BioPhotas, Inc. announced the FDA clearance of the Celluma, its award-winning and patented medical device, for an additional indication-for-use in treating full face wrinkles.
The FDA has previously cleared the Celluma for eight separate indications-for-use, including the treatment of peri-orbital wrinkles, acne, muscle and joint pain, muscle and joint stiffness, muscle tissue tension, muscle spasm, arthritis and compromised local blood circulation.
Commenting on the FDA clearance, Patrick Johnson, President & Chief Executive Officer for BioPhotas said, “The Celluma has really created a new category of Low-Level Light Therapy devices. It combines the power and efficacy of large professional panel devices with the affordability of small hand-held devices, in a single product that is FDA-cleared to treat the broadest range of muscle, joint and skin conditions on the market. In the Celluma, we have created an extraordinarily versatile product that is effective enough to be used in a professional setting and affordable enough to be used in the home.”
Based on NASA research, the Celluma Series delivers blue, red and near-infrared light energy to safely address a wide variety of musculoskeletal and dermatological conditions. Each wavelength is absorbed by different molecules which act as a signaling mechanism for different cellular processes. The Celluma’s proprietary flexible design and extra large light panel facilitates effective energy absorption by tissue and molds closely to the body for more efficient outcomes. The Celluma is now FDA-cleared to treat nine separate skin, muscle and joint conditions. In addition, the Celluma is CE-Certified as a Dermal Wound Healing device for sale in the European Union.
The Celluma series is protected by a United State utility patent. In addition, BioPhotas has recently received notification from patent authorities in the Europe Union and Australia that the Celluma has been granted utility patent coverage in those territories as well.
Commenting on these developments, Mr. Johnson continued “BioPhotas has on-going efforts to register its devices and protect those devices around the world. We are encouraged that the innovation in our products is recognized commercially, as well as by both global regulatory and intellectual property authorities.” Currently, the company has several other United States and foreign patent applications pending and has scheduled further clinical trials to prove efficacy in advanced therapeutic applications.
About BioPhotas, Inc.
In providing unique devices founded on NASA-developed technology and backed by clinical studies, BioPhotas is bringing to market safe, effective and affordable devices that unlock the clinical power of biophotonics. BioPhotas develops and markets devices for healthcare providers and consumers that conveniently treat a variety of skin, muscle and joint conditions. For more information about the Celluma please visit www.biophotas.com.