Visioneering Technologies Achieves CE Mark for NaturalVue® Family of 1 Day Contact Lenses
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).
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
LIAF: Experts at the European Parlament - E-Cigarettes Are a Potential Game Changer for European Health20.3.2018 18:27 | Pressemelding
The following is a statement from LIAF – Lega Italiana Anti Fumo: The panel discussion at the EU Parliament recognises the potential benefits of electronic cigarettes and for European countries to treat these products as regular consumer products to ensure equal access for all Europeans. Following a debate in which leading scientific experts presented the state-of-the-art evidence around e-cigarettes, it became clear that public health is increasingly moving on from an approach that solely advocates ‘quit-or-die’ to a harm reduction strategy. “I’m glad to have brought the Parliament attention to this important issue for public health. Today we have listened to the results of scientific studies and researches from a high-level expert’s roundtable, which have illustrated to us the advantages of electronic cigarettes and the potential public health benefits that these products pose when compared to the conventional cigarettes. As decision-makers, we need to take into considerations these
Morinaga Milk's New Probiotic Strain, Bifidobacterium breve A1, May Prevent Onset of Alzheimer's Disease20.3.2018 18:00 | Pressemelding
Morinaga Milk Industry Co., Ltd. (TOKYO:2264), a leading Japanese dairy product company, today announced the results of a new study investigating the preventive effects of its new probiotic strain Bifidobacterium breve A1 on a model of Alzheimer’s disease. Researchers found that B. breve A1 improved spatial recognition capability, as well as learning and memory capabilities, in cognitively deficient mice, indicating it could play an important role in preventing the onset of Alzheimer’s Disease in humans.1 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180320005052/en/ (Fig. 1) Effects of B. Breve A1 in improving spatial recognition, learning and memory capabilities (Graphic: Business Wire) The number of patients affected by dementia is increasing worldwide. One report estimates there were 46.8 million people worldwide living with dementia in 2015 and projects this number will reach 131.5 million by 2050.2 Alzheimer’s disease
Dubai Breaks Ground on World’s Biggest CSP Project20.3.2018 16:10 | Pressemelding
HH Sheikh Mohammed bin Rashid Al Maktoum, Vice President and Prime Minister of the UAE and Ruler of Dubai, broke ground on the 4th phase of the Mohammed bin Rashid Al Maktoum Solar Park. This is the biggest Concentrated Solar Power (CSP) investment project in the world, based on the Independent Power Producer (IPP) model, and will generate 700MW on a single site. It will have the world’s tallest solar tower at 260 metres, and the largest thermal energy storage capacity in the world. It will provide clean energy to 270,000 residences, reducing 1.4 million tonnes of carbon emissions annually. The project will use two technologies: a 600MW parabolic basin complex and a 100MW solar tower, over 43 square kilometres. This project, with AED14.2 billion in investments, achieved the lowest Levelised Cost of Electricity (LCOE) of USD 7.3 cents per kW/h. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180320006214/en/ Dubai breaks groun
Edgecore Networks Introduces 400G Open Networking20.3.2018 16:00 | Pressemelding
OCP Summit – Edgecore Networks, the leader in open networking, today announced its contribution to the Open Compute Project (OCP) of the design of a 400 Gigabit Ethernet (400G) data center switch, the industry’s first 400G open design, that will enable public and private network operators to increase dramatically the capacity of their infrastructures. “Four years ago, Edgecore contributed the industry’s first OCP-ACCEPTED™ network product, a 10G top-of-rack switch,” said George Tchaparian, CEO, Edgecore Networks. “Since then, we have contributed over 15 network product designs as open networking technology and deployments grew to include 25G/100G data center fabrics, deep-buffer data center interconnect switches, service provider access infrastructures, open modular chassis, and campus/branch/wireless networks. Now, Edgecore is introducing the industry’s first 400G open network switch, enabling network operators to respond to growing demands for network capacity, and increasing the ban
Technics Organizes World's First Full Turntable Orchestra20.3.2018 14:48 | Pressemelding
On March 20, 2018, the "Record Day," Panasonic Corporation released the video of the world's first full orchestra performance featuring Technics "turntables (analog record players)" as the only instruments, under the Technics brand's theme, "Rediscover Music." This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180320006023/en/ World's First Full Turntable Orchestra organized by Technics (Photo: Business Wire) Videos: - THE PHILHARMONIC TURNTABLE ORCHESTRA https://youtu.be/JGWuyMKT8wU - BEHIND THE BEATS : THE PHILHARMONIC TURNTABLE ORCHESTRA https://youtu.be/J2KK3vqJqog "The Philharmonic Turntable Orchestra" special website Thirty renowned DJs from around the world, including DJ Rena, the reigning Japanese world champion (youngest ever world champion in history), who took the "DMC World Championship" title in 2017 at just 12 years old*, came together to create the world's first "turntable orchestra." Using the Technics' iconic tu
Bentley Systems' Year in Infrastructure 2018 Conference and Awards Gala to be Held in London, Oct. 15-1820.3.2018 14:30 | Pressemelding
Bentley Systems, Incorporated, a leading global provider of comprehensive software solutions for advancing infrastructure, today announced that the Year in Infrastructure 2018 Conference will be held Oct. 15 through 18 in London at the Hilton London Metropole. Presented by Bentley Institute, the conference is a global gathering of leading industry executives and prominent thought leaders in the design, construction, and operations of the world’s infrastructure. The theme of this year’s conference is Going Digital: Advancements in Infrastructure. The conference features nearly 70 speakers and more than 50 informative sessions, including keynotes by leading industry experts, interactive workshops, forums, panel discussions, and product demonstrations. Attendees can visit the Technology Pavilion, which features exhibits and presentations from Bentley Systems and its strategic partners Microsoft, Siemens, Topcon, and Bureau Veritas. On the first day of the conference, Bentley Institute wil