Lund-based BiBBInstruments recently reported on its first quarter for 2023. The report focuses on the US market and the recent FDA clearance for EndoDrill GI. An exciting period now awaits the company, as discussions with customers and potential distribution partners in the US are on the horizon. BioStock contacted CEO Fredrik Lindblad to find out more about his expectations for the rest of the year.
Med tech company BiBBInstruments (BiBB) develops and manufactures a new type of motor driven biopsy instrument for endoscopic use, EndoDrill. The device has the potential to improve sampling and diagnostics of difficult-to-detect and life-threatening cancers.
EndoDrill GI approved in the US
The EndoDrill product family is patent pending and currently includes three product variants. The first product, EndoDrill GI, was recently put in the spotlight after the company received 510(k) clearance from the US Food and Drug Administration (FDA). 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.
Initiating marketing activities in the US
Following the good news from the FDA, the company has initiated talks with several US doctors who have expressed great interest in evaluating the product. The next step will be to initiate clinical marketing activities in the region starting in the third quarter of this year.
Another key upcoming milestone for BiBB is the peer-reviewed publication of data from clinical studies with EndoDrill in scientific journals. These publications would play a significant role in spreading the evidence collected about the EndoDrill products so far by endoscopists in Sweden. Two scientific articles are currently under review; one will report the results from the EDMX01 pilot study with EndoDrill GI, while the other will report results from EDUX02 with the sister product EndoDrill URO.
At the same time, the company states in its latest quarterly report that discussions are underway with potential distribution partners.
CE certificate in sight
When it comes to approval on the European market, CE certification according to the new MDR directive has taken longer than expected. According to BiBB, one well-defined measure remains to be implemented. This concerns a process related to an external supplier, i.e., it has nothing to do with the product design. BiBB expects to be able to obtain a new certificate during the third quarter. The CE certificate will then apply to the entire EndoDrill family with its three indication areas.
Once the certificate is in place, the company’s clinical partners in Sweden are ready to continue their evaluation of the product. The focus will then be on pancreatic cancer, which is the largest indication for EUS biopsy.
Green light from the European Patent Office
While this work is ongoing, the company has been notified from the European Patent Office that it intends to approve two patent applications for EndoDrill relating to the first patent family. Now only formalities remain before the approval can be published. After that, the patents will be valid until 2038 and 2039, respectively. Additionally, there are two other patent families that have entered the national phase of the patent approval process. Here, a response is expected this year at the earliest.
Aiming to strengthen finances
With regard to the financial aspects of the company, the operating profit amounted to -2.5 MSEK for the quarter. At the end of the period, the cash position was 9.3 MSEK, which, according to the company, means that the business is financed until the autumn. CEO Fredrik Lindblad writes in a statement that the company intends to raise capital before then.
Comments from the CEO
BioStock contacted Lindblad for a comment on the past quarter and to get his views on the company development during the rest of the year.
How would you describe the start of 2023, now that you are fresh off the FDA clearance?
– We are very pleased with the start of 2023. The fact that we have EndoDrill GI cleared in the US as the first motor driven endoscopic biopsy system is great and extremely important for our business development going forward. The US is the largest medical device market in the world, and the market that our potential business partners see as most important strategically.
– In initial discussions, we have seen that the interest from American endoscopists is at least as high as the interest we have met at home. We will soon be ready to start clinical marketing activities.
– Additionally, we are of course very pleased to have received advanced notice of patent approval for two patent applications for EndoDrill in Europe. This further strengthens our business position. We have thus created good opportunities for an exciting and value-creating upcoming period.
You write in the report that there are ongoing discussions with potential distribution partners. Is it possible to say something about where you are in these discussions?
– Right now, I can only reveal that we have been in discussions with potential global distribution partners for a long time, and that the interest has gone up significantly since we received FDA approval. Evaluation of the device in the US in the form of a series of clinical cases is the next natural step in the process.
What is important to you when it comes to choosing a distribution partner?
– Our dream candidate is already active and successful in the endoscopy market and more specifically in endoscopic ultrasound where the group markets conventional manually handled EUS biopsy instruments. The company is looking for an innovative cutting-edge technology to continue to lead the market. They have a worldwide distribution network and are happy to sell products in all three of our product arms, i.e. gastrointestinal tract, lungs and urology.
Finally, with approval in place for the US and being underway in Europe, what expectations should we have with regards to sales going forward?
– In the US, the next step is clinical evaluation of EndoDrill and continued discussions with global distribution partners. A broad launch of the FDA-cleared EndoDrill GI on the US market is not on the agenda quite yet. In Europe, the start of sales depends on when we receive the CE certificate according to MDR.
– Provided that we have the CE marking in place during Q3, which is what we hope for, and that the commercial EndoDrill system, with new industrialised motor unit, is ready during the same period, we could sell our first biopsy instruments by the end of the year or, perhaps more likely, during the first quarter of 2024.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.