NASDAQ: NVCN
TSX: NVC
- Tiara Clinical Updates presented at TVT and
ISMICS Medical Conferences -
VANCOUVER, June 20, 2016 /PRNewswire/ - Neovasc Inc.
("Neovasc" or the "Company") (NASDAQ: NVCN) (TSX:
NVC) reported today that the positive results of a single center,
retrospective study using the Reducer product were published in the
June 14, 2016 issue of The
Netherlands Heart Journal in an article titled "Safety and efficacy
of a device to narrow the coronary sinus for the treatment of
refractory angina: A single center real world experience". The
paper documented the results from 23 consecutive patients who were
implanted with the Reducer in order to treat their severe
refractory angina.
The published results demonstrated that in all 23 patients the
Reducer device was successfully implanted in a day hospital setting
without any adverse events. After a median follow-up of 9
months (range 8 – 14 months) it was found that 17 of 23 patients
showed at least one class improvement in their Canadian
Cardiovascular Society (CCS) angina score: 8 patients (34.8%)
improved by 1 CCS class, 7 (30.4%) by 2 CCS classes and 2 (8.7%) by
3 CCS classes.
"Despite the large range of available anti-ischaemic medical
therapies and revascularization techniques, a considerable number
of patients still suffer from angina which is refractory to medical
treatment," said Dr. Pierfrancesco
Agostoni, Interventional Cardiologist and senior author of
the study. "The results from this real world cohort, albeit from
one centre and a relatively small sample size, are consistent with
previous studies using Reducer such as COSIRA and found Reducer
implantation to be safe and efficacious, with the majority of
patients demonstrating significant improvement in angina symptoms
following treatment."
All the cases were performed at University Medical Center
Utrecht, Utrecht, The
Netherlands. The authors of the report include M. Abawi, F.
Nijhoff, P.R. Stella, M. Voskuil, D.
Benedetto, P.A. Doevendans and P. Agostoni. The article is
available at SpringerLink with Open Access
(http://link.springer.com/article/10.1007/s12471-016-0862-2).
In 2016 Neovasc initiated the REDUCER-I (An Observational Study
of the Neovasc Reducer™ System), in Belgium, Germany, the
Netherlands, Switzerland
and the United Kingdom. The study
is a 400 patient, 40 site, post market, multi-center, multi-country
three-arm, five-year follow-up study. Its primary endpoint is
the percentage of subjects who experience improvement in their
angina symptoms defined as a reduction in CCS grade at 6 months as
compared to baseline. This study is intended to provide
further clinical evidence supporting the use of the Reducer in this
patient population.
Tiara Clinical Update
Separately, several clinical
updates on Neovasc's Tiara transcatheter mitral valve product were
recently presented at key physician meetings in the US and
Canada. Tiara was featured in a number of presentations given
at the Transcatheter Valve Therapies (TVT) Conference held in
Chicago June 16-18. Dr. Martin
Leon presented an update on the Tiara clinical experience to
date. This presentation included case examples and a summary
of results from the 17 patients treated to date with Tiara at
centers in Belgium, Canada, Germany, Italy and the US. Of these initial
implantations, 14 of 17 (82%) were successful with excellent acute
results; 3 of the 17 patients were converted to open-heart
surgery. The 30-day all cause mortality rate in patients
implanted with Tiara was 3/17 (18%). The two longest follow-ups to
date have been 2.5 years and 2 years both with excellent ongoing
valve function. No mitral regurgitation, paravalvular leaks or
device fractures have been noted in any of the patient follow-up
echocardiographic assessments. In a separate session at TVT,
Dr. John Webb presented a videotaped
case of a 40mm Tiara device being implanted in a procedure
conducted at St. Paul's Hospital
in Vancouver Canada to treat a
patient with severe MR. Tiara was also featured in a
presentation given by Dr. Anson
Cheung at the 16th annual scientific meeting of
the International Society for Minimally Invasive Cardiothoracic
Surgery (ISMICS) held in Montreal
Canada June 15-18. During this
presentation Dr. Cheung provided an overview of the Tiara device
and provided a summary of the clinical results to date.
About Reducer
The Reducer is CE-marked in the European Union for the treatment of
refractory angina, a painful and debilitating condition that occurs
when the coronary arteries deliver an inadequate supply of blood to
the heart muscle, despite treatment with standard revascularization
or cardiac drug therapies. It affects millions of patients
worldwide, who typically lead severely restricted lives as a result
of their disabling symptoms, and its incidence is growing. The
Reducer provides relief of angina symptoms by altering blood flow
in the heart's circulatory system, thereby increasing the perfusion
of oxygenated blood to ischemic areas of the heart muscle.
Placement of the Reducer is performed using a minimally invasive
transvenous procedure that is similar to implanting a coronary
stent and is completed in approximately 20 minutes.
About Neovasc Inc.
Neovasc is a specialty medical device company that develops,
manufactures and markets products for the rapidly growing
cardiovascular marketplace. Its products in development
include the Tiara™, for the transcatheter treatment of mitral valve
disease and the Neovasc Reducer™ for the treatment of refractory
angina. 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.
This news release contains forward-looking statements within
the meaning of the U.S. Private Securities Litigation Reform Act of
1995 and applicable Canadian securities laws, including statements
that the study found Reducer implantation to be safe and
efficacious, that the majority or patients demonstrated significant
improvement in angina symptoms, and the intention to use the
REDUCER-I study to provide further clinical evidence supporting
Reducer use. The words "may", "will" and "intend" are intended
to identify these forward-looking statements. Forward-looking
statements are based on estimates and assumptions made by the
Company in light of its experience and its perception of historical
trends, current conditions and expected future developments, as
well as other factors that the Company believes are appropriate in
the circumstances. Many factors and assumptions could cause
the Company's actual results, performance or achievements to differ
materially from those expressed or implied by the forward-looking
statements, including, without limitation, potential changes in
circumstances relating to the Company's financing requirements,
whether as a result of unforeseen circumstances or otherwise; the
conduct or possible outcomes of any actual or threatened legal
proceedings, including any post-trial motions or appeals, which are
inherently uncertain; the potential benefits of the Neovasc
Reducer™ and Tiara™ as compared with other products; successful
enrollment of patients in studies and trials for the Neovasc
Reducer™ and Tiara™; results of the trials and studies for the
Neovasc Reducer™ and Tiara™ that meet the Company's expectations;
the Company's receipt of any required local and institutional
regulatory approvals and the timing and costs of obtaining such
approvals; European enrollment in our clinical trials, studies and
compassionate use cases and the success of applications
in Europe; the Company's ability to protect its intellectual
property; the Company's ability to raise additional funding;
changes in business strategy or development plans; existing
governmental regulations and changes in, or the failure to comply
with, governmental regulations and general economic and business
conditions, both nationally and in the regions in which the Company
operates. These risk factors and others relating to the Company are
discussed in greater detail in the "Risk Factors" section of the
Company's Annual Information Form, which is included in its Annual
Report on Form 40-F (copies of which filings may be obtained
at www.sedar.com or www.sec.gov). These
factors should be considered carefully, and readers should not
place undue reliance on the Company's forward-looking
statements. The Company has no intention and undertakes no
obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise,
except as required by law.
SOURCE Neovasc Inc.