|Over a week ago|
Neovasc files for CE Mark for Tiara TA Transapical system » 09:4305/2705/27/20
Neovasc announced that…
Neovasc announced that the company has filed for CE Mark for its Tiara TA Transapical mitral valve replacement system. Mitral Valve disease is one of the most common forms of heart disease that affects millions of patients worldwide. Traditional heart valve replacement surgery requires patients to be placed on a heart-lung bypass machine and results in lengthy recovery time. The Tiara TA transapical mitral valve replacement system uses a percutaneous or "key-hole" incision in the chest to completely replace the native mitral valve and avoids the need for heart-lung bypass. The less invasive approach may allow for more patients to be treated and more rapid recovery. In April, the European Parliament voted overwhelmingly to extend the Medical Device Directive by one year rather than to transition to a new approval process known and the European Medical Device Regulation.
Neovasc seeing return of elective procedures, progress on capital structure » 17:0605/2605/26/20
Neovasc announced a…
Neovasc announced a corporate update on its progress towards its value creation strategies. Fred Colen, Chief Executive Officer of Neovasc, commented, "Today's corporate update is a testament to the teamwork and commitment of our employees, physician partners and regulators around the globe. We would like to thank the investors who have given us the opportunity to advance our programs and we are thrilled to continue to advance our value creation strategies." We are beginning to see a return of elective procedures in Germany and other European markets. After a marked slowdown that began in March, Reducer implant rates in Germany, where the company has a direct sales team and NUB Status 1 designation for reimbursement, are once again approaching pre-COVID-19 levels. As previously discussed, the company is aware of the backlog of potential Reducer patients related to COVID-19 and the reduction in elective procedures in select European markets and we look forward to continued acceleration. The National Institute for Health and Care Excellence Interventional Procedures Programme in the U.K. has invited Neovasc to participate in guidance development for Reducer treatment of refractory angina. Neovasc is honored to be considered for review by NICE and we look forward to further collaboration as we establish the value of Reducer therapy in the United Kingdom. In the United States, the Reducer FDA Pre-Market Approval milestones continue to progress, with our "100-day Meeting" recently completed. The Company has applied for CE Mark Approval under the Medical Device Directive for the Tiara TA transapical mitral valve replacement system. The Company is working interactively with our Notified Body in Europe, to advance our submission. We continue to make progress with our transfemoral Tiara TF mitral valve replacement system program with the completion of several recent animal implants. We remain focused on a first-in-human implant towards the end of the year. Following the retirement of our 2017 notes, the recently announced financing of approximately $5M will enable the Company to support ongoing operations under terms more favorable to the Company, including the removal of the particularly onerous provisions that have challenged our capital structure since 2017. The Company believes our revamped capital structure will substantially improve the Company's ability to raise additional equity capital to fund the company to its critical milestones in 2020 and early 2021.
Neovasc price target lowered to $5 from $9 at H.C. Wainwright » 07:2705/0805/08/20
H.C. Wainwright analyst…
H.C. Wainwright analyst Vernon Bernardino lowered the firm's price target on Neovasc to $5 from $9 and reiterates a Buy rating on the shares following the company's Q1 results. The quarter showed the company started 2020 with strong Reducer revenues in January and February and was on track to have its best revenue quarter ever until the impact of the COVID-19 pandemic became widespread in March, Bernardino tells investors in a research note. The analyst remains bullish on the prospects of Reducer, a novel catheter-based treatment for refractory angina.
|Over a month ago|
Fly Intel: Top five analyst initiations » 10:2604/1304/13/20
RAPT, ALLO, CARR, TTGT, NVCN
Catch up on today's…
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Rapt Therapeutics (RAPT) initiated with a Buy at Roth Capital. 2. Allogene Therapeutics (ALLO) initiated with a Buy at SunTrust. 3. Carrier Global (CARR) initiated with a Neutral at Citi. 4. TechTarget (TTGT) initiated with a Buy at National Securities. 5. Neovasc (NVCN) initiated with an Outperform at Noble Capital. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.
Neovasc initiated with an Outperform at Noble Capital » 09:1604/1304/13/20
Noble Capital initiated…
Noble Capital initiated coverage of Neovasc with an Outperform rating and $15 price target.
|Over a quarter ago|
Neovasc expects current cash to last until August » 09:1403/0403/04/20
The company said,…
The company said, "The company had $14.1M cash on hand following the early January capital raise, and current cash is expected to last us until August of this year. Significantly, this capital will last beyond the maturity date of the remaining 2017 convertible notes on May 17, 2020. Retiring or amending those notes will be a positive step forward for the Company."
