BiBBInstruments has developed EndoDrill, a next-generation powered biopsy instrument that enables high-quality tissue samples during ultrasound-guided endoscopy (EUS/EBUS). With today's manually operated biopsy instruments, endoscopists obtain tissue samples through repeated, forceful, needle punctures – a method that can result in samples of inadequate quality.
EndoDrill instead uses an electrically powered rotating drill cylinder that delivers continuous samples with high precision. Better samples provide better diagnostics, which in turn should lead to better care. There is a clear and growing need for high-quality biopsy samples at EUS/EBUS for complete diagnostics, molecular profiling, fewer re-samplings and more accurate staging. The instrument is available in three variants: EndoDrill GI for the gastrointestinal tract, EndoDrill EBUS for lung diagnostics and EndoDrill URO for bladder cancer. The most advanced development has been achieved with the flagship product EndoDrill GI, which is FDA-approved and CE-marked according to the MDR.
Impressive results in product evaluations and clinical studies
The focus over the past year has been on getting clinics around the world to test the new product. New technology can be both exciting and promising, but commercial success requires buy-in from users – and that is exactly what BiBB has received. Reports of successful clinical introductions have followed one another, with a clear consensus: EndoDrill GI is easy to use and delivers high-quality core biopsies.
In a clinical case study conducted by Dr. Antonio Mendoza Ladd vid UC Davis Health in Sacramento, California, achieved 100 percent diagnostic accuracy. This means that high-quality core biopsies were obtained after a single needle puncture in all samples – which is very unusual for this type of diagnosis (national guidelines recommend two to five punctures).
In mid-March, EndoDrill GI showed its forefoot again – this time at a live patient case in conjunction with the annual meeting of the Portuguese Society of Gastrointestinal Endoscopy. Performing a live sampling can be seen as the ultimate test for a new medical device and EndoDrill passed the task with flying colors. Shortly thereafter, a retrospective multicenter study of 28 patients at five university hospitals in Europe and the United States was presented, in which the co-authors concluded that EndoDrill GI is both safe and effective.
First sale and strategic partnership
Successful evaluations led to BiBBInstruments receiving its first paying customer in UC Davis Health, Sacramento, California, at the end of January. A smaller, symbolic order, admittedly, but it is made at premium pricing and the signaling value is clear: the company is now officially in the commercialization phase.
A further step into that phase was taken with the signing of a declaration of intent (Letter of Intent) with TaeWoong Medical USA, which lays the foundation for a distribution partnership for EndoDrill GI in the US. The partnership was recently initiated during Digestive Disease Week (DDW) in San Diego, the world's largest GI congress, where BiBB and TaeWoong jointly demonstrated the product to potential customers.
The summer will be dedicated to training and the parties then plan a targeted launch in selected hospitals in the fall of 2025, followed by a broader national launch in 2026. BiBB was recently able to announce, very timely, that EndoDrill GI has received a Notice of Allowance from the US Patent and Trademark Office, which means that the technology is protected in the US market until 2039.
As for Europe, there are advanced discussions about partnerships here as well, but the focus will primarily be on getting off to a good start in the US. CEO Fredrik Lindblad estimates that the launch on the European market could begin in early 2026.
Warrant strengthens finances ahead of commercialization
To finance the continued commercialization and production scale-up, BiBB conducted a rights issue in January that raised SEK 27,6 million before issue costs. In connection with this, a new strategic life science investor entered the company, Danish Life Science Invest Fund 1. The reason for the entry is clear:
- We believe that the EndoDrill system has the potential to become the new standard instrument for taking biopsies within its field, replacing the needle stabbing method used today.
The issue also included warrants of series TO1 whose exercise period runs until June 5. If fully exercised, the option could provide up to SEK 9 million, which is primarily intended to be used to accelerate the launch of EndoDrill GI.
