After performing 15,000 biopsies (collection of tissue samples from organs), Lund professor Bruno Walther, one of Sweden’s most experienced surgeons in cancers of the oesophagus and stomach, had thought a lot about how very difficult it is to provide an early and reliable diagnosis for tumour changes growing deep within the body. It was obvious to Professor Walther and his colleagues around the world that the available instruments did not solve the problem, and that too many patients therefore bounced back and forth within the healthcare system without a clear diagnosis.
“Why not use a drilling function to be able to access deep tumour tissue?”
Ultimately, it was not Professor Walther who came up with a potential solution to the problem, but rather this son, Dr Charles Walther. Charles, cancer researcher at Lund University and senior physician in clinical pathology in Lund, viewed insufficient biopsy samples through his microscope on a daily basis. After several years of work with the problem of insufficient samples, both clinically and in his research, Charles got the idea for a drill instrument, the EndoDrill®, while out on a jog. “Why not use a drilling function to be able to access deep tumour tissue,” thought Charles. In 2012, Charles had filed to patent the idea and was a winner on the TV4 show “Uppfinnarna” [The Inventors], enabling the formation of BiBBInstruments AB in 2013.
Since then, BiBBInstruments developed and clinically validated the endoscopy instrument EndoDrill® GI Upper, with functionality that results in better tissue samples of submucosal (deep) tumours. The instrument was launched on the Swedish market in August 2017 and is the first instrument in a planned product family, EndoDrill®. Another instrument, EndoDrill® GI Upper Mini, for small and difficult-to-reach tumours in the upper GI tract was launched in May 2018. 2019 will see the launch of EndoDrill® Core Needle, a core needle instrument for diagnosing cancer forms such as breast and prostate. In 2020, commercialisation of the versatile EndoDrill® Model X for tissue sampling of tumours in the lungs and upper and lower gastrointestinal tract is planned.
- Charles Walther’s idea for a new biopsy instrument with a drilling-motion is finalized
- The first patent application is submitted for EndoDrill®
- Winner of TV4’s “The Inventors”
- BiBBInstruments AB is founded
- Awarded a grant of SEK 2 million from Vinnova
- CE-marking of reusable instruments
- Production of reusable instruments from ISO-certified manufacturers
- Start of a randomized clinical study at Skåne University Hospital in Lund
- PwC’s Innovation Award 2014 (Silver)
- Submission of second patent family
- Contribution of SEK 2.2 million from the Kamprad Family Foundation
- Randomized clinical trial comprising ten patients concluded (Proof of Concept)
- Positive FTO Analysis (Freedom To Operate, limited analysis)
- Registration of the EndoDrill® trademark in Sweden
- The company is awarded SuperStartup of the year-2016 by Veckans Affärer/ALMI
- Randomized clinical study published in Surgical Innovation
- Patent approved in China
- Audit for ISO 13485 certificate performed by notified body
- Fredrik Lindblad takes over as CEO
- First purchase order for the EndoDrill® GI Upper in Sweden
- The first series of commercial sterile disposable instruments manufactured
- The company receives SEK 4.6 million through a directed new share issue
- EndoDrill® GI Upper used in +60 patients
- Three ongoing academic studies with EndoDrill® GI Upper
- The disposable instrument EndoDrill® GI Upper is CE-marked
- BiBB’s Quality Management System is certified according to EN ISO 13485: 2012.
- Training of 15 hospitals in Sweden and several verified customer orders
- First deliveries of EndoDrill® GI Upper in Sweden
- The company is listed on AktieTorget
- Secures SEK 13 million in a heavily oversubscribed public offer
- First patent family approved in Europe
- Reinforcement of the sales department
- Two granted design patents for the EndoDrill® Core Needle in Europe
- Project grant from EU HORIZON Phase of SEK 0.5 million for preliminary study of EndoDrill® Model X.
- Launch of EndoDrill® GI Upper Mini in May
- Patent granted in China in August (“The handle”)
- Patent application submitted for EndoDrill® Model X
- EndoDrill® Core Needle approved for CE marking in October
- EndoDrill® approved for CE marking of extended indication (lower GI and lung)
- BiBB issues a rights issue of approximately SEK 20 million
- In February, BiBB initiates an evaluation of the EndoDrill® Core Needle in clinical use at three university hospitals in Sweden.