Post by icemandios on Apr 30, 2018 23:48:36 GMT
Neovasc Provides a General Update, Announces Filing of Annual Report on Form 20-F and Sets First Quarter 2018 Financial Results Conference Call and Webcast
NASDAQ, TSX: NVCN
VANCOUVER, April 30, 2018 /PRNewswire/ - Neovasc Inc. ("Neovasc" or the "Company") (NASDAQ, TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve replacement technologies, today provided a general corporate update, concurrent with filing its Annual Report on Form 20-F, to highlight the Company's progress over the last month and to confirm the date of the earnings call where these matters will be discussed further.
Operational Highlights
Implanted an additional six Tiaras™ ("Tiaras") since March 28, 2018 to bring the total to 56
Continuing progress on the Tiara transfemoral, trans-septal program
Additional publications and presentations supporting Neovasc Reducer™ ("Reducer") efficacy
Corporate Highlights
Received additional US$4.7 million in proceeds from investor-initiated exercises of Series C warrants (the "Series C Warrants") issued pursuant to the November 2017 underwritten public offering (the "2017 Public Transaction")
Reports 1,681,060,920 common shares of the Company ("Common Shares") issued and outstanding as at the date hereof
Continuing efforts to right-size the Company's capital structure
Continuing efforts to resolve legal matters and strengthen intellectual property portfolio
The Company has filed its Annual Report on Form 20-F with the U.S. Securities and Exchange Commission (the "SEC"). Please visit www.sec.gov to review the filing and for further details on these highlights.
The Company has completed six Tiara implants since March 28, 2018, the date of its last update; four for the Tiara-II study in Europe ("TIARA-II") and two for the Tiara-I study in Canada ("TIARA-I"). The apical in/out procedure time for these most recent four TIARA-II implants were 9 minutes, 9 minutes, 10 minutes and 12 minutes, respectively. For the two recent TIARA-I implants, they were 11 minutes and 45 minutes (mainly due to challenging echo imaging quality). To date, a total of 56 patients have been implanted with the Tiara. The 30-day survival rate remains at 90% overall and is at 92% for the TIARA-II study.
Furthermore, the Company remains on schedule for the first, small animal feasibility study for the transfemoral, trans-septal Tiara version in the first half of May 2018.
The Company reports that the Reducer was presented in several new publications:
EMH Media (Schweizerischer Ärzteverlag), Cardiovascular Medicine, 2018/04, Coronary Sinus Reducer Case Report, Dr. Kahr, at all, University Hospital of Zurich.
Journal of the American College of Cardiology ("JACC") publication, Vol. 11, No. 8, 2018: "Coronary Sinus Reducer Implantation for the Treatment of Chronic Refractory Angina", a single center experience, Dr. F. Giannini, et al.
Editorial in the same JACC edition by Dr. Wijns and Dr. Behan: "New Treatment Options for the "No Option" Patient with Refractory Angina".
An associated TCTMD publication from April 16, 2018 by Todd Neal, with comments from Dr. Suzanne Arnold.
EuroIntervention Online publication from April 24, 2018: "Coronary Sinus Reducer implantation improves symptoms, ischemia and physical capacity in patients with refractory angina unsuitable for myocardial revascularization", a single center experience, Dr. M. Konigstein, et al.
The Company has received an additional US$4,666,099 in proceeds from investor-initiated exercises of an additional 3,195,958 of the Series C Warrants. 10,273,972 Series C Warrants were originally issued in the 2017 Public Transaction, and 2,192,748 remained issued and outstanding at the close of business on April 24, 2018. Each Series C Warrant may be exercised at an exercise price equal to US$1.46 (subject to adjustment) at any time prior to 11:59 p.m. (New York time) on November 18, 2019 for a Series C unit (a "Series C Unit"), with each Series C Unit being comprised of one Common Share, one Series A warrant (a "Series A Warrant") and one Series B warrant (a "Series B Warrant").
At the close of business on April 24, 2018, there were 1,251,641 Series B Warrants outstanding and 2,192,748 Series B Warrants issuable upon exercise of the remaining Series C Warrants outstanding, if those Series C Warrants are exercised, 33,757,592 Series A Warrants outstanding and 2,192,748 Series A Warrants issuable upon exercise of the remaining Series C Warrants outstanding, if those Series C Warrants are exercised, 22,431,507 Series E warrants (the "Series E Warrants") outstanding and US$29,525,000 aggregate amount of senior secured convertible notes (the "Notes") outstanding. There were no Series D or F warrants outstanding or issuable at the same date.
