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Cardiogenesis Reports Fourth Quarter and Full-Year 2009 Results
4th Quarter Revenue Up 29% from Prior Year
IRVINE, Calif., March 3, 2010 /PRNewswire via COMTEX/ -- Cardiogenesis Corporation (Pink Sheets: CGCP), a leading developer of surgical products used in the treatment of cardiac patients suffering from severe angina, today reported financial results for its fourth quarter and year-ended December 31, 2009.
Revenues in the fourth quarter of 2009 totaled $3,132,000 a 29% increase from prior year fourth quarter revenues of $2,431,000. Higher quarterly revenues resulted in a gross margin of 84% and an operating income of $459,000. The operating income compares favorably with an operating loss of $555,000 in the 2008 fourth quarter. Net income for the quarter was $409,000 or $0.01 per basic and diluted share, as compared with net loss of $573,000, or $0.01 per basic and diluted share in the 2008 fourth quarter.
"The increase in fourth quarter sales is a direct result of focusing our sales team on the previously installed laser systems in U.S. hospitals," said Cardiogenesis Executive Chairman Paul McCormick, "These positive financial results will allow us to step up our investment in research and development as we prepare to initiate a U.S. clinical trial for our novel PHOENIX(TM) Delivery System, which combines myocardial tissue stimulation with the intramyocardial delivery of stem cells. We believe that the combination of our PHOENIX technology with bioactive cells represents an exciting growth opportunity for us and could potentially represent a new standard of care for delivery of stem cells to the heart."
Handpiece revenue in the fourth quarter of 2009 increased $412,000, or 24%, to $2,134,000 as compared to $1,722,000 in the same period of the prior year. Laser revenue in the fourth quarter of 2009 increased $327,000, or 48%, to $687,000 over the fourth quarter of 2008 as a result of higher average sales prices.
Revenues for the 2009 full-year totaled $10,354,000, a 15% decrease from revenues of $12,150,000 in 2008. Full-year handpiece revenue totaled $7,657,000, a decrease of $374,000, or 5%, from handpiece revenue of $8,031,000 for the year ended December 31, 2008. Laser revenue for the year ended December 31, 2009, reflecting the challenging capital equipment environment in 2009, was $1,453,000, a decrease of $1,505,000 from full-year 2008.
For the year ended December 31, 2009, Cardiogenesis reported an operating loss of $1,118,000 as compared with an operating loss of $320,000 for the same period in 2008. The net loss for 2009 was $1,234,000 or $0.03 per basic and diluted share, compared with a net loss of $315,000, or $0.01 per basic and diluted share, for full year 2008.
Gross margin was 84% of net revenues for the quarter ended December 31, 2009 as compared with 73% for the quarter ended December 31, 2008. Gross profit increased by $851,000 to $2,632,000 for the fourth quarter of 2009 as compared with $1,781,000 for the 2008 fourth quarter. The higher gross margin in the 2009 fourth quarter results primarily from higher average sales prices for both our handpieces and lasers. In addition, fourth quarter 2008 results included approximately $166,000 in inventory reserve charges that did not recur in the fourth quarter of 2009.
For the full year ended December 31, 2009, gross margin was 83% of net revenues as compared to 82% for the twelve months ended December 31, 2008. As a result of lower sales revenues in 2009, gross profit in absolute dollars decreased by $1,364,000 to $8,547,000 for the year ended December 31, 2009, as compared with $9,911,000 for the 2008 year.
Research and development expenses were $318,000 in the fourth quarter of 2009 as compared with $271,000 in the 2008 fourth quarter. For the full year 2009, R&D expenses of $1,331,000 were $427,000 or 47% above 2008 R&D expenses of $904,000. The dollar increase for the three month and full year periods are primarily attributed to submissions and follow-up with the Food and Drug Administration related to the PMA Application for the PEARL 8.0 handpiece and the Investigational Device Exemption to initiate a safety and feasibility trial for the PHOENIX Delivery System.
