Advancing EUS-biopsy
to improve and speed up cancer diagnotics

BiBB is a cancer diagnostics company that develops and manufactures EndoDrill®, a patented product line of electric-driven endoscopic biopsy instruments. EndoDrill® works with high 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 product portfolio targets the global market for ultrasound-guided (EUS/EBUS) biopsy instruments, which represents the most advanced and fastest-growing segment of endoscopy.

In 2023, EndoDrill® GI, BiBB’s lead product, received market clearance from the US FDA. At the beginning of 2024, BiBB received CE certification according to MDR in Europe for the entire EndoDrill® product family. EndoDrill® is thus the first and only electric-driven biopsy instrument to be market-cleared in both the US and Europe. The EndoDrill® system includes sterile disposable biopsy instruments with an associated drive system (reusable).

BiBB was founded in 2013 by Dr Charles Walther, cancer researcher at Lund University and senior physician in clinical pathology at Skåne University Hospital in Lund. BiBBInstruments is based at Medicon Village in Lund, and the BiBBInstruments share (Ticker: BIBB) is listed on the Spotlight Stock Market.

A Swedish listed medtech company that has developed the world’s first market cleared electric-driven biopsy system for endoscopy.

BiBB’s business model is based on the development and sale of innovative biopsy instruments in the premium segment under the EndoDrill® brand. The company creates value by building a patented product portfolio with three product variants for improved tissue sampling, used for subsequent diagnosis of several common cancer types. The products are intended for public and private hospitals offering advanced endoscopic and endobronchial ultrasound procedures (EUS/EBUS). Revenue is generated from the sale of capital equipment, the EndoDrill® Drive System, but primarily from recurring sales of the accompanying sterile biopsy instrument, the EndoDrill® Biopsy Instrument.

EndoDrill® is the world’s first powered biopsy instrument cleared for tissue sampling with EUS/EBUS. EndoDrill® GI received FDA 510(k) clearance in the U.S. in 2023, and all three product variants – EndoDrill® GI, EndoDrill® EBUS, and EndoDrill® URO – are CE-marked under the MDR in Europe (2024).

A series of successful clinical studies on EndoDrill® GI has been published: a Swedish pilot study (n=7), an American clinical case series (n=8), and a retrospective multicenter study conducted in the U.S. and Europe (n=28). EndoDrill® EBUS for lung cancer is in a late development phase. EndoDrill® URO has been successfully evaluated in an initial Swedish pilot study (n=10), with published data showing proof of concept for the indication of muscle-invasive bladder cancer (MIBC). Together with clinical partners, the company continues to generate scientific data for the most important indications. The extensive patent portfolio, consisting of three patent families, is continuously being strengthened.

BiBB began sales of EndoDrill® GI in January 2025 when a U.S. university hospital, following clinical evaluation, placed an order for the instrument. The goal is to sign agreements with one or more global distribution partners during 2025 to enable rapid international sales growth. The launch of EndoDrill® EBUS is planned for 2026.

A patented, regulatory-approved product portfolio of unique biopsy instruments in the fast-growing EUS/EBUS market positions BiBB as an attractive partner.

Mission
We make innovative endoscopic biopsy instruments that advance cancer treatment.

Our vision is to improve outcomes for cancer patients.

EUS-FNA/FNB – tissue sampling in the GI tract

Endoscopic ultrasound is used by EUS endoscopists to diagnose suspected tumour lesions. Due to its minimally invasive nature and ease of use, EUS has become the fastest growing endoscopic segment for an increasing number of indications. In addition to diagnostic examination, EUS has become important for staging and as a therapeutic method, such as the drainage of pancreatic cysts.

Ultrasound-guided samples are taken endoscopically with manually-handled needles, either fine needle aspiration (EUS-FNA, cytological sample) or biopsy (EUS-FNB, histological sample). The samples are sent to a pathological laboratory for further diagnostics. The method has evolved rapidly over the last two decades and is now used for suspected cancers of the gastrointestinal tract, such as the stomach, pancreas and liver. At pace with the growth of modern personalised treatment of various forms of tumours, increasing demands are being placed for accurate diagnosis prior to the start of treatment. High-quality samples are needed for diagnosis and staging, and to determine personalised treatment (size-reducing therapy, surgery, chemotherapy, radiation, etc.).

Even though ultrasound-guided needle instruments have been refined in recent decades, they usually only capture tissue fragments or tinged material with detached cells. The lack of high-quality solid core biopsies is the missing link in the cancer diagnostics chain.

Read about BiBB’s new biopsy instrument, EndoDrill® GI EndoDrill® GI

Therapeutic EUS – a new emerging field

EUS has recently evolved from a diagnostic tool to a versatile therapeutic method for the biliary tract, pancreas and liver in particular. This is a logical evolution. If you can reach the tumour and take tissue samples assisted by EUS, you can also perform local treatment.

The trend now is for more and more interventions to be minimally invasive with therapeutic EUS. EUS therapeutic instruments have been developed for interventions such as resection, drainage, stent placement, and drug injection.

Please note that the current EndoDrill® device is not cleared for therapeutic use.

BiBB was founded in 2013 by Dr Charles Walther, cancer researcher at Lund University and senior physician in clinical pathology at Skåne University Hospital in Lund. Charles saw insufficient biopsy samples under the microscope on a daily basis. At the same time, new targeted cancer treatments were emerging that required more and more information from the tissue samples collected. In conventional manual ultrasound-guided needle biopsy, the endoscopist punches out a mixture of blood, detached cells, and tissue fragments with a stabbing needle instrument. Charles could clearly see that a crucial link in endoscopic diagnostics was missing in the form of information-rich solid tissue samples (“core biopsies”).

The idea for the electric EndoDrill® was born while Charles was out running. Why not use motorised needle rotation (“Drill”) in endoscopic (“Endo”) sampling? Instead of the usual manual sampling, tissue samples could be taken using a precision electric drill. The hypothesis was that a rotating flexible needle cylinder should be able to cut finer, less blood contaminated tissue, while maintaining tissue architecture. These samples could better respond to the increasing demands of emerging personalised cancer treatment.

Ten eventful years have passed from the identification of a clinical need to market approvals and patent for the world’s first electric-driven biopsy instrument for endoscopy. Some of the most important milestones passed are shown in the timeline.