BiBBInstruments has developed a patented platform technology for electrically powered biopsy instruments. The company's main product, EndoDrill GI, is the first of its kind and has been developed to improve the ability to extract high-quality core tissue biopsies in gastrointestinal cancer diagnostics.
The product has market approval in both the US and Europe, and as the company releases its third quarter report, it is an eventful period behind it. The focus is on clinical evaluation, and in August EndoDrill GI was tested at the University Hospital. Sisters of Mercy in Zagreb, Croatia.
The test was carried out together with Dr. Tajana Pavic and her team in interventional gastroenterology. The results were, according to the company very promising and all samples resulted in complete histological diagnoses. Dr. Pavic, for her part, expressed 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 vid UC Davis Health in Sacramento, California. The study included patients with suspected gastrointestinal cancer 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 was also presented at a poster session at the well-regarded ACG Congress 2024 in Philadelphia.
Brands of great interest
These promising results have laid the foundation for great interest among endoscopists. This interest was recently confirmed at 7th Nordic EUS Meeting, where the feedback was very positive, precisely because of the product's ability to deliver high-quality tissue samples, even in difficult-to-reach lesions.
– The fact that several of the doctors immediately wanted to start testing the product clinically is good evidence that we have developed an attractive biopsy system, notes CEO Fredrik Lindblad. in a comment to BioStock.
Issuance opens the door to the market
The clinical evaluation paves the way for the upcoming 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 potential distribution partners.
At the end of the third quarter, the company's cash amounted to SEK 5,7 million, and cash flow for the period amounted to SEK –3,6 million. To finance the continued work, BiBBInstruments has decided to carry out a rights issue of approximately SEK 36,5 million. The proceeds will primarily finance continued clinical market studies, launch, marketing and partner development regarding EndoDrill GI, as well as the completion of the lung cancer version. EndoDrill EBUS.
The company also plans to raise 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's to come.
You are coming off an eventful quarter. As you now look towards commercialization of EndoDrill GI, how would you describe the position BiBBInstruments is in?
– I think we have a very exciting starting point. Over the past twenty years, endoscopic ultrasound with tissue sampling has grown rapidly and has become established as a standard of care for sampling many serious cancers. 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 mean a risk of incomplete diagnoses or that the patient is forced to have new samples taken.
– I believe that with the electrically powered EndoDrill we have a golden opportunity to introduce a more efficient biopsy instrument that better meets the future needs for treatment-based cancer diagnostics. In areas such as lung cancer, there is a growing demand for higher-quality samples to guide increasingly advanced and individualized cancer treatment.
You write in your quarterly report that discussions are ongoing with several potential distribution partners. Can you tell us more about these discussions?
– As I mentioned, we have developed a highly efficient new biopsy technique, but in order to eventually reach many patients worldwide, we need to enter into partnerships with global distributors. We are currently in discussions with several international distributors of equipment for ultrasound endoscopy. Interestingly, it is the distributors who have contacted us because they are curious about our EndoDrill system. This is despite the fact that they themselves manufacture and sell competing manual biopsy instruments.
You are moving the manufacturing of the disposable instruments to ensure large-scale production. What is the idea behind that and what are the manufacturing plans for the motor system itself?
– With plans to collaborate with one or more distribution partners, we need to increase production capacity for our sterile single-use instruments to meet expected increased demand. Therefore, we are switching to a Swedish contract manufacturer with extensive experience in volume manufacturing. The transfer is expected to be completed by mid-2025.
– However, the motor system 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 over the manufacturing, at least in the initial stage, this is handled internally by our own resources.
If we understand you correctly, you want to start marketing initiatives as soon as possible. Can you tell us a little about what initiatives you are planning?
– You could say that we are in a pre-launch phase right now where we are introducing EndoDrill GI to more and more hospitals in Europe and the US at the pace we can manage. These market studies are the last step before a targeted launch of EndoDrill GI to selected hospitals, i.e. that we convert successful evaluations into sales. We want to get more users who can create commitment to our EndoDrill technology and spread the message about a new Swedish innovation that takes better biopsies than anything else on the market.
– In parallel with the aforementioned selection process with potential distribution partners, we will begin sales under our own management to selected customers. There will be no major sales under our own management and we are not building our own sales organization. Rather, this is about an initial commercial validation of EndoDrill GI. More significant sales growth will be generated in collaboration with the aforementioned distribution partner or partners, and then an increased production capacity is an important step along the way.