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
AURAK Gains SACSCOC Accreditation15.12.2018 10:49 | Pressemelding
The Southern Association of Colleges and Schools Commission on Colleges (SACSCOC) officially announced the accreditation of the American University of Ras Al Khaimah (AURAK) at its 2018 Annual Meeting which was held in New Orleans, Louisiana, in the United States of America. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181215005017/en/ AURAK delegation during the SACSCOC conference in New Orleans” (Photo: AETOSWire) SACSCOC, the regional body for the accreditation of degree-granting higher education institutions in the Southern United States, has a membership of more than 800 institutions in the Southern states and other international sites approved by SACSCOC that award associate, baccalaureate, master’s, and/or doctoral degrees. SACSCOC also awards accreditation to other international institutions of higher education that satisfy all its requirements and demonstrate compliance with its accreditation standards. AURAK now
Lehman Brothers Treasury Announces Plans for Partial Wind-Down14.12.2018 17:41 | Pressemelding
Lehman Brothers Treasury Co. B.V. in liquidation (“LBT”) today, through its U.S. counsel Kramer Levin Naftalis & Frankel LLP, announced that LBT is planning a final cash distribution to its creditors. Professional holders of eligible notes will have the option to retain their investment by electing to receive substitute notes of one (or a few) series. Such election shall take place through a solicitation process. As a consequence, LBT will be able to reduce the number of series of notes outstanding from more than 3,700 to one or a few. Noteholders electing to receive substitute notes will be afforded the same economic entitlement to distributions received by LBT from Lehman Brothers Holdings Inc. (“LBHI”) through the substitute notes. The substitute notes will be denominated in U.S. dollars and future distributions will be made in U.S. dollars only. Noteholders who are not professional investors, or hold notes that are not eligible for substitution, or do not elect to receive substitut
Takeda Receives Positive CHMP Opinion for ADCETRIS® (brentuximab vedotin) for the Treatment of Adult Patients with Previously Untreated CD30+ Stage IV Hodgkin Lymphoma in Combination with AVD14.12.2018 17:00 | Pressemelding
Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the extension of the marketing authorization of ADCETRIS (brentuximab vedotin) and recommended its approval in combination with AVD in adult patients with previously untreated CD30+ Stage IV Hodgkin lymphoma. ADCETRIS is an antibody-drug conjugate (ADC) directed at CD30, a defining marker of Hodgkin lymphoma. ADCETRIS is currently not approved as a therapy for previously untreated Hodgkin lymphoma in Europe. “For a large number of previously untreated Hodgkin lymphoma patients diagnosed with Stage IV disease, progression will occur with current treatments, highlighting a true unmet need in this population,” said Anna Sureda, M.D., Ph.D., Head of the Hematology Department and Hematopoietic Stem Cell Transplant Programme, Institut Català d'Oncologia - Hospital Duran i Reynals. “In the ECHELON-1 cl
Diamond CBD, POTN Subsidiary, Enters the $46 Billion Coffee Market With the Release of Premium Line of CBD-Infused Coffee & Tea K-Kup Capsules14.12.2018 15:42 | Pressemelding
Diamond CBD Inc., wholly owned subsidiary of PotNetwork Holdings, Inc. (OTC Pink: POTN), a leader in hemp extraction and innovative CBD products for the wellness market, enters the Coffee segment, an industry expected to reach revenues of $46 Billion in 2018. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181214005308/en/ Experience a cup of Chill (Photo: Business Wire) Produced in accordance with a universal K-Cup design, these pods fit in almost all modern single cup coffee makers, making it an easily integrated enhancement to any environment, delivering 25mgs of CBD in a tasty favorite beverage at less than $5 per cup. This new line of premium Chill Coffee Capsules was recently added to the Company’s broad range of cannabinoid and natural hemp products. Each box comes with 4 individual capsules in original chill coffee, decaf chill coffee, chill black tea, and chill green tea flavors. The unit price for each box is $10.00
Henley & Partners Enlarges Executive Committee to Manage Expansion and Growth14.12.2018 14:00 | Pressemelding
Residence- and citizenship-by-investment programs have firmly established themselves over the past few years as the new frontier in terms of freedom, flexibility, and future-readiness, both for the countries issuing these programs and for the individual investors participating in them. The societal and economic value these programs generate is undisputed. The investment migration industry as a whole is currently grossing roughly USD 18 billion per year, with an expectation that it will hit the USD 20 billion mark very soon. Foreign direct investment (FDI) is now considered the lifeblood of economic growth for many developing and recovering smaller countries around the world. As such, the number of investment migration programs has been increasing rapidly, from just a handful of programs in the 1980s and 1990s to over 100 countries that now have investment migration provisions in their laws. There are more than 60 active programs today, with Moldova and Montenegro — both fast-growing Eu
Vargatef® plus docetaxel could be an option after failure of immunotherapy in lung cancer14.12.2018 09:07 | Pressemelding
Boehringer Ingelheim announced today the first interim results of VARGADO, an ongoing non-interventional study in routine clinical practice in Germany evaluating the efficacy and safety of Vargatef® (nintedanib) and docetaxel in patients with stage III/IV locally advanced or metastatic non-small cell lung cancer (NSCLC) of adenocarcinoma histology. The study consists of three cohorts, two of which allow for prior treatment with immune checkpoint inhibitors (ICIs) either in combination with chemotherapy in the first-line or as monotherapy in the second-line of treatment. The interim results from Cohort B (first-line chemotherapy, second-line immune checkpoint inhibitors, third-line Vargatef® plus docetaxel) were presented today at ESMO Immuno-Oncology Congress 2018 in Geneva.1 Despite a limited sample size, the VARGADO study adds to the body of evidence for nintedanib in lung adenocarcinoma following pre-treatment with chemotherapy and ICIs.1,3 The addition of nintedanib to docetaxel ha