This is a free preview for the upcoming Avedro Inc.
Company: Avedro, Inc
Symbol: AVDR
Description: They are a leading commercial-stage ophthalmic medical technology company focused on treating corneal ectatic disorders and improving vision to reduce dependency on eyeglasses or contact lenses.
Shares: 5 million
Price Range: $14.00-$16.00
Trade Date: 2/14
Underwriter(s): BofA Merrill Lynch, JP Morgan, Cowen, Guggenheim Securities, SVB Leerink
Terms Added: 2-4-19
Business (in their words) : Our proprietary Avedro Corneal Remodeling Platform is designed to strengthen, stabilize and reshape the cornea utilizing corneal cross-linking in minimally invasive and non-invasive outpatient procedures to treat corneal ectatic disorders and correct refractive conditions, which are caused by changes in the shape of the eye that prevent light from focusing on the retina, causing blurred vision. Our Avedro Corneal Remodeling Platform is comprised of our KXL and Mosaic systems, each of which delivers ultraviolet A, or UVA, light, and a suite of proprietary single-use riboflavin drug formulations, which, when applied together to the cornea, induce a biochemical reaction called corneal collagen cross-linking, or corneal cross-linking. Our KXL system in combination with our Photrexa drug formulations, which we launched in the United States in September 2016, is the first and only minimally invasive product offering approved by the U.S. Food and Drug Administration, or the FDA, indicated for the treatment of progressive keratoconus and corneal ectasia following refractive surgery. Additionally, the FDA granted us orphan drug designations and we have orphan drug exclusivity until 2023 that covers our Photrexa formulations used with our KXL system for our approved indications. We have obtained a Conformité Européene, or CE, mark for our Mosaic system, which allows it to be marketed throughout the European Union. The Mosaic system is capable of performing vision correction procedures and treating corneal ectatic disorders, and we began a targeted international launch in late 2017. We plan to seek FDA approval for our Mosaic system and its associated drug formulations for the treatment of presbyopia as an initial targeted indication. We have invested significantly to establish the safety and broad clinical utility of our Avedro Corneal Remodeling Platform and to drive its commercial adoption. We are the only company to have conducted randomized, sham-controlled clinical trials to receive marketing approval of a corneal cross-linking solution. We have conducted and supported more than 15 clinical trials and more than 130 peer-reviewed publications have been published, which provides support for what we believe are the benefits of our Avedro Corneal Remodeling Platform. To date, over 400,000 cross-linking procedures have been performed globally with our products, including more than 18,000 procedures performed in the United States alone.
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