Israeli startup Limaca Medical says it has developed a medical device to perform endoscopic ultrasound-guided biopsies that promise “ten times” greater procedural efficiency with less trauma than the commonly used endoscope.
Today, when patients need to undergo an endoscopic biopsy — in which sample cells are extracted to determine the presence or the extent of a disease in internal organs — surgeons use an ultrasound-guided endoscope, an illuminated optical tube with an ultrasound device that is inserted via the mouth through the esophagus to the stomach. From the stomach the ultrasound takes images of the required organ, deep within the patients’ body, via the gastric wall. The procedure is called an endoscopic ultrasound, or EUS.
Then, when the right position is reached, a needle catheter emerges from the head of the probe to puncture the gastric wall repeatedly to reach the targeted suspect area in the organ. To gather enough cell tissue, the needle needs to puncture the area “dozens or more times” to get enough issue to perform the test, explained Limaca’s CEO Assaf Klein in a phone interview.
The tissue is collected in a chamber within the needle, which is then extracted at the end of the biopsy procedure and ejected into a small biopsy container.
This is the way the procedure has been done for over 25 years, yet it does not extract the quality tissue required for advanced analysis, said Klein.
To be able to meet the demands of the advanced genetic sequencing analysis needed for growing use of precision medications, which hope to target the exact cancer by diagnosing specific genetic mutations, an improved kind of biopsy is needed, Klein said.
Limaca’s Precision biopsy device looks similar to regular EUS biopsy devices, but has an automated revolving needle at its edge. Once the needle perforates the gastric wall, it starts drilling. This gives the surgeons more control and enables them to precisely reach the area of interest in the organ. With just two or three stabs, the device is able to attain two or three “nice” sausage-shaped tissue samples, Klein said.
“We get kind of a geological sample of the tumor, mapping the different layers of the tumor just like with an earth sample, from the external layers to the more internal layers,” said Klein. The sample of tissue comes out intact, making it a high-quality sample that can then be better analyzed.
Limaca in November said it had closed $1.25 million of a $1.5 million round to complete its first-in-human (FIH) procedures, obtain regulatory approvals, and develop its second product aimed at endoscopic lung biopsies. Investors included the Israel- and Singapore-based fund The Trendlines Group Ltd.; Agriline, owned by a trust of which entrepreneur Vincent Tchenguiz is a discretionary beneficiary; and Limaca chairman and medical device industry veteran Carl Rickenbaugh.
Competing firms are seeking to improve the existing endoscopic technology, with changes to the needle tip only, but the handmade punctures are still part of their procedures, said Klein. “We are the first company going to clinical trials with an automated biopsy device.”
The startup has enrolled 10 patients for its in-patient study at the Rambam Health Care Campus in Israel. The ongoing study compares Limaca’s Precision to the best commercially available manual EUS biopsy devices, the firm said. Prof. Iyad Khamaysi, Limaca’s founder and medical director, is the director of the Invasive Endoscopy Unit at the Rambam Health Care Campus. He set up Limaca in 2017 as an academic spinoff of the hospital.
Initial results of the trial “have demonstrated ease of use, safety, and improved sample capture,” Khamaysi said in an email. “Oncology is shifting from general treatment protocols for all patients to precision medicine tailoring specific treatment, making it much more efficient for each patient. The Precision is the first automated endoscopic biopsy device, designed to acquire high-quality core tissue needed for genetic profiling to support precision medical treatments. It is my vision that the company will have a significant role in enabling precision medicine for those patients suffering from pancreatic cancer and other deep organ cancers.”
With the money raised, Limaca plans to expand the trial to Tel Aviv Sourasky Medical Center (Ichilov Hospital) and will initiate new trials in Europe and the US, said Klein.
“The plan is to set up a larger trial within a year and to commercialize the product during 2022,” Klein said.
Limaca will initially target biopsy sampling for pancreatic cancer, the statement said. Additional markets for the Precision device address biopsy sampling for the diagnosis of lung cancer, liver biopsy, lymphoma, and other cancers where endoscopic biopsy is feasible and subcutaneous tissue sampling is difficult.