Welcome to our dedicated page for Shockwave Medical news (Ticker: SWAV), a resource for investors and traders seeking the latest updates and insights on Shockwave Medical stock.
Overview
Shockwave Medical, Inc. is an innovative medical device company pioneering the interventional treatment of advanced cardiovascular disease. Employing breakthrough intravascular lithotripsy technology, the company addresses the persistent challenge of calcified plaque in atherosclerotic arteries. By integrating sonic pressure waves into its lithoplasty procedures, Shockwave Medical effectively disrupts rigid calcification while preserving the integrity of surrounding soft tissues, all with an easy-to-use push-button approach. This allows for gentle and effective balloon dilatation, thereby restoring blood flow in calcified, stenotic arteries.
Technology and Clinical Approach
The core of Shockwave Medical’s innovative approach lies in its lithoplasty catheter family. These devices harness sonic energy to selectively target and fracture calcified deposits, which is a critical advancement in the treatment of atherosclerotic cardiovascular disease. The technology’s design leverages decades of experience in areas such as kidney stone treatment, thereby translating proven safety and efficacy into the cardiovascular space. An integrated balloon catheter then allows for low-pressure dilatation of the targeted lesion, promoting a minimally invasive and patient-friendly intervention.
Market Position and Competitive Landscape
In a landscape where traditional treatments often struggle with heavily calcified lesions, Shockwave Medical has positioned itself at the forefront of interventional cardiology. The company’s lithoplasty procedures are supported by robust clinical evidence and are bolstered by the integration of devices such as the Shockwave Reducer, which is designed to alleviate symptoms in patients with refractory angina. This dual approach illustrates the company’s commitment to both disruption of calcified plaque and redistribution of blood flow, offering a comprehensive alternative to conventional revascularization techniques.
Clinical Evidence and Safety Profile
Shockwave Medical’s technologies have undergone rigorous clinical evaluation, demonstrating consistent procedural success with a favorable safety profile. Clinical studies have highlighted the efficacy of lithoplasty in safely modifying calcified lesions, while the Reducer technology has shown promising outcomes in reducing anginal symptoms in challenging patient cohorts. These outcomes are reinforced by data from multi-center observational studies and controlled clinical trials, supporting the company’s value proposition with solid clinical foundations.
Technology Integration and Ease of Use
The design philosophy underlying Shockwave Medical’s products emphasizes familiarity and simplicity. The procedures can be seamlessly integrated into existing cardiovascular treatment workflows, making the adoption process straightforward for clinicians. The platforms are engineered to operate at the push of a button, minimizing procedural complexity while maximizing therapeutic benefit. This user-centric design facilitates widespread adoption in clinical settings, reinforcing the technology’s effectiveness and reliability.
Significance in the Cardiovascular Device Sector
Shockwave Medical stands out in the cardiovascular device sector by addressing a long-standing clinical challenge—the treatment of calcified arterial lesions—with a unique, technology-driven approach. The company’s innovations not only improve patient outcomes by restoring blood flow but also offer a safe, effective alternative to traditional, high-pressure balloon dilatation and atherectomy methods. By continuing to build on a foundation of decades of technical expertise and clinical know-how, Shockwave Medical remains a significant player in the evolving field of cardiovascular therapeutics.
Shockwave Medical, a leader in Intravascular Lithotripsy (IVL) technology for treating calcified cardiovascular disease, announced its participation in the Canaccord Genuity 41st Annual Growth Conference from August 10-12, 2021. Management will engage in a live fireside chat on August 11, 2021, at 11:30 a.m. Eastern Time. The event will be accessible via a live and archived webcast on the company’s website. Shockwave Medical aims to redefine treatment standards for atherosclerotic cardiovascular disease by enhancing patient outcomes with their innovative IVL technology.
Shockwave Medical (Nasdaq: SWAV) will report its Q2 2021 financial results on August 9, 2021, before market open. The company is known for its innovative Intravascular Lithotripsy (IVL) technology aimed at treating calcified cardiovascular disease. A conference call for investors will take place at 5:30 a.m. PT / 8:30 a.m. ET. Domestic callers can dial (866) 795-9106, while international callers can reach (470) 495-9173, with the conference ID: 1687208. The call will also be available as a webcast for greater accessibility.
