First US clinical cases successfully conducted with EndoDrill GI
The cancer diagnostics company BiBBInstruments AB ("BiBB" or the "Company"), the developer of the world's first market-cleared motorized endoscopic core biopsy instrument, announces that the first US clinical procedures with EndoDrill® GI have successfully been performed by Dr Antonio Mendoza Ladd and his team at UC Davis Health, Sacramento, California. BiBB received 510(k) clearance from the US FDA for EndoDrill® GI in 2023 and clinical marketing activities will continue in the US.
BiBB’s CEO Fredrik Lindblad and founder Dr Charles Walther were present when Dr Antonio Mendoza Ladd, Medical Director of Endoscopy at UC Davis Health in Sacramento, CA, successfully performed tissue sampling on several patients in the upper GI tract with EndoDrill® GI, the world’s first endoscopic ultrasound-guided core needle biopsy (EUS-CNB) system. True core tissue samples were acquired that resembled the sample quality in the previous successful Swedish pilot study.
Dr Mendoza Ladd’s provided the following feedback: “I was very pleasantly impressed by the performance of the EndoDrill® needle. The design makes it simple to set up and easy to use. The tissue cores we obtained from our initial cases were unparalleled. We even had our pathology department ask us if the biopsy was an endoscopic FNA or a true surgical biopsy due to the unusually large amount of tissue that was submitted. This device will be a game changer in my opinion.”
Dr Mendoza Ladd and his team will continue to use EndoDrill® GI in various GI indications with possible case publications during the year.
"It was very encouraging to closely observe Dr. Mendoza Ladd and his team perform the first patient cases in the US. We have designed EndoDrill® to obtain true histological core biopsies, and we have on-site experienced a very promising start in the US, the world's largest market for EUS instruments.This is a significant milestone in our quest for better biopsies and improved diagnostics", says Dr Charles Walther, CMO and Founder of BiBB.
This is a translation of the Swedish press release. If there should be any discrepancies, the Swedish language version prevails.
For more information about BiBB, please contact:
Fredrik Lindblad, CEO
E-mail: fredrik.lindblad@bibbinstruments.com
Phone: +46 70 899 94 86
www.bibbinstruments.com
This disclosure contains information that BiBBInstruments AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on Feb 2, 2024
About BiBB
The cancer diagnostics company BiBBInstruments AB develops and manufactures EndoDrill®, a patented product series of electric-driven endoscopic biopsy instruments. The EndoDrill® instruments take high-quality tissue samples with high precision with the goal of improving the diagnosis of several serious cancers, e.g., in the stomach, pancreas, liver, lung, and bladder. The product portfolio targets the global market for endoscopic ultrasound guided (EUS/EBUS) biopsy instruments, which is the most advanced and fast-growing area of endoscopy. In 2023, EndoDrill® GI, BiBB's most important product variant, received market clearance from the US FDA as the first electric biopsy instrument for endoscopy in the US. The EndoDrill® system includes sterile disposable needle biopsy instruments with associated drive system (reusable part). The company was founded in 2013 by Dr Charles Walther, cancer researcher at Lund University and chief physician in clinical pathology at Skåne University Hospital in Lund. BiBBInstruments is based at Medicon Village in Lund and BiBBInstrument's share (Ticker: BIBB) is listed on Spotlight Stock Market.