FDA Grants Device Designation Status for Klox’s LumiHeal System
LAVAL, Quebec, DECEMBER 12, 2019 -- Klox Technologies Inc. (‘Klox’) a regenerative medicine company developing and commercializing its proprietary fluorescent light energy generating platform within dermatology, wound care, and animal health, today announced, following remitting a Request for Designation, that the US Food & Drug Administration’s Office of Combination Products has given the LumiHeal System Device designation and will be reviewed and regulated by the Center for Devices and Radiological Health (CDRH).
“This exciting milestone paves the way for Klox to address the single largest healthcare market which historically had been out of its reach,” said Carlo Bellini, President at Klox. “We are pleased with the designation and are dedicated to advancing the LumiHeal System in the US.”
“We commend the Office of Combination Products’ commitment for a diligent and objective assessment for jurisdictional determination of the LumiHeal System,” said Dr. Daniela Jukic Senior Director of Regulatory Affairs at Klox.
The company plans on filing a pre-market submission to CDRH shortly.
The LumiHeal System stimulates the skin’s own biological processes and repair mechanisms, which has shown to impact cellular signaling pathways and improved outcomes. The LumiHeal System is intended to be used in conjunction with standard of care practices for acute and chronic wounds and is currently commercially available in select European markets.
Klox Technologies Inc. is a private biomedical technology innovator, advancing the development and commercialization of its flagship fluorescent light energy generating technology within regenerative medicine. Klox has developed franchises in wound care, dermatology, animal health and oral health.
For more information please visit www.kloxtechnologies.com