Shockwave Medical (NASDAQ: SWAV) has announced the publication of three significant studies in the Journal of the American College of Cardiology: Cardiovascular Interventions on June 28, 2021, highlighting the safety and effectiveness of Intravascular Lithotripsy (IVL) in treating calcified cardiovascular diseases. The studies involved a pooled analysis of 628 patients with coronary IVL, demonstrating a high procedural success rate of 92.4% and low adverse events. Additionally, a randomized trial on peripheral IVL showed superior results to traditional angioplasty, with procedural success rates of 90.1%.
Shockwave Medical announced that the Centers for Medicare & Medicaid Services (CMS) has approved a Transitional Pass-Through (TPT) payment for its Shockwave C2 Coronary IVL device, starting July 1, 2021. This approval allows hospitals to receive incremental payments for the device in outpatient settings for three years. Additionally, a new billing code has been created. This follows a recent recommendation for the device to be included in the New Technology Add-on Payment (NTAP) program. The device offers improved treatment for calcified cardiac conditions.
Shockwave Medical, Inc. (Nasdaq: SWAV) announced a remarkable 110% revenue increase in Q1 2021, totaling $31.9 million compared to $15.2 million in Q1 2020. The launch of the Shockwave C2 device in the U.S. significantly contributed to this growth, alongside an improved gross margin of 75%. Operating expenses rose 45% to $41.5 million, leading to a net loss of $23.6 million. The company expects 2021 revenue to reach between $195 million and $205 million, showcasing a potential growth of 188% to 202% year-over-year.
Shockwave Medical (NASDAQ: SWAV) announced that the Centers for Medicare and Medicaid Services (CMS) included a New Technology Add-On Payment (NTAP) for coronary Intravascular Lithotripsy (IVL) in the proposed Fiscal Year 2022 Rule. This payment is an additional $3,666 to the hospital's MS-DRG payment when using this FDA-designated Breakthrough Device. The ruling is open for public comment and aims to enhance patient access to advanced treatments for severe coronary artery disease. Finalization is anticipated by October 1, 2021.
Shockwave Medical, Inc. (NASDAQ: SWAV) will participate in the Bank of America Securities 2021 Health Care Conference from May 10-12, 2021. The company’s management is set for a live Fireside Chat on May 11, 2021, at 3:30 p.m. Eastern Time. A live and archived webcast will be available on the company’s website. Shockwave is focused on innovating treatments for calcified cardiovascular disease through its Intravascular Lithotripsy (IVL) technology, which uses sonic pressure waves to enhance patient outcomes.
Shockwave Medical (Nasdaq: SWAV) will announce its Q1 2021 financial results after market close on May 10, 2021. This announcement will be followed by a conference call scheduled for 1:30 PM PT / 4:30 PM ET.
Interested investors can join by dialing (866) 795-9106 domestically or (470) 495-9173 internationally, using conference ID 5446898. A live webcast will also be available at Shockwave Medical's investor page.
Shockwave Medical has announced a preliminary revenue forecast of $31.0 million to $32.0 million for Q1 2021, reflecting a significant increase of 104% to 111% compared to Q1 2020. The company attributes this growth to the successful launch of its C2 Coronary IVL product, which has received positive reception in the U.S. market. Over 120 customers have purchased the C2 Launch Kit, and nearly 50% of accounts have completed launch activities. Shockwave will further discuss its performance in the Wells Fargo MedTech R&D Spotlight Call.
Shockwave Medical (NASDAQ: SWAV) announced the appointment of Sara Toyloy to its Board of Directors and Audit Committee. With over 30 years in regulatory and clinical affairs, Toyloy brings extensive experience to the company, having previously held key roles at leading medical device firms. Her expertise is expected to enhance Shockwave's mission to improve treatment for calcified cardiovascular disease through its innovative Intravascular Lithotripsy (IVL) technology. CEO Doug Godshall expressed confidence that Toyloy's contributions will further advance the company's goals.
FAQ
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