TechCare has announced that its Novokid has received CE mark approval as a class I medical device.
The approval is in line with the company's projected milestones to obtain CE approval during Q3 and to commence sales in Europe during Q4.
This achievement complements the recently announced strategic partnership with HoMedics for the North and South American markets.
Novokid is the first of its kind home use device, presenting a scientifically proven solution to eliminate lice, super lice and eggs.
Novokid is 100% natural, plant-based and pesticide-free. Utilizing a proprietary vapor-based delivery platform, Novokid employs a simple 10 minute dry treatment that requires no rinsing or washing. The treatment is fast, dry, clean and easily administered at home or on the go. Novokid can also be used as a maintenance and preventative treatment if used regularly.
"This is a major milestone for our company and an important step towards widespread availability of a scientifically proven, pesticide-free, simple and easy-to-use treatment for lice," stated Zvi Yemini, Chairman and CEO of TechCare Corp.
"Receiving approval to utilize the CE Mark clears the way for product distribution in 28 countries across Europe. The treatment of head lice is a $1.8 billion market globally, and the market in Europe is estimated to exceed $500 million. Combined with our milestone strategic partnership with HoMedics for the Americas, this achievement will help us initiate distribution agreements throughout Europe commencing in Q4."
Zvi Yemini, Chairman and CEO of TechCare Corp., added, "For those infected with lice, the treatment options have been limited to pesticide-based solutions that have very limited efficacy and carry significant risks.
“ Novokid has been scientifically proven as an effective treatment while being cost-effective, efficient and safe. We are eager to begin our commercial launch in Europe and are confident over time Novokid will become the preferred option for lice treatment."
Receipt of the Certificate of Conformance from The European Competent Authority confirms the legal requirements have been met and the company's device complies with the requirements of the Medical Device Directive 93/42 EEC amended by 2007/47 and the device may be CE marked.
TechCare is a technology company engaged in the design, development and commercialization of an innovative delivery platform utilizing vaporization of various natural, plant-based compounds, to enable a wide variety of treatment solutions.