Klox Technologies Inc. Files a De Novo Classification Request with the U.S. Food and Drug Administration

LAVAL, Quebec, FEBRUARY 4, 2020 -- Klox Technologies, Inc. (‘Klox’), a regenerative medicine company focused on the development of its proprietary FLE biomodulation platform, today announced that it has filed a De Novo Classification Request with the US FDA for its LumiHeal System following receipt of device designation in late 2019.

“This significant milestone represents Klox’s commitment to work with the US FDA and CDRH to deliver an innovative treatment modality for healthcare practitioners and patients alike within wound care” said Carlo Bellini, President of Klox. “We are currently in multiple discussions to further develop and potentially commercialize our system in the United States while remaining committed to advancing treatment options for this unmet medical need.”

The LumiHeal System has shown to stimulate the skin’s own biological processes and repair mechanisms, which impacts cellular signaling pathways and improves patient outcomes. The LumiHeal System is intended to be used in conjunction with standard of care practices for acute and chronic wounds.

Danny Matthews
SOLEBURY TROUT
dmatthews@troutgroup.com

Klox Technologies Inc. is a regenerative medicine company advancing the development and commercialization of its flagship FLE platform, which was the recipient at Targeting Mitochondria 2019 of the Innovation award for the effects of FLE on mitochondria dynamics. Klox has developed franchises in wound care, dermatology, and animal health.

For more information please visit www.kloxtechnologies.com