Neovasc targets obtaining CE Mark for TA Tiara by 2021 or earler » 09:1303/0403/04/20
The company said,…
The company said, "Eighty-two patients have been treated to date with transapical Tiara, and after extensive analysis of all Clinical data, the company believes there is sufficient evidence from the Tiara I and II clinical studies to support a CE Mark. Management plans to submit for CE Mark under the new European MDR regulations in 2020 and is targeting obtaining a CE Mark for the TA Tiara by 2021 or earlier. Regarding the next generation, transfemoral/trans-septal Tiara, the design has been frozen, and we are on track for clinical trials, including a first-in-human implant, by the end of 2020. Neovasc is targeting the large unmet need for mitral valve regurgitation and optimal treatment will require a variety of treatment options. The TF/TS Tiara features a unique "D shape" which mimics the native anatomy and is designed to avoid left ventricular outflow tract obstruction. Additionally, the TF/TS Tiara features full retrievability of the device after the atrial and ventricular portions of the valve have been deployed, until the point of final release. This key feature should further reduce implant risk for the patient, which combined with longer term functional benefits may provide many mitral valve regurgitation patients a new treatment option."
Neovasc expects further clarity on PMA application for Reducer in 2020 » 09:1103/0403/04/20
The company said,…
The company said, "The Company is increasingly bullish on Reducer and remains focused on capitalizing on the improving market dynamics for the device. Management believes the landscape for the treatment of refractory angina and ischemia is changing favorably. Focus in Interventional Cardiology is shifting towards the treatment of Angina for chronic ischemic patients either with or without coronary artery obstruction. There is growing interest in physiology driven by new diagnostic tools and new European Guidelines, to differentiate between angina caused by obstructive coronary artery disease or microvascular disease. The increasing rate of diagnosis of microvascular disease provides support for the treatment of refractory angina with the Reducer in appropriate patients. Additionally, Neovasc believes it has established the partnerships needed in Europe and is making significant progress selling Reducer in Germany with a newly expanded sales force, as evidenced by strong double-digit revenue growth. The company is in on-going discussions with FDA regarding the PMA application for the Reducer filed in late December. We are encouraged with the feedback to date and will continue to work with the FDA during the review process. We expect further clarity during the course of 2020."
Neovasc says Reducer featured in peer reviewed EuroIntervention » 09:0803/0303/03/20
Neovasc announced the…
Neovasc announced the Neovasc Reducer was featured in the peer reviewed publication EuroIntervention, the official Journal of EuroPCR and the European Association of Percutaneous Cardiovascular Interventions and highlighted in PCR Online. In the study published in EuroIntervention, "Coronary sinus Reducer implantation results in improved oxygen kinetics at cardiopulmonary exercise test in patients with refractory angina," in patients with obstructive coronary artery disease suffering from chronic refractory angina, treatment with coronary sinus Reducer implantation was associated with objective improvement in exercise capacity and oxygen kinetics tested by cardiopulmonary exercise testing as well as improvement in angina symptoms and quality of life. Patients with chronic refractory angina were treated with Reducer implantation at 2 medical centers: the Antwerp Cardiovascular Center in Belgium and the Tel Aviv Medical Center in Israel. An additional case report published in PCR Online entitled, "Coronary sinus reducer for microvascular angina," highlighted the successful implantation of the Reducer in a 61 year-old man with a history of coronary artery stenting, hypertension, type-2 diabetes and recurrent episodes of CCS class III-IV angina despite having non-obstructive coronary artery disease. Cardiac microcirculation testing revealed microvascular ischemia despite patent coronary arteries. The patient was treated with a Reducer and demonstrated objective improvement in microvascular coronary blood flow. He became asymptomatic in the weeks following the procedure.
SVB Leerink to hold a conference » 04:5502/2702/27/20
ABBV, BBIO, CYAD, DCPH, FULC, GH, IMVT, INGN, LMAT, NUAN, NVCN, RARE, QURE, SELB, VCEL, RDUS, PODD, RDHL, TCRR, ORGO, OSMT, MLND, ITCI, IFRX, STSA, MIRM
9th Annual Global…
9th Annual Global Healthcare Conference will be held in New York on February 25-27.