SANTA CLARA, Calif. - Shockwave Medical , Inc. (NASDAQ: NASDAQ:SWAV) announced today that recent data from the REDUCER-I trial presented at the American College of Cardiology's 73rd Annual Scientific Sessions in Atlanta, GA, points to positive outcomes for its Shockwave Reducer technology, aimed at treating refractory angina.
The six-month results from the observational study and interim long-term follow-up data extending to three years suggest that the device may offer symptom relief for patients with this condition.
The REDUCER-I study, which is a multi-center, post-market observational trial, enrolled 400 patients to assess the long-term outcomes of the Shockwave Reducer. The primary effectiveness endpoint was a reduction in Canadian Cardiovascular Society (CCS) grade at six months compared with baseline.
Results indicated that 70% of patients saw an improvement of at least one CCS class, and 24% improved by two or more classes. The percentage of patients with severe angina (CCS class III/IV) decreased from 72% at baseline to 18% at six months, with a mean change in CCS class of -0.9.
Longer-term follow-up confirmed the durability of symptom relief, with only 15% of patients at two years and 11% at three years experiencing severe angina symptoms. The device also exhibited a favorable safety profile, with low rates of serious adverse events (SAEs) and major adverse cardiac events (MACE) at 1.1% and 1.6%, respectively.
In a separate session at the conference, data from the ORBITA-COSMIC trial were presented, which supported the Shockwave Reducer's efficacy in providing symptomatic angina relief over time, despite missing the primary imaging endpoint of improved myocardial blood flow.
The Shockwave Reducer is currently under clinical investigation in the United States and Canada and is CE Marked in the European Union and the United Kingdom. In the U.S., it has been granted Breakthrough Device designation by the FDA and is being studied in the COSIRA-II clinical trial to support regulatory filing for approval.
This news is based on a press release statement from Shockwave Medical, Inc. The company is known for its innovative cardiovascular treatment products, including the Intravascular Lithotripsy (IVL) technology and the Shockwave Reducer, which is designed to redistribute blood flow within the heart to alleviate symptoms of refractory angina.
InvestingPro Insights
As Shockwave Medical, Inc. (NASDAQ: SWAV) continues to make waves with its innovative cardiovascular treatments, the company's financial health and market performance provide additional context for potential investors. Shockwave Medical's impressive gross profit margin stands at 86.94% for the last twelve months as of Q1 2023, showcasing their ability to maintain profitability amidst their clinical advancements.
Investors should note that Shockwave's stock is currently trading near its 52-week high, with a price 98.42% of that peak. The company's market capitalization is valued at 12.21 billion USD, reflecting the market's confidence in its growth trajectory. However, with a Price/Earnings (P/E) ratio of 79.82, some might argue the stock is trading at a high earnings multiple, which could suggest expectations of continued robust earnings growth.
With a strong return of 29.65% over the last month and an even more impressive 58.46% over the last three months, the company's stock performance has been noteworthy. For investors seeking more in-depth analysis, Shockwave Medical has a total of 18 "InvestingPro Tips" available on InvestingPro, providing a comprehensive look at the company's financials and market standing. To access these insights and more, use the coupon code PRONEWS24 for an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.