Cardiovascular Systems, Inc. (NASDAQ:CSII) recently announced the commercial launch of Diamondback 360 Coronary OAS Micro Crown (Micro Crown) in Japan, following the country’s Pharmaceuticals and Medical Devices Agency (“PMDA”) approval in March 2017.
The device has been approved for frontline treatment of severe calcified lesions and for facilitating access to arteries for percutaneous coronary interventions (PCI) thereafter. Interestingly, the approval was given following presentation of favorable 1-year data from its Coronary Orbital Atherectomy System Study (COAST).
The company noted that, with over 280,000 PCIs per year, of which 10-20% are projected to be extremely calcified, the Japan market for coronary interventions holds huge potential. Moreover, Micro Crown has received reimbursement approval, which will be implemented fully this month.
Cardiovascular Systems expects to successfully complete an initial Micro Crown stocking order in the third quarter of fiscal 2018 with Medikit Co., Ltd, as the exclusive distribution partner in Japan.
Recent Developments
In a bid to expand the peripheral and coronary interventions product portfolio, by adding supporting complementary products, Cardiovascular Systems signed two partnerships in January 2018. First, the company signed an exclusive U.S. distributor agreement with OrbusNeich for its OrbusNeich balloon products in the United States. The company also entered into an original equipment manufacturer (OEM) agreement with Integer Holdings (NYSE:ITGR) . Per the agreement, Cardiovascular Systems will manufacture self-branded ZILIENT guidewires to facilitate tip resilience and crossability in difficult arterial lesions.
Cardiovascular Systems has been pursuing product improvements and evaluating new technologies to strengthen and broaden its portfolio of powerful micro invasive tools. In 2017, the company received FDA approval for the Micro Crown system to facilitate stent delivery in patients with coronary artery disease (CAD).
Market Potential
The global market for coronary heart diseases is expected to see huge demand on the back of growing cases of chronic diseases. Moreover, going by a report published by Technavio, the global market for coronary heart diseases is expected to see a CAGR of more than 5% between 2017 and 2021. Considering the company’s efforts, we believe it is well-positioned to gain from the favorable trend in the CAD space.
Share Price Movement
Cardiovascular Systems has been outperforming the broader industry over the past month. The stock has gained 2.6% compared with the industry’s 1.3% rise.
Zacks Rank & Key Picks
Cardiovascular Systems carries a Zacks Rank #3 (Hold).
A few better-ranked stocks in the broader medical sector are PerkinElmer (NYSE:PKI) and Bio-Rad Laboratories (NYSE:BIO) .
Bio-Rad Laboratories has a Zacks Rank #2 (Buy). The company has a long-term expected earnings growth rate of 25%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
PerkinElmer has a long-term expected earnings growth rate of 12.3%. The stock carries a Zacks Rank #2.
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