Home News Full speed ahead for BiBBInstruments after FDA clearance

Full speed ahead for BiBBInstruments after FDA clearance

New Opportunities for BiBBInstruments

Full speed ahead for BiBBInstruments after FDA clearance

25 May, 2023

2022 was intensive in terms of regulatory work for BiBBInstruments. The work started paying off in March this year when the medical technology company was awarded FDA clearance for the company’s most important product, EndoDrill GI. The FDA clearance opened the door to the world’s largest market for ultrasound-guided endoscopy. This also means that BiBB is a step closer to reaching a global distribution agreement. Looking ahead, clinical market activities in the US and a clinical multicentre study in pancreatic cancer in Sweden are expected.

Med tech company BiBBInstruments (“BiBB“) is set on improving the sampling of difficult-to-detect and life-threatening forms of cancer. For this purpose, the company has developed an innovative type of motor-driven biopsy instrument for endoscopic use: EndoDrill. EndoDrill provides high-quality and solid tissue samples through its rotating, hollow needle, which increases the possibilities for more accurate diagnostics. Thus, it enables an earlier start of treatment.

There are three different product variants within the EndoDrill system: EndoDrill GI, EndoDrill URO, and EndoDrill EBUS. Two have undergone clinical evaluation: EndoDrill GI, for diagnosing tumours in the upper part of the gastrointestinal tract, and EndoDrill URO, for diagnosing muscle-invasive bladder cancer (MIBC). Meanwhile, EndoDrill EBUS is in late-stage development and is aimed at diagnosing lung cancer.

Reaping the fruits of 2022

BiBB was laser-focused on the regulatory work necessary for market approval of EndoDrill in Europe and for clearance in the US last year. This culminated in a review process for CE marking according to new MDR regulations in Europe and submission of a 510(k) application to the US Food and Drug Administration (FDA) for EndoDrill GI. While the MDR application is still being processed, FDA clearance was received in March of this year, opening the door for BiBB to the largest market in the world for ultrasound-guided endoscopy.

Only one small remark left to address stands in the way of obtaining the MDR-validated EC certificate for all three instruments in the EndoDrill product family. BiBB estimates this will happen in Q3 2023. BiBB also expects two articles to be published in scientific journals presenting the results from the two pilot studies, EDMX01 with EndoDrill GI and EDUX02 with EndoDrill URO.

New possibilities for BiBB

Advances in the regulatory area mean that several opportunities open for BiBB. Once the new, extended CE marking is obtained, the company plans to initiate a clinical study in Sweden for sampling with EndoDrill GI in pancreatic cancer. This happens to be the largest indication within EUS biopsy. BiBB is expected to start clinical marketing activities in the US with EndoDrill GI during the same quarter. It is important to emphasise that the company does not plan to conduct any large volume sales on its own.

A future key goal for the company is to strike a global distribution agreement with one of the leading distributors on the endoscopy market. Therefore, BiBB’s focus for the rest of 2023 and the coming years is to achieve the requirements that international partners have for reaching a global distribution agreement. Discussions with some of the leading companies in the endoscopy market have given BiBB a good picture of such requirements. They include market approvals, a strong IP-portfolio and clinical evidence for the main clinical EUS indications.

In parallel, BiBB intends to launch the product on a smaller scale in Sweden and at some larger hospitals in both Europe and the US. The goal is to obtain quick feedback from clinically active physicians more than generating any major revenue, with the latter being more likely to happen only after a global distribution agreement is in place. BiBB has already taken significant steps closer to this goal during the past year, and more milestones are expected to be achieved during the remainder of 2023. Read more here.

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.

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