Allium Medical Solutions: It Is All About Business Execution
Edison | Jan 02, 2018 06:59AM ET
Gardia Medical’s Wirion device is on track for FDA submission, expected by end-2017; approval is possible in Q218. If approved, it would become the only embolic protection system for all atherectomy procedures in the legs which we think will help to reach a strategic transaction. Furthermore, Allium Medical Solutions Ltd (TA:ALMD) Stents and IBI Medical are expected to gain approval in Russia in 2018 while approval in China is expected in early 2018. We expect initial revenues from Mexico in Q417 and from the strategic agreement in Russia in H118. In addition, Allevetix is due to start a clinical trial in the next few months and TruLeaf is progressing its large animals study. Our updated valuation is NIS1.68/share.
Gardia’s Wirion system nears FDA submission
Gardia is pursuing US approval of its Wirion device following strong data from the WISE-LE trial which met its primary and secondary endpoints early. Positive data on debris capture has been released and will be presented at the ISET conference in Florida in February 2018. A 510(k) submission to the FDA is expected by the end of the year; an approval decision could come in Q218. If approved, Wirion would become the only protection system cleared for all atherectomy procedures in the US. The company is advancing towards a strategic transaction for Gardia. We model Wirion revenue of NIS2.8m after full launch in 2018e, to NIS8.6m in 2020e.
To read the entire report Please click on the pdf File Below:
Get The News You Want
Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.