-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, SuQyryeASO6B8R8OOM65Cjwayin7lHqd28x6y+sH34GecXNflCbZod5VAo46Jdq8 yqeZ3ScRRlvVmUl3dWPM+g== 0000950134-08-011401.txt : 20080618 0000950134-08-011401.hdr.sgml : 20080618 20080618060244 ACCESSION NUMBER: 0000950134-08-011401 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20080618 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080618 DATE AS OF CHANGE: 20080618 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CARDIOGENESIS CORP /CA CENTRAL INDEX KEY: 0000863680 STANDARD INDUSTRIAL CLASSIFICATION: ORTHOPEDIC, PROSTHETIC & SURGICAL APPLIANCES & SUPPLIES [3842] IRS NUMBER: 770223740 STATE OF INCORPORATION: CA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-28288 FILM NUMBER: 08904542 BUSINESS ADDRESS: STREET 1: 11 MUSICK CITY: IRVINE STATE: CA ZIP: 92618 BUSINESS PHONE: 9494201800 MAIL ADDRESS: STREET 1: 11 MUSICK CITY: IRVINE STATE: CA ZIP: 92618 FORMER COMPANY: FORMER CONFORMED NAME: ECLIPSE SURGICAL TECHNOLOGIES INC DATE OF NAME CHANGE: 19940815 8-K 1 a41609e8vk.htm FORM 8-K e8vk
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 8-K
Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 18, 2008
CARDIOGENESIS CORPORATION
(Exact name of registrant as specified in its charter)
         
California   000-28288   77-0223740
         
(State or other jurisdiction of incorporation)   (Commission File Number)   (IRS Employer
Identification No.)
11 Musick
Irvine, CA 92618
(Address of principal executive offices, including zip code)
Registrant’s telephone number, including area code: (949) 420-1800
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
o   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
o   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
o   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 

 


TABLE OF CONTENTS

Item 8.01 Other Events
Item 9.01 Financial Statements and Exhibits
SIGNATURE
EXHIBIT INDEX
EXHIBIT 99.01


Table of Contents

Item 8.01 Other Events
On June 18, 2008, the Company issued a press release announcing preliminary results combining transmyocardial revascularization (TMR) with Platelet Rich Plasma (PRP).
The press release is attached hereto as Exhibit 99.01 and is incorporated herein by this reference.
The information in this Form 8-K and the Exhibits attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Act of 1934, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits
     (c) Exhibits
     
Exhibit Number   Exhibit Title or Description
99.01
  Press release of Cardiogenesis Corporation dated June 18, 2008 (furnished pursuant to Item 8.01)

 


Table of Contents

SIGNATURE
     Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
         
  CARDIOGENESIS CORPORATION
(Registrant)
 
 
Date: June 18, 2008  By:   /s/ William Abbott    
    William Abbott, Chief Financial Officer   
       

 


Table of Contents

EXHIBIT INDEX
         
     
Exhibit Number   Exhibit Title or Description
99.01
  Press release of Cardiogenesis Corporation dated June 18, 2008 (furnished pursuant to Item 8.01)

 

EX-99.01 2 a41609exv99w01.htm EXHIBIT 99.01 exv99w01
Exhibit 99.01
(Cardiogenesis Logo)
NEWS RELEASE for June 18, 2008 AT 6:00 AM ET
Contact:   William R. Abbott
Senior Vice President and Chief Financial Officer
949-420-1800
CARDIOGENESIS ANNOUNCES PRELIMINARY RESULTS COMBINING TMR +
PLATELET RICH PLASMA (PRP)
IRVINE, CA, June 18, 2008
Cardiogenesis Corporation (OTC: CGCP), a leading developer of surgical products for cardiac revascularization today announced an upcoming scientific presentation that describes the use of combining transmyocardial revascularization (TMR) with platelet rich plasma (PRP).
The presentation titled “Intramyocardial Injection of Autologous Platelet Rich Plasma combined with Transmyocardial Revascularization” will be presented by Kurt E. Wehberg, MD of Peninsula Regional Medical Center (Salisbury, Maryland) at the 34th annual meeting of the Western Thoracic Surgical Association on June 28, 2008 in Kona, Hawaii. The abstract of the presentation is available at http://www.westernthoracic.org/Abstracts/2008/BC8.html.
Dr. Wehberg will be presenting on a group of 25 consecutive patients treated with the Cardiogenesis holmium: YAG Laser TMR System. Eleven patients in the series received a combination therapy of TMR with an intramyocardial injection of autologous PRP, which is a concentration of platelets, white blood cells and circulating stem cells from the patients’ own peripheral blood. At six months, a blinded angina assessment demonstrated:
    Both groups achieved significant angina relief.
 