Sales and marketing expenses of $1,454,000 in the quarter ended December 31, 2009 decreased $175,000, or 11%, compared with $1,629,000 for the quarter ended December 31, 2008. For the twelve months ended December 31, 2009, sales and marketing expenditures totaled $5,558,000, a decrease of $929,000, or 14%, compared with $6,487,000 for in 2008.
General and administrative expenses for the quarter ended December 31, 2009 totaled $401,000 as compared to $436,000 during the quarter ended December 31, 2008. For the full year period ended December 31, 2009, general and administrative expenses totaled $2,776,000 as compared to $2,840,000 for the twelve months ended December 31, 2008.
About Cardiogenesis Corporation
Cardiogenesis is a medical device company specializing in the treatment of cardiovascular disease and is a leader in devices that treat severe angina. Our market leading holmium:YAG laser system and single use fiber-optic delivery systems are used to perform a FDA-cleared surgical procedure known as Transmyocardial Revascularization (TMR).
For more information on Cardiogenesis and its products, please visit our website at www.cardiogenesis.com.
Safe Harbor Statement
This press release contains forward-looking statements, including, without limitation, with respect to the Company's expectation to begin a U.S. clinical trial of the Company's PHOENIX(TM) Combination Delivery System. Any forward-looking statements in this news release 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; the effects of recent disruptions in global credit and equity markets and other 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-K for the year ended December 31, 2008 and the Company's other filings with the Securities and Exchange Commission. The Company disclaims any obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
CARDIOGENESIS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
Three months ended Year ended
December 31, December 31,
2009 2008 2009 2008
---- ---- ---- ----
(unaudited) (audited)
Net revenues $3,132 $2,431 $10,354 $12,150
Cost of revenues 500 650 1,807 2,239
--- --- ----- -----
Gross profit 2,632 1,781 8,547 9,911
----- ----- ----- -----
Operating expenses:
Research and development 318 271 1,331 904
Sales and marketing 1,454 1,629 5,558 6,487
General and administrative 401 436 2,776 2,840
--- --- ----- -----
Total operating expenses 2,173 2,336 9,665 10,231
----- ----- ----- ------
Operating income (loss) 459 (555) (1,118) (320)
Other income (expense):
Interest expense (1) (1) (36) (23)
Interest income - 4 3 59
Other non-operating expense (43) - (63) -
--- --- --- ---
Total other income (expense), net (44) 3 (96) 36
--- --- --- ---
Income (loss) before income taxes 415 (552) (1,214) (284)
Provision for income taxes 6 21 20 31
--- --- --- ---
Net income (loss) $409 $(573) $(1,234) $(315)
==== ===== ======= =====
Net earnings (loss) per share:
Basic and Diluted $0.01 $(0.01) $(0.03) $(0.01)
===== ====== ====== ======
Weighted average shares outstanding:
Basic and Diluted 45,549 45,402 45,526 45,320
------ ------ ------ ------
CARDIOGENESIS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
Years Ended December 31,
2009 2008
---- ----
(audited)
ASSETS
Current assets:
Cash and cash equivalents $2,568 $2,907
Accounts receivable, net of allowance for
doubtful accounts of $6 and $20, respectively 933 1,330
Inventories 914 1,164
Investments in marketable securities - 75
Prepaids and other current assets 253 395
--- ---
Total current assets 4,668 5,871
Property and equipment, net 341 382
Other assets, net 9 18
--- ---
Total assets $5,018 $6,271
====== ======
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
Accounts payable $127 $200
Accrued salaries and related 604 554
Accrued liabilities 299 549
Deferred revenue 744 800
Note payable 88 -
Current portion of capital lease obligations 9 6
--- ---
Total current liabilities 1,871 2,109
Capital lease obligations, less current portion 14 13
--- ---
Total liabilities 1,885 2,122
----- -----
Commitments and Contingencies
Shareholders' equity:
Preferred stock:
no par value; 5,000 shares authorized; none
issued and outstanding - -
Common stock:
no par value; 75,000 shares authorized;
45,549 and 45,487 shares issued and
outstanding, respectively 174,217 173,999
Accumulated deficit (171,084) (169,850)
-------- --------
Total shareholders' equity 3,133 4,149
----- -----
Total liabilities and shareholders' equity $5,018 $6,271
====== ======
SOURCE Cardiogenesis Corporation
Earnings CC is Monday
http://biz.yahoo.com/cc/5/101875.html
Been following for a while now, was going to buy at .12 and didn't. made a crazy move lately without news.
