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Shockwave Medical, Inc. (Nasdaq: SWAV) is redefining the treatment landscape for advanced cardiovascular diseases by pioneering the use of sonic pressure waves to target calcified plaque within arteries. The company’s flagship technology, Intravascular Lithotripsy (IVL), is inspired by the principles of kidney stone treatments developed over the past three decades. IVL technology safely fragments hard arterial calcium without harming the surrounding soft tissue, allowing for effective balloon dilatation and restoring blood flow.
Shockwave Medical’s portfolio includes the Lithoplasty® family of catheters, which deliver localized lithotripsy to disrupt calcified plaques in cardiovascular arteries. This innovative approach has demonstrated safety and consistent procedural success in clinical studies, such as those involving 95 patients with moderate to severely calcified lesions, with low procedural complications.
The technology is designed for ease of use, requiring only the push of a button, and seamlessly integrates with existing cardiovascular treatment protocols. Shockwave’s devices are garnering significant adoption, driven by their effectiveness in improving patient outcomes and simplicity of operation.
In recent developments, Shockwave Medical has achieved a significant milestone with the introduction of a new CPT® add-on code (+92972) for coronary IVL, effective January 1, 2024. This code recognizes the additional work associated with performing coronary IVL and ensures appropriate remuneration for physicians. This advancement is expected to further boost the adoption and financial viability of IVL procedures.
Financially, Shockwave Medical has reported robust growth. For the third quarter of 2023, the company generated $186.0 million in revenue, a 42% increase from the same period in 2022. The company’s gross profit for the quarter was $161.5 million, maintaining a high gross margin of 87%. With ongoing investments in sales force expansion and headcount, the company is well-positioned to support its growth trajectory.
On the strategic front, Shockwave Medical has recently acquired the Neovasc Reducer, a revolutionary device aimed at alleviating refractory angina by redistributing blood flow within the heart. The Reducer is currently under clinical investigation in the United States and has received CE Mark approval in Europe.
Looking ahead, Shockwave Medical expects to continue its growth momentum, projecting full-year 2023 revenue to range between $725 million and $730 million, representing a 48% to 49% increase over the prior year. The company’s strong financial health is underscored by its cash reserves, totaling $917.3 million as of September 30, 2023.
With a continuous pipeline of innovative products, strategic acquisitions, and a robust financial foundation, Shockwave Medical is poised to lead the transformation in the treatment of cardiovascular diseases. For more information, visit www.shockwavemedical.com.
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.
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