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Cardiovascular Systems (CSII) Finances New DCB Development
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Cardiovascular Systems, Inc. recently announced an acquisition option agreement with Chansu Vascular Technologies, LLC (CVT) for the development of a peripheral everolimus drug-coated balloon (DCB). The companies announced the initiation of enrollment in a first-in-human trial of the peripheral everolimus DCB, developed by CVT.
Per the terms of the deal, Cardiovascular Systems is providing milestone-based financing to CVT for the development of coronary and peripheral DCBs. The acquisition option agreement states that upon CVT’s completion of key technical and clinical milestones in the development program, CSI will have exclusive rights and obligations to acquire CVT, subject to the fulfillment of customary closing conditions.
However, the financial terms of the deal remained undisclosed.
DCBs and Everolimus
Per Cardiovascular Systems, DCBs are a widely accepted percutaneous interventional treatment option for femoropopliteal lesions in patients with peripheral artery disease. Going by ScienceDirect definition, these angioplasty balloons offer the advantage of better local drug uptake and theoretically less vessel distortion secondary to stenting. These might offer therapeutic benefits to lesions that are not compatible with stenting (in-stent restenosis, small vessels, and complex carinal bifurcation lesions).
CSII noted that Everolimus is the active drug in CVT’s DCB formulation. Everolimus acts as a cytostatic agent to reduce tissue hyperplasia and associated restenosis. This drug has a long history of safety and efficacy in coronary drug-eluting stent applications.
The Trial
CVT plans to enroll 75 patients at a minimum of four sites in France and Germany to support an IDE submission to the FDA and a subsequent U.S. pivotal clinical study.
According to Cardiovascular Systems spokesperson, on the heels of the success of the first-in-human experience with CVT’s coronary everolimus, DCB, in November 2021, the company plans to announce the first-in-human experience with the peripheral everolimus DCB. CSII expects these products to become the new generation line of therapies for the treatment of peripheral and coronary artery disease.
A Glance into CSII's Recent Product Update
Cardiovascular Systems has long been expanding its product portfolio to enhance its market reach and versatility. Currently, the company is pursuing product improvements and evaluating new technologies to strengthen and broaden its portfolio of powerful micro-invasive tools.
Image Source: Zacks Investment Research
During the second quarter of fiscal 2022, the company noted that it is currently in the process of launching the Scoreflex NC Scoring Balloon in the United States, post the receipt of the latest FDA PMA approval. Scoreflex NC is indicated for dilating a de novo stenotic coronary lesion and in-stent restenosis. According to management, Scoreflex NC represents a growing $50 million market in the United States, and the company anticipates Scoreflex NC to be well-received, backed by compelling clinical data.
In the fiscal second quarter, the company announced the development of intravascular lithotripsy balloons to treat coronary and peripheral artery diseases.
In June 2021, Cardiovascular Systems announced the commercial launch of a full line of OrbusNeich JADE percutaneous transluminal angioplasty (PTA) over-the-wire (OTW) balloon catheters in the United States.
In April 2021, Cardiovascular Systems completed a minority investment and entered into an acquisition option agreement with CarePICS -- a telehealth company offering a virtual care platform designed to improve the outcomes of patients suffering from peripheral artery disease, critical limb ischemia and lower extremity wounds.
In March 2021, Cardiovascular Systems acquired a line of peripheral support catheters from WavePoint Medical.
Share Price Performance
Over the past year, Cardiovascular Systems has underperformed the industry. The stock has declined 51.2% compared with the industry’s 16.9% fall.
Zacks Rank and Key Picks
Cardiovascular Systems currently carries a Zacks Rank #4 (Sell).
A few better-ranked stocks in the broader medical space are McKesson Corporation (MCK - Free Report) , AMN Healthcare Services, Inc. (AMN - Free Report) and Bio-Rad Laboratories, Inc. (BIO - Free Report) .
McKesson has a long-term earnings growth rate of 11.8%. MCK has gained 49.7% compared with the industry’s 4.7% growth in the past year.
AMN Healthcare, carrying a Zacks Rank #1, has a long-term earnings growth rate of 16.2%. The company surpassed earnings estimates in the trailing four quarters, delivering a surprise of 19.5%, on average.
AMN Healthcare has outperformed its industry over the past year. AMN has gained 23.8% versus the 62% industry decline.
Bio-Rad reported fourth-quarter 2021 adjusted EPS of $3.21, which surpassed the Zacks Consensus Estimate by 11.9%. It currently has a Zacks Rank #2.
Bio-Rad has an earnings yield of 2.3%, which compares favorably with the industry’s negative yield. BIO surpassed earnings estimates in the trailing four quarters, the average surprise being 66.9%.
