to the potential applications for InVue across cancer surgery.

“From breast and head and neck cancer to other solid tumour procedures, the opportunity is to bring cellular-level information directly into the operating theatre where life-changing decisions need to be made.”

“That is a compelling clinical proposition, and a significant commercial opportunity as we build toward US market entry.”

Optiscan will now continue its clinical and commercial preparations while the FDA reviews the InVue submission.

This article was developed in collaboration with Optiscan Imaging, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

SOURCE: The Australian