Revenio Group Corporation (OMXH: REG1V, formerly Done Solutions) notified the stock exchange at 18.25 Finnish time today that its subsidiary Icare Finland Oy has decided to suspend U.S. FDA trading license process for its home tonometer Icare ONE intended for glaucoma patients self-use at home. Revenio said that the application has not progressed in the way the company had hoped, both regarding the feedback and its speed. The timing of the stock exchange release was bizarre to say the least, with just the closing auction remaining for the day, allowing only the quickest draw to sell on the news.
While the news does not have any immediate effect on earnings, near-term upside has been lost and the stock is likely to be under some pressure in Thursday trading. Revenio expects that there will be more clarity regarding the regulatory guidance on the entire home use category in the United States at a later date. The product is already being sold in other geographies. Icare generates most of its sales from its eye care professional product Icare PRO tonometry. Revenio group also has other segments but the health care segment has been generating much of the returns.
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