The medical technology company BiBBInstruments ( "BiBB”) is developing EndoDrill, an electrically powered biopsy instrument for endoscopic use in serious cancers. EndoDrill offers desirable features compared to today’s manually operated endoscopic ultrasound (EUS) needle instruments. The product takes higher quality tissue samples in less time and is more user-friendly than the instruments currently used in EUS sampling.
Successes during the year
I Fredrik Lindblad CEO's words for the 2022 year-end report, it is clear that the year was a success for BiBB. In February, a new share issue was carried out and the impressive results from the first pilot study EDMX01 w/ EndoDrill GI, indicated for deep gastric tumors, was presented in May at Digestive Disease Week (DDW) Congress in San Diego.
Another important milestone was the completion of the company's second pilot study, EDUX02, with EndoDrill URO. This instrument is intended for sampling suspected muscle-invasive bladder cancer (MIBC). The results from both EDMX01 and EDUX02 are expected to be published in scientific journals in the future. For EndoDrill URO, continued clinical evaluation will follow – provided that the study meets the predefined efficacy measures – in the form of an already regulatory approved randomized controlled efficacy study. BiBB's third product variant, EndoDrill EBUS (endobronchial ultrasound) for endoscopic sampling of the respiratory tract-lung, is also being further developed by the company.
Regulatory processes limit clinical activities
The year was also marked by extensive regulatory processes. BiBB has placed extra focus on obtaining market approval according to FDA requirements and the new regulatory framework MDR (Medical Device Regulation). The company's previously valid EC certificate under the old MDD (Medical Device Directive) expired in August. As with so many other medical device companies, clinical activities have therefore been put on hold until an MDR approval is in place.
However, according to BiBB, only a small part of the MDR review process remains. Market approval in both the US and Europe is expected for EndoDrill in 2023.
Financing plans and expansion of the study program
Following market approvals, BiBB plans to further accelerate clinical activities. In addition to initiating an efficacy study with EndoDrill URO in MIBC, the company intends to expand the evaluation of EndoDrill GI to pancreatic cancer – the deadliest and most difficult-to-diagnose cancer. This is also the largest indication for EUS biopsy. Endoscopists at Swedish university hospitals have recognized the potential of the instrument and are eagerly awaiting the start of clinical activities with EndoDrill.
EndoDrill GI is the product variant that the company first expects to release for sale in Sweden, and the company also intends to begin this during the latter part of the year. However, the overall business strategy is to enter into a distribution agreement with a global player. During its participation in international congresses, BiBB has, to its advantage, noticed a clear interest from potential global partners.
Overall, the company's successes in 2022, as well as that in January, received European Intention To Grant, BiBB can be said to have taken significant steps in the right direction towards such collaboration.
BiBB's cash balance at the end of the year was approximately SEK 13,4 million. According to the company, this will finance activities until late summer 2023. Before the summer counts BiBB with conducting a financing round that will be used to expand the study program, as well as for the initial launch of EndoDrill GI in Sweden.
CEO comments
BioStock contacted CEO Fredrik Lindblad to get his thoughts on expectations for 2023.
Fredrik, you plan to release EndoDrill GI for sale in Sweden this year. What are your expectations for the launch?
– I expect, assuming we receive the MDR EC certificate in time, that we will sell a couple of EndoDrill GI products to Swedish customers by the end of the year. We do not expect any significant sales volumes until we have signed a distribution agreement with a major player. However, the first launch is very important as it gives us quick feedback from customers and confirms that hospitals using advanced endoscopy are prepared to pay for our new unique biopsy system.
Given the major steps BiBB has taken in clinical evaluation and towards regulatory approval, but also the great interest shown by global players for EndoDrill at international conferences, how do you think the prospects for your goal of entering into a global distribution agreement have changed in 2022?
– At conferences during the year, our EndoDrill system attracted more interest from doctors and industry than we had dared to hope for. We now know that some of the global companies are following our development steps and we know what is required of us in the future.
What are the biggest challenges for BiBB in 2023 and how do you plan to meet them?
– Right now we are facing the biggest challenge of the year – the massive regulatory work to get EndoDrill approved in Europe and the US. Over the past six months, the entire team has been working in parallel with the MDR and FDA processes, which has meant an enormous effort for an organization with relatively few employees. We hope that all our work will be rewarded with regulatory approvals during the year, which will open up very interesting opportunities for our company.