BiBBInstruments aims to revolutionise pancreatic cancer diagnostics
Currently, pancreatic cancer is too often detected in its late stages, significantly contributing to the high mortality rate. Medtech company BiBBInstruments is developing the world’s first CE-marked electric driven ultrasound-guided endoscopic biopsy instrument, EndoDrill. The device could become a useful tool in diagnosing pancreatic cancer earlier in the course of the disease. CEO Fredrik Lindblad spoke to BioStock about the device and its potential within this indication.
Pancreatic cancer is one of the deadliest forms of cancer, mainly due to its aggressive nature, late appearing symptoms, and immediate and correct diagnosis is key for treatment. However, the deep-seated position of the pancreas makes tissue sampling difficult and therefore there is an increased need for new biopsy instruments that improve the ability to take high-quality samples in the pancreas. Globally, incidence and mortality rates have continued to increase, with some experts anticipating pancreatic cancer to surpass colorectal cancer as the second leading cause of cancer deaths by 2030.
Cancer.net reports that there is currently an 11 per cent 5-year survival rate for patients in the US. The report goes on to suggest that the number goes up to 42 per cent if the cancer is detected in the early stages. An early and correct diagnosis is thus of great importance to reduce mortality.
Deficiencies in today’s pancreatic cancer diagnostics
Today’s diagnostic methods for pancreatic cancer are mainly ultrasound, MRI, CT, and endoscopic ultrasound (EUS) tissue sampling. The latter method is essential in diagnosing the disease as it provides the highest sensitivity to detect cancer in the pancreas. Via EUS, the doctor can take tumour samples for histological diagnostics using fine-needle aspiration (EUS-FNA) or fine-needle biopsy (EUS-FNB).
Recent studies have shown that EUS-FNB is preferable to EUS-FNA as the biopsy samples contains more tissue and thus have a higher sensitivity to distinguish malignancy. However, despite the importance of this sampling method, it has shortcomings. Crucially, samples are often sparse and blood-contaminated, complicating analysis and subsequent diagnostics.
Developing an improved sampling instrument
The Swedish medical technology company BiBBInstruments (“BiBB“) has noticed this flaw in cancer diagnostics and is developing a sampling method, EndoDrill, which is instead based on core needle biopsy (CNB). CNB is already used successfully today in the diagnosis of, for example, breast cancer, among others.
As pioneers in the endoscopic CNB field, BiBB’s intention is to offer EndoDrill as the world’s first CE-marked (2020) EUS-CNB instrument. The instrument is motor driven, which simplifies use and significantly increases biopsy size and quality, compared to today’s existing manual instruments. EndoDrill samples intact core tissue that provides more data being significantly larger and less blood-contaminated than tissue sampled through both EUS-FNA and EUS-FNB methods.
Forthcoming clinical evaluation in pancreatic cancer
BiBB has come a long way with the EndoDrill system, which includes a product portfolio of three product variants. Two have been initially clinically evaluated with good results: EndoDrill GI for the diagnosis of tumours in the upper gastrointestinal tract and EndoDrill URO for the diagnosis of muscle-invasive bladder cancer (MIBC). The third variant, EndoDrill EBUS, is in late development and indicated for lung cancer.
BiBB sees strong potential for EndoDrill GI in pancreatic cancer as well, and the company intends to focus on this indication next. In fact, pancreatic cancer is the most common indication for EUS biopsy. Starting clinical evaluation in pancreatic cancer, therefore, will lead to further important value-driving milestones for the company.
According to BiBB, clinical partners are eagerly waiting to continue the evaluation of EndoDrill. However, before these activities can take off, BiBB needs to receive approval for its MDR certification application. For now, the company’s CE marking is in accordance with the previously applicable MDD regulation, which expired in August 2022.
CEO tells more
BiBB’s CEO Fredrik Lindblad told BioStock more about EndoDrill’s potential in pancreatic cancer diagnostics.
Fredrik, why is pancreatic cancer the most common indication for EUS biopsy?
– EUS guided biopsy (EUS-FNA, EUS-FNB) has in just 25 years become the method of choice to diagnose pancreatic cancer and has proved to have a higher diagnostic sensitivity (the ability to correctly detect the disease) than other methods for recognizing early pancreatic tumors. The sampled tissue is required to confirm the diagnosis and to determine the benign or malignant nature of the tumor. Endoscopy as a method is considered efficient, safe, and minimally invasive and EUS is the most advanced and fastest growing segment. For the pancreas indication EUS is used for diagnosis, staging and for a growing number of therapeutic applications.
What do you hope that EndoDrill will be able to offer patients with pancreatic cancer?
– Our aim is to offer a superior EUS biopsy instrument with the highest diagnostic accuracy. With EndoDrill’s unique electric-driven rotational needle it is for the first time possible to acquire true core biopsies within endoscopy. Today, conventional EUS-FNA needles detects cancer in about 85 % of pancreatic cases. However, much more information, e.g type and genetic profiling, is needed to confirm diagnosis, guide treatment and improve outcomes.
– This information is provided by a core biopsy. With EndoDrill’s ability to sample core tissue we want to offer sampling of biopsies packed with information. We strive to approach 100 % sensitivity and a definite histological diagnosis at the first EUS examination in order to save lives and reduce suffering and health care costs. In addition, according to our users, EndoDrill is easier to use even for less experienced EUS endoscopists.
Have you had dialogues with current and potential clinical partners regarding the start of clinical evaluation of EndoDrill within the indication, and, if so, how are the dialogues progressing?
– We have ongoing discussions with EUS endoscopists at several Swedish university hospitals. They are very eager to begin the first clinical cases in pancreatic cancer as soon as we have received the new CE mark according to MDR. The plan is to follow up initial patient cases with a multicenter study.
What type of tissue sample does EndoDrill deliver and why is this important?
– In contrast to the mess of cells and tissue fragments taken with conventional EUS needles, EndoDrill can sample visible tissue cylinders, i.e. core biopsies. This type of biopsy is easier to process and has the highest diagnostic accuracy of all types of tissue samples. The evolution from fine needle sampling to core needle sampling has already revolutionized diagnostic outcome in breast and prostate cancer. Thanks to the EndoDrill device endoscopists has for the first time a user-friendly instrument that can take the same high-quality samples within the gastrointestinal tract, e.g. pancreas, stomach, colon and lungs, EndoDrill’s core tissue samples make it easier for doctors to differentiate malignancy from benign diseases. In addition, EndoDrill provides additional tissue for molecular profiling for the rapidly expanding field of personalized medicine.
Finally, what is the market potential for EUS biopsy in pancreatic cancer diagnostics?
– Globally, there are about 495 000 new cases of pancreatic cancer every year (WHO, 2020). The current guidelines recommend tissue diagnosis for two groups of patients accounting for up to 85 % of patients with pancreatic cases. It means that the number of potential candidates for EUS biopsy exceeds 400 000 patients per year.
The only thing holding back increased use of EUS is the lack of advanced equipment and experienced EUS endoscopists as EUS is technically challenging with a long learning curve. Despite these challenges, the number of EUS procedures in the USA have increased from about 10 000 procedures in 2000 to about 310 000 procedures in 2019 (MarketScan 2021, all EUS indications,)
It is said that the new era of personalized medicine will have the most influence on the advancement of the EUS field for both diagnostic and therapeutic purposes. We see EndoDrill ability to sample better biopsies in an easier way, as an important contribution to this new era of cancer treatment. Thus we have high expectations of an exciting future for our EndoDrill concept.The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.