Needs and market

The market for EUS biopsy instruments

The initial market for BiBB is the fast-growing premium segment of ultrasound-guided (EUS) biopsy instruments. The market is dominated by some of the world’s largest medtech companies. An ultrasound endoscope combines a camera and ultrasound in the tip to obtain images of the internal organs. There is also an instrument channel, where a flexible biopsy instrument (disposable) can be inserted to collect one or more tissue samples. EUS is the fastest-growing endoscopic segment, and new applications for diagnosis, staging and treatment are constantly being added. More than 1 million biopsy procedures are performed each year with EUS fine-needle instruments, and it already constitutes a global SEK multi-billion market (TMR 2018). In the United States alone, there are over 1,200 hospitals using endoscopic ultrasound to diagnose cancer patients.

With EUS, endoscopists have a safe and minimally invasive way to examine organs, such as suspected tumours in the pancreas or lymph nodes between the lungs, and collect tissue samples with fine needles. The corresponding procedure for diagnosing lung cancer is called an endobronchial ultrasound (EBUS). In just a short time, the procedure has made its way into all international guidelines, and is now the method of choice for staging metastasized lung cancer.

This ultrasound technology makes it possible to access hard-to-reach organs and, for example, get information on whether it is possible to remove the tumour. While today’s ultrasound-guided endoscopic needle instruments have revolutionised sampling for many severe types of cancer, these manually-operated instruments have several limitations, such as their inability to collect the high-quality pieces of tissue needed to make a complete treatment-determining diagnosis.

Conventional manual biopsy instruments do not meet today’s needs

Today’s ultrasound-guided endoscopy fine needles (EUS-FNA/FNB, EBUS-TBNA) are used to collect tissue samples for many serious forms of cancer in the lungs, stomach, oesophagus, liver, pancreas, colon, lymph metastases and other organs connected to the gastrointestinal tract. The flexible needle instrument is inserted into the tumour with a repeated stabbing motion. Daubs of cells and tissue fragments adhere to the tip of the needle. The overarching need during endoscopic sampling is to take solid, cohesive core biopsies to enable a complete treatment-determining diagnosis. Even though existing ultrasound-guided needles have been refined in recent decades, they often do not meet demands because they at best take small fragments of tissue and usually a “daub” of detached cells (cytology).

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. To increase the chances that the daub of cells or the tissue fragment will enable diagnosis, it is not uncommon to use a pathologist in the operating room for Rapid On-Site Evaluation (ROSE), centrifuge the sample, take multiple samples at different sites, and use different techniques to aspirate the cell sample.

Another limitation is that the needles are relatively rigid to be able to penetrate the tissue with the manual stabbing motion. For sampling with a heavily angled endoscope, for example in pancreatic tumours, the endoscopist is forced to choose a less rigid needle instrument with a smaller needle diameter. This makes it possible to collect tissue samples, but at the risk of getting a poorer sample due to the fine dimension.

Tissue samples of substandard quality lead to incomplete diagnosis, thereby increasing the risk of repeated samplings, resource-intensive diagnostics, suboptimal treatment, poorer prognosis, and unnecessary operations for patients.

Thus, there is an obvious unmet clinical need for EndoDrill® Model X to fill.

Huge increase in the number of cancer cases and an ever-growing need for early diagnosis

Cancer is the second most common cause of death in the world, after cardiovascular disease. According to a report from the WHO (World Cancer Report, 2020), the number of cancer cases in the world is expected to increase by 50%, from 18.1 million cases in 2018 to over 27 million cases by 2040. The increase is mainly due to the world population growing in terms of both size and age. The risk of developing cancer increases as age increases. Alcohol consumption, obesity and physical activity are other contributing factors.

Consequently, the need for cancer diagnosis methods for the earliest possible detection will be very high in the foreseeable future.