The FDA has cleared the Celluma, BioPhotas' biophotonic medical device, for six separate Indications-For-Use, including the treatment of acne, muscle and joint pain, muscle and joint stiffness, muscle spasm, arthritis, and compromised local blood circulation.
Research funded by NASA and DARPA using light emitting diodes (LED) or biophotonic therapy has been scientifically proven in recent clinical trials to up-regulate cellular function in the treatment of many common conditions, restoring the body's natural ability to heal itself. Contrasted to many widely accepted therapies where vital tissue is intentionally damaged to create a healing response, using LED light to "re-energize" cellular function in a non-invasive manner allows the body to maintain vitality as nature intended.
Commenting on the FDA clearance, Patrick Johnson, president and CEO for BioPhotas says, "Receiving FDA clearance for six separate indications-for-use is a major milestone for us in the development of our product portfolio and the growth of the company. Our goal in developing the Celluma was to create a safe, effective and convenient device that could be used in the home and in a professional medical setting, and to do that at a fraction of the cost of the competition. We believe we have accomplished that goal with a product that is proprietary in design and novel in clinical application for pain management and certain skin conditions."
Pain caused by a variety of reasons impacts over 100 million Americans and affects quality of life, work productivity and can be a huge emotional and financial burden. Similarly, acne is the most common skin disorder in the United States, affecting 40 to 50 million Americans. Nearly 85% of all people have acne at some point in their lives. The Celluma is designed and priced for the mass consumer market, while offering medical professionals a viable alternative treatment modality.
Continuing, Johnson says, "BioPhotas' vision is to address the rapidly growing market opportunity in global healthcare and wellness with the proven science of biophotonics and LED technology featured in the Celluma to provide effective, affordable and predictable solutions for medical practitioners and consumers alike. The Celluma will give consumers and medical professionals affordable access to a powerful clinical technology that could otherwise cost five to 20 times more, particularly when compared to cold lasers used to treat the same conditions.
The Celluma uses three distinct wave lengths of light energy, modulated with proprietary electronic algorithms to effectively treat a variety of skin, muscle and joint conditions. The Celluma is distinct from other light therapy devices given a novel flexible design that molds to the body to allow the light to be absorbed more effectively leading to higher efficacy and more predictable outcomes.