BioPhotas, Inc. has received the US Food and Drug Administration (FDA) Over-The-Counter (OTC) clearances for its proprietary biophotonic medical device, Celluma.
The Celluma had been previously cleared for six separate Indications-For-Use on a Prescription basis, including the treatment of acne, muscle and joint pain, muscle and joint stiffness, muscle spasm, arthritis and compromised local blood circulation.
Following the Celluma’s 2013 clearance by the FDA as a prescription device, thousands of Celluma treatments have been administered by state licensed practitioners across the country. The FDA has now cleared the Celluma for the same Indications-For-Use for sales directly to consumers, as well as by medical and wellness professionals.
Commenting on the FDA clearances, Patrick Johnson, president & chief executive officer for BioPhotas said, “Receiving OTC clearances from the FDA for the Celluma is just the next step on a long-term regulatory roadmap for BioPhotas. In addition to the OTC clearance of the Celluma, we currently have a 510(k) application in with the FDA pursuing two additional dermatological indications-for-use in the area of skin rejuvenation. BioPhotas is also funding research at the Beckman Laser Institute at the University of California, Irvine, investigating the use of the Celluma in accelerating wound healing and comparing the device’s effectiveness to Class IV cold lasers.”
Researchers from the Beckman Laser Institute will be presenting their preliminary findings from this research in San Francisco at the annual meeting of the Society of Photo-Optical Instrumentation Engineers next month.
Specifically, the Beckman research demonstrates that Celluma-stimulated wound healing performs as well as clinical lasers and that a combination of the Low-Level Light Therapy plus a propriety pharmacological therapy for wound healing developed at the University of California, Irvine and San Diego campuses, significantly outperforms either treatment modality alone. BioPhotas has just secured exclusive negotiation rights to commercialize this proprietary therapy for wound healing, an area of rapid growth in healthcare.
Continuing, Johnson said, “When we began to develop the Celluma, we ultimately saw it as an affordable and effective device for accelerating wound healing. We are encouraged by the initial findings of the Beckman Laser Institute and understand that there is still considerable work required to commercialize a combined drug/device therapy using the Celluma. In the meantime, we are confident that with its current and pending FDA clearance, the Celluma will give consumers and medical professionals affordable access to a powerful clinical technology that could otherwise cost 5 to 20 times more, particularly when compared to cold lasers used to treat the same conditions.”
BioPhotas, Inc. is a medical device company that was established to offer a new approach to biophotonic therapy for medical providers and consumers.