Specialty medical device company that develops, manufactures and markets products for the rapidly growing cardiovascular marketplace, Neovasc, Inc. (NASDAQ:NVCN), provides investors with an update on its newest program.
VANCOUVER, Dec. 6, 2016 /PRNewswire/ – Neovasc Inc. (“Neovasc” or the “Company”) (NVCN) (NVC.TO) today provided an update on the clinical experience with its Tiara™ transcatheter mitral valve. Tiara™ is a novel transcatheter device designed to treat mitral regurgitation (MR), a condition that is often severe and can lead to heart failure and death.
To date, 22 patients have been treated with the Tiara™ valve at medical centers in Canada, the U.S. and Europe with more implantations scheduled for the coming weeks. The technical success rate in these implantations was 19/22 or 86%. In these technically successful implantations, paravalvular leak levels were reported as mild, trace or absent in 100% of these cases. All cause 30-day mortality in the 19 patients who have reached 30 days post implant with Tiara™ is 15.7% (3/19). The 3 remaining patients treated within the last 30 days are recovering well. Of note, there has been no 30-day mortality reported in any of the last 8 patients treated over a month ago.
To date, the longest patient follow up available is nearing 3 years post implant, where the Tiara™ valve remains fully functional. There have been no reported adverse events related to the valve performance. There have been no frame fractures, or any device performance issues observed with the Tiara™ in any patient follow-up.
The results noted above were presented today by Dr. Shmuel Banai, at the ICI Meeting 2016 (ICI) in Tel Aviv, Israel. ICI is the premier International Conference for Innovations in Cardiovascular Systems.
Tiara has demonstrated the ability to treat a range of different patient anatomies, including patients with pre-existing prosthetic aortic valves (both mechanical and biological) and those with prior mitral repair surgery including mitral rings, which may be contra indications for other devices.
“Tiara’s unique shape and trigonal tab anchoring system enables the device to be securely implanted with reduced risk of projecting into the LVOT or potentially interfering with prosthetic aortic valves which are commonly present in this patient population,” stated Alexei Marko, Neovasc CEO. “Furthermore, the Tiara anchoring system does not rely significantly on the integrity of the native mitral leaflets and therefore can be suitable for certain degenerative MR patients with flail leaflets or calcification. It has also been successfully shown that the design of Tiara makes it suitable for certain cases where mitral rings have been previously implanted in patients.”
TIARA II, a 115 patient, non-randomized, prospective clinical study evaluating Tiara’s safety and performance, recently received approval to begin enrolling patients in Italy. It is expected that data from this study will be used to file for CE Mark approval for Tiara™. CE Mark is the European Union (EU) regulatory approval to commercialize a medical device. It is anticipated that the first implantations in the TIARA II trial will be conducted by the medical team at San Raffaele Hospital in Milan, Italy in the first quarter of 2017. The Company will be initiating additional investigational sites in 2017 as required approvals are obtained.
Tiara™ is a self-expanding mitral bioprosthesis specifically designed to treat mitral valve regurgitation (MR) by replacing the diseased valve. Conventional surgical treatments are only appropriate for about half of MR patients, who number an estimated four million in the U.S. with a similar number of patients effected throughout Europe. Tiara™ is implanted in the heart using a minimally invasive, transapical transcatheter approach and is designed to replace the diseased native mitral valve without the need for open-heart surgery or use of a cardiac bypass machine.
About Neovasc Inc.
Neovasc is a specialty medical device company that develops, manufactures and markets products for the rapidly growing cardiovascular marketplace. Its products include the Neovasc Reducer™, for the treatment of refractory angina which is not currently available in the U.S. and has been available in Europe since 2015 and the Tiara™, for the transcatheter treatment of mitral valve disease, which is currently under investigation in the US, Canada and Europe. The Company also sells a line of advanced biological tissue products that are used as key components in third-party medical products including transcatheter heart valves. For more information, visit: www.neovasc.com.
Neovasc, Inc. (NASDAQ:NVCN) shares have moved -11.57% on the news thus far today and have traded in the range of $1.96 – 2.53 during the current session. In order to take a look at where the stock might be headed longer term, investors often look to research firms that cover the stock. Sell-side research firms currently have a consensus one-year price target of $8.08 on the stock. This is according to brokerage analysts polled by Thomson Reuters First Call. The sell-side analysts are projecting earnings per share of $-0.09 for the next fiscal quarter. For the current year, analysts are predicting earnings of $-1.44 per share according to First Call.
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In looking at where the stock is trading on a technical level, the stock is trading +232.45% away from its 50-day moving average of $0.64. Based on the most recent available data, the equity is -56.68% off of its 52-week high of $4.94 and +478.38% away from its 52-week low which is $0.37.
Today, the stock opened at $2.40 and the last bid at the time of writing stood at $2.14. During the session thus far, the equity dipped down to $1.96 and touched $2.53 as the high point. Neovasc, Inc. (NASDAQ:NVCN) has a market cap of $143.09M and has seen an average daily volume of 3,830,660 over the past three months.
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