Despite the advancements made in cancer therapeutics over the last decade, cancer remains one of the top causes of death worldwide. Early detection plays a big role in keeping the cancer death rates low, and Swedish medtech BiBBInstruments is addressing the issue with its EndoDrill Model X, the first CE-marked electric endoscopic biopsy device. The device can provide better tumour samples, which can result in a more complete and accurate cancer diagnosis and thus lead to earlier treatment in patients afflicted by some of the most serious cancers. BioStock spoke with the company’s CEO Fredrik Lindblad to learn more about BiBBInstrument and the EndoDrill Model X.
According to data on cancer compiled by Oxford University researchers and published in Our World in Data, around 10 million people die from cancer each year, making it the second leading cause of death world-wide. The good news is that cancer death rates have declined over the last three decades and, in the US at least, five-year survival rates have increased significantly for almost every type of cancer since the 1970s.
There are two big factors associated to the encouraging numbers: better treatments and, in particular, improved detection of cancers that lead to an early diagnosis. In fact, according to a 2019 report by the American Cancer Society (ACS), advanced screening methods have helped reduce breast cancer mortality by 40 per cent between 1989 and 2016, prostate cancer mortality has decreased by 51 per cent between 1993 and 2016, just to give some prominent examples. For other more difficult-to-detect cancers, such as pancreatic and lung cancer, the figures are not as encouraging with a reported five-year survival of about 5-10 per cent and 20-25 per cent, respectively.
Endoscopic biopsy instruments need an upgrade
A relatively new examination method is endoscopic ultrasound (EUS), a minimally invasive procedure to assess gastrointestinal and lung diseases. The procedure is done with a flexible endoscope equipped with an ultrasound probe able to visualize the deeper regions of organs within the body. Thanks to ultrasound guidance, representative samples can be taken safely, without harming the surrounding tissue.
Endoscopic ultrasound is used for cancer diagnosis and staging for ambiguous, deep, small, and difficult-to-access tumour changes. Samples are taken with a fine needle, either through fine needle aspiration (EUS-FNA, cytological sample) or biopsy (EUS-FNB, histological sample). The method has developed rapidly over the past two decades and is now used in suspected cancer in the upper gastrointestinal tract down to the rectum, including the oesophagus, stomach, pancreas, bile ducts, gallbladder and adrenal glands.
EUS needle instruments have evolved and improved significantly since they were first developed in the 1990s. EUS is the fastest growing endoscopic procedure, especially in the US, however, the failed detection rate of devices currently used in the clinic continues to be too high. When sampling suspected pancreatic and lung cancer patients with today’s conventional needle instruments, approximately 10-15 per cent of these patients are misdiagnosed. This is despite the use of many resource-intensive tools to improve diagnostic exchange, such as a pathologist in the room (Rapid-on-site evaluation, ROSE) and/or centrifugation of low-quality samples.
Meet BiBBInstrument’s EndoDrill Model X
The failure rates can be linked to the fact that manual tissue sampling is performed with stabbing movements with the conventional fine needles, which results in a smear of cell and tissue fragments, thus a poor sample quality. The Lund-based medtech BiBBInstruments, founded by Dr Charles Walther in 2013 and listed on the Spotlight Stock Market in 2017, has developed an alternative sampling method based on core needle biopsy (CNB) instead of FNA or FNB. CNBs have a more well-preserved cell architecture, which provides more information and thus a simpler diagnosis. In fact, the method is already the “gold standard” for non-endoscopic sampling of suspected breast and prostate cancers, which have 90 and 98 per cent survival, respectively.
The company’s innovative biopsy instrument is called the EndoDrill Model X (the second generation of the product), the world’s first CE-marked (2020) electric endoscopic biopsy device. It involves the electric drilling of core tissue instead of manual stabbing with a fine needle instrument. Thanks to the flexibility of the instrument, it is very user-friendly even with strongly angled endoscopes. With EndoDrill Model X, only 1-2 drill passes are required compared to 3-5 needle passes and a total of 30-50 stabs with a conventional fine needle. The tissue is thus kept more intact, which enables more accurate and reliable diagnostics.
BiBBInstruments has produced a video explaining in more detail how the EndoDrill Model X works and what its benefits are compared to conventional EUS devices. Watch the video below.
A new vision for cancer diagnostics
The company is currently evaluating the EndoDrill Model X in a clinical trial (EDMX01) in Sweden that began during the second half of 2020. Towards the latter months of 2020, the EndoDrill Model X received broad CE approval, i.e., market approval in Europe for all common endoscopic indications, including suspected tumours for many of the most serious cancers: lung, stomach, oesophagus, liver, pancreas, colon, lymph metastases and other organs related to the gastrointestinal tract. This means that BiBBInstruments is establishing itself as a pioneer in electric endoscopic biopsy devices and will be the first in the world to be able to offer core needle biopsies in endoscopic examination.
BioStock was able to get in touch with the company’s CEO Fredrik Lindblad to learn more about the company and his vision for better cancer diagnostics.
Fredrik Lindblad, could you tell us more about the vision for BiBBInstruments and how the EndoDrill Model X can make that vision a reality?
– We at BiBB want to improve the odds for cancer patients. We want to make a real difference in healthcare by enabling earlier and more accurate diagnostics for many hard-to-diagnose cancers.
