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Shockwave Medical's (SWAV) IVL Cleared for Use in China

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Shockwave Medical, Inc. (SWAV - Free Report) , along with Genesis MedTech Group, received approval from China’s National Medical Products Administration for Intravascular Lithotripsy (“IVL”). The clearance paves the way for Shockwave Medical to market and sell the Shockwave IVL System with the Shockwave C2 Coronary IVL Catheters and the Shockwave M5 and S4 Peripheral IVL Catheters in China.

Notably, Shockwave Medical and Genesis MedTech formed a joint venture in March 2021. This was aimed to be a partnership to distribute Shockwave Medical’s products in China and leverage Genesis MedTech’s Wuxi research and development, and production base to advance the manufacturing of Shockwave Medical’s products for the local Chinese market.

The latest regulatory approval is expected to aid Shockwave Medical in significantly expanding its global footprint in the Peripheral Artery Disease (PAD) and Coronary Artery Disease (CAD) treatment space, and solidify its position worldwide.

Significance of the Approval

Per the current estimates, with the increasing aging population in China, there is a growing prevalence of the calcified vascular disease. Resources also estimate that the risk of developing coronary artery calcification increases with age. According to Statistica, China had a population of more than 1.4 billion in 2020, 50% of whom were above the age of 40.

Per a medical expert well-versed with the clinical IVL procedure in China on severely calcified lesions in peripheral arteries, Shockwave IVL provides a powerful solution to calcified lesions that could not be effectively treated in the past. Thus, the expert believes it to be a promising approach for future treatments of such patients.

The Shockwave M5 and S4 IVL Catheters and Shockwave C2 Coronary IVL Catheters, used for the treatment of arterial calcification lesions, are approved in the United States, the European Union and other select international jurisdictions. These have been widely used to treat patients with peripheral arterial and coronary artery diseases across the world.

Per management, the approval in China is a milestone in the international expansion of Shockwave Medical’s IVL technology and is looking forward to bringing IVL to physicians and patients in China for the treatment of arterial calcification.

Industry Prospects

Per a report by Research and Markets published on Business Wire, the global PAD market was estimated to be more than $4.53 billion in 2019 and is anticipated to reach $8.78 billion by 2030, seeing a CAGR of 6.2%. Factors like rapid growth in the elderly population and subsequent increase in the prevalence of PAD cases, and a rising number of people suffering from diabetes and high blood pressure are likely to drive the market.

Given the market potential, the latest regulatory clearance is expected to provide a significant boost to Shockwave Medical’s business globally.

Recent Developments

This month, Shockwave Medical announced that long-term data from the Disrupt PAD III trial found that superior vessel preparation with IVL led to excellent long-term outcomes out to two years with the preservation of future treatment options compared to percutaneous transluminal angioplasty in the treatment of calcified PAD.

This month, Shockwave Medical announced new data that confirms excellent one-year outcomes with coronary IVL in both women and men from the Disrupt CAD clinical program.

In May, Shockwave Medical announced solid first-quarter 2022 results, wherein the company recorded a stupendous increase in its recognized revenues. Shockwave Medical also received regulatory approval for the Shockwave C2 Coronary IVL Catheter in Japan at the same time.

Price Performance

Shares of the company have lost 6% in the past year compared with the industry’s 16.5% fall and the S&P 500's 5.8% decline.

 

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Zacks Rank & Key Picks

Currently, Shockwave Medical carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the broader medical space are Alkermes plc (ALKS - Free Report) , Veeva Systems Inc. (VEEV - Free Report) and AMN Healthcare Services, Inc. (AMN - Free Report) .

Alkermes, carrying a Zacks Rank #2 (Buy) at present, has an estimated long-term growth rate of 25.1%. ALKS’s earnings surpassed estimates in the trailing four quarters, the average beat being 350.5%.

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Alkermes has gained 35.7% against the industry’s 37.2% fall over the past year.

Veeva Systems has an estimated long-term growth rate of 18.1%. VEEV’s earnings surpassed estimates in the trailing four quarters, the average beat being 9.6%. It currently carries a Zacks Rank #2.

Veeva Systems has lost 38.4% compared with the industry’s 58.1% fall over the past year.

AMN Healthcare has an estimated long-term growth rate of 1.1%. AMN’s earnings surpassed estimates in the trailing four quarters, the average beat being 15.6%. It currently sports a Zacks Rank #1.

AMN Healthcare has lost 0.2% compared with the industry’s 63.2% fall over the past year.