With the help of Rambam MedTech Ltd., Dr. Iyad Khamaysi, the director of Rambam’s Advanced Endoscopy Unit in the Department of Gastroenterology, recently founded a company that will commercialize the biopsy device he invented.
The new company, Limaca Medical, was established thanks to funding by Trendlines Investment Group, which has facilitated by Rambam MedTech. Dr. Khamaysi’s Precision™ EUS biopsy device is now on track for FDA 510K approval and clinical studies are being planned.
Dr. Khamaysi often found himself questioning traditional techniques that provided less than optimal results. However, it took a squash corer and a sprained thumb to inspire a new device to facilitate high quality pancreatic tissue sample acquisition for diagnostics and precision medicine. Over the years, he had seen remarkable advances in the ield, but he was disturbed by the lack of progress with how pancreatic tissue samples were acquired via endoscopic ultrasound (EUS) for cancer diagnostics. After 25 years, there had been no change in how tissue samples were obtained, and, in comparison with other biopsy samples, pancreatic samples were of relatively poor quality and inadequate for application to more advanced therapeutics such as precision medicine. There had to be a better way.
When considering possible solutions, he realized that the way pancreatic tissue samples were acquired wasn’t very different from how one removed seeds from small zucchinis before stuffing them with rice. An instrument similar in shape to a wide needle was pushed into the center of the vegetable – then with a quick twist – the seeds would come out in one contiguous lump. But you had to twist the utensil, otherwise nothing came out. This made him wonder, could a biopsy needle acquire a contiguous tissue sample that easily – with just a small rotation?
His ideas for an innovative endoscopic biopsy device crystalized following a minor hand injury. Performing biopsies became extremely difficult since his injured thumb was not strong enough to apply the pressure needed for the needle to enter the pancreatic tissue. Dr. Khamaysi’s mind was flooded with ideas, but he needed to partner with someone if he was going to develop something that would reach his patients, particularly after discussing possible solutions with a colleague at the Technion. Fortunately, the work environment at Rambam Health Care Campus placed a strong emphasis on developing innovative solutions for real clinical needs. The hospital had established
ambam MedTech Ltd. to help physicians just like Dr. Khamaysi.
Rambam MedTech’s team immediately understood the importance of Dr. Khamaysi’s idea and helped him through the entire process from a feasibility study and introducing him to potential research and development partners, through actual product development.
“Rambam MedTech invited someone from Trendlines Investment Group to speak to us,” Dr. Khamaysi recalls. “They encouraged us, and I liked their ideas. A cooperative agreement was signed between myself, Rambam MedTech, and Trendlines. Everything progressed quickly from there.”
Two patents were filed, one for the rotational biopsy needle, and another for the automatic mechanical pressure device to advance the needle into the tissue.
Working together with Rambam MedTech and Trendlines, Dr. Khamaysi founded Limaca Medical, with Assaf Klein as its CEO. Dr. Khamaysi explains that “Limaca comes from the ancient Greek for a snail, and the picture in our mind is the long shell that twists in a spiral – kind of like what the needle has to do to take the biopsy.”
His device, Precision™, represents a novel endoscopic ultrasound-guided biopsy device for precision medicine. The high-quality core-tissue samples that are obtained are ideal for precise analysis, improved diagnostic accuracy, and patient-specific treatment with improved clinical outcomes. To date, more than US$3 million have been provided by external investors. The device is scheduled to receive 510K FDA approval by the end of 2020 and has been successfully used with 10 patients. Clinical trials are scheduled to begin shortly. The device was awarded a Seal of Excellence by the EU Framework Programme for Research and Innovation (November 24, 2020), and was presented at the prestigious annual meeting of the Society of Gastrointestinal and Endoscopic Surgeons
