Imaging techniques have improved dramatically in recent decades. However, when it comes to cancer diagnostics, doctors still rely heavily on biopsies to confirm and/or determine the stage of suspected cancer.
Endoscopic ultrasound (EUS) is now the standard procedure for diagnosing and staging deeper and more difficult-to-reach tumors, such as those in the upper gastrointestinal tract down to the rectum, including the esophagus, stomach, pancreas, bile ducts, gallbladder, and adrenal glands. Samples are taken with a fine needle, either by fine needle aspiration (EUS-FNA, cytological sample) or biopsy (EUS-FNB, histological sample).
EUS is the fastest growing endoscopic examination method, especially in the United States. However, the detection rate and sample quality of the instruments currently used clinically still leave much to be desired in terms of diagnostic information. This is mainly due to the variable quality of the tissue sample, which is often fragmented and blood-stained.
The founding of BiBBInstruments
This gap in cancer diagnostics motivated clinical pathologist Dr. Charles Walther to develop a better biopsy technique, based on core needle biopsy (CNB) instead of FNA or FNB. The innovation is based on a motor-driven drilling motion rather than a manual chopping motion. This produces coherent samples, which provides more information faster. In fact, CNB is already the “gold standard” for non-endoscopic sampling of suspected breast and prostate cancer, which has 90 and 98 percent survival rates, respectively. In 2007, Dr. Walther began the work that eventually led to the founding of the Lund-based medical technology company BiBBInstruments (BiBB) 2013. This led to the development of EndoDrill, the world's first market-approved motor-driven EUS-CNB instrument.
»BiBB was founded on the vision of creating a cancer biopsy instrument that would fill the need for better and more reliable cancer biopsies« — Dr. Charles Walther, Founder BiBBInstruments
EndoDrill fills a vacuum
Today, BiBB's biopsy instruments are part of a product family that includes three variants: EndoDrill GI, EndoDrill URO and EndoDrill EBUS. EndoDrill GI is specifically for diagnosing tumors in the upper gastrointestinal tract and is the most developmentally advanced product variant. EndoDrill URO, for the diagnosis of muscle invasive bladder cancer (MIBC), is also in clinical development. Finally, EndoDrill EBUS is in a late development phase and aims to diagnose lung cancer.
Regulatory progress in 2023
Earlier this year, BiBB received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for EndoDrill GI. In an interview with BioStock, CEO Fredrik Lindblad about the importance of this decision.
The FDA approval has rightly captured much of the media attention, as the decision opened the door to the world's largest market for endoscopic instruments. By the end of the year, BiBB in addition to obtaining CE marking under the latest EU regulation – MDR. This will cover all three product variants and give the company the go-ahead to commercialize EndoDrill in Europe.
Both of these milestones will solidify the company's position and open doors for continued development and expansion.
»We believe we have an opportunity to help patients and healthcare professionals with EndoDrill. Ultimately, that is what drives us«
Conversation with the founder
BioStock contacted Dr. Charles Walther to learn more about the company's journey and his vision for better cancer diagnostics.
Charles, this year you celebrate the 10th anniversary of BiBBInstruments as a company. However, the journey began long before that. Can you briefly tell us about your vision that led you to found BiBBInstruments?
– The vision was to create a cancer biopsy instrument that would fill the need for better and more reliable cancer biopsies. As a doctor, it was really frustrating to see substandard samples and the significance of this for the patient with uncertainty and further waiting for a new and perhaps more complicated diagnostic procedure. This frustration drove me towards research to find out what type of sample could provide more information and thus help the patient in the best way. BiBB was then founded to achieve the goal of better biopsies by combining healthcare, academia and industry. If successful, it would help patients, promote research and a value-creating business. This was and still is my vision!
Did you encounter any obstacles on the way from academia to industry, and what were your main sources of inspiration and motivation?
– The first challenge was to realize that commercial operations were the most rational way to achieve my vision and in a concrete way help patients. A company was needed to develop the instrument and make it commercially viable to reach patients. But making this leap from academia to industry was a scary step to take because it was really outside my comfort zone. My parents were a great source of motivation during that transition – my father, now a retired professor of surgery, has a lot of experience in this field and he continues to inspire me with his knowledge. My mother, on the other hand, gave me the courage to take the step from academia to industry. In fact, the company is named after my mother who was called Bibbi.
In the years since the start of this venture, the endoscopy landscape has evolved, with other players also hoping to grab a piece of the cancer diagnostics pie in the coming years. What is EndoDrill's strongest competitor right now?
– The main competitor is actually the current standard manual instrument, i.e. manual sampling needles offered by several of the world's largest medical technology companies. Our goal is to improve diagnostic results and simplify it for healthcare professionals through our motorized drilling technology. We want to elevate endoscopic diagnostics to the same level as in breast and prostate cancer by delivering the same type of high-quality biopsies and improve the user experience by making sampling easier and more consistent.
How important is it to be humble when approaching commercialization?
– Very important! Innovation means introducing something new in the hope of improving patients’ lives. You also have to make it commercially viable to reach as many patients around the world as possible. It is not an easy task and you face many challenges when working with innovation, care and commercialization. The whole process tests your endurance and makes you both humble and grateful.
What are the biggest challenges ahead and is the company prepared to handle them?
– The main goal for all of us at BiBB is to expand the clinical use of EndoDrill and quickly respond to the challenges we will face. For example, to continue to support healthcare professionals and deliver high-quality biopsies, which our initial study data has shown we are doing. We feel excited and ready for the next phase of our journey and the challenges that lie ahead.
Finally, how confident are you that your vision will become a reality?
– We are confident and humble about the tasks ahead. We know that EndoDrill has great potential as it delivers high-quality tissue biopsies, but it must be proven in a larger context, i.e. by different doctors, in several countries and for several clinical indications. If we succeed, the value created for patients and healthcare professionals will also be an added value for BiBB's owners. We believe that we have an opportunity to help patients and healthcare professionals with EndoDrill. Ultimately, this is what drives us.