There were 1,681,060,920 Common Shares issued and outstanding at the close of business on April 24, 2018. The decline in our share price since our last earnings call has led to the future-priced warrants and Notes outstanding as at that date being more dilutive than estimated at the time of the earnings call.
The Company is continuing its efforts to reduce the warrant overhang of the last financing. The Company will also be seeking shareholder approval at the next Annual and Special General Meeting, scheduled for June 4, 2018, to carry out a share consolidation at an appropriate time. Further information will be contained in the Management Information Circular for the Annual and Special General Meeting. Management believes that this is the only path forward to re-establish compliance with the US$1.00 minimum bid price requirement for listing on the Nasdaq Capital Market.
The Company announced that it will report financial results for the quarter ended March 31, 2018 and host a conference call and webcast at 4:30pm Eastern Time on Thursday, May 10, 2018. Management will provide a full update, including further discussion on these matters, during the call and in its filings.
Conference Call & Webcast
Thursday, May 10th @ 4:30pm Eastern Time
Domestic:
800-239-9838
International:
323-794-2551
Passcode:
9386338
Webcast:
public.viavid.com/index.php?id=129196
Replays available through May 24th:
Domestic:
844-512-2921
International:
412-317-6671
Conference ID:
9386338
About the Securities Issued in the November 2017 Financings
For details concerning the terms of the securities issued pursuant to the 2017 Public Transaction and concurrent private placement (together with the 2017 Public Transaction, the "2017 Financings"), including the Series A Warrants, Series B Warrants, Series C Warrants, Series E Warrants and the Notes, see the prospectus supplement dated November 10, 2017 and the forms of such securities filed on SEDAR at www.sedar.com and with the SEC at www.sec.gov. For a description of the risks associated with these securities, including dilution to shareholders due to exercises or conversions of the Company's outstanding warrants (the "Warrants") and Notes, and the Company's need for significant additional funding, among other things, see the Company's Annual Report on Form 20-F, which is available on SEDAR at www.sedar.com and as filed with the SEC at www.sec.gov.
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 Reducer, for the treatment of refractory angina, which is not currently available in the United States and has been available in Europe since 2015, and the Tiara, for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada and Europe. For more information, visit: www.neovasc.com.
NASDAQ, TSX: NVCN
VANCOUVER, April 30, 2018 /PRNewswire/ - Neovasc Inc. ("Neovasc" or the "Company") (NASDAQ, TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve replacement technologies, today provided a general corporate update, concurrent with filing its Annual Report on Form 20-F, to highlight the Company's progress over the last month and to confirm the date of the earnings call where these matters will be discussed further.
Operational Highlights
Implanted an additional six Tiaras™ ("Tiaras") since March 28, 2018 to bring the total to 56
Continuing progress on the Tiara transfemoral, trans-septal program
Additional publications and presentations supporting Neovasc Reducer™ ("Reducer") efficacy
Corporate Highlights
Received additional US$4.7 million in proceeds from investor-initiated exercises of Series C warrants (the "Series C Warrants") issued pursuant to the November 2017 underwritten public offering (the "2017 Public Transaction")
Reports 1,681,060,920 common shares of the Company ("Common Shares") issued and outstanding as at the date hereof
Continuing efforts to right-size the Company's capital structure
Continuing efforts to resolve legal matters and strengthen intellectual property portfolio
The Company has filed its Annual Report on Form 20-F with the U.S. Securities and Exchange Commission (the "SEC"). Please visit www.sec.gov to review the filing and for further details on these highlights.
The Company has completed six Tiara implants since March 28, 2018, the date of its last update; four for the Tiara-II study in Europe ("TIARA-II") and two for the Tiara-I study in Canada ("TIARA-I"). The apical in/out procedure time for these most recent four TIARA-II implants were 9 minutes, 9 minutes, 10 minutes and 12 minutes, respectively. For the two recent TIARA-I implants, they were 11 minutes and 45 minutes (mainly due to challenging echo imaging quality). To date, a total of 56 patients have been implanted with the Tiara. The 30-day survival rate remains at 90% overall and is at 92% for the TIARA-II study.
Furthermore, the Company remains on schedule for the first, small animal feasibility study for the transfemoral, trans-septal Tiara version in the first half of May 2018.
