THE PRODUCT IS FDA CLEARED AND IN CLINICAL PHASE
EndoDrill® is a new patent-pending product family of electric-driven endoscopic biopsy instruments currently in clinical phase. EndoDrill® is developed to offer unique tissue sampling of high-quality core biopies. The product includes a handle with flexible drill cylinder (disposable component) coupled with a motor unit, foot pedal and cables (reusable component). The product family is being developed for most endoscopic tissue acquisition indications, e.g. in the oesophagus, stomach, pancreas, colon, lungs and bladder. Since the end of 2020, EndoDrill® is the world’s first CE-approved electric driven biopsy instrument for endoscopy – making it the first one granted market approval. The primary segment of EndoDrill® is the fast-growing premium market for ultrasound-guided biopsy instruments (EUS-FNA/FNB, EBUS-TBNA).
The goal of EndoDrill® is to be able to – for the first time – harvest the same solid core biopsies collected with rigid needle instruments when diagnosing breast and prostate cancer. For these more easily accessible organs, samples are taken by inserting a needle from outside the body into the target area (called a percutaneous biopsy), unlike endoscopic sampling, which takes place with long, flexible needle instruments that are inserted via natural body openings like the mouth. For sample collection from the breast and prostate, development over the years has gone from cell samples with fine needles to histological core biopsies with coarser needles. A large and intact piece of tissue sample provides more information and opens up a variety of possibilities in personalised treatment for some of the most serious forms of cancer.
Today’s EUS needle instruments are inserted into the tumour with a repeated stabbing motion, and daubs of cells and tissue fragments adhere to the tip of the needle. Because of the manual method and the generally low sample quality, experienced endoscopists are required for the sampling and skilled pathologists are needed for the evaluation.
EndoDrill® will simplify the entire diagnostic process for some of the most troublesome forms of cancer. With a high-quality core biopsy right from the first examination, the goal of a complete treatment-determining diagnosis is achieved immediately. Consequently, resource-intensive methods and the need for repeated sampling are avoided. Instead of manual sampling with a stabbing motion, samples are taken with the help of electric high-speed drilling. With a flexible rotating cylinder, the endoscopist cuts out fine samples, while maintaining tissue architecture under high precision. Early and complete diagnosis makes it possible to apply the right treatment, such as tumour surgery, immediately. This, in turn, can both save lives and save healthcare resources.
The product has several unique properties. First and foremost is the ability to take the named core biopsies, even with endoscopy, as well as enabling sampling of both superficial and deep-lying tumours and sampling of several biopsies at once (multiple sampling) via a magazine function. Another very important and unique property is the ultra-flexible design, which enables sampling with a heavily angled endoscope. This means that you can take high-quality samples even if the tumours are very difficult to access.
Ultra-flexibility for hard-to-reach tumors
In preclinical trials and bench tests, BiBB has compared EndoDrill® with market-leading competitors (EUS-FNB). The results show that the samples taken with EndoDrill® are considerably larger than those taken with EUS-FNB.
In the autumn of 2020, the first clinical study was initiated at three Swedish university hospitals (EDMX01) for sampling of suspected cancer in the stomach. The study was successfully completed in 2021, please find more information in the section “Clinical studies”.