(Image via Neovasc Inc.)
The Healthcare sector has a wide selection of companies with a diverse array of verticals, each boasting unique core technology to address vastly different issues that affect millions around the world.
One serious condition that persists is chronic, refractory angina (RA) pectoris, which affects millions of patients worldwide and, despite optimal medical or surgical treatments, the chest pain it causes can be difficult for patients. Methods to treat this condition represent a potential multi-billion-dollar opportunity.
RA is an expensive, often debilitating condition and both patients and physicians are looking for new alternatives ….
Enter: Neovasc Inc. (TSX: NVCN, OTCQB: NVCN, Forum) is a specialty medical device company that develops, manufactures and markets products for the rapidly growing cardiovascular marketplace.
While more than 1.2 million patients undergo stent (PCI) and bypass surgery (CABG) procedures per year in the US and EU, more than 250,000 of those patients who are already revascularized continue to experience angina, even with contemporary stents or bypass surgery. Additionally, there are over 5 million patients in the United States that suffer from mitral valve regurgitation (MR). Patients suffering from MR suffer from shortness of breath and have a decreased life-expectancy.
The Vancouver-based company is out to change that through the development of its minimally invasive transcatheter mitral valve replacement technologies, and minimally invasive devices for the treatment of RA.
Its products include the Neovasc Reducer (pictured above right), for the treatment of RA, which is not currently commercially available in the United States, but has been commercially available in Europe since 2015, and Tiara (pictured left), for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada, Israel, and Europe. Let’s dig a little deeper into these platforms:
Neovasc Reducer:
This device provides relief by altering blood flow within the heart's myocardium and increasing the perfusion of oxygenated blood to ischemic areas of the heart.
Placement involves a minimally invasive transvenous procedure that lasts approximately 20 minutes.
The Reducer has received its Conformitè Europëenne (CE) Mark, the EU’s mandatory conformity grading for regulating all goods sold within the Europe.
It is also under investigation in the United States for the treatment of RA, 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 because of their disabling symptoms, and its incidence is growing. The Reducer provides relief of angina symptoms by altering blood flow within the myocardium of the heart and increasing the perfusion of oxygenated blood to ischemic areas of the heart muscle.
The US Food and Drug Administration (FDA) granted the Reducer a Breakthrough Device designation in October 2018. The designation is granted to devices with potential to provide a more effective treatment of life-threatening or irreversibly debilitating diseases.
In June 2021, the Reducer received its first national reimbursement from England’s National Health Service.
The NHS included the Reducer in the High-Cost Tariff Excluded Devices (HCTED) national catalogue, a purchase and supply system for medical devices designed to support the accelerated adoption of effective new technologies. Hospital providers can now order the Reducer and bill the cost of the device directly to the NHS.
The Reducer is CE-marked in the European Union for the treatment of RA, a debilitating condition that occurs when the coronary arteries won’t deliver enough blood supply to the heart, despite treatment with standard revascularization or cardiac drug therapies.
REDUCER-I: Real World Clinical Trial Results
(Image via Neovasc Inc. Click to enlarge.)
Professor Jonathan Hill, MD, Consultant Interventional Cardiologist at Royal Brompton & Harefield NHS Foundation Trust, London, commented that the clinical data on Reducer therapy, much of it developed in the UK, continues to demonstrate efficacy and excellent safety.
“Inclusion in the HCTED catalogue is an important step for Reducer therapy and will help new centers to begin utilizing the device. This is good news for the many patients suffering from refractory angina in the UK.”
Fred Colen, President and Chief Executive Officer of Neovasc, added that in expanding reimbursement for Reducer to enable broader market access has been a cornerstone of the value creation strategy at Neovasc.
“We are pleased with the NHS decision that follows the positive American Medical Association decision to establish a new Category III CPT code to report the transcatheter implantation of a coronary sinus reduction device. We are honored that the NHS has assessed the Reducer as an effective new therapy for patients.”
The Reducer has been studied and published in the New England Journal of Medicine, which is a significant publication in the eyes of the medical community and having such coverage adds confidence that the platform works, as very few medical technologies make it into the publication. With this coverage going for it, there is also reason to believe the device has merit.
(Image via Neovasc Inc. Click to enlarge.)
RA, resulting in continued symptoms despite maximal medical therapy and without revascularization options, is estimated to affect 600,000 to 1.8 million Americans, with 50,000 to 100,000 new cases every year.
COSIRA-II study:
In August 2021, Neovasc reported that it had filed a supplement to the Coronary Sinus Reducer for RA II (COSIRA-II) Investigational Device Exemption (IDE) Study with the FDA.
Following multiple productive discussions with the FDA over the past several months, the protocol for the previously approved COSIRA-II study has been supplemented in consideration of additional experience and key questions arising from the October 2020 Circulatory Systems Devices Panel Meeting regarding the Neovasc Reducer.
