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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 (NASDAQ: SWAV) has entered a joint venture with Genesis MedTech Group to enhance the availability of Intravascular Lithotripsy (IVL) in China. The partnership aims to commercialize IVL products for coronary and peripheral treatments, combining Shockwave’s expertise with Genesis’s established sales network in the region. Named Genesis Shockwave Private Limited, this venture will enable the distribution of both Shockwave-branded and locally developed IVL products. This initiative aligns with Shockwave's strategy to expand global access to IVL technologies.
Shockwave Medical (Nasdaq: SWAV) reported its Q4 and full-year 2020 financial results, achieving $22.7 million in revenue for Q4, a 59% increase year-over-year, and $67.8 million for the full year, up 58%. Gross profit for Q4 reached $16.2 million (72% margin) compared to $8.8 million (61% margin) in Q4 2019. Despite revenue growth, the net loss increased to $15.9 million in Q4 and $65.7 million for the year. The company received FDA approval for its C2 device and gained significant payment codes from CMS for IVL procedures, highlighting advancements in their proprietary IVL technology.
Shockwave Medical (NASDAQ: SWAV) announced FDA Pre-Market Approval for its innovative sonic pressure wave therapy to treat severely calcified coronary artery disease. This technology is designed to disrupt calcified plaque, improving blood flow and patient outcomes during angioplasty. The method has been adopted in over 50 countries, treating more than 25,000 patients since its initial launch. The approval marks a significant milestone in addressing coronary calcification, promising to enhance procedural safety and effectiveness.
Shockwave Medical, Inc. (Nasdaq: SWAV) will report its financial results for the fourth quarter and full year 2020 on February 17, 2021, after market close. A conference call for investors is scheduled for 1:30 p.m. PT / 4:30 p.m. ET. Investors can participate via a domestic line at (866) 795-9106 or international line at (470) 495-9173, using conference ID: 7854854. The call will also be available through a live and archived webcast on the company's investor relations website.
Shockwave Medical (NASDAQ: SWAV) announced the addition of four new HCPCS codes for Intravascular Lithotripsy (IVL) procedures in the below-the-knee (BTK) setting, effective January 1, 2021. The Centers for Medicare & Medicaid Services (CMS) recognized that BTK IVL procedures require more resources than other lower extremity procedures, thus enhancing payment rates. This move is expected to improve access to IVL technology for Medicare patients. Additionally, IVL procedures will be covered in Ambulatory Surgical Center settings as part of the 2021 OPPS final rule.
Shockwave Medical, a pioneer in Intravascular Lithotripsy (IVL) for treating calcified cardiovascular disease, will participate in the Piper Sandler 32nd Annual Virtual Healthcare Conference from December 1 to 3, 2020. Their management is set for a live fireside chat on December 2, 2020, at 8:30 a.m. Eastern Time. The event will be available via webcast on the company's website. Shockwave aims to revolutionize treatment for atherosclerotic cardiovascular disease, offering a minimally invasive solution that enhances patient outcomes through the localized delivery of sonic pressure waves.
Shockwave Medical reported $19.6 million in revenue for Q3 2020, a 73% increase from Q3 2019, driven by sales force expansion and market penetration. The gross profit was $14.3 million with a gross margin of 73%, up from 61% year-over-year. Operating expenses rose to $27.1 million, a 36% increase due to headcount growth. The net loss for the quarter was $12.9 million, or $0.38 per share. Due to COVID-19 uncertainties, the company is not providing financial guidance for 2020.
Shockwave Medical (SWAV) announced positive findings from the Disrupt PAD III study, the largest randomized trial focusing on severely calcified peripheral lesions. The study revealed that Intravascular Lithotripsy (IVL) outperformed percutaneous transluminal angioplasty (PTA) in achieving procedural success, with a success rate of 65.8% versus 50.4%. Key results included a significant reduction in arterial dissections and the need for bail-out stenting. This study lays the groundwork for IVL as the new standard in treating complex patients often excluded from clinical trials.
Shockwave Medical (SWAV) will host a webcast investor update on November 7, 2020, at 11:00 a.m. ET during the VIVA20 conference. Dr. William Gray will present findings from the PAD III study, followed by a discussion with company executives. Additionally, Shockwave will report its Q3 2020 financial results on November 9, 2020, after market close, with a live teleconference scheduled for 1:30 p.m. PT. The events will be accessible via the company’s investor relations website, providing insights into their innovative treatment for calcified cardiovascular disease.
Shockwave Medical (NASDAQ: SWAV) announced that acute results from the DISRUPT PAD III study will be presented at VIVA20, a virtual conference on November 7, 2020. This study, the largest of its kind, focuses on treating severely calcified peripheral lesions with Intravascular Lithotripsy (IVL). Key outcomes include procedural success, defined by residual stenosis less than or equal to 30% without significant complications. Over 300 patients were enrolled across multiple countries, providing critical insights for challenging vascular treatments.
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