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.
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 announced successful results from the Disrupt CAD III study, which met primary safety and effectiveness endpoints for its Coronary IVL System. The study involved 384 patients across four countries, showing a 30-day freedom from major adverse cardiovascular events (MACE) rate of 92.2% and a procedural success rate of 92.4%. These findings highlight the device's efficacy in treating severely calcified coronary lesions, establishing a new benchmark in interventional cardiology.
Shockwave Medical (NASDAQ: SWAV) has rescheduled its CAD III Investor Webcast Event to take place on October 15, 2020, at 2:30 p.m. ET, during TCT Connect. The webcast will feature the presentation of the DISRUPT CAD III trial results by a principal investigator, a panel discussion, and a Q&A session. Interested attendees can access the live audio webcast through the Investors section on the company's website. Shockwave is dedicated to advancing the treatment of calcified cardiovascular disease using its innovative Intravascular Lithotripsy technology.
Shockwave Medical (NASDAQ: SWAV) announced that pivotal results from the DISRUPT CAD III study will be presented at TCT Connect on October 15, 2020. This study is critical as it assesses the safety and effectiveness of the Shockwave Coronary IVL System in treating severely calcified coronary arteries, enrolling 384 patients at 47 sites across multiple countries. The study's results could significantly impact treatment protocols for coronary artery disease.
Shockwave Medical, Inc. (NASDAQ: SWAV) announced its participation in the Canaccord Genuity 40th Annual Growth Conference, set for August 11-13, 2020. The company will host a live fireside chat on August 12, 2020, at 2:30 p.m. Eastern Time, which can be accessed via a webcast on their website. Shockwave Medical specializes in Intravascular Lithotripsy (IVL), a novel technique aimed at improving treatment outcomes for complex calcified cardiovascular disease through sonic pressure waves. For further details, visit their investor relations page.
Shockwave Medical (Nasdaq: SWAV) announced it will release its Q2 2020 financial results on August 11, 2020, after market close. A teleconference will follow, starting at 1:30 p.m. PT / 4:30 p.m. ET. Investors can listen live by calling (866) 795-9106 (domestic) or (470) 495-9173 (international) and using conference ID 8889064. Shockwave Medical specializes in Intravascular Lithotripsy (IVL)
Shockwave Medical (NASDAQ: SWAV) announced the appointment of Maria Sainz to its Board of Directors and Compensation Committee on July 20, 2020. Sainz brings over 25 years of experience in medical technology, having held leadership roles at Aegea Medical, Cardiokinetix, and Concentric Medical. Her expertise in commercialization and product launches is expected to bolster Shockwave’s growth as it advances its Intravascular Lithotripsy (IVL) technology aimed at treating calcified cardiovascular disease. The company is focused on establishing new standards for patient care in this area.
Shockwave Medical (NASDAQ: SWAV) announced a ruling from the USPTO regarding inter partes review cases initiated by Cardiovascular Systems, Inc. (CSI). The PTAB upheld the validity of a key claim of Shockwave's U.S. Patent No. 8,956,371 while invalidating some claims of this patent and all claims of U.S. Patent No. 8,728,091. Shockwave disagrees with the invalidity findings and intends to appeal. Despite these challenges, all claims remain enforceable until the appeals are resolved, and the company continues to develop its Intravascular Lithotripsy (IVL) technologies, benefiting over 30,000 patients.
Shockwave Medical, Inc. (SWAV) has announced pricing for its public offering of 1,700,000 shares at $45.75 each, aiming for gross proceeds of approximately $77.8 million. This offering is scheduled to close on June 19, 2020, pending customary conditions. Underwriters also hold a 30-day option to purchase an additional 255,000 shares. Morgan Stanley and BofA Securities are leading the offering, with funds intended for expanding operations and further product development in treating calcified cardiovascular disease.
Shockwave Medical (SWAV) announced a public offering of 1,700,000 shares of its common stock, with a 30-day option for underwriters to purchase an additional 255,000 shares. The offering is subject to market conditions and has no guaranteed completion date. Morgan Stanley and BofA Securities are leading the offering. The registration statement for these securities has been filed with the SEC and became effective upon filing. This offering aims to strengthen Shockwave's position in the cardiovascular treatment market, specifically using Intravascular Lithotripsy technology.
Shockwave Medical (SWAV) announced that the Centers for Medicare & Medicaid Services (CMS) issued new coding for Intravascular Lithotripsy (IVL) procedures in peripheral arteries, effective July 1 and October 1, 2020. These codes will align Medicare payment rates for IVL with other similar procedures, validating the technology as a unique treatment for calcified cardiovascular disease. CEO Doug Godshall noted this decision enables CMS to gather cost data specific to IVL, essential for future reimbursement adjustments.
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