Current endoscopic ultrasound (EUS) procedures for tissue sampling, which aim to identify and diagnose tumors in hard-to-reach areas, can result in tissue fragmentation and blood contamination. This leads to unsatisfactory detection rates, increased healthcare costs, and may contribute to late diagnoses leading to delayed treatment initiation for affected patients.
BiBBInstruments (BiBB) is behind the world's first electrically powered endoscopic core biopsy instrument, EndoDrill. The device, which is tailored for EUS-guided tissue sampling, has received FDA 510(k) clearance in the US and CE marking in Europe, and is currently undergoing clinical evaluations in both the US and Scandinavia. Read more here.
Successful clinical evaluations
Earlier this year, BiBBInstruments announced that it had successfully performed the first clinical procedures with one of three EndoDrill variants, EndoDrill GI, developed for the gastrointestinal (GI) tract in the USA at UC Davis Health. Dr. Antonio Mendoza Ladd, who led the evaluations, praised the device as a “game changer” for its ability to lead to more accurate cancer diagnoses and thereby improve patient treatment outcomes.
A clinical evaluation was initiated in Scandinavia during the spring. BiBB's tour has taken the team to Haukeland University Hospital in Bergen, Norway, and to Swedish University Hospital in Stockholm (Karolinska), Örebro and Linköping. The instrument has been rigorously tested in varied and challenging gastrointestinal tumors involving, among others, the pancreas, lymph nodes, submucosal tumors (SEL) and the abdominal wall. EndoDrill GI has been consistently described as a user-friendly biopsy instrument that safely takes high-quality core tissue biopsies.
In a recent comment to BioStock, BiBB's CEO expressed Fredrik Lindblad strong confidence in EndoDrill's commercial potential following the encouraging clinical results.
– I must say that the recent patient cases strengthen our confidence in the EndoDrill technology. It has been a fantastic experience to follow the doctors and staff in the endoscopy room together with our founder Dr. Charles Walther"Personally, it has been rewarding to be close to doctors using EndoDrill GI for the first time and to hear positive exclamations as a "game changer" when they take unusually large biopsy samples," says Lindblad.
The evaluations will continue at the above-mentioned hospitals as well as additional centers interested in testing the BiBB biopsy system.
Editorial recognition speaks to EndoDrill's potential
In an article titled Echoendoscopy: past, present and future of a trip to inner space, published in the South American Medical Journal Revista de Gastroenterología del Peru, Dr. Mendoza Ladd highlights the transformative process of endoscopic ultrasound over the past few decades. The article highlights EndoDrill’s potential to address the common problem of insufficient tissue samples in pathology, positioning it as a significant advance in EUS technology: “without sufficient tissue, there is no clear diagnosis: tissue is the issue.”
“It is gratifying that EndoDrill is being recognized as a promising new EUS instrument in an article describing the future of endoscopic ultrasound. Moreover, by an endoscopist who has recently tested the product clinically,” says BiBB founder and CMO Dr. Charles Walther.
Positive trend for BiBB
BiBB has had an active flow of positive news in recent months, with increasing interest in EndoDrill from the medical community. In addition to the successful clinical evaluations, EndoDrill was mentioned as a “New Kid on the Block” on ESGE Days congress in Berlin on April 25–27. Read more about this here.
In addition, BiBB's shareholders continue to strongly believe in the company's technology – a recent directed new issue which provided the company with SEK 10 million. This will help finance ongoing and future clinical evaluations and prepare for the planned launch of EndoDrill GI later this year.
In response to the positive news flow, the share price has increased twofold since the news of the first successful clinical evaluations in the US in February. Read more about the latest events in the company here.