The following is a press release submitted to SOURCE media through its business wire service. (Stock photo used with report.)
NATICK – Curadel Surgical Innovations Inc., a privately held natick company specializing in the development of near-infrared fluorescent contrast agents for image-guided surgery, thsi week announced a worldwide distribution deal with a tier one medical technology company to distribute ZW800-1 in the U.S. and EU, upon approval by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) respectively.
This news follows the Company’s announcement during the second half of 2020 of a highly prestigious $4 million National Cancer Institute Small Business Innovation Research (SBIR) Phase 2B Bridge Award, granted for the potential widespread use of ZW800-1 in gynecological and other oncologic surgeries. ZW800-1 is an investigational contrast agent for intraoperative anatomical enhancement of the ureters expected to assist surgeons avoid inadvertent damage of these tube-like structures connecting the kidneys to the urinary bladder.
ZW800-1 is a first-in-class near-infrared fluorescent (NIR) contrast agents called zwitterionic. The investigational contrast agent, when used in conjunction with an appropriate imaging system, provides contrast by converting NIR light from a lower wavelength to a higher one, visually enhancing the anatomical structure with high sensitivity and specificity. With high brightness and renal-only clearance, a low dose of ZW800-1 has been shown in Phase 2 clinical trials to provide several hours of visualization of the ureters. Currently, intraoperative identification of the ureters during abdominal and pelvic surgeries is extremely difficult.
The company is developing additional contrast agents using the FLARE® technology platform to enhance the anatomy of malignant and non-malignant tumors, blood vessels, nerves, lymph nodes, intervertebral discs, and cartilage.
“Near-infrared fluorescent light empowers surgeons to see anatomy that would otherwise be invisible, in real-time,” said John V. Frangioni, M.D., Ph.D., Chief Executive Office of Curadel Surgical Innovations. “ZW800-1 is only the beginning of what FLARE® can do for the surgical community.”
FLARE® Technology was invented by Dr. Frangioni while he was a professor of medicine and radiology at the Harvard Medical School. The technology is owned by Beth Israel Deaconess Medical Center, a teaching hospital of Harvard Medical School, and is licensed to CSI.
Founded in 2014, Curadel Surgical Innovations, Inc. (CSI) is a privately held company headquartered in Natick, specializing in the development, manufacture, marketing, and commercialization of contrast agents for image-guided surgery.