Starting some DD here, this thing has lots of potential
Positron Delivers SPECT Based Automated Radiopharmaceutical Dose Dispensing Unit to South American Nuclear Pharmacy Dec 19, 2008 11:26:00 AM Copyright Business Wire 2008 HOUSTON--(BUSINESS WIRE)-- Positron Corporation (POSC.OB) announced today that it has completed the sale and delivery of its SPECT based Nuclear Pharm-AssistTM device to Comci, LTDA in Bogota, Colombia. The Nuclear Pharm-AssistTM is an automated dose dispensing machine sold to pharmacies and healthcare providers designed to increase productivity, decrease or eliminate exposure issues while offering a platform for USP-797 and regulatory compliance. The Nuclear Pharm-AssistTM streamlines the production and delivery of radiopharmaceuticals allowing for the establishment of unique distribution models within the Nuclear Medicine market. "We are delighted to work with Comci on our state of the art SPECT based Nuclear Pharm-AssistTM," said Joe Oliverio, President of Positron. "Our automated dose dispensing technology enables Positron to be more integrated around the sale and distribution of radiopharmaceuticals to our customers."
CGCP (.23) Cardiogenesis Receives FDA Approval for PEARL 5.0 Robotic Hand Piece
Tuesday, November 13 2007 7:29 AM, EST PR Newswire "US Press Releases "
IRVINE, Calif ., Nov. 13 /PRNewswire-FirstCall/ -- Cardiogenesis Corporation (OTC: CGCP.PK), a leading developer of surgical products for transmyocardial revascularization (TMR) today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for its PEARL (Port Enabled Angina Relief using Laser) 5.0 Robotic Delivery System. The PEARL 5.0 is the only TMR delivery system compatible with robotic surgical systems.
"The Cardiogenesis TMR system uses laser energy delivered through a small optical fiber to create channels in heart muscle that doesn't have enough blood supply, thus helping patients with disabling chest pain or angina," said Louis A. Brunsting, III, M.D at Centennial Medical Center , Nashville, TN , the principal investigator for the PEARL investigational device exemption (IDE) clinical study. "The PEARL 5.0 device now allows this form of treatment to be performed entirely endoscopically, with only a few port incisions. This new minimally invasive approach, utilizing a surgical robotic system, can markedly reduce hospitalization and recovery time for patients, facilitating their return to an active lifestyle."
The PEARL 5.0 Robotic delivery system consists of the CrystalFlex(TM) fiber optic within a handpiece with an extended length flexible shaft to allow it to be introduced through small incisions in the chest wall through a 5 mm port. The end of the flexible shaft is designed to enable the grasping and manipulation of the tip by surgical robotic tools within the chest cavity for placement on the surface of the targeted area of the heart muscle. The CrystalFlex fiber optic is then advanced through the flexible shaft into the heart muscle using the handpiece control to create a series of laser channels.
"FDA approval of the PEARL 5.0 is a significant achievement for Cardiogenesis and an important advancement for patients suffering from heart disease who are not candidates for coronary stents or bypass surgery," said Richard Lanigan, President of Cardiogenesis. "Physicians can now offer the proven clinical benefits of TMR utilizing the less invasive approach via robotic surgical systems. We believe the PEARL 5.0 Robotic delivery system approval increases the number of patients who can be effectively treated with TMR."
About Transmyocardial Revascularization (TMR)
TMR is for the treatment of advanced coronary artery disease in patients whose chronic angina symptoms are not relieved by medication and have an area of the heart that cannot be treated by percutaneous intervention or bypass surgery. Three out of four patients who received TMR in studies have shown a significant reduction in their angina pain. Additionally, patient benefits have been shown to endure beyond five years, and TMR has been shown to help patients live longer. TMR is reimbursed by Medicare, Medicaid and most private payers when performed as a stand alone procedure and when performed adjunctively to bypass surgery.
