for fluorescence guided surgical and interventional oncology
a fluorescence imaging system for open surgical procedures
imaging systems and imaging agents are in the development pipeline
is part of the Bracco Group since October 2017
The Global Challenge Currently, the identification of tumours during surgery or interventional endoscopy relies on visual inspection and palpation. As tumour tissue is sometimes difficult to distinguish from healthy tissue surgical resection of tumour is incomplete in up to 40% of procedures1. This has medical as well as financial implications, impairing patient treatment outcomes.
Our Response A development pipeline combining highly sensitive imaging systems with tumour targeted imaging agents to visualize tumours during surgical or interventional procedures in real-time, enabling a more sensitive and accurate detection of the tumour1.
Fluorescence Guided Surgical Oncology
The imaging agent BEVA800TM labels cancer lesions during laparotomy in patients diagnosed with peritoneal carcinomatosis of colorectal origin employing the EXPLORER AIR prototype (Harlaar et al. (2016) Lancet Gastroenterol. 1:283-90).
Disclaimer: BEVA800TM is under investigational use and not commercially available.
Fluorescence Guided Interventional Oncology
The imaging agent BEVA800TM labels cancer lesions in patients diagnosed with Barrett’s Esophagus employing the EXPLORER FLUOSCOPE prototype (Nagengast et al. (2019) Gut 86:7-10).
Disclaimer: BEVA800TM and EXPLORER FLUOSCOPE are under investigational use and not commercially available
1 Lamberts et al. (2016) Clin. Cancer Res.; Koller et al. (2018) Nat. Comm.; Harlaar et al. (2016) Lancet Hepatol.; Nagengast et al. (2017) Gut; Tjalma et al. (2020) Gut; Hartmans et al. (2018) Theranostics
The EXPLORER AIR® II is an intra-operative imaging system to visualize fluorescence in the near infra-red range in vivo. It has been designed to combine highest sensitivity with reliable imaging fidelity and convenience of use.
The system allows real-time imaging during surgery and its prototype has been tested by academic centres in a variety of indications 2.
The US FDA has cleared the EXPLORER AIR® II for ICG based perfusion imaging. Submission for clearance in conjunction with pafolacianine in July 2022.
2 Lamberts et al. (2016); Koller et al. (2018) Nat. Comm.; Harlaar et al. (2016) Lancet Hepatol.
SurgVision develops a complete portfolio based on its proprietary high-performance technology to address the needs of next generation oncological intra-operative imaging.
Ovarian cancer, head & neck cancer, breast cancer, perfusion imaging, and others.
510(k) clearance for ICG based perfusion imaging, CE expected Q3/2022
Barrett's Esophagus, colorectal cancer, gastric cancer and others.
Lung cancer, prostate cancer, colorectal cancer and others.
First generation in 2023
Second generation in 2026
Barrett's Esophagus, esophageal cancer, gastric cancer.
Observing things under the right light, makes them clearer
First in human testing NIR imaging device in surgical oncology1
1 Van Dam et al. (2011) Nat. Med.
Foundation of SurgVision B.V.. Between 2013 and 2019: Clinical utility of the technology demonstrated in 6 clinical trials with > 160 pt in different open surgical and endoscopic settings2
2 Lamberts and al. (2016); Koller et al. (2018) Nat. Comm.; Harlaar et al. (2016) Lancet Hepatol.; Nagengast et al. (2017) Gut; Tjalma et al. (2020) Gut; Hartmans et al. (2018) Theranostics.
Comparison of Explorer Air prototype with other NIR imaging devices confirms outstanding performance 3
3 Dsouza et al. (2016) J. Biomed Opt.
Acquisition by Bracco
Start development of EXPLORER AIR® II
Conceptual design of Explorer Laparoscope
ISO 13485 / MDR compliance audit by notified body
EXPLORER AIR® II: 510(k) submission and CE class IIa request under MDR.
Explorer Endoscopo prototype: EMC testing passed
EXPLORER AIR® II: US 510(k) clearance for ICG based perfusion imaging
EXPLORER AIR® II: US 510(k) submission for expanded indication of use with pafolacianine