U.S. FDA Grants LumiHeal® System De Novo Clearance

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LAVAL, QC, Dec. 14, 2021 /PRNewswire/ - Klox Technologies Inc. (Klox, or the Company), the leading provider of Fluorescent Light Energy (FLE)-based Systems for treating diseases and conditions affecting the skin and soft tissues, announces that the United States Food and Drug Administration (FDA) has granted the Company De Novo clearance for the LumiHeal^® System. The LumiHeal System is the first FLE-based device cleared by the FDA and it is currently indicated to provide fluorescent and blue light to post-surgical incisions for scar management.

The LumiHeal System is a first-in-class, proprietary, non-invasive, non-thermal treatment that employs FLE for reducing the appearance and feel of acute post-surgical incisions.

"The FDA De Novo review process is designed to determine that the clinical benefits outweigh the clinical risks associated with a medical device when there is no substantially equivalent predicate device. It is a rigorous process, and we worked diligently with the FDA to achieve the landmark grant of our De Novo request for classification," stated Dr. Daniela Jukic, Senior Director, Regulatory Affairs, Compliance and Quality Assurance.

"We believe that the LumiHeal System can make a significant difference in the way we manage post-surgically incisions and opens the way to further indications for the U.S. market", stated Mr. Howard Walthall, CEO of Lumiheal Therapeutics, Inc., Klox Technologies' US-based partner located in Alabama.

About Klox Technologies Inc.
Klox Technologies Inc., is a private regenerative medicine company focused on the development of its proprietary Fluorescent Light Energy platform, also known as Fluorescence Biomodulation, for specific skin and soft tissue conditions and diseases.

About Lumiheal Therapeutics Inc.
Lumiheal Therapeutics, Inc., is a private regenerative medicine company focused on the development and commercialization of products based on Klox's proprietary Fluorescent Light Energy platform for wound, burn, and surgical incision indications.

Forward Looking Statements
Certain statements contained in this newswire, other than statements of fact that are independently verifiable at the date hereof, may constitute forward-looking statements. Forward looking statements generally can be identified by the use of the words "may", "could", "should", "would", "will", "expect", "intend", "plan", "estimate", "project", "anticipate", "believe" or "continue", or the negative thereof or similar variations. Examples of such forward looking statements include those regarding cosmetics and medical devices and medical applications and clinical trials and the status and related results thereto, as well those regarding continuing and further development and commercialization efforts. Such statements, based as they are on the current analysis and expectations of management, inherently involve numerous risks and uncertainties, known and unknown, many of which are beyond Klox Technologies Inc.'s control. Such risks include, but are not limited to, the impact of general economic conditions, general conditions in the medical, cosmetics and/or consumer goods industries, changes in the regulatory environment in the jurisdictions in which Klox Technologies Inc. does business, financial and commercial markets volatility, fluctuations in costs, and changes to the competitive environment, as well as other risks. Consequently, actual future results may differ materially from the anticipated results expressed in forward-looking statements. In the case of forward-looking statements regarding investigational product candidates and continuing and further development efforts, specific risks which could cause actual results to differ materially from Klox Technologies Inc.'s current analysis and expectations include failure to demonstrate the safety, tolerability and efficacy of our products, final and quality-controlled verification of data and the related analyses, and the expense and uncertainty of obtaining regulatory approval.

Dr. Daniela Jukic
Senior Director, Regulatory Affairs
Compliance and Quality Assurance
Klox Technologies Inc.
[email protected]

Mr. Howard Walthall
CEO
Lumiheal Therapeutics Inc.
[email protected]

SOURCE KLOX Technologies Inc.

Related Links

http://www.kloxtechnologies.com/