US-based medical device company ClearPoint Neuro has formally announced the development of its proprietary Robotic Neuro-Navigation System.

This new product category will enable the company’s Navigation software to operate the KUKA LBR Med Robotic Arm to support all minimally invasive cranial surgical procedures, including cell and gene therapy infusions, laser catheter placement, biopsy workflows and deep brain stimulation and stereotactic EEG lead placements.

The company plans to demonstrate a prototype of this robotic system at the 75^th Annual Congress of Neurological Surgeons (CNS) in Los Angeles, scheduled to be held from October 13 to 15.

"Everything we do at ClearPoint Neuro is viewed through the lens of 'how does this help us extend our lead in neuro drug delivery and help our partners prepare for the commercialisation of these new cell and gene therapies," commented Jeremy Stigall, CBO and GM of the Biologics and Drug Delivery Business at ClearPoint.

He emphasised, "Many of our BioPharma partners have the same dilemma that ClearPoint is helping to solve. On one side, they see the clear value of MRI guidance for drug delivery clinical trials and regulatory submissions, yet the requirements for MRI guidance can be viewed as narrow in flexibility and surgeon choice and can, therefore, limit adoption. On the other side, BioPharma understands that providing too much flexibility with the surgical technique can lead to less-than-optimal results because the ability to train on the crucial surgical technique in a consistent and organised manner can be lost with that flexibility. Just like a lean manufacturing line, you cannot increase quality and reduce procedure time and cost without consistency and repetition. BioPharma needs a single navigation partner that can provide that sweet spot of offering BOTH consistency and flexibility."

"The addition of the ClearPoint Neuro Robotic Neuro-Navigation System to our portfolio is designed to do exactly that - to provide consistency and flexibility to the commercial launches of various cell and gene therapies," Stigall added.

Joe Burnett, President and CEO of ClearPoint Neuro, underscored that robotics will inevitably play a significant role in the future of neurosurgery.

The company has not yet submitted its Robotic Neuro-Navigation System for regulatory review. It plans to continue developing the product, aiming to commercialise it alongside the anticipated approvals of several neuro cell and gene therapies currently undergoing expedited FDA review.

Headquartered in Solana Beach, California, ClearPoint Neuro is a device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine.

Photo: SmartFrame Array Neuro Navigation System