Visioneering Technologies, Inc. (ASX: VTI), an innovative US-based medical device company dedicated to developing advanced products that improve vision, announced today receipt of the European CE Mark (Conformité Européenne) for commercialization in the European Union of its portfolio of proprietary NaturalVue® (etafilcon A) brand 1 Day Contact Lenses, including Sphere, Toric, Multifocal and Multifocal Toric. VTI’s CE Mark includes an indication for VTI’s unique NaturalVue Multifocal (NVMF) for myopic progression control (the control of progressive nearsightedness). NVMF contact lenses feature VTI’s innovative Neurofocus Optics® Technology, which employs a patented extended depth-of-focus design to address known optical risk factors associated with myopia progression. The innovative NVMF lens design allows it to be used for both myopic progression control and presbyopia (the age-related loss of ability to see near objects).
“It is very exciting that we now have available a CE marked product with indications for both myopic progression control and presbyopia, that provides excellent near, intermediate and distance vision in a daily disposable multifocal contact lens,” said Andrew D. Price, FBDO(Hons) CL, CEO of The ADP Consultancy specializing in ocular surface/contact lens clinical care, clinical trials and eye care practitioner education in the UK. “For a company the size of VTI to have developed such a uniquely powerful, elegant high-performance product is very remarkable. I look forward to prescribing NaturalVue Multifocal lenses to both my adult and school-age patients.”
The CE Mark is awarded by the European Union’s (EU) Notified Body and indicates that a product’s design conforms to the stringent requirements of the Medical Device Directive (MDD 93/42/EEC). The CE Mark allows VTI to commercialize its contact lens products in Europe, as well as to prepare regulatory submissions to launch its products in additional countries, including Australia, New Zealand, Hong Kong, Singapore, and others.
“We are thrilled to have achieved the CE Mark for our contact lenses. This is a tremendous accomplishment, and speaks volumes towards our commitment to making innovative new products available to patients and practitioners worldwide,” said Dr. Stephen Snowdy, CEO of Visioneering Technologies. “VTI is now poised to expand our product availability internationally in 2018, including some Asian countries, where up to 90% of children are burdened with myopia.”
Paediatric myopia progression affects a high percentage of children in industrialized nations. A recent study published in the peer-reviewed journal, Eye and Contact Lens, documented that VTI’s NaturalVue MF lens delivered approximately 96% reduction (average of both eyes) of annualized myopic progression in children aged 6 to 19, with 98.4% of the children showing a decrease in the rate of worsening of their myopia.i
Visioneering Technologies, Inc. (ASX:VTI), headquartered in Atlanta, Georgia, is an innovative company dedicated to developing products that improve vision. With a portfolio of technologies, the Company uses creative and differentiated design approaches to develop products that enhance practitioner and patient experiences. Its revolutionary new contact lens, the NaturalVue™ Multifocal (MF) contact lens, can be used in two of the largest eye-care markets globally: presbyopia (age-related difficulty in seeing close objects) and myopia (near-sightedness, or difficulty seeing distant objects). VTI optical designs have been awarded twelve patents worldwide, with an additional seven pending. For more information, visit www.vtivision.com.
Foreign ownership restrictions:
VTI’s CHESS Depositary Interests (CDIs) are issued in reliance on the exemption from registration contained in Regulation S of the US Securities Act of 1933 (Securities Act) for offers which are made outside the US. Accordingly, the CDIs have not been, and will not be, registered under the Securities Act or the laws of any state or other jurisdiction in the US. As a result of relying on the Regulation S exemption, the CDIs are ‘restricted securities’ under Rule 144 of the Securities Act. This means that you are unable to sell the CDIs into the US or to a US person for the foreseeable future except in very limited circumstances after the expiration of a restricted period, unless the re-sale of the CDIs is registered under the Securities Act or an exemption is available. To enforce the above transfer restrictions, all CDIs issued bear a ‘FOR US’ designation on the Australian Securities Exchange (ASX). This designation restricts any CDIs from being sold on ASX to US persons. However, you are still able to freely transfer your CDIs on ASX to any person other than a US person. In addition, hedging transactions with regard to the CDIs may only be conducted in accordance with the Securities Act.
i Cooper J, O’Connor, B, Watanabe R, Fuerst R, Berger S, Eisenberg N, Dillehay SM. Case series analysis of myopic progression control with a unique extended depth of focus multifocal contact lens. Eye & Contact Lens. 2017;(e-pub prior to publication, Oct).