In the very near future, clinicians injecting dermal fillers on the face will have the benefit of a guided “smart” needle that senses blood vessels, thereby dramatically reducing the risk of adverse events such as necrosis and blindness.
That is the goal of an experienced team composed of leading clinicians, academics, and researchers developing S3 Inject, a first-in-class safety innovation that has entered human trials.
“When physicians inject the fillers, they hope experience and technique will enable them to avoid adverse events,” Irina Erenburg, PhD, said during the virtual annual Masters of Aesthetics Symposium. “If they inadvertently hit a blood vessel, the filler can actually occlude that vessel and cause either an infarct of the skin or, in certain serious cases, blindness. This is a challenging adverse event that every injector is focused on avoiding. While hyaluronidase is used as a rescue [medication] in certain cases, the risk is real,” she added.
Vision abnormalities, including blindness, and necrosis are among the adverse events associated with dermal fillers that have been reported to the Food and Drug Administration.
S3 Inject is a sensing needle that can differentiate tissues such as fat, blood vessels, and muscle. Its proprietary algorithms provide immediate feedback via a micro LED light embedded in the needle hub.
Results from recent human trials demonstrate that, as the needle tip passes through different biological tissues and fluids, “it senses changes in specific electrical properties and with that information sends a very precise signal to the needle hub,” said Dr. Erenburg, CEO and President of Waltham, Mass.–based Blossom Innovations, a company focused on developing early stage medical devices in dermatology. “With that information, the physician can make real-time treatment decisions.”
Currently, in order to determine if the needle is in a blood vessel, physicians pull back on the syringe and look for a flash of blood. “In speaking with physicians, the pull back technique has limitations, in part, because filler in the syringe can limit easy pull back to check the presence of a blood vessel,” she said. “Our needles provide an immediate response for a safer injection.”
Blossom Innovations has developed a proprietary manufacturing process that will initially target 27 gauge needles, but over time it plans to introduce multiple sizes, as well as cannulas.
“The physicians in our industry are committed to patient safety and they’re looking for better outcomes with a solution that does not impact their technique,” said Dr. Erenburg, who founded Blossom Innovations along with R. Rox Anderson, MD, director of the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston; Dieter Manstein, MD, PhD, also at Massachusetts General Hospital; and Henry H.L. Chan, MD, PhD, of the Hong Kong Dermatology and Laser Center.
During market research for S3 Inject, which was conducted with 15 leading injectors, thought leaders, and trend makers, the country’s leading injectors expressed strong interest in “solutions that allow them to provide additional safety for their patients and provide personal reassurance to the physician,” she said. “They definitely would want to train all their physicians and injectors on its use.”
As clinical testing continues, the company is preparing to submit data to the FDA’s Premarket Notification program, known as the 510(k) process. “Our intent is to create a scale-up manufacturing over the course of the coming year in time for our clearance, with a planned launch at the end of 2021,” Dr. Erenburg said. “Based on our clinical research and physician discussions, we are confident that S3 Inject is a breakthrough safety technology which will drive a better outcome for patients.”
