BiBBInstrument’s CEO: “Distributors are contacting us”
BiBBInstruments recently released its report for the third quarter and at the same time announced a rights issue of approximately SEK 36.5 million. BioStock contacted CEO Fredrik Lindblad to learn more.
BiBBInstruments has developed a patented platform technology for electric-driven biopsy instruments. The company’s main product, EndoDrill GI, is the first of its kind and has been developed to improve the possibility of extracting high-quality core tissue biopsies for cancer diagnostics of the gastrointestinal tract. The product has gained market approval in both the US and Europe. BiBBInstrument’s Q3 report summarises an eventful period with a lot of focus on the ongoing clinical evaluations. In August, EndoDrill GI was tested at the University Hospital Sestre Milosrdnice in Zagreb, Croatia.
The test was conducted together with Dr. Tajana Pavic and her team in interventional gastroenterology. According to the company, the results were very promising and all samples resulted in complete histological diagnoses. Dr. Pavic, for her part, said that she was “more than satisfied” with the evaluation.
Good results from case series
On the other side of the Atlantic, the product has been evaluated in a clinical case series, which was conducted in collaboration with Dr. Antonio Mendoza Ladd at UC Davis Health in Sacramento, California. The study included patients with suspected cancer of the gastrointestinal tract and the results showed 100 percent diagnostic accuracy. This means that all samples resulted in high-quality core biopsies after a single needle puncture – something that is very unusual in this type of diagnosis.
According to Dr. Mendoza Ladd, the ability to obtain larger and more uniform tissue samples is a crucial factor in ensuring better diagnostic results.
The results of the initial eight patient cases were recently published in the scientific journal Endoscopy International Open and were also presented at a poster session at the renowned ACG Congress 2024 in Philadelphia.
Sees great interest
These promising results have laid the foundation for a great deal of interest among endoscopists. The interest was recently confirmed at the 7th Nordic EUS Meeting, where the product received positive feedback for its ability to deliver high-quality tissue samples, even in hard-to-reach lesions.
– The fact that several of the doctors immediately wanted to start testing the product clinically is a good acknowledgment that we have developed an attractive biopsy system, says CEO Fredrik Lindblad in a comment to BioStock.
Rights issue opens the door to the market
The clinical evaluation paves the way for future market launch to selected hospitals. BiBBInstruments is in full swing with preparations for the launch. Among other things, the production of the disposable instruments is currently being moved to a Swedish contract manufacturer to ensure volume production. In addition, the company states that it is in discussions with several possible distribution partners.
At the end of the third quarter, the company’s cash stood at SEK 5.7 million, and cash flow for the period amounted to SEK –3.6 million. To finance the ongoing work, BiBBInstruments has decided to carry out a rights issue of approximately SEK 36.5 million.
The company also plans to take out a bridge loan of SEK 3.0 million to ensure liquidity until the completion of the issue.
CEO comments
After an eventful quarter, BioStock took the opportunity to contact CEO Fredrik Lindblad to get his thoughts on what is to come.
You are putting an eventful quarter behind you. As you now start to look towards commercialisation of EndoDrill GI, how would you describe BiBBInstruments position?
– I think we are in a very exciting starting position. Over the past twenty years, endoscopic ultrasound with tissue sampling has grown rapidly and become a standard of care for obtaining samples from many types of serious cancerous tumors. At the same time, there have been only small improvements in the manual fine-needle instruments used, which are limited by an inability to take high-quality biopsies. Not being able to take high-quality biopsies can entail a risk of incomplete diagnoses or having to take new samples from the patient.
– I believe that with the electric-driven EndoDrill, we have a golden opportunity to introduce a more efficient biopsy instrument that better meets the future needs of treatment-based cancer diagnostics. In areas such as lung cancer, the demand for higher-quality samples is increasing to guide increasingly advanced and individualised cancer treatment.
In the Q3 report, you write that discussions are ongoing with several potential distribution partners. Could you provide more details about these discussions?
– As I mentioned, we have developed a highly effective new biopsy technology, but in order to eventually reach many patients worldwide, we need to initiate partnerships with global distributors. At the moment, we are in discussions with several international distributors of ultrasound endoscopy equipment.
– The interesting thing is that the distributors are the ones who contacted us, because they are curious about our EndoDrill system. They did this even though they themselves manufacture and sell competing manual biopsy instruments.
You are in the process of moving the production of the disposable instruments to ensure large-scale production. Why is that and what are the manufacturing plans for the motor unit?
– With the plans to work with one or more distribution partners, we need to increase the production capacity of our sterile disposable instruments, so that we can meet a presumed increase in demand. Therefore, we are switching to a Swedish contract manufacturer with extensive experience in volume production. The transfer is expected to be completed by mid-2025.
– The motor system, on the other hand, is not a volume product, as each hospital does not need more than a couple of reusable systems for the sampling procedures. In order to have full control of production, at least in the initial stage, this is handled internally by our own resources.
If we interpret you correctly, you want to get started with marketing efforts as soon as possible. Can you tell us a little about what kind of initiatives you are planning?
– You could say that we are in a pre-launch phase right now where we are introducing EndoDrill GI at more and more hospitals in Europe and the US at the pace that we can manage. These market studies are the final step before a targeted launch of EndoDrill GI to selected hospitals, i.e. we convert successful evaluations into sales. We want to get more users who can create engagement for our EndoDrill technology and spread the word about a new Swedish innovation that takes better biopsies than anything else on the market.
– In parallel with the mentioned selection process with possible distribution partners, we will start our own sales to selected customers. We will not have any major sales in-house and we are not building our own sales organisation. Rather, this represents an initial commercial validation of EndoDrill GI. More significant sales growth will be generated in collaboration with the mentioned distribution partner(s), making increased production capacity an important step on the way.
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.
