Cardiovascular Systems, Inc. (NASDAQ: CSII) has completed enrollment for the ECLIPSE coronary trial, the largest randomized trial of its kind, involving 2,000 patients with severely calcified coronary lesions. This multi-center trial aims to compare outcomes between orbital atherectomy and conventional angioplasty followed by drug-eluting stent (DES) implantation. Key endpoints include post-procedural cross-sectional area and one-year clinical outcomes related to target vessel failure. Results are anticipated in fall 2024, with the potential to guide treatment strategies for coronary artery disease.
Cardiovascular Systems, Inc. (NASDAQ: CSII) reported its second quarter financial results for fiscal 2023, ending December 31, 2022, with revenues reaching $61.5 million, up 3.9% year-over-year. The gross profit margin stood at 70.0%, although selling, general, and administrative expenses rose 3.1% to $41.6 million. Research and development expenses increased by 7.4%, totaling $9.5 million. CSI posted a net loss of $7.9 million ($0.20 per share), an improvement from the previous year's loss of $9.0 million. Adjusted EBITDA loss also increased to $3.7 million. The company had $132.0 million in cash and marketable securities with no long-term debt. Due to an upcoming acquisition by Abbott Laboratories (NYSE: ABT), CSI canceled its conference call on February 9, 2023.
Cardiovascular Systems, Inc. (CSII) is set to announce its operating results for the quarter ending December 31, 2022 before market opens on February 9, 2023. A conference call to discuss these results will occur at 9:00 a.m. ET the same day.
CSII specializes in developing medical devices for vascular and coronary disease, particularly with its orbital atherectomy system that treats plaque in arteries. This system aims to overcome limitations of existing treatments.
Cardiovascular Systems, Inc. (CSII) has initiated the KAIZEN clinical study of its Diamondback 360© Peripheral Orbital Atherectomy System (OAS) in Japan, targeting calcified plaque in patients with peripheral artery disease (PAD). The study aims for regulatory approval and involves up to 100 subjects across 12 sites. Positive early feedback from Dr. Tatsuya Nakama noted the device's effectiveness and safety. This study follows previous positive outcomes of OAS in the U.S., indicating its potential to address unmet needs in treating severely calcified arteries.
Cardiovascular Systems, Inc. (CSII) has announced that Innova Vascular, Inc. has submitted a 510(k) Premarket Notification to the FDA for thrombectomy devices to treat peripheral vascular disease. CSI plans to acquire and commercialize these devices, which will enhance its existing portfolio. Commercialization could begin in about 6 months, pending FDA clearance. The acquisition agreement includes financing for Innova, contingent on meeting development milestones. This partnership aims to expand treatment options for deep vein thrombosis and pulmonary embolism.
Cardiovascular Systems, Inc. (CSII) announced plans to participate in the Stifel 2022 Healthcare Conference on November 16, 2022, at 1:15 p.m. ET, where it will also host investor meetings. Additionally, the company will host investor meetings at the Canaccord Genuity MedTech Conference on November 17, 2022. CSII specializes in innovative treatment systems for vascular and coronary diseases, notably its orbital atherectomy system designed to treat calcified plaque in arterial vessels.
Cardiovascular Systems, Inc. (CSII) reported first-quarter revenues of $59.7 million, a 2.2% increase year-over-year. Worldwide coronary revenue rose 7.9%, but peripheral revenue fell by less than 1%. Net loss for the quarter was $10.6 million, or $0.27 per share, compared to a loss of $8.6 million last year. The company reiterates its fiscal 2023 revenue guidance of $255 million to $265 million, suggesting growth of 8% to 12%. Adjusted EBITDA loss widened to $5.2 million. CSI remains optimistic about market recovery and product expansion.
Cardiovascular Systems, Inc. (CSII) has announced the full market release of the 2.00 Max Crown for Peripheral Orbital Atherectomy Systems. This device enhances treatment capabilities for patients with peripheral artery disease by enabling effective treatment of mixed plaque morphologies. With a 70-micron diamond-coated crown, it offers significant luminal gain for calcified lesions above the knee. CEO Scott R. Ward highlighted this launch as a step toward broadening CSII's product portfolio, aiming to improve patient outcomes during peripheral interventions.
Cardiovascular Systems, Inc. (NASDAQ: CSII) will announce its operating results for Q3 2022 on November 3, 2022, before market opening. A conference call will follow at 8:00 a.m. CT for discussion of the results. The company specializes in medical devices for vascular and coronary diseases, with a focus on its orbital atherectomy system designed to treat calcified plaque in arterial vessels.
Cardiovascular Systems, Inc. (CSII) reported fourth-quarter revenues of $62.5 million, a 12% decrease year-over-year but an 11% increase sequentially. The company anticipates fiscal 2023 revenues between $255 million and $265 million, projecting 8% to 12% growth compared to fiscal 2022. A net loss of $9.7 million was reported for Q4, an increase from $5.3 million in the prior year, with an Adjusted EBITDA loss of $4.3 million. Key operational milestones were achieved, with growth in both peripheral and coronary business segments.