Indocyanine Green

MINNEAPOLIS--( BUSINESS WIRE )-- Vergent Bioscience , a clinical-stage biotechnology company developing tumor-targeted imaging agents, announced that data published in The Annals of Thoracic Surgery reinforce the clinical potential of VGT-309, the company’s investigational intraoperative molecular imaging (IMI) agent, to help surgeons see difficult-to-find and previously undetected tumors in the lung during surgery. The findings support previous clinical trial results suggesting that VGT-309 could help ensure all tumor tissue is removed during minimally invasive and robotic-assisted surgical procedures. “The expanded use of minimally invasive surgery, including robotic-assisted technologies, for lung cancer has created a significant and growing need for better visualization during these surgeries, which can be curative when lung cancer is diagnosed early enough and all tumor tissue is removed,” said John Santini, Ph.D., president and chief executive officer at Vergent Bioscience. “We are pleased that data from our clinical program continue to suggest VGT-309 may help overcome existing challenges to tumor visualization and thereby optimize surgical outcomes for physicians and patients.” The Phase 2* efficacy study evaluated the frequency that IMI with VGT-309 improved surgical outcomes in 40 individuals with suspected or proven cancer in the lung who were eligible for surgery. The primary efficacy endpoint was the proportion of patients with at least one clinically significant event. Clinically significant events were defined as localization of lesions not found by standard surgical techniques, identification of synchronous and occult cancers, and identification of inadequate surgical margin. Each patient in the study received VGT-309 preoperatively through intravenous infusion. Following an attempt to localize the target lesion using standard surgical techniques, investigators used a commercially available near infrared (NIR) endoscope to visualize the lesion, which was then assessed by pathology. Of the 40 participants administered VGT-309 who underwent the standard-of-care surgical resection for suspected lung cancer, 17 (42.5%) had at least one clinically significant event. VGT-309 with NIR fluorescence imaging visualized a range of primary and metastatic tumor types intraoperatively, including adenocarcinoma in situ, invasive adenocarcinoma, lymphoma, colorectal cancer, neuroendocrine tumors, sarcomas, and squamous cell carcinoma. VGT-309 appeared safe and well tolerated in this study, with no infusion reactions and no drug-related serious adverse events. “While the prevalence of minimally invasive surgery has increased over the years, these surgical approaches require surgeons to work in a small area with a restricted view and limited tactile clues, increasing the possibility that tumor tissue will be difficult to locate or even missed,” said study investigator and senior author Sunil Singhal, M.D., chief of the Division of Thoracic Surgery in the Perelman School of Medicine at University of Pennsylvania. “The study findings published today in The Annals of Thoracic Surgery add to the growing body of evidence suggesting that VGT-309 has the potential to provide meaningful benefit to both surgeons and cancer patients during minimally invasive surgery.” To further evaluate the efficacy of VGT-309, Vergent is currently conducting the Phase 2 multicenter VISUALIZE study ( NCT06145048) . Investigators at six sites in the United States and Australia plan to enroll 100 patients in this Phase 2 study, which Vergent expects to complete by the end of 2024. *This clinical trial ( ClinicalTrials.gov Identifier: NCT05400226) was supported by the National Cancer Institute of the National Institutes of Health under award number R44CA277890. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. About VGT-309 VGT-309 is a tumor-targeted fluorescent imaging agent designed to enable a complete solution for optimal tumor visualization during open, minimally invasive and robotic-assisted surgical procedures. VGT-309 is delivered to patients via a short intravenous infusion several hours before surgery. Invented in Professor Matt Bogyo’s Lab at Stanford University School of Medicine, the molecule binds tightly (i.e., covalently) to cathepsins, a family of proteases that are overexpressed across a broad range of solid tumors. This approach, if successful, provides distinct clinical advantages and positions VGT-309 as an ideal tumor imaging agent. VGT-309’s imaging component is the near infrared (NIR) dye indocyanine green (ICG), which is compatible with all commercially available NIR intraoperative imaging systems that support MIS technologies and is a preferred dye to minimize confounding background autofluorescence. About Vergent Bioscience, Inc. Vergent Bioscience is a clinical-stage biotechnology company that is helping surgeons realize the full potential of minimally invasive and robotic-assisted surgery by improving the visibility of tumors. Vergent’s lead compound, VGT-309, is a tumor-targeted fluorescent imaging agent designed to enable surgeons to see difficult-to-find or previously undetected tumors in real-time during surgery, so that they can ensure all tumor tissue is removed. The company is first evaluating VGT-309 for cancer in the lung, with the potential to expand its application to a wide range of solid tumors. Vergent Bioscience is a privately held company based in Minneapolis, MN.

CMR Surgical's vLimeLite system will first be installed at Gloucestershire Royal Hospitals NHS Trust in the U.K. for use in upper gastrointestinal surgery procedures. CMR Surgical is launching a new imaging technology to help users of its Versius robot visualize the flow of blood through organs during a procedure. The company’s vLimeLite add-on incorporates a near-infrared fluorescent light that reacts with the injectable medical dye indocyanine green, known as ICG. The CE-marked system aims to highlight blood vessels and tissue perfusion beyond the naked eye, as well as the body’s bile duct anatomy. “This is the most significant update of Versius since it launched back in 2019,” CEO Supratim Bose said in the company’s announcement. “We have listened to the needs of surgeons, and I’m delighted that we have been able to give them what they want—a best-in-class ICG product that we know will make a real difference for their patients.” The system will first be installed at Gloucestershire Royal Hospitals NHS Trust in the U.K. for use in upper gastrointestinal surgery procedures. CMR said it plans to roll out vLimeLite first in the U.K., Ireland and Hong Kong before obtaining additional regulatory approvals and expanding globally over the course of this year. vLimeLite will launch with video overlays that integrate with Versius’ 3D vision and will allow the surgeon to toggle between green, cyan and grayscale ICG viewing modes. “I think what is really special is the overlay mode option, which means Versius surgeons will be able to use our integrated ICG system while continuing to view in full color with the same video quality,” said Mark Slack, CMR co-founder and chief medical officer. “vLimeLite truly allows surgeons to see what was once invisible to them.” In January, CMR reported what it described as its strongest quarter on record, in terms of system placements and procedures performed. Over the course of the full 12 months of 2023, the company said its install base grew 50% over 2022’s tally, with surgery counts growing more than 60% to a total of more than 17,000 since Versius’ launch. The numbers follow expansions in Europe, Asia, the Middle East, Africa and Latin America. The company also said it plans to launch new instrumentation options and digital software for Versius in 2024. Late last year, CMR opened a new manufacturing facility near its home in Cambridge, U.K., that it says has the capacity to produce up to 500 Versius systems per year.