Scaling for Success

Prof. Iyad Khamaysi, Director of Advanced Endoscopy at the Rambam Health Care Campus, is one of Israel's foremost experts on endoscopic ultrasound-guided (EUS) biopsy procedures for diagnosing pancreatic tumors. For years, he was frustrated by the fact that there were many drawbacks with the existing standard of care for this procedure: it was time-consuming, required significant amounts of redo cases and, most importantly, the tissue samples were usually fragmented, bloody and not always adequate for pathology evaluation. In fact, in up to 20% of cases, the quality of the tissue extracted during the biopsy was so low that it was impossible to arrive at a definitive diagnosis, thereby requiring the patient to return for a second biopsy under sedation.

One day, while coring zucchinis to prepare them to be stuffed, Prof. Khamaysi had an idea: if he would have a biopsy needle similar to a zucchini corer, rather than straight, he could extract tissue from the designated organ by rotational tissue cutting and, he surmised, this would be more effective and lead to better outcomes. Soon afterwards, when the Trendlines Group came to Rambam in search of unmet medical needs, Prof. Khamaysi joined forces with them and they decided to found a new company to explore his idea.

In 2017, Limaca Medical was founded in the Trendlines Group 's medical device incubator in northern Israel and received significant funding from the Israel Innovation Authority. Assaf Klein, a seasoned executive in the medical device industry, was the Founding CEO and he has been leading the company ever since.

Breakthrough device

After the establishment of the company and exploration of different rotational tissue cutting concepts, Limaca Medical succeeded in developing the next-generation alternative to the standard endoscopic biopsy technique. The innovative device offers high quality tissue samples, which enables more accurate pathological analysis, and suits the most advanced diagnostic methods, including molecular profiling testing. This supports optimal clinical decision-making in cancer therapy.

While conventional tools are manual, and more dependent on the physician's skill and experience, Limaca's Precision-GI™ is motorized and offers a more effective, more precise and less user-dependent biopsy device. The entire procedure is more efficient, and, most importantly, since the device is designed to sample high-quality core tissue, it supports an optimal diagnosis process which is, of course, the whole purpose of conducting a biopsy.

Patients benefit by avoiding the need to repeat unsuccessful biopsies, which delays a timely diagnosis and the start of treatment. In this deadly disease, timely treatment is crucial and has a critical impact on patients' prognosis and overall health outcomes.

The development of the first generation of the Limaca endoscopic ultrasound-guided biopsy device was completed in 2018, with a first-in-human trial taking place in Rambam Medical Center in Haifa the following year. The company developed and validated its second-generation device in 2021-22, and in 2023 received the FDA's Breakthrough Device Designation and FDA clearance for commercial use.

The Precision-GI™ demonstrated excellent results in a second clinical trial evaluating its safety and efficacy in comparison to manual FNB needles, with adequate sampling, greater procedural efficacy and a higher histological quality score. To date, the device has been used to perform more than 300 EUS biopsy procedures at leading endoscopy centers in the United States.

"The procedure is super easy for the physician, and the results after just one pass are phenomenal. The core sample is not fragmented or bloody. It's impressive. The quality of the biopsy tissue is amazing. This will be very revolutionary for quality of tissue overall," attests Dr. Carlos Robles-Medranda, Head of Endoscopy Services at the IECED Medical Institute, and one of the endoscopy experts who conducted the clinical trial on Limaca's Precision-GI™ device. Dr. Robles-Medranda's feedback is highly respected, given his status as a globally recognized key opinion leader in GI Endoscopy.

United States, Japan and beyond

In August 2023, Precision-GI™ received FDA 510(k) clearance and, later that year, a special reimbursement code from the Centers for Medicare and Medicaid (CMC), the federal agency responsible for healthcare coverage. Subsequently, Limaca Medical started to market the device in the United States. The company recently signed a commercial agreement with a leading strategic player and the device is now being introduced in medical centers throughout the U.S. Initial feedback from physicians has been extremely positive.

"The Limaca device is very simple and intuitive to use. This device standardizes the fine needle biopsy process and takes out the variability among endoscopists to acquire adequate tissue samples," says Dr. Mohamad Eloubeidi, Director of Endoscopy and President of the Alabama Gastroenterology Society. Dr. Eloubeidi is one of the most experienced and well-respected endoscopic biopsy experts in the U.S.

"During the product launch, the demand exceeded the expectations of our distribution partner. They reported that doctors who perform endoscopic biopsies are responding with great enthusiasm," Limaca Medical CEO Assaf Klein confirms.

The American market is especially receptive following the device's approval by the Centers for Medicare & Medicaid Services (CMS) for Transitional Pass-Through (TPT) payments. This approval allows hospitals to be reimbursed for the full product cost for Medicare patients when the Limaca device is used during their biopsy procedures.

The company is also planning to expand its market reach to new countries over the next few years, and the important Japanese market is next. Limaca has a Japanese partner who is working on the product's registration and the process is expected to be completed by the end of this year. Commercialization in Japan will begin early next year.

"Looking ahead at 2027, Limaca Medical plans to scale its production capacity, growing sales in the vast American market, as well as expending sales globally and adding clinical indications based on the company's technological platform," reveals Klein.

A company on the rise

In less than ten years, Limaca Medical has evolved from an excellent idea for solving a significant unmet clinical need to a rapidly growing company whose state-of-the-art medical device is being used by physicians in leading medical centers.

Indeed, the company has expanded significantly over the past years—from an early-stage R&D startup into a manufacturing company with international reach, featuring in-house engineering, marketing, finance, manufacturing, and sales. Yet, Limaca Medical has maintained a warm, family-like atmosphere and a friendly working environment.

To further support this transition, Limaca Medical is launching a Series A funding round that will enable the company to scale up production and expand into new fields and markets, as well as additional indications.

Specifically, after successfully leading the next generation of endoscopic biopsy needles for pancreatic tumors and other GI diseases, the company plans to use its biopsy platform to develop a similar tool for lung cancer biopsies. Since lung cancer is the most common cancer according to the WHO, with approximately 2.5 million new cases annually worldwide, there is significant demand for a superior endoscopic biopsy device to diagnose these types of tumors.

Limaca Medical is part of the elite group of Israeli startups that began with an excellent idea addressing a genuine clinical need and, through remarkable determination and perseverance, overcame significant challenges to bring their next-generation technology to global markets—all while making a meaningful contribution to improving precision medicine in cancer care.

For more information, visit www.limaca-medical.com

Partnered with Limaca Medical