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Cardiovascular Systems (CSII) Expands Lithotripsy Technology

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Cardiovascular Systems, Inc. (CSII - Free Report) has recently undertaken considerable strides toward commercializing intravascular lithotripsy (IVL) systems to treat calcific coronary and peripheral artery disease. The IVL systems are intended to address the limitations of existing technology, enabling physicians to cross and treat more difficult atherosclerotic lesions. The feasibility testing of a proprietary console and related IVL balloon catheters has been completed.

It’s worth noting that lithotripsy is a medical procedure that has been successfully utilized to treat kidney and gall stones and has lately found application in calcified coronary and peripheral arteries treatment.

The commercialization of the IVL systems to treat calcific coronary and peripheral artery disease is anticipated to be highly complementary to Cardiovascular Systems’ broader portfolio of advanced vessel preparation technologies.

Management expects the successful commercialization of IVL systems to enhance patient access to care while advancing the company’s overall market position in complex coronary and peripheral disease.

Strategic Benefits of IVL Commercialization

Including a coronary IVL system in Cardiovascular Systems’ current coronary product offering will enable the company to offer products that efficiently treat a broader spectrum of calcific coronary lesions, bringing the company’s total addressable market (United States) to $1.3 billion. The company expects to begin enrollment of patients in an investigational device exemption study for the coronary IVL system during calendar 2023.

Zacks Investment ResearchImage Source: Zacks Investment Research

Meanwhile, the addition of a peripheral IVL system to Cardiovascular Systems’ peripheral orbital atherectomy device line will boost its treatable patient population across an even broader range of calcified arteries above and below the knee. This will bring Cardiovascular Systems’ addressable market (United States) to approximately $1 billion. The company intends to start the first-in-human experience for the peripheral IVL system in calendar year 2023.

Industry Prospects

Per a report published in Allied Market Research, the peripheral artery disease market is expected to see a CAGR of 8.5% from 2020 to 2027 owing to factors such as a rapid surge in the geriatric population and a subsequent rise in the prevalence of peripheral artery diseases as well as an increase in product approvals. Meanwhile, according to another report published in Mordor Intelligence, the coronary artery disease therapeutics market is anticipated to exhibit a CAGR of 5.5% from 2018 to 2026.

Notable Developments

In November 2021, Cardiovascular Systems announced the beginning of enrollment in a first-in-human trial for coronary everolimus drug-coated balloon (DCB). The coronary DCB, developed by the Chansu Vascular Technologies, LLC, was used to treat in-stent restenosis in the left anterior descending artery. The first patient was successfully treated at the Israeli-Georgian Medical Research Clinic Helsicore in Tbilisi, Georgia.

In September 2021, the company reported the first successful patient treated with its ViperCross peripheral support catheter, which delivers support and flexibility for efficiently navigating tortuous anatomy and crossing complex lesions. The ViperCross also provides outstanding guidewire support and allows for easy guidewire exchange. Per management, with the commercial launch of ViperCross, the company currently offers a complete portfolio of products for the treatment of peripheral artery disease.

Share Price Performance

The stock has underperformed its industry over the past year. It has declined 57.1% compared with the industry’s 9.6% fall.

Zacks Rank and Key Picks

Currently, Cardiovascular Systems carries a Zacks Rank #3 (Hold).

A few better-ranked stocks in the broader medical space that investors can consider are Baxter International Inc. (BAX - Free Report) , Apollo Endosurgery, Inc. (APEN - Free Report) and Hologic, Inc. (HOLX - Free Report) .

Baxter, carrying a Zacks Rank #1 (Strong Buy), has a long-term earnings growth rate of 9.5%. Baxter’s earnings surpassed estimates in the trailing four quarters, delivering a surprise of 10.2%, on average. You can see the complete list of today’s Zacks #1 Rank stocks here.

Baxter has outperformed its industry over the past year. BAX has gained 7.1% against the 9.6% industry decline.

Apollo Endosurgery, carrying a Zacks Rank #2 (Buy), has a long-term earnings growth rate of 7%. Apollo Endosurgery‘s earnings surpassed estimates in the trailing four quarters, delivering a surprise of 25.6%, on average.

Apollo Endosurgery has outperformed its industry in the past year. APEN has gained 51.6% versus the industry’s 3.9% fall.

Hologic, sporting a Zacks Rank #2, has a long-term earnings growth rate of 7.4%. The company surpassed earnings estimates in three of the trailing four quarters and missed in one, delivering an average surprise of 29.2%.

Hologic has underperformed its industry over the past year. HOLX has declined 8.6% versus the industry’s 4% drop.