BiBBInstruments develops biopsy instruments with the goal of improving the diagnostics of several of the most common cancers. Main product EndoDrill GI is the world's first market-approved powered biopsy instrument for endoscopic use, enabling safer and more precise diagnoses by obtaining high-quality core tissue samples. The product has received regulatory approval in both the US and Europe and is now undergoing a series of clinical evaluations at several leading university hospitals in preparation for an imminent launch.
The results so far have been promising. EndoDrill GI has provided high-quality core tissue samples and demonstrated high diagnostic accuracy in a clear majority of patient cases.
Also sees great potential in lung cancer
In addition to EndoDrill GI, which is intended for use in the organs of the gastrointestinal tract, BiBBInstruments is also developing EndoDrill EBUS. This new, closely related product is based on the same electrically powered technology, but is to be used for the diagnosis of lung cancer. In this common form of cancer with high mortality, it is difficult to obtain reliable samples with today's manual needle instruments that meet the requirements for emerging individual-based treatment. The fast-growing EBUS segment and the EndoDrill technology's ability to obtain high-quality core biopsies mean that the company sees great potential in EndoDrill EBUS.
Close contact with potential partners
As BiBBInstruments approaches the market launch of EndoDrill GI, an important parameter of the strategy is to establish collaboration with established global players with existing marketing channels. Several potential partners have contacted the company and are following the development with great interest. The plan is to carry out a targeted, smaller launch under its own management to selected hospitals, and then launch in other markets together with one or more distributors.
Another important parameter is to scale up the production of the sterile disposable instruments. To meet future commercial demand, BiBBInstruments is now moving production to the Swedish contract manufacturer. Genoa, which is expected to be completed by mid-2025.
Rights issue will open the door to the market
To finance its investments and ensure a strong financial position, BiBBInstruments is carrying out a rights issue of units of approximately SEK 36,5 million. The issue is covered to approximately 75,5 percent by subscription commitments, subscription intentions and guarantee commitments. To ensure liquidity until the completion of the issue, the company has also raised a bridge loan of SEK 3 million from the existing owner. Tibia Consultant. The issue also includes warrants of series TO 1. If the options are fully exercised at the end of May 2025, the company can receive an additional approximately SEK 11,9–21,9 million upon full redemption.
CEO comments
BioStock has contacted the CEO Fredrik Lindblad to find out more about the issue, continued product development and launch work.
EndoDrill GI is the world's first electrically powered endoscopic biopsy instrument. What does this type of sampling look like with today's manual instruments and what does healthcare gain from switching to yours?
– Manual needle instruments are currently offered by some of the world's largest medical device companies. These products work, as evidenced by increased global demand, but they also have several significant limitations, such as an inability to take high-quality core biopsies.
– EndoDrill GI looks like other disposable instruments at first glance, but we have added a patented motorized, rotating needle. This has been shown in clinical studies and evaluations to provide a completely different sample quality that better meets today's and future diagnostic requirements. Healthcare – and not least patients – benefit from the fact that a complete, treatment-based diagnosis can be established as early as possible.
Your instrument takes high-quality so-called core tissue samples. Why is that important in this context?
– Simply put, a larger and more continuous tissue sample can provide more diagnostic information. EndoDrill biopsies help make subsequent analysis in the pathology lab easier, faster and more accurate. This in turn means that treating physicians, oncologists, can initiate personalized treatment as soon as possible.
EndoDrill GI is currently being evaluated in several hospitals in Europe and the US. What is the feedback from the clinics?
– Overall, we have received very positive feedback. Doctors find the system easy to use, that they obtain core biopsies after few needle punctures, and without serious complications. Users also report high control and precision during sampling. The high sample quality was also confirmed in the recently published case series from UC Davis Health in Sacramento. In all eight initial patient cases, a complete diagnosis was obtained, and this after only one needle puncture.
Why even do these clinical validation studies when the product is already regulatory approved?
– Good question! When it comes to launching an innovative product, we have more to prove than if we had developed yet another manual biopsy instrument. The market studies we are currently conducting serve several important functions.
– We are testing EndoDrill GI in different hospital environments with users who have varying experiences. We get rapid clinical feedback, often with our team on site in the examination room, which generates both interest at medical conferences and data for scientific publications. All of this contributes to more doctors becoming curious about the new, innovative biopsy technique from Sweden. It gives us a solid foundation for the upcoming launch phase
Established players in the sector are following you with great interest. What feedback have you received from them?
– It is no secret that we are looking for one or more distribution partners for the upcoming global launch of our product line. We are in discussions with several potential partners, and interestingly, it is these distributors who have taken the initiative and contacted us.
What needs to happen now to get a partnership agreement in place?
– As is well known, an agreement has two parties, and in the end it should feel right for both. We are focusing on distributors with a clear growth strategy in our field, ultrasound endoscopy, where EndoDrill can become a high-profile product in their range. We are having several in-depth discussions and look forward to communicating the results later.
To be concrete, what specific steps remain before an actual launch, and what timeline can that translate into?
– For a launch with one or more distributors, there are two steps remaining. First, both parties must agree on acceptable contract terms. Then, the move to a Swedish contract manufacturer of our disposable instruments needs to be implemented, so that we can offer commercial volumes. We expect that the new contract manufacturer can start manufacturing our instruments in the middle of next year. Before then, we plan to start sales to selected hospitals under our own management.
You also see great potential in lung cancer diagnostics. Why?
– Lung cancer is the leading cause of cancer-related death in the world. Early detection and correct diagnosis are crucial to be able to initiate the right treatment on time. As precision medicine has developed and become a cornerstone in the treatment of lung cancer, the demands on the quality of tissue samples have increased.
– High-quality core biopsies with EndoDrill EBUS can improve diagnostic accuracy and enable advanced genetic testing. This can reduce the risk of misdiagnosis and enable tailored treatment, increasing the chances of survival and recovery for the patient.
You are now carrying out a rights issue of an initial amount of approximately SEK 36,5 million. How will the proceeds be used?
– The issue will finance our entry into the commercial phase. This includes a move to a new contract manufacturer for scaled-up production of the single-use instruments and an agreement with a global distribution partner. For EndoDrill GI, continued clinical evaluations are planned in the US and Europe, as well as a randomized multicenter study to further strengthen the clinical evidence.
– The product will initially be soft-launched in-house to selected hospitals, and then – when the new manufacturing unit is in operation – a broader launch will begin together with a selected distribution partner.
In conclusion, why is BiBBInstruments a good investment right now?
– We are coming from a development phase where significant resources have been invested in building a solid foundation in the form of refined technology, market approvals and clinical proof-of-concept. During the initial market studies in 2024, we have received confirmation that we have developed a truly effective product that users appreciate.
– An innovative product that takes better samples than today's manual products is the most important piece of the puzzle for our upcoming commercial journey. The timing of investing in BiBB is really interesting, as we have an exciting commercialization phase waiting just around the corner.
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