It has been an eventful start to the year for BiBBInstruments. While the standout moment was the FDA market clearance for EndoDrill GI, the Swedish medtech posted a number other key milestones that are sure to work as a springboard for the rest of the year. BioStock got in touch with BiBB’s CEO Fredrik Lindblad to learn more.
Lund-based BiBBInstruments (BiBB) develops EndoDrill, a motor driven biopsy instrument for endoscopic use in serious cancers. The device is the first endoscopic ultrasound (EUS) core needle biopsy instrument to be CE-marked (2020). It is attractive to physicians because it takes more high-quality tissue samples in a shorter time and is more user-friendly than the instruments currently used in EUS examinations.
BiBB has released its mid-year quarterly report, and the message is clear: the numerous milestones achieved during the first part of 2023 setup for potentially an even more active second part of the year.
FDA market clearance and European patent
The spotlight milestone came in the spring in the form of a 510(k) clearance from the US Food and Drug Administration (FDA) for BiBB’s lead product EndoDrill GI. The instrument is used for diagnosis of tumours in the upper gastrointestinal tract. This opened the door to the world’s largest market for endoscopic instruments. In an interview with BioStock, CEO Fredrik Lindblad talked about the importance of the approval.
The FDA clearance has taken up a lot of the media oxygen. However, another key milestone for BiBB was receiving two Intention to Grant notices from the European Patent Office (EPO) regarding patents that will give broad protection for the whole EndoDrill system. This includes not only EndoDrill GI, but also EndoDrill URO and EndoDrill EBUS. Read more about these products and the importance of the patent approvals here.
Both of these milestones have cemented the company’s position and opened doors for continued development and expansion.
Successful studies and new share issue
Another noteworthy event was the publication of the clinical study on EndoDrill URO for muscle-invasive bladder cancer in European Urology Open Science. The study shows that EndoDrill URO is the first endoscopic tissue sampling instrument that can safely take treatment-critical samples in cases of suspicion of deep-growing tumours in the bladder. This is a significant step forward in the fight against a form of cancer that is often difficult to diagnose at early stages. Read more here.
BiBB also successfully carried out a fully subscribed directed share issue of approximately SEK 10.1 million at the end of May. This capital will give the company the financial strength needed to continue its ambitious growth plan.
With such an impressive track record of progress over recent quarters, BiBB has shown that they are well-positioned to make a significant impact on the global medical technology market. Moreover, with a cash balance of approximately SEK 14.6 million at the end of June, according to CEO Fredrik Lindblad, BiBB’s activities are financed well into 2024.
To learn more, BioStock got in touch with BiBB’s CEO Fredrik Lindblad.
Fredrik, BiBB has had an intense first half of the year, and the FDA clearance for EndoDrill GI obviously stands out. Could you update us on the current preparations for clinical evaluation for this product in the US?
– Right now, we are in the final stages of our preparations for the initial clinical evaluation in the USA. We plan to conduct the first US clinical cases in the near future. North America is by far the largest market for EUS biopsy instruments, so it will be very interesting to receive direct feedback from some potential customers over there.
What is your plan for cementing the presence of EndoDrill GI on the Swedish market?
– We are in the final stage of obtaining CE marking according to the new EU directive, MDR. During the autumn, we expect that all three product variants (EndoDrill GI, EndoDrill EBUS and EndoDrill URO) will be CE marked and thus be market approved in Europe.
– Our first Scandinavian launch activity will be to exhibit EndoDrill GI in Oslo at the 6th Nordic EUS Meeting, November 30 – December 1, 2023. It is an annual Nordic congress for expert physicians in endoscopic ultrasound (EUS), i.e. exactly our target group for EndoDrill GI. It will be the first time we show EndoDrill GI at a medical congress, and we look forward to exciting demonstrations and discussions. In addition to preparations for commercialisation of EndoDrill GI, we will initiate a multicenter trial in pancreatic cancer together with our Swedish clinical partners. This is the main indication for EndoDrill GI.
Coming off the recent capital raise with the directed share issue, what can you tell us about BiBB’s financial situation?
– Our liquidity is satisfactory with a cash balance of approximately SEK 14,6 million at the end of June 2023. Since we maintain a relatively modest burn rate for the life science industry, we expect our operations to be financed well into 2024.
Finally, what should we be looking out for from BiBB in the coming months?
– Now, very exciting months await. We expect, among other things, to start the clinical evaluation with EndoDrill GI in the US, to obtain CE approval according to MDR for the entire EndoDrill product line in Europe, and, finally, to premiere our new commercial EndoDrill GI system at a Nordic congress for advanced endoscopy.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.