SonoClear raise for FDA clearance.

MedWatch: The Trondheim company will now seek approval from the American drug authority (FDA). Sonoclear, established in 2016, makes technology that is the result of a collaboration between surgeons and engineers from St. Olavs Hospital, NTNU and the research foundation SINTEF.

The company, which grew out of the ultrasound and image-guided therapy community in Trondheim, is developing an advanced acoustic coupling fluid called the Sonoclear system. It is made to improve diagnostic accuracy in ultrasound-guided procedures, especially in neurosurgery.

Peter Balmforth, CEO of Sonoclear, explains it like this:

“After a brain operation, where tumor tissue is removed, the surgeons fill the cavity with fluid so they can ‘see’ with ultrasound. The fluid used today, saline, means that with ultrasound you cannot see well enough whether there are tumor remnants left, because it creates a strong white light at the bottom of the cavity. We wanted to find a fluid that avoids this. Noise signals that disturb the ultrasound image, so-called enhancement artifacts, have been a problem in all ultrasound examinations because they make it difficult to understand and read the ultrasound images,” says Balmforth.

Strict requirements: This sterile fluid is designed to imitate the ultrasound signature of normal, healthy tissue. This gives surgeons clearer images and thus a better basis for decisions when removing brain tumors. “We have worked for many years and landed on the version we have now,” he says.

There are strict requirements for everything that comes into contact with the brain. The company has carried out a study at six hospitals in Europe and is now working on data reading and publication. The study included 44 patients, all of whom received Sonoclear.

“In the study, each patient was their own control group, where today’s fluid was put in first. Then an image was taken, and after that Sonoclear was put in, and then an image was taken again,” says Balmforth.

Great potential: Sonoclear has taken out a convertible loan for bridge financing to finish the study. The company now needs up to 40 million kroner. The plan is to apply for approval from the FDA.

“We have also switched our production partner to a world-class supplier. That is difficult in Norway at the moment, but we have good investors that we have support from, including SINTEF Venture IV, Sarsia, Co-Founder and Sparebanken Midt-Norge,” he says.

What is the potential of the product?

“In Europe and the USA, the goal is an orphan indication. It concerns few people, but the conditions treated with brain surgery are always very serious. The mortality for patients with grade 4 glioblastoma is very high. Removing as much tumor as possible is the only way to help them. We get an image within five minutes, and a quick, good picture of residual tumor. It is estimated that there are 105,000 operations in Europe, the USA and the United Kingdom combined. We must also do a bridge study because we are changing the production factory. This will be done in Germany,” says Balmforth.

Sonoclear vil hente 40 millioner kroner (2025, March 12). MedWatch. https://medwatch.no/nyheter/legemidler_biotek/article18296111.ece