The Road to 1 million

The constant flow of new products in every aspect of our lives creates the illusion that the road from concept to commercial product is relatively quick and straightforward. We read about a new cure and we assume that it is available now to patients.

For medical devices, the road to bringing a product to a patient is actually quite lengthy and very costly. An innovative technology first requires a lengthy design process to develop a functional product. This is followed by extensive pre-clinical studies and clinical trials to establish safety and efficacy.

At each step, there may be technological challenges which force detours and even returning back to the “drawing board” more than once. Then begin the bumps and potholes…regulatory and insurance coverage submissions in each country hopefully followed by approvals.

We decided to take a look at the timeline how Exablate Neuro’s innovative technology came to reach the milestone of 1,000 patients treated.

I would be remiss if I did not thank the hundreds of individuals – engineers, scientists, physicians, researchers, technicians, nurses, INSIGHTEC employees and more – at numerous institutions across the planet who contributed to making this technological innovation a reality.

Focused ultrasound has been under investigation for use in the brain for more than 50 years as a potential alternative to functional neurosurgery as well as surgical resection. However, development and acceptance was hindered by two major factors: the need for a craniotomy and the lack of real time feedback which led to unpredictable and non-reproducible clinical outcomes.

Until very recently, focused ultrasound treatment required the removal of a section of the skull. In fact, transcranial ultrasound treatment was considered to be impossible due to the attenuation of the acoustic beam caused by the skull’s irregular shape and thickness as well as the absorption of the energy causing heating of the skull.

INSIGHTEC is the first and only company to develop a solution that can deliver ultrasound energy across the skull without incisions to a target deep in the brain. The Exablate Neuro system is integrated MR imaging for real-time thermal feedback, allowing patient-specific adjustments during the treatment.

The first procedures performed with the 1st generation Exablate Neuro system (ExAblate 3000) were at Brigham & Womens Hospital in Boston, Massachusetts in 2005. This was a one-of-kind prototype which supported the first three clinical cases.

This system looks quite similar to the current system on first look, however, in reality, there are many technological differences. While the system demonstrated the ability to produce a thermal focal spot through an intact skull, the focusing resolution (500 elements), power (700W), skull cooling (20°C) and imaging performance were not sufficient.

The R&D team returned to the lab to address the main limitations and initiated a complete redesign. After three years, the 2^nd generation Exablate Neuro system (ExAblate 4000 ) was used in clinical trials to treat chronic neuropathic pain patients in Zurich, Switzerland. The system featured a redesign of the transducer to 1000 elements, increased the power to over 2000W and expanded compatibility with 3T MRI. A new stereotactic frame and silicone membrane solved earlier patient movement and comfort issues. The system demonstrated effective thalamic lesioning, however, initial clinical feedback identified additional shortcomings.

A few steps forward and a few steps back…then huge leaps forward to the current 3rd generation Exablate Neuro system. New safety mechanisms were added with acoustic monitoring in real-time, improved algorithms and workflow were introduced. This version has been at the center of multiple clinical trials and regulatory milestones including:

Today, there are more than 35 Exablate Neuro systems installed around the world treating essential tremor patients and being used in research for additional clinical indications.

As we celebrate the 1000^th patient, our eyes and efforts are clearly focused on the road ahead to 1 million!