    The TMR + PRP group had a lower average angina score (0.4 vs 1.7, p=0.07) than the TMR alone group, and were more likely to be angina free (71% vs 23%, p=0.04).
 
    Ejection fraction (EF) improved in the TMR + PRP group (+9.0% vs. -2.0%, p=0.07) compared to the TMR group.
The authors conclude, “These preliminary results suggest that combining intramyocardial injection of PRP with TMR may be more efficacious at relieving angina and improving myocardial function than TMR alone.”
Richard Lanigan, President of Cardiogenesis, noted, “The results that Dr. Wehberg will present not only reinforce the clinical utility of TMR, but also suggests that our TMR system can enhance the effectiveness of a biologic agent.” Lanigan added, “Dr. Wehberg utilized the FDA

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approved Cardiogenesis TMR System along with readily available PRP as combination therapy in his series with favorable results. Earlier this month, at the 10th annual meeting of the International Society of Minimally Invasive Cardiothoracic Surgeons (ISMICS) meeting in Boston, Dr. Guillermo Reyes (La Princesa University Hospital, Madrid) reported on the use of the Company’s PHOENIX System that enables a combination TMR and biologics delivery in a single handpiece. Dr. Reyes reported the combination of TMR with bone marrow derived stem cells had demonstrated an improvement in angina class and reduction in the use of nitrates for the treated patients. These two reports demonstrate the clinical potential for TMR to enhance the effect of biologic substances through their precise delivery into the stimulated tissue border zone around the holmium: YAG TMR channels. Our focus is to build on this early work and provide clinicians with effective tools to treat the large patient population suffering from refractory angina by means of TMR and TMR plus biologics.”
About Cardiogenesis Corporation
Cardiogenesis is a medical device company specializing in the treatment of cardiovascular disease and is a leader in devices that stimulate cardiac angiogenesis. The company’s market leading holmium:YAG laser system and disposable fiber-optic accessories are used to perform a FDA-cleared surgical procedure known as Transmyocardial Revascularization (TMR) to treat patients suffering from angina. Surgical products and accessories for the Cardiogenesis TMR procedure, which are marketed in the U.S. and around the world, have been shown to reduce angina and improve the quality of life in patients with coronary artery disease.
For more information on the company and its products, please visit the Cardiogenesis company website at http://www.cardiogenesis.com or the direct to patient website at http://www.heartofnewlife.com.
With the exception of historical information, the statements set forth above include forward-looking statements. Any forward-looking statements in this news release related to the possible effectiveness of the company’s technologies and the effect of such technologies on the company’s sales, profitability, the adoption of its technology and products and FDA clearances are based on current expectations and beliefs and are subject to numerous risks and uncertainties, many of which are outside the company’s control, that could cause actual results to differ materially. Factors that could affect the accuracy of these forward-looking statements include, but are not limited to: any inability by the company to sustain profitable operations or obtain additional financing on favorable terms if and when needed; any failure to obtain required regulatory approvals; failure of the medical community to expand its acceptance of TMR procedures; possible adverse governmental rulings or regulations, including any FDA regulations or rulings; the company’s ability to comply with international and domestic regulatory requirements; possible adverse Medicare or other third-party reimbursement policies or adverse changes in those policies; any inability by the company to ship product on a timely basis; the company’s ability to manage its growth; adverse economic developments that could adversely affect the market for our products or our ability to raise needed financing; actions by our competitors; and the company’s ability to protect its intellectual property. Other factors that could cause Cardiogenesis’ actual results to differ materially are discussed in the “Risk Factors” section of the company’s Annual Report on Form 10-KSB for the year ended December 31, 2007 and the company’s other recent SEC filings. The company disclaims any obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

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