Cancer diagnostics company BiBBInstruments released its 2020 annual report last week where the company outlines its main achievements from last year, including the launch of clinical evaluation of the world’s first CE-marked electric endoscopic biopsy instrument. Due to production problems, in April 2021, BiBBInstruments had to pause the recruitment of patients in its two ongoing clinical studies. However, in mid-May, after intensive work, the company was able to announce that studies could be resumed after a complete change of supplier.
As outlined by BiBBInstrument’s 2020 annual report, last year was a big year for the Lund-based medtech company. 2020 was all about developing the EndoDrill Model X and prepping it for introduction into the clinic. This included regulatory approval by the authorities and increased patent protection.
Towards the end of the year, BiBBInstrument’s electric biopsy instrument received full CE market approval for use in Europe for all common endoscopic indications, which means that the company is now establishing itself as a pioneer in electrically powered endoscopic biopsy instruments and will be the first in the world to be able to offer core biopsies in endoscopic examination.
Finally, at the end of 2020, BiBBInstruments was able to carry out a directed new share issue of approximately 16.2 million SEK to finance BiBB’s activities during 2021. The subscribers include the investment company Creades AB, Lovisa Hamrin, Svanberg & Co Invest AB, JCC Group Invest AB and Mastan AB. This helped the company end 2020 with 21.9 million SEK in cash, which, according to the company’s own forecast, will keep the show running at least through the rest of this year.
After preparing for the multicentre clinical study EDMX01, BiBB was able to overcome several of the challenges brought on by the pandemic to begin recruiting for the clinical trial, and the first patient was included in October 2020. EDMX01, which includes 20 patients, is aimed at validating EndoDrill Model X for stomach tumours by taking comparative samples from each patient with both EndoDrill Model X as well as with the leading competing fine-needle instrument (EUS-FNB). The study is being conducted at three Swedish university hospitals, and, so far, the sampling has worked well, and the patients are said to be in good health.
Then, during the first quarter of 2021, BiBBInstruments began recruiting patients for its clinical pilot study EDUX02 for validating EndoDrill Model X in suspected muscle invasive bladder cancer. This is a significant opportunity as there are no marketed products that can take deep tissue samples already at the first endoscopic examination. The pilot study is run by one university hospital and includes 10 patients. A follow-up effect study is already planned and reviewed by regulatory authorities provided that the pilot study goes according to plan.
Keeping to the schedule despite small delays
While both studies have been able to weather the most problematic effects of the pandemic, due to a problem in the production of EndoDrill Model X a few weeks ago, there was a temporary halt in the delivery of new instruments, which led to a short pause in patient recruitment. Fortunately, last week, the company was able to announce that both studies resumed after a change of supplier, which was recently approved by the Swedish Medical Products Agency. This means that both studies’ timelines remain on schedule and are planned to be completed in 2021.
BiBBInstrument’s CEO, Fredrik Lindblad, was very pleased with the work done by his team to replace the instrument supplier:
»For just over a month now, we have worked intensively to replace a critical supplier who has quality problems. Thanks to a fantastic team, we have secured new deliveries in a short time, and we can now inform our clinical partners that they can start recruiting patients again. This feels very gratifying.«
Moving forward with confidence
Overall, this means that BiBBInstruments can progress with its scheduled activities throughout the rest of this year without having to worry about supply issues, and hopefully without having to worry about pandemic-related delays.
In the Annual Report, Lindblad mentions that the company is developing an X-prototype for lung cancer. He considers this a very promising area where sampling with endobronchial ultrasound-guided fine-needle instruments (so-called EBUS-TBNA) has become the first-hand method for staging lung cancer in the last decade. The prototype, which is expected to be completed in Q2/Q3 2021, will initially be evaluated by a pulmonologist and then clinical studies can be planned.
He also mentions a plan to initiate discussions with the FDA regarding classification and market approval for EndoDrill Model X in the US, as well as a plan to submit an MDR application later in the year.
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