EndoDrill® – the world’s first market-cleared powered biopsy method for true core sampling

EndoDrill® products are engineered to obtain high-quality tissue samples, aiming to improve diagnostics for several cancer types, including stomach, pancreatic, liver, lung, and bladder cancer. This innovative technology is helping redefine the growing field of endoscopic ultrasound-guided tissue acquisition in cancer diagnostics. The powered, high-speed rotational EndoDrill® needle technique enables true core biopsies, addressing the limitations of today’s standard manual needles.

EndoDrill® is designed for ease of use and consists of a sterile, single-use EndoDrill® Biopsy Instrument paired with the reusable EndoDrill® Drive System. The product received FDA 510(k) clearance in the U.S. in 2023, followed by CE certification under the MDR in Europe in 2024. Commercial launch will begin in the U.S. in 2025, in collaboration with distribution partner TaeWoong Medical USA.

An initial clinical pilot study, EDMX01, showed 100% diagnostic accuracy when analysing samples taken with EndoDrill® GI.

Powered rotation is the key to improved biopsies

Unlike conventional manual needle instruments, EndoDrill® features a powered drill-tip cylinder. This design enables deep, precise tissue sampling. One or more solid core biopsies are extracted – providing the tissue architecture required for complete histological diagnosis, staging, and genetic analysis.

The EndoDrill® product line includes single-use biopsy instruments with a flexible drill-tip cylinder and a reusable drive system consisting of a motor unit, foot pedal, and drive cable. EndoDrill® is specifically developed to collect tissue samples of the highest quality during ultrasound-guided endoscopic procedures (EUS/EBUS).

Today’s manual EUS/EBUS needle instruments are inserted into tumors using a repeated stabbing motion, and detached cells and tissue fragments adhere to the tip of the needle. The method requires skilled endoscopists for sampling and experienced pathologists for evaluation. To increase the chances of the fragmented cell material leading to a diagnosis, it is not uncommon to use a variety of supplemental methods, such as having a pathologist in the operating room for Rapid On-Site Evaluation (ROSE), centrifuging the sample (i.e., cellblock), taking multiple samples at different sites, and using different techniques to aspirate the cell sample.

EndoDrill® is designed to simplify the diagnostic process. Instead of manual sampling through repeated stabbing, tissue is collected using a powered, user-friendly drilling technique. In the majority of cases, a single needle pass is sufficient to obtain a diagnostic result*.

*Mendoza Ladd A, Pham KDC, Pavic T, Glavas R, Swahn F. EndoDrill® core needle biopsy: preliminary multicenter experience. Endoscopy. 2025;57(Suppl 2):182–3. doi:10.1055/s-0045-1805456.

The new era of personalised cancer treatment requires high-quality core biopsies for histological diagnosis and genetic analysis.

The endoscopist drills out core biopsy samples in which the tissue architecture is preserved, often with low or no blood contamination. Sampling with EndoDrill® may become more reproducible and standardized (i.e., less dependent on the experience and skill of the endoscopist).

Another very important and unique feature is the flexible design, which enables sampling at a highly angulated position. This means that high-quality samples can be taken from very hard-to-reach tumours, which are often technically challenging to access with today’s more rigid biopsy needles.

Ultraflexible needle provides easy access even to difficult anatomical locations.

Using the new EndoDrill® high-quality core needle biopsy (CNB) at the first examination makes it possible to achieve the goal of a treatment-determining diagnosis immediately, while avoiding resource-intensive methods and repeated sampling. Early definitive diagnosis with histological and genetic information enables personalised treatment to be initiated immediately, which can save both lives and healthcare resources.

From EUS tissue sampling with fine-needle aspiration of cells (EUS-FNA) of the 2000s to fine-needle biopsy (EUS-FNB) of tissue fragments of the 2010s, introduction of the powered EndoDrill® is the 2020s’ solution for the sampling of high-quality core needle biopsies (EUS-CNB). It is a long-awaited improvement in diagnostics for many types of cancer, with the potential to eventually establish a new standard of care for endoscopic sampling.

EndoDrill® GI is used for endoscopic ultrasound (EUS) tissue sampling for all indications in the gastrointestinal tract, such as in the pancreas, stomach, oesophagus, lymph nodes and liver.

