So far this year, BiBBInstruments has obtained an FDA market clearance for EndoDrill GI, completed a fully subscribed directed share issue, published positive data for EndoDrill URO and received two patent approvals in Europe. On the agenda now is an expected CE certificate according to MDR for market approval in Europe of the entire EndoDrill product series, as well as the premiere of the EndoDrill GI system for specialists in endoscopic ultrasound. In the US, a clinical evaluation of the EndoDrill GI will soon begin at hospitals using endoscopic ultrasound.
BiBBInstruments develops three biopsy instruments that are part of the same product family. EndoDrill GI, EndoDrill URO and EndoDrill EBUS. EndoDrill GI is developed for diagnosing tumours in the upper part of the gastrointestinal tract, EndoDrill URO, for the diagnosis of muscle-invasive bladder cancer (MIBC), and EndoDrill EBUSis intended for the diagnosis of lung cancer. EndoDrill is the world’s first market-cleared motor-driven EUS-CNB instrument, i.e. a biopsy technique based on core needle biopsy rather than fine needle aspiration (EUS-FNA, cytological sample) or fine needle biopsy (EUS-FNB, histological sample). The goal is that the technology should provide significantly higher quality tissue samples, which today can be fragmented and contaminated with blood.
Progress during the year
As founder Dr. Charles Walther mentioned in a recent interview with BioStock, the company was founded with the vision of creating a cancer biopsy instrument that could provide better and more reliable diagnostic tissue samples. In 2023, the Lund-based company has taken several steps towards the goal of realising this vision. One of these was the market clearance for EndoDrill GI by the US Food and Drug Administration (FDA).
At the end of May, BiBB carried out a fully subscribed directed share issue of approximately 10.1 million SEK, which means that the company is financed well into next year. In addition, the results from the first clinical study with EndoDrill URO showed that the instrument is safe to use and can take decisive samples earlier in the care process if bladder cancer is suspected.
CEO: “Exciting times ahead”
In the Q3 report published last week, the company stated that it recently submitted a final report to the company’s notified body for obtaining the CE certificate according to MDR for market approval in Europe of the entire EndoDrill product series. The company expects a positive decision as early as Q4 of this year. According to the company, this paves the way for an expanded study program and the launch of EndoDrill GI in Sweden during the first half of 2024.
Another key point in the calendar is BiBB’s first exhibition of a commercial EndoDrill system, which will take place during the 6th Nordic EUS Congress in Oslo, Nov 30 – Dec 1. The opportunity is well chosen as the participants, specialists in endoscopic ultrasound, are exactly the target group that has long been looking for better biopsy methods.
The company will soon also be facing a clinical evaluation of EndoDrill GI in the US as a result of the FDA clearance last spring. The company will introduce the EndoDrill method on-site at US hospitals. The response from users will be crucial for continued marketing activities in the US market.
Commenting on the expectations for the coming months, CEO Fredrik Lindblad told BioStock:
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.
“After the regulatory processes that tested our patience, exciting times now await with clinical marketing activities in Europe and the US for our innovative biopsy method.”