The case series included four patients – three with suspected liver disease and one with a suspected pancreatic tumor – who underwent endoscopic ultrasound-guided (EUS) biopsy with the EndoDrill GI. In all cases, diagnostic tissue samples were obtained, including one case where previous percutaneous sampling had been nondiagnostic. The diagnoses included autoimmune hepatitis, liver cirrhosis, and pancreatic adenocarcinoma.
The evaluation was led by Dr. Mohammed Barawi and was carried out in collaboration with his team at Henry Ford St. John HospitalDr. Barawi's team emphasized both diagnostic performance and procedural safety with BiBBinstruments EndoDrill GI in its abstract:
- The use of the EndoDrill device demonstrated strong diagnostic utility across an array of clinical presentations. Due to the clinical necessity for adequate tissue samples to establish molecular pathology, EndoDrill yielded safe and effective results in this limited sample size.
The technology enables core biopsies
EndoDrill GI is the world's first FDA-cleared endoscopic ultrasound biopsy instrument. Unlike conventional manual needles, it is equipped with a motor that rotates the needle, allowing the collection of intact tissue samples, known as core biopsies. This improves histological yield and enables molecular analysis, which is essential for accurate diagnosis and treatment decisions.
EndoDrill GI received 510(k) clearance in the US in 2023 and CE marking in Europe in 2024. It has been clinically introduced in more than ten hospitals in the US and Europe.
US launch planned
Henry Ford St. John Hospital is the second U.S. center to evaluate EndoDrill GI, following initial clinical use at UC Davis Health in California. The evaluation at Henry Ford highlighted both the diagnostic performance and procedural safety of the instrument. BiBBInstruments is now preparing a US launch in collaboration with TaeWoong Medical USA, which has an exclusive distribution agreement. The first commercial deliveries are expected to take place later in 2025.
Comments from the CEO
CEO of BiBBInstruments Fredrik Lindblad sees the result as an important success ahead of the company's upcoming launch in the US. We contacted Fredrik for comment.
How do you assess the significance of the results from Henry Ford St. John Hospital for the upcoming US launch?
– We came into contact with Henry Ford St. John Hospital through TaeWoong, who counts the hospital as an important reference customer. A successful clinical case series is a promising start to our collaboration ahead of the upcoming launch.
Can you comment on how the instruments have been received so far?
– I think the abstract presentation from Dr. Barawi’s team clearly demonstrates their initial clinical experience with our instrument. They report that EndoDrill GI obtains tissue samples safely and effectively in this small series. In their closing remarks, they describe "[EndoDrill GI] as a new and exciting device in our endoscopy toolbox.”
How are you working to increase awareness and use of your biopsy products among American physicians?
– In the US, the marketing of EndoDrill GI will be led by our partner, TaeWoong Medical USA, with strong support from the BiBB team. During the fall, we will launch a series of initiatives to increase awareness of the brand, including through participation in congresses, concrete product demonstrations, national webinars and targeted campaigns in digital and social media.
What are the biggest commercial opportunities for EndoDrill GI in the coming years?
– The US, the world’s largest market for endoscopic ultrasound equipment, represents the primary commercial opportunity for EndoDrill GI. Initially, EndoDrill GI is expected to be used for select high-value cases, but its superior diagnostic yield and ease of use could eventually make the instrument the preferred choice for an increasing proportion of procedures.
What are the plans for further clinical activities in both the US and Europe?
Our short-term priority is the US. There, we will initially support on-site product demonstrations, including patient cases, in collaboration with TaeWoong reference customers. In parallel, we are in discussions with leading clinical centers on new studies designed to strengthen our evidence base. Details will be announced at a later stage, but these activities are expected to further validate EndoDrill GI and support broader use.
See also a interview with BiBBInstruments founder and CMO, Dr. Charles Walther, who has visited clinics around the world where EndoDrill GI is undergoing evaluation. In the interview, the inventor of the EndoDrill technology discusses the reception from the medical community, what it feels like to see the technology perform in practice, and what lies ahead.
The content of BioStock's news and analysis is independent, but BioStock's operations are to some extent financed by companies in the industry. This post refers to a company from which BioStock has received funding.