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 ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Game of Thrones Winter is Coming™ Launches Worldwide26.3.2019 02:00:00 EETTiedote

Yoozoo Games, a leading game developer and publisher, today announced the global launch of Game of Thrones Winter is Coming™ , a real-time strategy PC browser game officially licensed by Warner Bros. Interactive Entertainment under license from HBO®. The game is now available in English, with additional languages to follow. HBO, Warner Bros. Interactive Entertainment and Yoozoo Games have collaborated to recreate Westeros on a massive scale, delivering an authentic and immersive multiplayer world laid out across the Seven Kingdoms – complete with major landmarks and castles from the epic TV series. The story begins immediately following the death of Eddard Stark, when the player emerges as a new Westeros lord or lady in his stead. Strategising starts in earnest in Game of Thrones Winter is Coming as players aim to build an impenetrable base, train a victorious army and recruit faithful followers from a pool of iconic characters. As players progress, they must continue to acquire the mi

Earth Networks Announces Completion of Severe Weather Early Warning System for PAGASA26.3.2019 02:00:00 EETTiedote

Earth Networks announced today the completion of the Philippines’ first nationwide severe weather monitoring and alerting network with associated software services for the Philippine Atmospheric, Geophysical, and Astronomical Services Administration (PAGASA), the National Meteorological and Hydrological Services (NMHS) agency of the Republic of the Philippines. The announcement was made at the 6th annual InterMET Asia conference in Singapore. Initiated in 2017, and formally commissioned this week, the technology partnership between PAGASA and Earth Networks is the first of its kind in the Philippines and surrounding regions, powered by a network of total lightning sensors and real-time automatic weather stations for mesoscale monitoring. Installed and operated together with Philippines partner West Point Engineering, the 10-year program includes: Real-time lightning detection powered by the Earth Networks Total Lightning Network On-the-ground weather monitoring via the Earth Networks W

bluebird bio Statement on European Regulatory Status of LentiGlobin™26.3.2019 01:40:00 EETTiedote

A third party press release was issued today stating that the EMA (European Medicines Agency) issued an approval for the conditional Marketing Authorization Application (MAA) for LentiGlobin™, bluebird bio’s investigational gene therapy for the treatment of transfusion dependent β-thalassemia (TDT). LentiGlobin for TDT is scheduled to be reviewed as part of the CHMP (Committee on Human Medicinal Products) meeting from March 25 – 28, however no opinion has been issued by the CHMP. If the CHMP’s opinion is issued it would then be reviewed by the European Commission (EC), which has the authority to grant approval for the use of LentiGlobin in the EU. About bluebird bio, Inc. bluebird bio is pioneering gene therapy with purpose. From our Cambridge, Mass., headquarters, we’re developing gene therapies for severe genetic diseases and cancer, with the goal that people facing potentially fatal conditions with limited treatment options can live their lives fully. Beyond our labs, we’re working

Celgene Submits Application to FDA for Ozanimod for the Treatment of Relapsing Forms of Multiple Sclerosis25.3.2019 23:30:00 EETTiedote

Celgene Corporation (NASDAQ:CELG) today announced that the Company has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for ozanimod for the treatment of adults with relapsing forms of multiple sclerosis (RMS). Ozanimod is an oral, sphingosine 1-phosphate (S1P) receptor modulator, which binds with high affinity selectively to S1P subtypes 1 (S1P1) and 5 (S1P5). The pivotal efficacy and safety data provided in the application result from the SUNBEAM™ and RADIANCE™ Part B phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled trials. “New oral treatment options with differentiated profiles like ozanimod are needed to help address an unmet need for people with relapsing forms of MS,” said Jay Backstrom, M.D., Chief Medical Officer for Celgene. “With concurrent applications in the U.S. and EU, we look forward to advancing this promising medicine through the regulatory review process to provide a new option for the treatment of RMS in

AVLT and UKTS Announce the European Medicines Agency’s Approval of the Conditional Marketing Authorization Application for Zynteglo™ (Previously Known as Lentiglobin™) Gene Therapy for the Treatment of Transfusion Dependent Beta Thalassaemia25.3.2019 22:50:00 EETTiedote

Associazione Veneta Lotta alla Talassemia (AVLT) and the UK Thalassaemia Society (UKTS) announced today that the European Medicines Agency (EMA) has approved bluebird bio’s application for Conditional Marketing Authorization (cMAA) of their product Zynteglo™, a gene therapy for the treatment of adolescents and adults with transfusion-dependent β-thalassaemia (TDT) who do not have a β0/β0 genotype. As a result of this marketing authorisation, Zynteglo™ is now approved for use in all European countries covered by the European Medicines Agency. Zynteglo™ has been given ‘conditional authorisation’. This means that there is more evidence to be submitted, which the company is required to provide under specific obligations. Every year, the EMA will review any new information that becomes available. “People living with transfusion-dependent β-thalassaemia have a reduced life expectancy, requiring life-long frequent blood transfusions that are life-saving but may lead to complications, includin

Historic Partnership between the Weizmann Institute of Science and Institut Curie25.3.2019 19:54:00 EETTiedote

On March 22, the Weizmann Institute of Science in Rehovot, Israel, and Institut Curie in Paris, France, two major world-class research institutes, signed an historic partnership that will allow their teams to work closely together to improve knowledge in the field of life sciences, particularly in the areas of physics and chemistry, and most specifically - in the field of cancer research. This is a milestone in the history of these two institutes that have been working together for 15 years, particularly in the field of biophysics. Collaborative research programs This partnership will extend to many disciplines, including physics, chemistry, cellular biology, epigenetics, genetics, immunology and single cell approaches, imagery and data collection. The complementarity of the research between the various groups at Institut Curie and at the Weizmann Institute has been recognized in particular at the occasion of joint scientific workshops held regularly alternatively in Paris and Rehovot.

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