Tag Archives: Cardiovascular Systems

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Cardiovascular Systems Prices Public Offering of Common Stock

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By Business Wirevia The Motley Fool

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Cardiovascular Systems Prices Public Offering of Common Stock

ST. PAUL, Minn.–(BUSINESS WIRE)– Cardiovascular Systems, Inc. (CSI) (NAS: CSII) , a medical device company focused on developing and commercializing innovative interventional treatment systems for vascular disease, today announced the pricing of an underwritten public offering of 2,000,000 shares of its common stock, at a price to the public of $17.60 per share. The net proceeds to CSI from the sale of the shares, after deducting underwriting discounts and commissions, and estimated expenses, are expected to be approximately $33 million. All of the shares in the offering are to be sold by CSI. The offering is expected to close on or about March 25, 2013.

In connection with the offering, CSI has also granted the underwriters a 30-day option to purchase up to an additional 300,000 shares to cover over-allotments, if any.

Leerink Swann LLC is acting as the sole book-running manager of the offering. JMP Securities LLC is acting as co-manager.

The offering will be conducted pursuant to an effective shelf registration statement, including a base prospectus, which is on file with the Securities and Exchange Commission (SEC). A final prospectus supplement related to the offering will be filed with the SEC. Copies of the final prospectus supplement and the base prospectus relating to the offering, when available, may be obtained by visiting EDGAR on the SEC‘s website at http://www.sec.gov. Alternatively, copies of the final prospectus supplement and base prospectus related to the offering, when available, may be obtained from Leerink Swann LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by calling (800) 808-7525 ext. 4814.

This press release does not constitute an offer to sell or a solicitation of an offer to buy any securities of CSI, and there will not be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

About Cardiovascular Systems, Inc.

Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing innovative solutions for treating vascular and coronary disease. The company’s Orbital Atherectomy Systems treat calcified and fibrotic plaque in arterial vessels throughout the leg in a few minutes of treatment time, and address many of the limitations associated with existing surgical, catheter and …read more
Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

Cardiovascular Systems Announces Proposed Public Offering of Common Stock

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By Business Wirevia The Motley Fool

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Cardiovascular Systems Announces Proposed Public Offering of Common Stock

ST. PAUL, Minn.–(BUSINESS WIRE)– Cardiovascular Systems, Inc. (“CSI“) (NAS: CSII) , a medical device company focused on developing and commercializing innovative interventional treatment systems for vascular disease, today announced that it intends to offer and sell shares of its common stock, subject to market and other conditions, in an underwritten public offering. All of the shares in the offering are to be sold by CSI. CSI also expects to grant the underwriters a 30-day option to purchase additional shares of its common stock to cover over-allotments, if any.

Leerink Swann LLC is acting as the sole book-running manager of the offering. JMP Securities LLC is acting as co-manager.

The offering will be conducted pursuant to an effective shelf registration statement, including a base prospectus, which is on file with the Securities and Exchange Commission (“SEC“). A preliminary prospectus supplement related to the offering will be filed with the SEC. Copies of the preliminary prospectus supplement and the base prospectus relating to the offering, when available, may be obtained by visiting EDGAR on the SEC‘s website at http://www.sec.gov. Alternatively, copies of the preliminary prospectus supplement and base prospectus related to the offering, when available, may be obtained from Leerink Swann LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by calling (800) 808-7525 ext. 4814.

This press release does not constitute an offer to sell or a solicitation of an offer to buy any securities of CSI, and there will not be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

About Cardiovascular Systems, Inc.

Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing innovative solutions for treating vascular and coronary disease. The company’s Orbital Atherectomy Systems treat calcified and fibrotic plaque in arterial vessels throughout the leg in a few minutes of treatment time, and address many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. The U.S. Food and Drug Administration (“FDA”) granted 510(k) clearance for the use of the Diamondback Orbital Atherectomy System in August 2007. To date, over 100,000 of CSI‘s devices have been sold to institutions across the United States. CSI recently completed its ORBIT II …read more
Source: FULL ARTICLE at DailyFinance

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Cardiovascular Systems Completes PMA Submission of Orbital Atherectomy System for Coronary Artery Di

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By Business Wirevia The Motley Fool

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Cardiovascular Systems Completes PMA Submission of Orbital Atherectomy System for Coronary Artery Disease Treatment

Modular Application Includes ORBIT II Data that Surpassed the Trial’s Primary Endpoints

ST. PAUL, Minn.–(BUSINESS WIRE)– Cardiovascular Systems, Inc. (CSI) (NAS: CSII) , announced today that it has submitted its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its orbital atherectomy system, used to treat calcified coronary arteries.

The completed PMA application marks another major coronary milestone for CSI, following the release of ORBIT II pivotal trial results at the recent 2013 American College of Cardiology (ACC) conference. CSI‘s technology produced clinical outcomes that exceeded the trial’s two primary safety and efficacy endpoints by a significant margin—within one of the most challenging patient populations.

“Coronary arterial calcium is a vastly underestimated problem in medicine today, and there is a pressing need for a solution,” said David L. Martin, president and CEO of Cardiovascular Systems. “The ORBIT II results we shared at ACC show that our orbital atherectomy technology may be a viable treatment option for calcified coronary arteries. We look forward to working with the FDA on a potential coronary indication for this most challenging, underserved patient population.”

The company completed ORBIT II enrollment of 443 patients at 49 U.S. medical centers in November 2012. ORBIT II is evaluating the safety and effectiveness of the company’s orbital atherectomy technology in treating patients with severely calcified coronary lesions. This is the first Investigational Device Exemption study in history to evaluate this problematic subset of patients. At ACC, Dr. Jeffrey Chambers of Metropolitan Heart and Vascular Institute, Minneapolis, presented data that showed a 30-day freedom from MACE (major adverse cardiac events) rate of 89.8 percent and procedural success of 89.1 percent (including in-hospital MACE).

According to estimates, moderate to severe arterial calcium is present in nearly 40 percent of patients undergoing a percutaneous coronary intervention. Moderate-to-severe calcium contributes to poor outcomes and higher treatment costs in coronary interventions when traditional therapies are used, including a significantly higher occurrence of death and MACE. Coronary approval would open up a large, underserved market opportunity for CSI, estimated to exceed $1.5 billion annually in the United States.

The FDA agreed to a modular PMA process that allowed CSI to submit the first two modules covering preclinical data and manufacturing/quality systems, while still collecting, compiling and analyzing the clinical data. CSI has now …read more
Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

Cardiovascular Systems to Present Pivotal Orbit II Coronary Data at the 2013 American College of Car

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Cardiovascular Systems to Present Pivotal Orbit II Coronary Data at the 2013 American College of Cardiology Conference

ST. PAUL, Minn., & SAN FRANCISCO–(BUSINESS WIRE)– Cardiovascular Systems, Inc. (CSI) (NAS: CSII) , will present data from its ORBIT II study of coronary artery disease at the 2013 American College of Cardiology (ACC) conference in San Francisco, Mar. 9-11, 2013. This marks the first time CSI will share results from this landmark pivotal trial, which is the first Investigational Device Exemption (IDE) study in history to seek approval for treating severely calcified coronary lesions.

ORBIT II is evaluating the safety and effectiveness of the company’s orbital atherectomy technology in treating this problematic subset of patients. Moderate to severe arterial calcium is present in nearly 40 percent of patients undergoing a percutaneous coronary intervention, according to estimates. Moderate to severe calcium contributes to poor outcomes and higher treatment costs in coronary interventions when traditional therapies are used, including a significantly higher occurrence of death and major adverse coronary events. A coronary application would open up a large, underserved market opportunity for CSI, estimated to exceed $1.5 billion annually in the United States.

CSI completed ORBIT II enrollment of 443 patients at 49 U.S. medical centers in November 2012. CSI is targeting the end of March to submit its Premarket Approval application to the Food and Drug Administration (FDA).

…read more
Source: FULL ARTICLE at DailyFinance

 


Oral Presentation at ACC: Mar. 9