• Currently being evaluated at hospitals in Europe and the U.S. (2025)

• Retrospective multicenter study: EndoDrill® GI – effective and safe (2025).

• First purchase order received from a hospital in the U.S. (2025).

• U.S. clinical case series published in a peer-reviewed scientific journal – 100% diagnostic accuracy (2024).

• Swedish clinical pilot study published in a peer-reviewed scientific journal – 100% diagnostic accuracy (2024).

• Successful U.S. case series published in a peer-reviewed scientific journal (2024).

• CE-marked under MDR in February 2024.

• FDA-cleared for the U.S. market in March 2023.

EndoDrill® GI is the world’s first market-cleared electric-driven EUS-CNB instrument.

EndoDrill® EBUS is used in the airways during endobronchial ultrasound (EBUS) sampling for the diagnosis and staging of lung cancer. As more and more targeted treatments become available, demands on the quality of diagnostic tissue samples are increasing, and today’s fine-needle instruments do not fully meet expectations. EndoDrill® EBUS is designed to meet the new requirements for histopathological and genetic analyses. With the right diagnosis, the right treatment can be initiated –even in severe cases

• Planned launch in 2026.
• CE marked according to MDR in February 2024.

Aiming to revolutionize lung cancer diagnostics by enabling both histopathological and genetic analyses.

EndoDrill® URO is used with a standard cystoscope for sampling of muscle-invasive bladder cancer (MIBC). The purpose of EndoDrill® URO is to take tissue samples of deep-growing bladder tumors for the first time already at the initial cystoscopy. With an earlier diagnosis, today’s invasive surgical procedures (TURB) could be avoided and the treatment of patients with MIBC could be started earlier. An initial pilot study shows that EndoDrill® URO safely can take treatment-based samples earlier in the care chain if MIBC is suspected.

• CE marked according to MDR in February 2024,
• Pilot study completed in 2022 and positive data published in June 2023.

Potential paradigm shift for the diagnosis of muscle-invasive bladder cancer (MIBC).

Study EDMX01 with EndoDrill® GI

In the autumn of 2020, the first clinical study, EDMX01, was initiated at three Swedish university hospitals for sampling hard-to-diagnose upper gastrointestinal cancer (SEL tumours).

The analysis showed that EndoDrill® safely collected high-quality tissue samples, known as core biopsies, even in comparison with leading fine needle biopsy instruments (EUS-FNB). The study was presented in May 2022 at the DDW congress in San Diego, USA,

The study was presented in May 2022 at the DDW congress in San Diego, USA, and published in the peer reviewed Scandinavian Journal of Gastroenterology in March 2024. 

The ultrasound image clearly shows when EndoDrill® GI is drilled into a submucosal tumour.

The series of images below from case 2 of study EDMX01 shows the difference in tissue sample quality when biopsies are taken from the same tumour with EndoDrill® GI and a leading EUS-FNB instrument. Large and solid tissue samples contain more information and improve diagnostic accuracy.

Download the poster from DDW

Link to the scientific publication in Scandinavian Journal of Gastroenterology

Case studies in 2024 and 2025 with EndoDrill® GI in Europe and the US

After receiving FDA 510(k) clearance and CE marking (MDR) for EndoDrill® GI, product evaluations began at several hospitals in Europe and the US in the spring of 2024 and are ongoing. The evaluations have included a variety of tumor types, with positive outcomes reported in two published scientific papers (see below). The pictures shown below are a selection of high-quality core biopsies that BiBB’s team documented on site in examination rooms.

Clinical Case Series in the US Shows 100% Diagnostic Accuracy with EndoDrill GI

In January 2024, Dr. Antonio Mendoza Ladd, medical director of endoscopy at UC Davis Health in Sacramento, California, started a product evaluation of the FDA-cleared EndoDrill® GI. The results from the first eight patient cases have now been published in the article “Initial Experience With The Transmural Use Of A New Endoscopic Ultrasound Electric Core Needle Biopsy Device: A Case Series” in Endoscopy International Open¹.