About Cardiogenesis Corporation
Founded in 1989, Cardiogenesis (OTC: CGCP.PK) is a leading medical device company that designs, develops and distributes laser-based surgical products and disposable fiber-optic accessories that treat diffuse coronary artery disease with a procedure called transmyocardial revascularization (TMR). Its products are marketed in the U.S. and around the world, and have been shown to reduce angina and improve the quality of life in patients. Cardiogenesis is located in Irvine, California . For more information on the company and its products, please visit http://www.cardiogenesis.com or the direct-to-patient website http://www.heartofnewlife.com or call 800.238.2205.
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 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 or PMC 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; restrictions contained in our convertible debt obligations requiring the issuance of shares rather than repayment in cash; 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, 2006 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.
SOURCE Cardiogenesis Corporation
This email reply from CGCP about coming off the pinks: Thank you for your inquiry.
As we noted in our filings, we expect to seek reinstatement of trading of the Company's stock on the OTC Bulletin Board as soon as reasonably practicable.
That process consists of finding a market maker who then trades in the stock for a minimum of 20 trading days. The market maker then applies to the NASD for a relisting which is then approved (or denied) by NASD. The process is currently underway and, while we cannot identify a date, we are hopeful that it will be soon.
Thank you for your interest in Cardiogenesis and if you require any further clarification, please do not hesitate to contact us.
Rosemary Sadler
Assistant to Chairman
Cardiogenesis Announces Passing of Director, Joseph R. Kletzel, II
IRVINE, Calif., Jan 17, 2007 /PRNewswire-FirstCall via COMTEX News Network/ -- Cardiogenesis Corporation (OTC: CGCP), is deeply saddened to announce that Joseph R. Kletzel, II, valued member of the Cardiogenesis Board of Directors, died on Monday, January 15.
He was very well respected in the medical device industry as a leader and a man of impeccable integrity. Mr. Kletzel had been a member of Cardiogenesis' Board of Directors since 2001 and employed in a series of senior management positions beginning in 2004, most recently serving as Executive Chairman since November, 2006.
Richard Lanigan, President of Cardiogenesis, noted. "Joe will be greatly missed, both as a respected colleague and as a friend, whose integrity and respect for others will always be remembered."
Previous to joining Cardiogenesis, Mr. Kletzel's medical device career achievements included positions as Chief Operating Officer for Advanced Tissue Sciences in La Jolla, California; President of the Research Division of Fisher Scientific International in Pittsburgh, Pennsylvania; and President and COO of Devon Industries in Chatsworth, California. He earned his BS in Biology from Villanova University and achieved the rank of Captain while serving on active duty in the U.S. Marine Corps.
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. Surgical products and accessories for the Company's minimally invasive Percutaneous Myocardial Channeling (PMC) procedure are currently being marketed in Europe and other international markets.
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 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 or PMC 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; restrictions contained in our convertible debt obligations requiring the issuance of shares rather than repayment in cash; 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-K for the year ended December 31, 2005, the Company's Quarterly Report on Form 10-QSB for the quarter ended September 30, 2006, 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.
SOURCE Cardiogenesis Corporation
Cardiogenesis Corporation, +1-949-420-1800
http://www.cardiogenesis.com
SC 13G/A
PERKINS CAPITAL MANAGEMENT INC filed this Form SC 13G/A on 01/12/07
>
SECURITIES AND EXCHANGE
COMMISSION
Washington, D.C. 20549
SCHEDULE 13G/A
Under the Securities Exchange Act of 1934
Amendment No. | 6 |
CardioGenesis Corporation
(Name of Issuer)
Common Shares
(Title of Class of Securities)
14159W-10-9
(CUSIP Number)
December 31, 2006
(Date of Event Which Requires Filing of this Statement)
Check the appropriate box to designate the rule pursuant to which this Schedule
is filed:
[X] Rule 13d-1(b)
[ ] Rule 13d-1(c)
[ ] Rule 13d-1(d)
* The remainder of this cover page shall be filled out for a reporting person's
initial filing on this form with respect to the subject class of securities, and
for any subsequent amendment containing information which would alter the
disclosures provided in a prior cover page.
