Special Report: Optiscan is beefing up its presence in the US as it works toward securing US regulatory approvals for its confocal endomicroscopic imaging technologies. 

Optiscan (ASX:OIL) has started to ramp up its presence in the US after announcing the establishment of a US Regional Office in Rochester Minnesota and the appointment of two US-based executives.

The company has taken up premises at the Minnesota BioBusiness Center as it looks to grow its US operations and cement its presence in the Minnesota medtech landscape.

The Minnesota BioBusiness Center serves as an incubator for private R&D companies to promote biotechnology development, and to support research in the Rochester area. “It’s the ideal space for us to be in at this phase of our expansion into the US. The Rochester ecosystem is full of medtech and biotech startups, established companies and large strategics, and has ready access to local research labs and hospitals which can only facilitate our growth.” says Optiscan CEO & Managing Director, Dr Camile Farah.

As part of the new presence, Optiscan has appointed a new Head of Clinical Affairs, Ken Lock, who comes to Optiscan with vast experience running global clinical trials to support commercialisation of Class II and Class III medical devices in the US.

Lock also has extensive experience with the FDA, including clinical strategy development, protocol negotiation, trial submissions and outcome reporting. In addition, he has experience selecting clinical trials sites, study execution, safety reporting and CRO management.

Nicole Williams, meanwhile, has been appointed as Head of Regulatory Affairs, and comes to Optiscan with significant experience in medical devices, sterilisation, and medical device reprocessors.

Williams has worked at leading companies including STERIS, Richard Wolf Medical Instruments, and more recently at Sterilucent where she worked as Director of Clinical & Regulatory Affairs.

Over a 20-year period, she has led teams in multiple ISO 13485 certifications, prepared multiple 510k submissions leading to regulatory approvals, and maintained global registrations.

Williams also has deep experience and knowledge of surgical endoscopes and sterilisation; and has worked across multiple medical device types, with experience in development, regulatory, quality, sales, software, and technical training at Medical Optics and Alphasource Group.

Lock and Williams will start their new roles today, and will operate between Minneapolis/St Paul and Optiscan’s new Regional Office in Rochester, while being supported by the wider Optiscan team in Australia.

“Both Ken and Nicole bring a wealth of relevant and critical experience and expertise to support the company’s expansion in the US as we roll out our portfolio of new clinical devices,” said Dr. Farah.

“Both will play key roles leading our clinical and regulatory portfolios as the company establishes clinical studies in the US and progresses its regulatory submissions to satisfy the FDA before clinical deployment.”

 

OIL’s portfolio of imaging devices

OIL’s expanding portfolio of devices also includes one for oral cancer imaging, a new surgical device that will focus on breast cancer surgery in the first instance, and a second generation flexible endomicroscope for gastrointestinal (GI) imaging in development.

The company’s unique technology has essentially created a pen-sized digital microscope with hundreds of specially miniaturised components that enable real time microscopic imaging anywhere in the body on any tissue, to produce high resolution digital pathology images at the single-cell level.

The company’s continued innovation and investment in R&D has recently been awarded a $3 million CRC-P grant by the Australian Federal Government to work on its second-generation Edge-AI-enabled gastrointestinal (GI) endomicroscope.

 

Looking ahead: securing FDA approval

The new US appointments are made as Optiscan works toward securing US regulatory approvals.

The company’s flagship technology is its patented confocal endomicroscopic imaging devices for early diagnosis, surgical management, and non-invasive long term monitoring of cancer and other chronic diseases.

These miniaturised endomicroscopes provide a unique way of performing  cancer surgery, giving surgeons power to assess accuracy of cancer removal in real-time, while the patient is still on the operating table instead of waiting days or weeks for a final decision by a pathologist.

“We are confident that our presence at the Minnesota BioBusiness Center and the appointment of new Heads of Clinical and Regulatory Affairs will buttress our US strategy, as we work toward securing US regulatory approval,” said Dr. Farah.

“The complexity of the FDA regulatory pathway and that of our device/drug combination product necessitates that the company has local experts to support both the clinical and regulatory effort required to secure appropriate approvals for our precision surgery and digital pathology solutions.

“This process will be ongoing as we rollout various hardware and software clinical solutions and continue to innovate,” Farah added.

 

This article was developed in collaboration with Optiscan, 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.

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