EndoDrill® – a groundbreaking, market-cleared
biopsy method for enabling EUS-CNB

EndoDrill® instruments work with precision to take high-quality tissue samples with the aim of improving diagnostics for several types of cancer, such as stomach, pancreatic, liver, lung and bladder cancer. The innovative product technology redefines the growing area of endoscopic ultrasound-guided tissue acquisition for cancer diagnostics. The motorised high-speed rotational EndoDrill® needle enables high-quality core biopsies, overcoming the limitations of today’s standard manual needles.

In 2023, EndoDrill® GI, BiBB’s lead product, received market clearance from the US FDA as the first electric-driven biopsy instrument for endoscopy in the USA. At the beginning of 2024, CE certification according to MDR was obtained in Europe for the entire EndoDrill® product family. The EndoDrill® system has been designed to be easy to use consisting of a sterile disposable EndoDrill® Biopsy Instrument with an associated EndoDrill®Drive System.

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

Electric-driven rotation is the key to improved biopsies

Unlike conventional manual needle instruments, the FDA-cleared EndoDrill® uses an electric-driven drill cylinder. The design enables deep sampling with high precision. One or more high-quality and solid core biopsies are drilled out – a requirement for complete histological diagnosis, staging and genetic analysis.

EndoDrill® consists of a biopsy instrument with flexible drill cylinder (disposable) and a drive system (reusable) with associated motor unit, foot pedal and drive cable. EndoDrill® has been developed to collect tissue samples of the highest possible quality during ultrasound-guided endoscopic examinations (EUS/EBUS).

Today’s manual EUS/EBUS needle instruments are inserted into the tumour with a repeated stabbing motion, and detached cells and tissue fragments adhere to the tip of the needle. The method requires experienced endoscopists for sampling and skilled 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® simplifies the entire diagnostic process. Instead of manual sampling with a stabbing motion, samples are taken with the help of electric-driven and user-friendly precision drilling.

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

With a flexible rotating needle cylinder, the endoscopist cuts out fine core samples without blood contamination, while maintaining tissue architecture under high precision. Sampling with EndoDrill® becomes more reproducible and standardised, i.e. less dependent on the experience and skill of the endoscopist.

Another very important and unique feature is the ultra-flexible design, which enables sampling with a highly angled. This means that high-quality samples can be taken from very hard-to-reach tumours, which is often technically challenging 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 electric 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.

• Successful U.S. case study in 2024, published in 2024, presented at ACG 2024,
• CE marked according to MDR in February 2024,
• FDA cleared for the US market in March 2023,
• Successful pilot study completed in 2022, presented at DDW 2022, published 2024.

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

EndoDrill® EBUS is used in the respiratory tract in endobronchial ultrasound (EBUS) sampling for the diagnosis and staging of lung cancer. As more and more targeted treatments are available, the demands on the quality of diagnostic tissue samples increase and today’s fine-needle instruments do not fully live up to expectations. EndoDrill® EBUS has been designed to meet the new requirements for histopathological and genetic analyses. With the right diagnosis, you can start the right treatment even in severe cases.

EndoDrill® EBUS is used in the respiratory tract in endobronchial ultrasound (EBUS) sampling for the diagnosis and staging of lung cancer.

• CE marked according to MDR in February 2024,
• Late-stage development project.

Revolutionary biopsy instrument for lung cancer that enables 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. BiBB plans to initiate further clinical studies to systematically follow up on how the product works in clinical use.

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.

* Swahn et al, 2022, EndoDrill® Model X Biopsy Instrument, The Advent of the Firts EUS Guided 17 Gauge Core Needle Biopsy, Poster session presented at DDW, San Diego.

Download the poster from DDW

Link to the scientific publication in Scandinavian Journal of Gastroenterology

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

After receiving FDA 510(k) clearance and CE marking (MDR) for EndoDrill® GI, case evaluations began at several hospitals in Europe and the US in the spring of 2024. EndoDrill® GI is used for sampling with endoscopic ultrasound in the organs of the gastrointestinal tract. The evaluations have included many different tumor types and have started very positively. Below is 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 clinical evaluation of the FDA-cleared EndoDrill® GI, which is still ongoing. 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 effect was 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

Would you like to try EndoDrill® GI?

Are you an EUS endoscopist interested in clinically evaluating EndoDrill® GI? If so, please email info@bibbinstruments.com, and our clinical support team will be in touch. This offer is currently available in Europe and the United States, where the product has received regulatory clearance (CE-MDR in Europe and FDA 510(k) in the U.S.).

”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

BiBB has another ongoing study programme for the urinary tract that involves tissue sampling with EndoDrill® in a standard endoscope for muscle-invasive bladder cancer (MIBC), i.e. tumours that have grown through the bladder mucosa and muscle. An initial clinical study on ten patients was completed in 2022, and the results were published in the journal European Urology Open Science in June 2023. The study shows that EndoDrill® URO can safely take 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 is planned and has 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® can replace today’s standardised sampling as part of what is known as a TURBT procedure. The hypothesis is that the lead time from sampling to treatment start can be significantly reduced, which can improve 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 electric-driven EndoDrill® system is protected by two approved patents in Europe 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.