ASX Announcement • 17 November 2019 • Visioneering Technologies (ASX:VTI)
- Singapore’s Health Sciences Authority granted medical device registration to Visioneering’s NaturalVue® Multifocal contact lenses (NVMF)
- The registration in Singapore includes use of NVMF for the treatment of myopia progression
- VTI now turns its attention to seeking distribution and other logistical elements for its launch of sales in Singapore
Atlanta, Georgia, Sunday, 17 November 2019: US-based medical device company and producer of the NaturalVue® (etafilcon A) Multifocal 1 Day Contact Lenses, Visioneering Technologies, Inc (ASX: VTI) (‘Visioneering’ or ‘the Company’) is pleased to announce that it has achieved medical device registration from Singapore’s Health Sciences Authority. The registration covers the use of the Company’s NaturalVue® Multifocal contact lenses for the control of myopia progression.
Visioneering sells patented revolutionary daily disposable contact lenses that address two underserved populations: presbyopia (loss of near vision in people over 40-45), and paediatric myopia (nearsightedness in children).
Strong need for myopia management solutions
With approximately 80% of its 18-year-olds being nearsighted, or myopic, Singapore represents a large opportunity for treatments that slow the progression of myopia in children and young adults. VTI believes its NVMF is an ideal product to address this need.
Data presented in January 2019 by eye care practitioners showed that in 141 children wearing NaturalVue® Multifocal an average decrease of myopia progression of 90% was seen, compared to the rate of progression prior to wearing NaturalVue®, and a 55% decrease in the pace of lengthening of the eye (n=36)1. Inhibition of myopia progression was consistent between children who had worn the lens daily for one year and those who had worn the lenses daily for up to 4 years. NVMF is readily available in powers up to -12.25 diopters, which exceeds the power availability of other myopia control products such as orthokeratology or other daily disposable contact lenses.
Visioneering’s entry into Singapore follows its expansion into Hong Kong, Europe, and ANZ
With the award of this registration, Visioneering will now turn its attention to establishing partnerships in Singapore that will facilitate sales and fulfillment, and expects first sale in Singapore to occur in the coming months. Since its IPO in 2017, Visioneering has obtained clearances and launched its products for myopia progression control and presbyopia in Australia, New Zealand, Europe, Hong Kong, and now Singapore. The Company also expects to launch in Canada in early 2020.
In the US alone, the addressable market for paediatric myopia is estimated at $2bn per annum. Visioneering estimates the market in China to be as large as $11bn, with sizable markets also in Japan, Korea, Southeast Asia, and Hong Kong.
Visioneering Technologies CEO Stephen Snowdy, PhD, said: “With registration in Singapore, VTI continues its international expansion. We recently launched in Europe and Hong Kong, including partnering in Europe with Menicon, one of the largest global players in contact lenses and myopia control. VTI will continue working to make our revolutionary products available to patients in need. In 2020, we expect to launch NVMF in Canada and plan to introduce additional products in the United States and elsewhere”.
About Visioneering Technologies
Visioneering Technologies Inc. (ASX:VTI) is an innovative eye care company committed to redefining vision. Since its founding in 2008, Visioneering has brought together clinical, marketing, engineering, manufacturing and regulatory leaders from top vision care businesses to provide new solutions for presbyopia, myopia and astigmatism.
Headquartered in the US, Visioneering designs, manufactures, sells and distributes contact lenses. Its flagship product is the NaturalVue® Multifocal contact lens, and VTI has expanded its portfolio of technologies to address a range of eye care issues. The company has grown operations across the United States, Australia and Europe and is expanding into Asia with a focus on markets with high rates of myopia.
To learn more, please 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.
This announcement contains or may contain forward-looking statements that are based on management’s beliefs, assumptions and expectations and on information currently available to management.
All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements. These include, without limitation, US commercial market acceptance and US sales of our product, as well as our expectations with respect to our ability to develop and commercialize new products.
Management believes that these forward-looking statements are reasonable when made. You should not place undue reliance on forward-looking statements because they speak only as of the date when made. VTI does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. VTI may not actually achieve the plans, projections or expectations disclosed in forward-looking statements. Actual results, developments or events could differ materially from those disclosed in the forward-looking statements.
1. O’Connor, B, Jeruss J, Aller T, Dillehay SM. Myopia Management with A Unique Extended Depth of Focus Contact Lens: A Case Series Analysis. Paper presented at Global Specialty Lens Symposia. January, 2018.