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 high-end segment under the EndoDrill® brand. The company creates value by designing a patented product portfolio with three product variants for improved tissue sampling used for subsequent diagnosis of several common forms of cancer. The products are intended for public and private hospitals offering advanced endoscopic/endobronchial ultrasound (EUS/EBUS). Revenue will be generated from the sales of capital equipment (EndoDrill® Drive System), but mainly from recurring sales of the associated sterile EndoDrill® Biopsy Instrument.

EndoDrill® is the world’s first market approved electric biopsy instrument for EUS/EBUS tissue sampling. EndoDrill® GI has FDA 510(k) clearance in the US (2023) and all three product variants, EndoDrill® GI, EndoDrill® EBUS and EndoDrill® URO, are CE marked according to MDR in Europe (2024).

EndoDrill® GI and EndoDrill® URO are in clinical phase, and Clinical Proof-of-Concept has been demonstrated in the indications of gastric tumours (SEL) and muscle-invasive bladder cancer (MIBC). EndoDrill® EBUS for lung cancer is in late-stage development. Together with its clinical partners, the company continues to generate scientific data for the most important indications. The extensive patent portfolio, comprising three patent families, is continuously being strengthened.

The product line with EndoDrill® GI as the first instrument will initially be launched by the company itself in its home market of Sweden and in selected hospitals in Europe and the USA. Having its own sales gives the company proximity to end customers for quick feedback and the opportunity to continuously improve the service to customers. The goal is to sign an agreement with one or more global distribution partners for rapid international sales growth. A patent-protected regulatory cleared product portfolio of unique biopsy instruments in the fast-growing EUS/EBUS market, will make BiBB 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.