The information required in the remainder of this cover page shall not be deemed
to be "filed" for the purpose of Section 18 of the Securities Exchange Act of
1934 ("Act") or otherwise subject to the liabilities of that section of the Act
but shall be subject to all other provisions of the Act (however, see the
Notes).
CUSIP No. 14159W-10-9 13G/A Page 2 of 5 Pages
________________________________________________________________________________
1. NAME OF REPORTING PERSON
S.S. OR I.R.S. IDENTIFICATION NO. OF ABOVE PERSON
Perkins Capital Management, Inc. 14-1501962
________________________________________________________________________________
2. CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP*
(a) [_]
(b) [_]
________________________________________________________________________________
3. SEC USE ONLY
________________________________________________________________________________
4. CITIZENSHIP OR PLACE OF ORGANIZATION
State of Minnesota
________________________________________________________________________________
5. SOLE VOTING POWER
3,070,550
NUMBER OF _________________________________________________________________
SHARES 6. SHARED VOTING POWER
BENEFICIALLY
OWNED BY EACH 0
REPORTING _________________________________________________________________
PERSON WITH 7. SOLE DISPOSITIVE POWER
6,342,550
_________________________________________________________________
8. SHARED DISPOSITIVE POWER
0
________________________________________________________________________________
9. AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
6,342,550
________________________________________________________________________________
10. CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (9) EXCLUDES CERTAIN SHARES*
[_]
________________________________________________________________________________
11. PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (9)
14.0%
________________________________________________________________________________
12. TYPE OF REPORTING PERSON*
IA
________________________________________________________________________________
*SEE INSTRUCTIONS BEFORE FILLING OUT!
Item 1(a) Name of Issuer:
CardioGenesis Corporation
Item 1(b) Address of Issuer's Principal Executive Offices:
11 Musick
Irvine, CA 92618
Item 2(a) Name of Person Filing:
Perkins Capital Management, Inc.
Item 2(b) Address of Principal Business Office or, if None, Residence:
730 East Lake Street
Wayzata, MN 55391
Item 2(c) Citizenship:
State of Minnesota
Item 2(d) Title of Class of Securities:
Common Shares
Item 2(e) CUSIP Number:
14159W-10-9
Item 3. If this statement is filed pursuant to Rules 240.13d-1(b) or
240.13d-2(b) or (c), check whether the person filing is a:
(a) [_] Broker or dealer registered under Section 15 of the Act (15
U.S.C.78o);
(b) [_] Bank as defined in Section 3(a)(6) of the Act (15 U.S.C.78c);
(c) [_] Insurance company as defined in Section 3(a)(19) of the Act (15
U.S.C.78c);
(d) [_] Investment company registered under Section 8 of the Investment
Company Act of 1940 (15 U.S.C.8a-8);
(e) [X] An Investment Adviser in accordance with Section 240. 13d-1(b)(1)
(ii)(E);
(f) [_] An employee benefit plan or endowment fund in accordance with
Section 240. 13d-1(b)(1)(ii)(F);
(g) [_] A parent holding company or control person in accordance with
Section 240. 13d-1(b)(1)(ii)(G);
(h) [_] A savings association as defined in Section 3(b) of the Federal
Deposit Insurance Act (12 U.S.C. 1813);
(i) [_] A church plan that is excluded from the definition of an
investment company under Section 3(c)(14) of the Investment
Company Act of 1940 (15 U.S.C.80a-3);
(j) [_] Group, in accordance with Section 240. 13d-1(b)(1)(ii)(J).
If this statement is filed pursuant to Section 240 13d-1(c),
check this box. [ ]
Item 4. Ownership.
(a) Amount beneficially owned:
6,342,550
(b) Percent of class:
14.0%
(c) Number of shares as to which such person has:
(i) Sole power to vote or to direct the vote
3,070,550
(ii) Shared power to vote or to direct the vote
0
(iii) Sole power to dispose or to direct the disposition of
6,342,550
(iv) Shared power to dispose or to direct the disposition of
0
Item 5. Ownership of Five Percent or Less of a Class.