– The key to realising our vision is the newly developed EndoDrill Model X. It is the world’s first CE-marked electric biopsy instrument for endoscopic use. We believe that the EndoDrill Model X can revolutionise the biopsy sampling of several of the most serious cancers because the instrument offers several unique properties that are missing from the market. The most important feature of the device is that it takes contiguous core biopsies that enable complete diagnosis already at the first examination.
The EndoDrill Model X is an endoscopic biopsy device using a core needle to take biopsies. What makes the device unique compared to similar options that are currently available?
– Today’s manual ultrasound-guided fine needles (EUS-FNA/FNB), which have been on the market for about 20years, are inserted into the tumour with a repeated manual, stabbing motion. At the tip of the needle, cell lubrication and tissue fragments get stuck, which often provide a low sample quality.
– The EndoDrill Model X uses an electric rotating drill cylinder instead. Repeated manual stabbings in the suspectedtumour with standard fine needles are replaced with effective precision drilling. The design offers a variety ofadvantages over conventional fine needles. It also provides larger tissue pieces (core biopsies), which is advantageous since it provides more information for diagnostics.
– With EndoDrill Model X you can take several tissue samples in a single pass. Additionally, compared to existing fine needle instruments, it is an extremely flexible biopsy instrument, meaning that you can take samples with a heavilyangled endoscope, which is necessary in several clinical situations.
What is the company’s patent situation?
– The IP portfolio is one of our most important assets. For our Classic version (EndoDrill Generation 1 manual drillscrew), we have granted patents in the US, Canada, Europe, and China. For the new EndoDrill Model X, we havethree patent applications pending, one of which is European and two are international (PCT). For EndoDrill Model X,we plan to file more patent applications to further strengthen the patent situation.
– In addition to patents, we have had the EndoDrill brand approved in the US, Europe, India, China and Japan.
What is the goal of the EDMX01 clinical trial?
– The study involving 20 patients at three Swedish university hospitals takes comparative samples of each patient with both the EndoDrill Model X and the leading competing needle instruments (EUS-FNA/FNB). The primary goal is to demonstrate that EndoDrill Model X is a safe method of ultrasound-controlled sampling. Secondary target refers to the diagnostic quality of samples comparing samples taken with EndoDrill Model X with samples taken with conventional EUS-FNA/FNB with standard biopsy needles.
What is the aimed timeline for the EDMX01 clinical trial, and will the pandemic have an impact on this timeline by slowing down patient recruitment?
– We expect that we will keep our communicated timetable, i.e., that the study will be completed in 2021. The clinicalstudy has never been forced to stop completely during the pandemic, but the restrictions have hampered the recruitment rate during the winter months. We expect the situation to normalise as a larger proportion of thepopulation takes part in the vaccination programme.
BiBBInstruments is the first company to offer core needle biopsies in endoscopic examination and EndoDrill Model X is the first CE-marked electric endoscopic biopsy device. How does being a pioneer in this field shape the competitive landscape for the company?
– The fact that we are early means that we have time to optimise the method, clinically validate the design and buildup a patent protection. We have already spent several hours testing different materials, dimensions, motors, speed,etc. We believe very much in the design that we have developed as it provides excellent tissue samples compared toeverything else we have seen.
– It would be fantastic if EndoDrill Model X could contribute to a paradigm shift in endoscopy from the relatively low-quality samples (cytology) of the last two decades to core biopsies with well-preserved cell architecture (histology).This development has already occurred in breast and prostate cancer (where coarser, stiff needles are used fromoutside) with very positive results. With EndoDrill Model X, we want to offer the same type of core biopsies to all doctors working in the endoscopy field, thereby improving the diagnostics of several of the deadliest cancers, such as stomach, pancreatic and lung cancers.
What is the market potential for EndoDrill Model X?
– If we look at the primary market segment, ultrasound-guided biopsy needles (EUS-FNA/FNB, EBUS-TBNA),approximately 1.1 million procedures are performed globally per year (TMR 2018). With a target price ofapproximately SEK 7,000 for the disposable instrument, the total addressable market for the EndoDrill Model X will beover SEK 7 billion. The main indications are tumours of the pancreas, lung, lymph nodes and stomach.
– In addition to the deal regarding the disposable instrument, there is also market potential for the reusable equipment(motor unit, cables and foot pedal). We expect that every hospital that will use the EndoDrill Model X needs at leasttwo reusable systems.
Finally, in short what is the company’s long-term business strategy?
– We intend to take advantage of the fact that we have developed the world’s first market approved (CE marked) electric biopsy instruments for endoscopy. BiBB’s ambition is not to build a global sales organisation, but in the long term we want to collaborate with a larger global distribution partner for rapid international sales growth.
– To attract the best partners, we need to take BiBB and EndoDrill Model X to a commercial phase. In a few years’ time, we will have a market-approved product portfolio (CE mark/FDA 510(k)), positive clinical data for the most important indications, a stable commercial design that has been gradually launched in-house in Sweden and at selected hospitals in Europe and the US.
– A unique product portfolio in the premium EUS biopsy instrument segment, as well as good sales growth, will make BiBB a suitable takeover candidate in the fast-growing EUS market.
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.