VTI write up from that newsletter Rant Rat guy (Nick Kelso)

He's a pretty astute guy - good read below

VTI-Visioneering Technologies Limited today closed up 57% to finish at 9.4c on $2.7m stock traded. The reason they were up today was because they have announced that the U.S. FDA has granted approval for the first contact lens specifically cleared in the US to slow the progression of nearsightedness in children. The registration was granted to Cooper Vision’s MiSight 1 day contact lens. A few of us caught up with the CEO recently after the investor relations chick was kind enough to bring him past while he was out from the US, very impressive guy and a very impressive story 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. Some details on today's news are listed below: FDA approves first contact lens indicated to slow the progression of nearsightedness in children Highlights The U.S. Food and Drug Administration (FDA) granted approval on November 18, 2019 for CooperVision’s MiSight contact lens The approval helps to clarify the regulatory path for Visioneering and other companies Resources that CooperVision invests in education and marketing in the U.S. regarding the importance of treating myopia progression should benefit Visioneering as well 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 the U.S. FDA has granted approval for the first contact lens specifically cleared in the US to slow the progression of nearsightedness in children. The registration was granted to CooperVision’s MiSight® 1 day contact lens. This approval represents a major step forward for the field of myopia progression control and demonstrates the rapidly emerging interest in the U.S. for new products that treat myopia progression. The approach used to gain U.S. clearance of MiSight may indicate a relaxation of some clinical trial guidelines that previously had been suggested by the FDA, but were prohibitive to the execution of efficient clinical trials in myopia progression. With this potential shift of requirements towards more achievable clinical trials for myopia progression control products, Visioneering is considering its next steps with regard to pursuing a specific claim for myopia progression control for its NaturalVue Multifocal (NVMF) contact lenses in the U.S. NVMF currently is approved, or registered, specifically for the treatment of myopia progression in Europe, Australia, New Zealand, Hong Kong, and Singapore. In the U.S., NVMF is approved for the correction of myopia, but not specifically for myopia progression control. However, many eye care professionals in the U.S. currently use NVMF for treating myopia progression as it employs a unique optical design that has been shown in peer reviewed, published data to slow the progression of myopia in children by over 90%. MiSight is available in distance powers up to -6.00 diopters. NVMF is available in a full range of distance powers, up to -12.25 diopters, enabling treatment of a greater portion of the myopic population than MiSight. Visioneering Technologies CEO Stephen Snowdy, PhD, said: “The U.S. approval of MiSight is very positive for Visioneering and the industry, and an exciting time for practitioners of myopia progression in the U.S. This achievement may establish a pathway to FDA approval specifically for myopia progression control in the U.S. for other innovators like Visioneering. We estimate that the addressable market for myopia progression in the U.S. is approximately US$2 billion. This FDA announcement should help to highlight the need for myopia progression control, and therefore benefit patients, practitioners and innovators.”

Some knob from my office with the CEO of VTI Stephen Snowdy a few weeks ago testing out the product. Hopefully he bought himself a few shares, although he's a knob he's a pretty smart cat too I must admit !!!