If this statement is being filed to report the fact that as of the date
hereof the reporting person has ceased to be the beneficial owner of more than
five percent of the class of securities, check the following [ ].
Item 6. Ownership of More than Five Percent on Behalf of Another Person.
n/a
Item 7. Identification and Classification of the Subsidiary Which Acquired the
Security Being Reported on by the Parent Holding Company.
n/a
Item 8. Identification and Classification of Members of the Group.
n/a
Item 9. Notice of Dissolution of Group.
n/a
Item 10. Certification.
By signing below I certify that, to the best of my knowledge and belief,
the securities referred to above were not acquired and are not held for the
purpose of and do not have the effect of changing or influencing the control of
the issuer of such securities and were not acquired and are not held in
connection with or as a participant in any transaction having such purpose or
effect.
SIGNATURE
After reasonable inquiry and to the best of my knowledge and belief, I
certify that the information set forth in this statement is true, complete and
correct.
January 12, 2007
-----------------------------
(Date)
/s/ Richard C. Perkins
----------------------------
(Signature)
Richard C. Perkins
Executive VP/Portfolio Manager
-----------------------------
(Name/Title)
From CGCP on when they will be back on OTCBB-Thank you for your inquiry.
As we noted in our filings, we expect to seek reinstatement of trading of the Company's stock on the OTC Bulletin Board as soon as reasonably practicable.
That process consists of finding a market maker who then trades in the stock for a minimum of 20 trading days. The market maker then applies to the NASD for a relisting which is then approved (or denied) by NASD. The process is currently underway and, while we cannot identify a date, we are hopeful that it will be soon.
Thank you for your interest in Cardiogenesis and if you require any further clarification, please do not hesitate to contact us.
Rosemary Sadler
Assistant to Chairman
This is a notification that the new Cardiogenesis website is now available.
Please visit:http://www.cardiogenesis.com/
If you have any questions, please email me.
Thanks,
Chelsea Madren
Corporate Communications Specialist
Yes finally some Insider buying,. Name and Address of Reporting Person*LANIGAN RICHARD P
--------------------------------------------------------------------------------
(Last) (First) (Middle)
11 MUSICK
--------------------------------------------------------------------------------
(Street)IRVINE CA 92618
--------------------------------------------------------------------------------
(City) (State) (Zip)
2. Issuer Name and Ticker or Trading Symbol
CARDIOGENESIS CORP /CA [CGCP.PK] 5. Relationship of Reporting Person(s) to Issuer
(Check all applicable) Director 10% Owner
X Officer (give title below) Other (specify below)
Senior VP of Operations
3. Date of Earliest Transaction (Month/Day/Year)
11/29/2006
4. If Amendment, Date of Original Filed (Month/Day/Year)
6. Individual or Joint/Group Filing (Check Applicable Line)X Form filed by One Reporting Person
Form filed by More than One Reporting Person
Table I - Non-Derivative Securities Acquired, Disposed of, or Beneficially Owned
1.Title of Security
(Instr. 3) 2. Transaction Date (Month/Day/Year) 2A. Deemed Execution Date, if any (Month/Day/Year) 3. Transaction Code
(Instr. 8) 4. Securities Acquired (A) or Disposed of (D)
(Instr. 3, 4 and 5) 5. Amount of Securities Beneficially Owned Following Reported Transaction(s)
(Instr. 3 and 4) 6. Ownership Form: Direct (D) or Indirect (I)
(Instr. 4) 7. Nature of Indirect Beneficial Ownership
(Instr. 4)
Code V Amount (A) or (D) Price
Common Stock 11/29/2006 P 30,000 A $ 0.33 83,765 D
Table II - Derivative Securities Acquired, Disposed of, or Beneficially Owned
(e.g., puts, calls, warrants, options, convertible securities)
1. Title of Derivative Security
(Instr. 3) 2. Conversion or Exercise Price of Derivative Security 3. Transaction Date (Month/Day/Year) 3A. Deemed Execution Date, if any (Month/Day/Year) 4. Transaction Code
(Instr. 8) 5. Number of Derivative Securities Acquired (A) or Disposed of (D)
(Instr. 3, 4, and 5) 6. Date Exercisable and Expiration Date
(Month/Day/Year) 7. Title and Amount of Underlying Securities
(Instr. 3 and 4) 8. Price of Derivative Security
(Instr. 5) 9. Number of Derivative Securities Beneficially Owned Following Reported Transaction(s)
(Instr. 4) 10. Ownership Form of Derivative Security: Direct (D) or Indirect (I)
(Instr. 4) 11. Nature of Indirect Beneficial Ownership
(Instr. 4)
Code V (A) (D) Date Exercisable Expiration Date Title Amount or Number of Shares
Explanation of Responses:
/s/ Richard P. Lanigan 12/01/2006
** Signature of Reporting Person Date
Reminder: Report on a separate line for each class of securities beneficially owned directly or indirectly.
