GreenMark Biomedical has secured regulatory clearance from the US Food and Drug Administration (FDA) to market its LumiCare Caries Detection Rinse as a 510(k) Class II Medical Device. GreenMark plans to commence sales of the product this fall.
“Gaining FDA clearance for our LumiCare device at this particular time is especially gratifying given the significant pandemic challenges of the last year. I need to acknowledge the efforts of the entire GreenMark team and our regulatory partners,” said Dr. Steven Bloembergen, PhD, GreenMark’s founder, chairman, and CEO.
Dental caries, the world’s most prevalent chronic disease, affects more than 95% of Americans over their lifetimes and, when left untreated, can lead to dental caries, the company said.
LumiCare enhances visualization of carious lesions, cavities and pre-cavities, by targeting and illuminating subsurface porosities in enamel, aiding in the detection of caries, GreenMark Biomedical said. The technology uses bioresorbable starch-based nanoparticles that degrade due to enzymes in saliva by the time the patient is ready to leave the dental office
Validation studies have been performed on a range of caries severity, including cavitated as well as early, non-cavitated lesions, GreenMark Biomedical said.
“Since 2015, we’ve worked alongside our research partners at the University of Michigan to realize our vision of detecting the early stages of caries and repairing teeth non-invasively,” said Dr. Nathan Jones, MSc, PhD, co-inventor and vice president of technology at GreenMark Biomedical.
Identifying lesions early creates an opportunity to avoid invasive treatment options required once a cavity has formed, the company said.
“While detecting and treating caries noninvasively with this breakthrough nanotechnology sounds like science fiction, the reality is that integration into dental practices is just around the corner,” said Lou Shuman, DMD, CEO of Cellerant Consulting Group, which named LumiCare rinse a 2020 Best of Class winner in the Emerging Technology category of its Best of Class Technology Awards.
Prior to launch, GreenMark Biomedical said it will scale its manufacturing and solidify its distribution channels.
“Our company’s passion for creating new products that benefit dental professionals and their patients takes another step forward as we approach commercial availability of our LumiCare product,” said Adam Laird, director of business development.
GreenMark Biomedical said it will continue to sponsor research studies with leading clinicians and academicians on LumiCare, as well as other applications of its nanotechnology platform for noninvasive and preventive dental treatment.
“Our company aims to help advance the standard of care in the management of dental caries through contemporary scientific understanding of this disease,” said Wendy Bloembergen, MD, vice president of clinical affairs. “We recognize the impact that early stage caries detection combined with minimally invasive preventative treatment can have for dental practices and their patients.”
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