BiBBInstruments’ EndoDrill premier received with enthusiasm
While waiting on the highly anticipated CE certificate according to MDR, BiBBInstruments has continued preparations for market launch of its next-generation motor-driven endoscopic biopsy system – EndoDrill GI. The Swedish medtech premiered the commercial version of the instrument at the 6th Nordic EUS Congress earlier this month, generating quite the buzz, according to BiBB. BioStock spoke with BiBB’s Founder Dr Charles Walther to learn more.
Endoscopic ultrasound (EUS) is the fastest growing endoscopic procedure for cancer diagnostics, especially in the US. However, the quality of samples from the devices currently used in the clinic is still quite poor. The insufficient sample quality – not least in the case of cancer in the lungs and the organs of the gastrointestinal tract – leads to a significant gap in the field.
Dr Charles Walther, a clinical pathologist at Lund University Hospital, noticed this gap. The frustration felt when seeing inadequate tissue samples taken from cancer patients reached a limit in 2013. Taking inspiration from his father, a now retired Professor of Surgery, and his mother, who gave Charles the drive to cross the bridge from academia to industry, Charles decided to found BiBBInstruments (BiBB) for the development of EndoDrill. The instrument is now the world’s first market approved motor-driven EUS-Core Needle Biopsy (CNB) device.
Read more about BiBB’s story here.
Towards the market
BiBB is well on its way towards commercialisation with EndoDrill in Europe. Specifically EndoDrill GI, the device variant made for diagnosing tumours in the upper part of the gastrointestinal tract, e. g. solid pancreatic tumors. The big factor still in the way of market launch is obtaining the CE certificate according to MDR.
According to BiBB’s CEO Fredrik Lindblad, the company recently submitted a final report to the notified body for obtaining the certificate, i.e. market approval for EndoDrill in Europe. A positive decision is expected in the near future, and it would pave the way for an expanded study programme and the launch of EndoDrill GI in Sweden during the first half of 2024.
Thanks to receiving FDA clearance for EndoDrill GI last spring, preparations for clinical evaluation of the device are in the works in the US. The company will introduce the instrument at US hospitals, where the response from users will be crucial for continued marketing activities for that specific market. Read more here.
EndoDrill GI Premier
In the meantime, BiBB premiered EndoDrill GI at the 6th Nordic EUS Congress in Oslo, which took place between November 30 and December 1. The conference brought together EUS specialists, i.e. the target group that has been longing for better biopsy methods and would be interested in BiBB’s device.
To learn more, BioStock got in touch with Dr Charles Walther to get his insights on the response to EndoDrill at the Congress.
Charles, why was the 6th Nordic EUS Congress the right place to premier EndoDrill GI, and why now?
– The conference that took place in Oslo is the only annual meeting for all EUS endoscopists in the Nordic region, and we could not resist the opportunity to exhibit EndoDrill GI to a variety of potential customers. The timing felt perfect as we are approaching market approval in Europe.
As founder, how did it feel to showcase a product that emerged out of an idea that you have been fostering and developing for more than a decade?
– It felt really good! We had great discussions with fellow colleagues, and the need for EndoDrill was confirmed several times during the meeting. We are proud of the work we have done, and to be told that, if we succeed, we will make a real contribution to patients, is something I will never forget.
Could you give us a sense of the response you received at the conference?
– I have to say it felt like a fantastic premiere of our new product. After the exhibition, our CEO Fredrik and I were able to conclude that all the main key opinion leaders in the Nordic countries were enthusiastic and wanted to clinically evaluate our system as soon as it is market approved in Europe. It was also great to see one of our clinical partners, Dr Fredrik Swahn from Karolinska University Hospital, present EndoDrill GI on stage as the next generation of EUS biopsy instruments.
Finally, did you learn something new about EndoDrill and its potential during all the conversations with the Nordic participants?
– We were told by several endoscopists that we had developed a very multifaceted instrument, almost like the EUS undustry’s equivalent of a Swiss army knife. The visitors saw new possibilities beyond biopsy, and we have probably not understood the full potential of EndoDrill ourselves. This will be interesting to explore in the future!
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.
