Business Wire

Visioneering Technologies Achieves CE Mark for NaturalVue® Family of 1 Day Contact Lenses

Jaa

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

About VTI:

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.

MKT-VTI-PR50 r0

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).

Contact information

Company
Visioneering Technologies, Inc.
Stephen Snowdy
CEO
ssnowdy@vtivision.com
or
Investor and media relations
WE Buchan
Kyahn Williamson, +61 (3) 9866 4722
kwilliamson@buchanwe.com.au

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

WELL Building Standard Gaining Momentum in Europe18.5.2018 17:47Tiedote

As Greenbuild Europe came to a close in Berlin, the International WELL Building Institute™ (IWBI™) used the occasion to highlight how the WELL Building Standard™ (WELL™) has elevated health and well-being to the forefront of sustainability conversations across Europe. WELL continues to advance the healthy building movement as the premier standard for buildings, interior spaces and communities seeking to implement, validate and measure features that promote human health and wellness. The resonance of the program has spurred innovations across the building, design and construction industries, providing projects with customizable approaches to address geographical and cultural health concerns. To date, WELL has enrolled more than 830 projects encompassing over 155 million square feet of real estate in 32 countries worldwide. In Europe nearly 190 projects across 13 countries are engaged with WELL, representing 25% of global WELL project square footage. The strong growth of WELL over the pa

Utimaco Announces Intent to Acquire Atalla from Micro Focus18.5.2018 12:03Tiedote

Utimaco, the global #2 in Hardware Security Modules (HSMs), today announced the intent to acquire the Atalla HSM and ESKM business lines from Micro Focus, which were previously owned by Hewlett Packard Enterprise (HPE) prior to the September 2017 merger of its Software business with Micro Focus. Germany-based Utimaco, active in the HSM market for over 35 years, is a global manufacturer of general purpose HSMs. Utimaco has built its market leading position focusing on indirect sales through OEM or channel business partners and selling its SecurityServer product line into industries as diverse as automotive, government, media & entertainment, smart metering, semiconductors, telecommunications and the banking and financial services sectors. Utimaco is traditionally strong in its German home market based on its longstanding German banking association certification (DK) and has recently achieved PCI accreditation for the SecurityServer product line. With the acquisition of Atalla, one of th

Janssen to Present New Data in Urothelial, Haematologic and Prostate Cancers at ASCO 2018, including Best of ASCO Selections18.5.2018 10:00Tiedote

The Janssen Pharmaceutical Companies of Johnson & Johnson, today announced 21 company-sponsored abstracts will be presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL on June 1-5. New data analyses in support of a portfolio of products, including the investigational treatments erdafitinib and apalutamide, as well as approved treatments Imbruvica® (ibrutinib), Darzalex® (daratumumab), and Zytiga® (abiraterone acetate) will be highlighted across urothelial, haematologic and prostate cancers. Notably, Phase 2 trial results for the investigational compound erdafitinib, which received U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation, will be presented during an oral presentation on Sunday, June 3 (Abstract #4503).1,2 For haematologic cancers, Phase 3 data from the iNNOVATE study will provide the first look at ibrutinib plus rituximab versus placebo plus rituximab in patients with newly diagnosed and relapsed/refractory Wald

Karisma Hotels & Resorts to Open Allure Palazzi Kotor Bay Hotel by Karisma in June 201818.5.2018 09:00Tiedote

Karisma Hotels & Resorts, an award-winning luxury hotel collection which owns and manages properties in Latin America, the Caribbean and Europe, is pleased to announce the opening of Allure Palazzi Kotor Bay Hotel by Karisma in June 2018. Built from the ground up in Montenegro’s idyllic Dobrota, the exclusive five-star beachfront property seamlessly blends stunning architecture and design with its mountainous landscape, offering spellbinding views of Kotor Bay. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180517006456/en/ Rendering of Allure Palazzi Kotor Bay (Photo: Business Wire) Sitting on Kotor Bay’s only private beach, the resort features 89 premium guestrooms, 10 villas with private beachfront access, and three breathtaking penthouse suites, each with a balcony or terrace. Allure Palazzi Kotor Bay’s accommodations encompass sumptuous bedding, divine amenities, and carefully selected color palettes bringing the sunny

Siemens Financial Services Selects GTC’s @GlobalTrade Platform for Management of Export Documentary Credits18.5.2018 07:00Tiedote

GlobalTrade Corporation (GTC) has announced today that Siemens Financial Services (SFS) has selected its @GlobalTrade Multi-bank Trade Finance Platform for management of its export documentary credits. The platform will be initially rolled out in Germany and thereafter expanded to Siemens entities globally. The system will electronically aggregate all incoming documentary credits in a global database, facilitate review and approval, assist in preparation of compliant documents and enable faster presentation of documents electronically to advising and issuing banks. Gerhard Heubeck, Head of Trade Finance Advisory at Siemens Financial Services, reasons the need for the new system implementation as follows: "After many years of using one of the first standard IT systems available for export documentary credits, the time has come to find a successor tool capable to meet the new requirements such as multi-client capability, processing of new SWIFT message formats, global accessibility, and

PayPal Significantly Expands Global Omnichannel Platform With Acquisition of iZettle18.5.2018 01:35Tiedote

PayPal Holdings, Inc. (NASDAQ: PYPL) announced today that it has agreed to acquire iZettle, the leading small business commerce platform in Europe and Latin America, for $2.2 billion USD. The acquisition of iZettle significantly expands PayPal’s in-store presence, strengthening PayPal’s platform to help millions of small businesses around the world grow and thrive in an omnichannel retail environment. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180517006443/en/ Left to right: Jacob de Geer, CEO and Co-Founder of iZettle, Dan Schulman, President and CEO of PayPal, and Bill Ready, EVP, Chief Operating Officer of PayPal. (Photo: Business Wire) “Small businesses are the engine of the global economy and we are continuing to expand our platform to help them compete and win online, in-store and via mobile,” said PayPal President and CEO Dan Schulman. “iZettle and PayPal are a strategic fit, with a shared mission, values and cult

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme