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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) announced promising one-year outcomes for coronary Intravascular Lithotripsy (IVL) presented at the 2022 SCAI Scientific Sessions. The pooled analysis from the Disrupt CAD III & IV studies showed similar safety and effectiveness in both women (n=106) and men (n=342), contradicting previous findings from atherectomy. With procedural success rates of 90.6% for women and 93.0% for men, and low rates of major adverse cardiac events (MACE), IVL is suggested as a first-line therapy, especially for female patients with calcified lesions.
Shockwave Medical (SWAV) reported a remarkable 194% revenue increase in Q1 2022, achieving $93.6 million compared to $31.9 million in Q1 2021. The growth was fueled by the launch of the Shockwave C2 coronary product and the recovery from pandemic-related impacts. The company also attained a gross margin of 86% and posted a net income of $14.5 million, reversing a loss of $23.6 million in the previous year. Looking ahead, Shockwave projects full-year revenue between $435 million and $455 million, upping previous guidance for substantial growth.
SANTA CLARA, Calif., April 27, 2022 – Shockwave Medical, Inc. (NASDAQ: SWAV) will announce its Q1 2022 financial results after market close on May 9, 2022. A conference call will follow at 1:30 p.m. PT. Additionally, management will participate in a fireside chat at the BofA Securities Healthcare Conference on May 11, 2022, at 3:20 p.m. PT, and at the UBS Global Healthcare Conference on May 23, 2022, at 8:30 a.m. ET. Interested parties can access these events via the Investors section on the company’s website.
Shockwave Medical has announced the global launch of its M5+ peripheral IVL catheter following CE Mark and FDA clearance. Designed to enhance the treatment of severely calcified cardiovascular conditions, the catheter reduces treatment time and broadens access for larger vessels. It features faster cycle times, extended length, and new sizes to treat complex lesions in various arteries, including femoral and renal arteries. The M5+ catheter is now commercially available in both Europe and the U.S., furthering Shockwave's commitment to improving treatment options in cardiovascular care.
Shockwave Medical (NASDAQ: SWAV) announced regulatory approval of the Shockwave C2 Coronary Intravascular Lithotripsy Catheter in Japan, a critical step in treating severely calcified cardiovascular disease. Supported by data from the Disrupt CAD IV study, which showed a 93.8% success rate without major adverse events, this catheter offers a new solution for challenging cases. The partnership with the Japanese Association of Cardiovascular Intervention and Therapeutics will facilitate its adoption. The next step involves reimbursement approval from Japan's Ministry of Health.
Shockwave Medical has been named the second most innovative medical device company by Fast Company in its 2022 list. The recognition highlights the impact of their Intravascular Lithotripsy (IVL) technology, which treats severely calcified cardiovascular disease. Since its market introduction in 2017, IVL has expanded globally, being adopted rapidly by thousands of physicians. CEO Doug Godshall emphasized the company's commitment to innovation in improving patient outcomes. This accolade underscores Shockwave's position as a leader in transforming cardiovascular treatments.
Shockwave Medical, Inc. (SWAV) announced its financial results for Q4 and full year 2021. The company achieved revenue of $84.2 million for Q4, up 271% year-over-year, and $237.1 million for the full year, a 250% increase. Gross profit for Q4 was $71.5 million with a gross margin of 85%. Operating expenses rose to $57.5 million, up 79% from last year. A net income of $12.9 million was reported for Q4. For 2022, the company projects revenue of $405 million to $425 million, indicating 71%-79% growth.
Shockwave Medical (NASDAQ: SWAV) will participate in the SVB Leerink 11th Annual Global Healthcare Conference from February 14-18, 2022. A fireside chat featuring Shockwave management is scheduled for February 18 at 3:00 p.m. ET. Interested parties can access a live and archived webcast via the company’s website.
Shockwave Medical is focused on innovative treatments for calcified cardiovascular disease using Intravascular Lithotripsy (IVL), which utilizes sonic pressure waves to enhance patient outcomes in a minimally invasive manner.
Shockwave Medical, Inc. (Nasdaq: SWAV) announced the schedule for its upcoming quarterly earnings releases. The Fourth Quarter 2021 earnings will occur on February 17, 2022, followed by the First Quarter 2022 on May 9, 2022, Second Quarter 2022 on August 8, 2022, and Third Quarter 2022 on November 7, 2022. All calls are set for 4:30 p.m. ET. Investors can listen live or access archived webcasts at the company’s investor relations website.
Shockwave Medical (SWAV) has launched the Disrupt BTK II post-market study to evaluate the Shockwave Peripheral IVL System for treating calcified peripheral lesions below the knee, especially in patients with critical limb ischemia (CLI). The study aims to enroll 250 patients across 40 sites globally, assessing the long-term effectiveness and safety of IVL. This study seeks to address a significant unmet clinical need, as many CLI patients lack effective treatment options. The primary endpoints include procedural success and the absence of major adverse limb events.
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