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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.
SANTA CLARA, Calif., April 24, 2023 (GLOBE NEWSWIRE) -- Shockwave Medical (NASDAQ: SWAV) will release its first quarter 2023 financial results on May 8, 2023, after market close. A conference call is scheduled for that day at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time.
Additionally, on May 10, 2023, at 11:20 a.m. Pacific Time, Shockwave Medical's management will participate in a fireside chat during the BofA Securities 2023 Healthcare Conference in Las Vegas, NV. Live and archived webcasts of these events can be accessed via the company's website.
Shockwave Medical focuses on developing Intravascular Lithotripsy (IVL) to treat calcified cardiovascular disease, aiming to establish a new standard in interventional treatment through innovative sonic pressure waves that improve patient outcomes.
Shockwave Medical has completed its acquisition of Neovasc for US$27.25 per share, with an additional potential cash payment of up to US$12.00 per share tied to regulatory milestones. The Neovasc Reducer System, designed to treat refractory angina, is a significant addition to Shockwave’s portfolio. Annually, up to 800,000 patients in the U.S. and Europe suffer from refractory angina, highlighting the need for advanced treatment options. The Reducer has received Breakthrough Device designation from the FDA and is under clinical trial in the COSIRA-II study. Post-acquisition, Neovasc’s shares will be delisted from both the Toronto Stock Exchange and Nasdaq, and the company plans to cease its reporting obligations under U.S. securities laws. Shareholders must meet tax certification requirements to receive the acquisition consideration.
Shockwave Medical has announced the full U.S. commercial availability of the Shockwave L6 Peripheral IVL Catheter, following FDA clearance. This catheter is designed to treat severely calcified lesions in large peripheral vessels, including the iliac and common femoral arteries. It addresses challenges with standard techniques that often lead to lower success rates and higher complications. The L6 catheter's new sizes (8.0, 9.0, 10.0, and 12.0 mm) enhance the company’s IVL portfolio, aiming to improve patient outcomes in complex cases.
Shockwave Medical reported impressive financial results for Q4 and full year 2022, with revenues of $144.0 million for Q4, a 71% increase year-over-year, and $489.7 million for the full year, up 107%. The gross profit for Q4 rose to $126.5 million with an 88% gross margin. Net income soared to $140.9 million in Q4 versus $12.9 million in Q4 2021. Total cash and investments reached $304.5 million. For 2023, the company projects revenues between $660 million and $680 million, indicating a growth forecast of 35% to 39%.
Shockwave Medical (NASDAQ: SWAV) announced that the Society of Cardiovascular Angiography and Intervention (SCAI) has updated its treatment guidelines to include coronary Intravascular Lithotripsy (IVL) for all U.S. catheterization labs, even those without surgical backup. This marks a significant shift from the 2014 guidelines, thereby enhancing patient access to treatment for severely calcified lesions. The new guidance aims to improve patient outcomes and streamline care processes, reducing unnecessary patient transfers. The company anticipates increased adoption of IVL as a result of this update.
Shockwave Medical (NASDAQ: SWAV) has announced its acquisition of Neovasc (NASDAQ, TSX: NVCN) for $27.25 per share, valuing the transaction at approximately $100 million. This acquisition aims to address the $5 billion refractory angina market by integrating Neovasc's unique Reducer System, which has shown promise in managing angina unresponsive to traditional therapies. Shockwave also reported preliminary revenues of $143-144 million for Q4 2022, a 71% increase from the previous year, and projected 2023 revenues of $660-680 million. This transaction is expected to be finalized in H1 2023, subject to shareholder approval.
Shockwave Medical (Nasdaq: SWAV) announced the schedule for its upcoming quarterly earnings releases and conference calls for 2023. Earnings for Q4 2022 will be released on February 16, 2023, at 4:30 p.m. ET, followed by Q1 on May 8, Q2 on August 7, and Q3 on November 6, all at 4:30 p.m. ET. These events will be accessible via dial-in and webcast. The company is committed to innovating treatment for calcified cardiovascular disease through its Intravascular Lithotripsy (IVL) technology, aimed at improving patient outcomes.
Shockwave Medical (NASDAQ: SWAV) is set to participate in the Piper Sandler 34th Annual Virtual Healthcare Conference from November 29 to December 1, 2022. The company's management will host a live fireside chat on November 30, 2022, at 9:30 a.m. Eastern Time. Interested parties can access the live and archived webcast via the company's Investors' section. Shockwave focuses on advancing the treatment of calcified cardiovascular disease through its Intravascular Lithotripsy (IVL) technology, aiming to enhance patient outcomes.
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