Enrollment initiated for Phase I-II study at UCSD, Stanford and Harvard
MADISON, Wis.–(BUSINESS WIRE)–OnLume Inc., a Madison, Wisconsin-based medical imaging company with unique technology for improving surgical precision in the operating room, has announced the start of participation in a clinical trial combining its fluorescence-guided surgery (FGS) imaging device with a novel nerve-targeting agent.
OnLume has unique FGS imaging technology to illuminate critical anatomy in real time during surgery to optimize surgical precision, which can lead to improved patient outcomes, reduced morbidity and reduced costs.
This Phase I-II study relates to the Investigational New Drug (IND) application for the use of ALM-488 in head and neck surgery. ALM-488 was developed by Alume Biosciences Inc. and is an intravenously administered peptide-dye conjugate for fluorescence highlighting of nerves during surgery. The IND was approved by the US FDA Division of Medical Imaging and Radiation Medicine (DMIRM), which is responsible for drug products used in the image-based diagnosis and monitoring of diseases (Clinicaltrials.gov: NCT04420689).
The study will proceed at three sites, including the University of California at San Diego (UCSD), Stanford Medical Center and Harvard-Massachusetts Eye & Ear.
Alume Bioscience’s CEO and founder Quyen Nguyen, MD/PhD, stated, “As surgeons, we rely on our experience to identify nerves, but often they are buried or appear indistinguishable from adjacent non-nerve tissue. This study aims to demonstrate improvement of surgical precision by making nerves ‘glow’ with fluorescence. We are pleased to incorporate OnLume’s advanced fluorescence visualization technology into this clinical trial.”
OnLume’s CTO & Co-founder Adam Uselmann stated, “We are excited to work with Dr. (Read more…) Quyen Nguyen’s team on this groundbreaking clinical trial that may help to significantly reduce or prevent nerve injuries during surgery.”
About OnLume Inc.: OnLume recently received its first FDA clearance to bring its fluorescence-guided surgery imaging system to market. The technology is cleared for fluorescence imaging of blood flow and tissue perfusion before, during, and after vascular, gastrointestinal, organ transplant, plastic, reconstructive and microsurgeries. OnLume is expanding clinical indications of its imaging platform to help identify critical anatomy in real time during surgery that is otherwise invisible to surgeons.
Contacts
OnLume Contact Information:
James A. Bowman
Chief Executive Officer
jim.bowman@onlume.com
http://www.onlume.com/