Carmat: Green Light To Conclude Feasibility Study
Edison | Nov 30, 2015 07:16AM ET
Green light to conclude feasibility study
Carmat (PA:ALCAR) has obtained regulatory authorisation to conclude the feasibility study of its artificial heart and to adopt a new clinical protocol enabling patients with less severe heart failure to participate. This should pave the way for a CE mark study in 2016 and could lead to a launch in CE mark regions in H217. Our valuation is raised from €591m to €611m (€129/share).
Regulators approve final step in feasibility study
The French health regulator (ANSM) and person protection committee (CPP) have given Carmat the go-ahead to finalise the four-person feasibility study of its novel artificial heart. This follows a review of Carmat’s proposed solutions to address the malfunctioning of the device in an earlier patient, caused by a minute leak of blood into the activating liquid of the prosthesis. Carmat aims to start a pivotal study in early 2016, which may pave the way for a CE mark grant and launch in 2017.
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.