Home News BiBBInstruments aims for US market entry in 2023

BiBBInstruments aims for US market entry in 2023

BiBBInstruments FDA 2022

BiBBInstruments aims for US market entry in 2023

23 June, 2022

Lund-based BiBBInstruments is developing the world’s first electric biopsy instrument, EndoDrill, with the ambition of facilitating and accelerating the diagnosis of some of the most serious cancer forms. The company’s recent meetings with the FDA, following a market entry application, put EndoDrill on a clear regulatory pathway to US market access.  A green light from the FDA would thus grant the company access to the largest and most important market for EUS endoscopy.

Approximately 10 million people worldwide die from cancer each year. Often, the fatal outcome can be traced to late detection of the disease. An earlier diagnosis would therefore be highly desirable. However, this requires sufficiently accurate and effective diagnostic tools.

Swedish medtech company BiBBInstruments´ “BiBB” ambition is to offer exactly this with EndoDrill, the world’s first CE-marked (2020) EUS (endoscopic ultrasound) biopsy device that enables sampling of core tissue. By taking core biopsies through endoscopic ultrasound (EUS-CNB), instead of today’s fine needle aspiration (EUS-FNA) and biopsy (EUS-FNB), EndoDrill provides more intact and substantially less blood-contaminated samples, thus producing more reliable results for analysis.

BiBB, a pioneer in EUS-CNB, estimates the global market potential at about 1 billion USD. The company wants to take advantage of this potential – something that was made clear with the recent application for market entry in the US to the FDA.

Read more about EndoDrill’s advantages over the competition here.

Aiming for the US market

The US by far is the largest and most important market for EUS endoscopy, which in turn is also the fastest-growing endoscopic segment. Establishing a presence on the US market would therefore be very important in terms of BiBBs’ general market potential.

The company has had a close dialogue with the FDA regarding the authority’s requirements for US market entry, which has led to an action plan aimed at fulfilling such requirements as soon as possible. With this plan, the company expects to get EndoDrill on the American market in 2023. This would mean the right to sell and market EndoDrill in by far the largest market in the world. Read more about the company’s market potential here.

Additionally, following regulatory approval, BiBB would initiate clinical evaluations with EndoDrill at high-end US hospitals. Positive results in these studies, as well as clinical experiences of using EndoDrill among leading doctors in the country, is also something that would increase the chance of successful commercialisation.

BiBB’s CEO Fredrik Lindblad commented on the recent discussions with the FDA:

»The USA is by far the largest and most important market for our new endoscopic biopsy instrument, EndoDrill. Our regulatory application with subsequent discussions with the FDA has clarified what BiBB needs to do to meet the requirements for market entry. Our goal is to be able to announce next year that in addition to previous CE marking in Europe, we are positioned to enter and start up commercialisation activities in the USA.«

CE marked in Europe

Regarding the European market, the company has already laid a foundation with the CE marking of EndoDrill, which was obtained in 2020 according to the older MDD regulations. Certification according to the new MDR regulations is expected to be obtained in the second half of 2022. The goal of receiving the regulatory backing in the US in addition to the already awarded CE mark in Europe would result in broad coverage in terms of the company’s overall market potential. Read more about BiBB’s path to commercialisation here.

Clinical interest and validation

Adding momentum to BiBB’s commercialisation potential is EndoDrill’s clinical validation. The pilot study EDXM01 with EndoDrill GI, which delivered convincing data earlier than expected and thus came to an early end, was successfully presented at Digestive Disease Week (DDW) in May. Read more here. Moreover, the pilot study EDUX02 with EndoDrill URO indicated for muscle-invasive bladder cancer is still ongoing; however, it expected to be completed shortly. The study will then be followed up by an already regulatory-approved and planned effect study.

Due in large part to BiBB’s quick clinical progression, clinically active doctors have opened their eyes to the company’s device, as several at a number of Sweden’s university hospitals have shown interest in follow up clinical studies with EndoDrill GI on different tumour forms, something that has come a long way in the planning for BiBB.

Interest has also been intensifying regarding EndoDrill EBUS, intended for endoscopic sampling for lung cancer. The company is in late development of a clinical instrument that will be evaluated in a planned clinical study.

Overall, BiBB is in a very eventful and exciting phase regarding the clinical validation of the EndoDrill product family. It will certainly be exciting to follow BiBB for the rest of the year, which is thus expected to be intensive in terms of the company’s clinical development.

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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