Neovasc Inc (US) (NASDAQ:NVCN) investors are overwhelmingly excited today after the medical device maker provided a positive 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.
Neovasc shares reacted to the news, jumping 57% to $2.23 in Tuesday’s trading session.
“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. (Original Source)
On the ratings front, NVCN stock has been the subject of a number of recent research reports. In a report issued on December 2, Leerink analyst Danielle Antalffy reiterated a Buy rating on NVCN, with a price target of $10, which represents a potential upside of 465% from where the stock is currently trading. Separately, on August 10, Canaccord’s Jason Mills reiterated a Buy rating on the stock.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Danielle Antalffy and Jason Mills have a yearly average return of 9.7% and 1.1% respectively. Antalffy has a success rate of 53% and is ranked #412 out of 4256 analysts, while Mills has a success rate of 50% and is ranked #1468.
Neovasc, Inc. operates as a specialty medical device company that develops and manufactures products for the rapidly growing cardiovascular device marketplace. Its products include the Neovasc Reducer for the treatment of refractory angina, the Tiara technology in development for the transcatheter treatment of mitral valve disease and a line of advanced biological tissue products that are used as key components in a variety of third-party medical products, such as vascular surgical patches and transcatheter heart valves. The company also offers pericardial tissue processing, vascular product development, design and manufacturing solutions to industry partners.