The Company reports that the Reducer was presented in several new publications:
EMH Media (Schweizerischer Ärzteverlag), Cardiovascular Medicine, 2018/04, Coronary Sinus Reducer Case Report, Dr. Kahr, at all, University Hospital of Zurich.
Journal of the American College of Cardiology ("JACC") publication, Vol. 11, No. 8, 2018: "Coronary Sinus Reducer Implantation for the Treatment of Chronic Refractory Angina", a single center experience, Dr. F. Giannini, et al.
Editorial in the same JACC edition by Dr. Wijns and Dr. Behan: "New Treatment Options for the "No Option" Patient with Refractory Angina".
An associated TCTMD publication from April 16, 2018 by Todd Neal, with comments from Dr. Suzanne Arnold.
EuroIntervention Online publication from April 24, 2018: "Coronary Sinus Reducer implantation improves symptoms, ischemia and physical capacity in patients with refractory angina unsuitable for myocardial revascularization", a single center experience, Dr. M. Konigstein, et al.
The Company has received an additional US$4,666,099 in proceeds from investor-initiated exercises of an additional 3,195,958 of the Series C Warrants. 10,273,972 Series C Warrants were originally issued in the 2017 Public Transaction, and 2,192,748 remained issued and outstanding at the close of business on April 24, 2018. Each Series C Warrant may be exercised at an exercise price equal to US$1.46 (subject to adjustment) at any time prior to 11:59 p.m. (New York time) on November 18, 2019 for a Series C unit (a "Series C Unit"), with each Series C Unit being comprised of one Common Share, one Series A warrant (a "Series A Warrant") and one Series B warrant (a "Series B Warrant").
At the close of business on April 24, 2018, there were 1,251,641 Series B Warrants outstanding and 2,192,748 Series B Warrants issuable upon exercise of the remaining Series C Warrants outstanding, if those Series C Warrants are exercised, 33,757,592 Series A Warrants outstanding and 2,192,748 Series A Warrants issuable upon exercise of the remaining Series C Warrants outstanding, if those Series C Warrants are exercised, 22,431,507 Series E warrants (the "Series E Warrants") outstanding and US$29,525,000 aggregate amount of senior secured convertible notes (the "Notes") outstanding. There were no Series D or F warrants outstanding or issuable at the same date.
There were 1,681,060,920 Common Shares issued and outstanding at the close of business on April 24, 2018. The decline in our share price since our last earnings call has led to the future-priced warrants and Notes outstanding as at that date being more dilutive than estimated at the time of the earnings call.
The Company is continuing its efforts to reduce the warrant overhang of the last financing. The Company will also be seeking shareholder approval at the next Annual and Special General Meeting, scheduled for June 4, 2018, to carry out a share consolidation at an appropriate time. Further information will be contained in the Management Information Circular for the Annual and Special General Meeting. Management believes that this is the only path forward to re-establish compliance with the US$1.00 minimum bid price requirement for listing on the Nasdaq Capital Market.
The Company announced that it will report financial results for the quarter ended March 31, 2018 and host a conference call and webcast at 4:30pm Eastern Time on Thursday, May 10, 2018. Management will provide a full update, including further discussion on these matters, during the call and in its filings.
Conference Call & Webcast
Thursday, May 10th @ 4:30pm Eastern Time
Domestic:
800-239-9838
International:
323-794-2551
Passcode:
9386338
Webcast:
public.viavid.com/index.php?id=129196
Replays available through May 24th:
Domestic:
844-512-2921
International:
412-317-6671
Conference ID:
9386338
About the Securities Issued in the November 2017 Financings
For details concerning the terms of the securities issued pursuant to the 2017 Public Transaction and concurrent private placement (together with the 2017 Public Transaction, the "2017 Financings"), including the Series A Warrants, Series B Warrants, Series C Warrants, Series E Warrants and the Notes, see the prospectus supplement dated November 10, 2017 and the forms of such securities filed on SEDAR at www.sedar.com and with the SEC at www.sec.gov. For a description of the risks associated with these securities, including dilution to shareholders due to exercises or conversions of the Company's outstanding warrants (the "Warrants") and Notes, and the Company's need for significant additional funding, among other things, see the Company's Annual Report on Form 20-F, which is available on SEDAR at www.sedar.com and as filed with the SEC at www.sec.gov.
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 Reducer, for the treatment of refractory angina, which is not currently available in the United States and has been available in Europe since 2015, and the Tiara, for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada and Europe. For more information, visit: www.neovasc.com.