COSIRA-II is a randomized, sham-controlled trial investigating the safety and effectiveness of the Reducer for patients suffering from RA. The proposed primary endpoint of the trial is change in exercise tolerance testing time via a modified Bruce protocol between baseline and 6-month follow-up. The study is planned to enroll approximately 380 patients at up to 50 sites primarily in the United States.
The trial will include patients with Canadian Cardiovascular Society (CCS) Class III-IV RA on maximally tolerated medical therapy without further options for revascularization via coronary intervention or bypass grafting. The principal investigators of the trial are Gregg Stone, M.D., Mt. Sinai Health System, New York, NY and Tim Henry, M.D., Christ Hospital, Cincinnati, OH.
In a media release for investors on this news, Lisa Becker, the company’s Vice President of Regulatory Affairs, Global Angina Therapies, called the submission of the IDE Supplement is an important step as the team works toward commencing the trial later this year.
“Our intention is to run a definitive trial that will provide the clinical evidence to answer the outstanding questions from the FDA. The input from the COSIRA-II Executive Steering Committee as well as the discussions with FDA have been instrumental in our efforts to initiate and advance this trial.”
Neovasc Tiara:
A novel transcatheter device, the Neovasc Tiara is designed to treat mitral regurgitation (MR), a condition that is often severe and can lead to heart failure and death.
More than five million patients suffer from mitral regurgitation in the US and EU, according to data published in a 2015 study, “Secondary Mitral Regurgitation in Heart Failure”.
Prognosis is poor for patients who remain untreated and a vast majority of patients with MR do not receive adequate treatment due to complexity of disease and device solutions.
With no single approach to be found that could treat all patients, the company anticipates this to become a market valued at more than $2 billion by 2023. Initial Tiara results appear to be promising.
Additional Finite Element Analysis (FEA) work is underway to characterize device performance over time, as well as additional fatigue testing, which is required to validate device durability. Clinical results to date suggest strong device performance in vivo.
Neovasc’s management is targeting the second half of next year for a regulatory decision from the EU.
Meet the team:
Coming to the team with more than 20 years of experience in medical device regulatory affairs, Lisa Becker has dealt with medical devices from cardiac rhythm management to vascular support, pulmonary artery pressure monitoring, cardiac occluders, heart valves and most recently, structural heart products.
Having earned her Bachelor of Science in Organizational Behavior with a General Engineering minor from the United States Air Force Academy, she served nearly ten years on active duty in the US Air Force while obtaining her Master of Science.
Neovasc is also led by its CEO Fred Colen, who has seen success in commercializing new medical technology products. He was President and CEO of BeneChill, a brain cooling company and President of the Boston Scientific Cardiac Rhythm Management Group. He also served as Boston Scientific’s Chief Technology Officer for eight years.
Chief Operating Officer Bill Little, worked as Divisional Vice President of Global Marketing, and Head of Customer and New Market Insights at Abbott Vascular. He previously served as Vice President of Global Cardiovascular Therapies for St. Jude Medical and joined Abbott through the acquisition of the company. While at St. Jude Medical, Bill oversaw marketing and strategy for the structural heart and vascular portfolios.
Chief Financial Officer Chris Clark received his designation as a Chartered Accountant from the Institute of Chartered Accountants of England and Wales and articled with KPMG. He has an honors degree in Economics from Swansea University and a post graduate diploma from Keble College, Oxford.
Planning for Direct Sales Force Expansion:
(Image via Neovasc Inc. Click to enlarge.)
Investment summary:
Medical investments are often long-term plays and Neovasc Inc. has turned into an execution story with a reduced dilution risk, given the company’s recent $72M capital raise, something that should make investors, especially those involved in the health care space, sit up and take notice.
As COO Little explained in an interview with Stockhouse Editorial, Neovasc’s story is an engaging and straightforward proposition that targets a need that has gone underserved for millions for years … but that is about to change.
“People think they are having heart attacks and show up in the ER frequently because they have this chest pain and we are all taught when you have chest pain, go to the hospital. So that's what they do. They get a bunch of tests and frequently, they end up getting unnecessary procedures because the physicians were willing to just try anything. To have a therapy that has already been studied and published in the New England Journal of Medicine, that has been given breakthrough status by the FDA, This is a big deal. That’s our story.”
Backed by an experienced management team in this field, Neovasc generated revenues of approximately $633,000 in Q2 2021, up 123% from the same period in 2020, and a sequential 40% increase from Q1 2021. An additional capital raise of $72 million places the company in stronger position.
Neovasc is a very well funded operation with a solid medical and business plan set to advance key treatment platforms to alleviate unmet medical needs.
Investors have not seen the company’s full potential.
To find out more and stay up to date on the company’s news, visit neovasc.com.
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FULL DISCLOSURE: This is a paid article produced by Stockhouse Publishing.