These patient cases represent the first transmural (through the wall of the gastrointestinal tract) biopsies using an EUS-CNB instrument (EndoDrill® GI) on tumors in the pancreas (n=5), retroperitoneum (n=2), and mediastinum (n=1). In all eight patient cases, a diagnosis was achieved using tissue biopsies taken with EndoDrill® GI (100% diagnostic accuracy) after a single needle pass. In four of these cases, patients had first undergone biopsies using manual EUS-FNA/FNB needle instruments (the current “gold standard”), which provided insufficient tissue samples for diagnosis. In all these cases, tissue samples obtained with EndoDrill® GI resulted in a complete diagnosis. The samples from EndoDrill® GI showed less blood contamination, fewer artifacts, and more intact tissue cores compared to what is typically seen with standard EUS-FNA/FNB instruments. The only noted adverse eventwas one case of mild bleeding, which was successfully controlled.

The authors’ impressions after the initial cases with EndoDrill® GI are that the tissue sampling method is effective, safe, and easy to install and use. They conclude by recommending a randomized clinical study comparing EndoDrill GI with standard EUS-FNA/FNB needle instruments to further assess the product’s efficacy and safety.

1 Mendoza Ladd A, Alsamman A, Meiklejohn K et al. Initial Experience With The Transmural Use Of A New Endoscopic Ultrasound Electric Core Needle Biopsy Device: A Case Series. Endoscopy International Open 2024. doi: 10.1055/a-2427-2311

Download the scientific article

The case series was also presented at a poster session at ACG 2024 in Philadelphia on Oct 29, 2024.Download the poster

Retrospective Analysis Concludes that EndoDrill GI is Safe and Effective

A retrospective analysis conducted in the US and Europe was presented at ESGE Days in Barcelona on April 3, 2025. The study included data from the use of EndoDrill® GI for core tissue sampling in 28 patients across five university hospitals: Sacramento (USA), Bergen, Stockholm, Linköping, and Zagreb. The most common tumor locations were the pancreas, retroperitoneum, and stomach. In 22 of the 28 cases, a single needle puncture with EndoDrill® GI was sufficient to obtain diagnostic tissue samples.

The authors conclude: “The overall initial experience with this new EUS-CB device was positive. Our findings suggest that the device is effective and safe. Its effectiveness at obtaining adequate tissue with one pass could potentially shorten the overall duration of the procedure. Prospective studies comparing it to FNA/FNB needles will be required to further assess performance and safety.“

Link to the Abstract

”This device will be a game changer in my opinion.”

Dr Antonio Mendoza Ladd MD, AGAF, FACG, FASGE Associate Professor of Medicine UC Davis Medical Director of Endoscopy UC Davis Health

Link to video

Study EDUX02 with EndoDrill® URO

Professor Fredrik Liedberg and his team at Skåne University Hospital are conducting an ongoing study programme focused on the urinary tract, which involves tissue sampling with EndoDrill® URO using a standard endoscope for muscle-invasive bladder cancer (MIBC)—i.e., tumours that have penetrated the bladder mucosa and muscle. A pilot clinical study involving ten patients was completed in 2022, and the results were published in the journal European Urology Open Science in June 2023. The study demonstrates that EndoDrill® URO can safely obtain treatment-determining samples earlier in the care chain when muscle-invasive bladder tumours are suspected. The research team concludes that there is reason to follow up the pilot study with a randomised efficacy study, which has been planned and received regulatory approval. The project also includes a health economic analysis.

The urologists’ long-term aim with the clinical programme is to demonstrate that early sampling with EndoDrill® URO can replace today’s standardised sampling as part of the TURBT procedure. The hypothesis is that the lead time from sampling to treatment initiation can be significantly reduced, potentially improving survival for this serious type of tumour.

Link to the article in European Urology Open Science here

”Histological verification and molecular classification of MIBC are possible for samples collected…”

(Eriksson P, et al., Urodrill – a novel MRI-guided endoscopic biopsy technique to sample and molecularly classify muscle-invasive bladder cancer without fractionating the specimen during transurethral resection, European Urology Open Science, Volume 53, July 2023, Pages 78-82)

The EDUX02 study demonstrates that EndoDrill® URO is the first endoscopic biopsy instrument that safely collects treatment-determining samples when bladder cancer is suspected.

A growing IP portfolio

BiBB’s IP portfolio is one of the company’s most critical assets. All of BiBB’s products have either been granted a patent or have a patent pending. The powered EndoDrill® system is protected by  approved patents in USA (NoA), Europe, Japan, India and China and three pending international patent applications that have entered the national phase. In addition to patents, the EndoDrill® brand is registered in the major markets.