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Beskrivning
| Land | Sverige |
|---|---|
| Lista | Spotlight |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
The cancer diagnostics company BiBBInstruments AB ("BiBB"), the developer of the world's first market-cleared electric-driven biopsy instrument for endoscopy, announces that the University Hospital Center Sestre Milosrdnice in Zagreb, Croatia, has started a clinical evaluation with EndoDrill[®] GI. This makes the hospital the first in southern Europe to test EndoDrill[®] GI. Dr. Tajana Pavic, Head of Interventional Gastroenterology Unit, performed the patient cases.
The EndoDrill[®] GI instrument provided high-quality core tissue biopsies in all four patient cases, including three solid pancreatic tumors and an enlarged lymph node in the stomach. Dr. Pavic and the team were impressed by the large and intact tissue samples obtained with the EndoDrill[®] GI, something they don't often see when using standard EUS needle biopsy. Dr. Pavic summarized the first four patient cases with: "Nice samples and a very fast procedure".
Clinical market evaluations of EndoDrill[®] GI will continue in Zagreb as well as at hospitals in the US and Scandinavia. On September 19-20, EndoDrill[®] GI will be exhibited at the 7th Nordic EUS Meeting in Copenhagen, a Nordic congress for endoscopic ultrasound specialists. Subsequently, further evaluations of EndoDrill[®] GI at new hospitals in Europe and the US are planned for the autumn. Rapid follow-up of user feedback on-site is essential during the introduction of a medical technology innovation.
About EndoDrill[®] GI
EndoDrill[®] GI is the world's first market-cleared electric-driven biopsy instrument for endoscopic ultrasound (EUS). The instrument is used for EUS-guided tissue sampling for all indications in the gastrointestinal tract, e.g. pancreas, stomach, oesophagus, lymph nodes, and liver. EndoDrill[®] GI received FDA 510(k) clearance in the US in 2023 and CE approval in Europe in early 2024. The product is being evaluated clinically in the US and Europe with a planned launch in Sweden later in 2024.
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
About BiBB
The cancer diagnostics company BiBBInstruments AB develops and manufactures EndoDrill[®], a patented product line 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, such as stomach, pancreas, liver, lung, and bladder. The product portfolio is aimed at the global market for ultrasound-guided endoscopic (EUS/EBUS) biopsy instruments, which constitute the most advanced and fast-growing area of endoscopy. BiBB received 510(k) clearance from the US FDA for the lead product EndoDrill[®] GI in 2023. At the beginning of 2024, CE marking according to MDR was also obtained for all three product variants: EndoDrill[®] GI, EndoDrill[®] EBUS and EndoDrill[®] URO. Thus EndoDrill[®] is the first cleared electric endoscopic biopsy system in both the US and Europe. The EndoDrill[®] system includes sterile disposable biopsy instruments with associated drive system. The company was founded in 2013 by Dr. Charles Walther, cancer researcher at Lund University and senior consultant in clinical pathology at Skåne University Hospital in Lund. BiBBInstruments is based at Medicon Village in Lund and the BiBBInstruments share (ticker: BIBB) is listed on Spotlight Stock Market.