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Cardiovascular Systems (CSII) Finances New DCB Development
Cardiovascular Systems, Inc. recently announced an acquisition option agreement with Chansu Vascular Technologies, LLC (CVT) for the development of a peripheral everolimus drug-coated balloon (DCB). The companies announced the initiation of enrollment in a first-in-human trial of the peripheral everolimus DCB, developed by CVT.
Per the terms of the deal, Cardiovascular Systems is providing milestone-based financing to CVT for the development of coronary and peripheral DCBs. The acquisition option agreement states that upon CVT’s completion of key technical and clinical milestones in the development program, CSI will have exclusive rights and obligations to acquire CVT, subject to the fulfillment of customary closing conditions.
However, the financial terms of the deal remained undisclosed.
DCBs and Everolimus
Per Cardiovascular Systems, DCBs are a widely accepted percutaneous interventional treatment option for femoropopliteal lesions in patients with peripheral artery disease. Going by ScienceDirect definition, these angioplasty balloons offer the advantage of better local drug uptake and theoretically less vessel distortion secondary to stenting. These might offer therapeutic benefits to lesions that are not compatible with stenting (in-stent restenosis, small vessels, and complex carinal bifurcation lesions).
CSII noted that Everolimus is the active drug in CVT’s DCB formulation. Everolimus acts as a cytostatic agent to reduce tissue hyperplasia and associated restenosis. This drug has a long history of safety and efficacy in coronary drug-eluting stent applications.
The Trial
CVT plans to enroll 75 patients at a minimum of four sites in France and Germany to support an IDE submission to the FDA and a subsequent U.S. pivotal clinical study.
According to Cardiovascular Systems spokesperson, on the heels of the success of the first-in-human experience with CVT’s coronary everolimus, DCB, in November 2021, the company plans to announce the first-in-human experience with the peripheral everolimus DCB. CSII expects these products to become the new generation line of therapies for the treatment of peripheral and coronary artery disease.
A Glance into CSII's Recent Product Update
Cardiovascular Systems has long been expanding its product portfolio to enhance its market reach and versatility. Currently, the company is pursuing product improvements and evaluating new technologies to strengthen and broaden its portfolio of powerful micro-invasive tools.
Image Source: Zacks Investment Research
During the second quarter of fiscal 2022, the company noted that it is currently in the process of launching the Scoreflex NC Scoring Balloon in the United States, post the receipt of the latest FDA PMA approval. Scoreflex NC is indicated for dilating a de novo stenotic coronary lesion and in-stent restenosis. According to management, Scoreflex NC represents a growing $50 million market in the United States, and the company anticipates Scoreflex NC to be well-received, backed by compelling clinical data.
In the fiscal second quarter, the company announced the development of intravascular lithotripsy balloons to treat coronary and peripheral artery diseases.
In June 2021, Cardiovascular Systems announced the commercial launch of a full line of OrbusNeich JADE percutaneous transluminal angioplasty (PTA) over-the-wire (OTW) balloon catheters in the United States.
In April 2021, Cardiovascular Systems completed a minority investment and entered into an acquisition option agreement with CarePICS -- a telehealth company offering a virtual care platform designed to improve the outcomes of patients suffering from peripheral artery disease, critical limb ischemia and lower extremity wounds.
In March 2021, Cardiovascular Systems acquired a line of peripheral support catheters from WavePoint Medical.
Share Price Performance
Over the past year, Cardiovascular Systems has underperformed the industry. The stock has declined 51.2% compared with the industry’s 16.9% fall.
Zacks Rank and Key Picks
Cardiovascular Systems currently carries a Zacks Rank #4 (Sell).
A few better-ranked stocks in the broader medical space are McKesson Corporation (MCK - Free Report) , AMN Healthcare Services, Inc. (AMN - Free Report) and Bio-Rad Laboratories, Inc. (BIO - Free Report) .
McKesson, carrying a Zacks Rank #2, reported third-quarter fiscal 2022 adjusted EPS of $6.15, which beat the Zacks Consensus Estimate of $5.38 by 14.3%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
McKesson has a long-term earnings growth rate of 11.8%. MCK has gained 49.7% compared with the industry’s 4.7% growth in the past year.
AMN Healthcare, carrying a Zacks Rank #1, has a long-term earnings growth rate of 16.2%. The company surpassed earnings estimates in the trailing four quarters, delivering a surprise of 19.5%, on average.
AMN Healthcare has outperformed its industry over the past year. AMN has gained 23.8% versus the 62% industry decline.
Bio-Rad reported fourth-quarter 2021 adjusted EPS of $3.21, which surpassed the Zacks Consensus Estimate by 11.9%. It currently has a Zacks Rank #2.
Bio-Rad has an earnings yield of 2.3%, which compares favorably with the industry’s negative yield. BIO surpassed earnings estimates in the trailing four quarters, the average surprise being 66.9%.