* If the form is filed by more than one reporting person, see Instruction 4(b)(v).
** Intentional misstatements or omissions of facts constitute Federal Criminal Violations See 18 U.S.C. 1001 and 15 U.S.C. 78ff(a).
Note: File three copies of this Form, one of which must be manually signed. If space is insufficient, see Instruction 6 for procedure.
Persons who respond to the collection of information contained in this form are not required to respond unless the form displays a currently valid OMB Number.
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About CardioGenesis and Angiogenesis | Coronary Heart Disease Glossary
TMR Patients | Cardiac and Medical Professionals
Transmyocardial Revascularization - TMR Information
Percutaneous Myocardial Revascularization - PMR Information
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Cardiogenesis Announces Opening of New Facility
Cardiogenesis Relocates to New Facility in Irvine California
IRVINE, Calif., Oct. 11 /PRNewswire-FirstCall/ -- Cardiogenesis Corporation (OTC: CGCP), a leading developer of surgical products and accessories used in angina-relieving procedures, announced today that the Company has moved into a new facility in Irvine, California.
The new corporate office and light manufacturing facility is located at 11 Musick, Irvine, California. "Our new facility provides us with additional lab and testing space as well as warehousing for our controlled inventory. It is a single level facility that will enhance our productivity, as well as reduce our overall operating costs. We are consolidating what was previously spread out among three sites into our new facility," stated Joseph R. Kletzel, II Chairman and CEO.
The company had previously announced it was taking specific steps to improve its overall operating efficiency. Kletzel explained, "Our new facility supports our operating objectives for growth and efficiency going forward. At the same time, we expect that this move will reduce our overall facility costs by over 50% or approximately $300,000 on an annualized basis." The company completed the move on the weekend of October 7th and 8th, and is now fully functional in its new Irvine facility.
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 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 or PMC 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; restrictions contained in our convertible debt obligations requiring the issuance of shares rather than repayment in cash; 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-K for the year ended December 31, 2005, the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2006, 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.
SOURCE Cardiogenesis Corporation
-0- 10/11/2006
/CONTACT: William R. Abbott, Senior Vice President and Chief Financial
Officer of Cardiogenesis Corporation, +1-949-420-1800/
(CGCP)
CO: Cardiogenesis Corporation
ST: California
IN: BIO HEA MTC OTC
SU:
Cardiogenesis Advanced Delivery System Gains European Approval
Cardiogenesis Receives CE Mark Approval to Market PHOENIX Combination Delivery System
IRVINE, Calif., Oct. 10 /PRNewswire-FirstCall/ -- Cardiogenesis Corporation (OTC: CGCP), a leading developer of surgical products and accessories used in angina-relieving procedures, announced today that the company has received CE Mark approval for marketing its advanced combination delivery system.
The device, called the PHOENIX Combination Delivery System, provides for the delivery of the company's proprietary Ho: YAG laser energy used for transmyocardial revascularization along with precise delivery of a biologic or pharmacologic therapeutic material to areas of the myocardium that cannot be bypassed during cardiac surgery. It has been estimated that up to 6% of patients receiving a diagnostic catheterization (over 120,000 patients worldwide) with advanced coronary artery disease are not candidates for stenting or bypass surgery, and up to 25% of the 800,000 bypass procedures performed worldwide annually have areas of the heart muscle that are poor targets for bypass due to severe coronary artery disease.
Regarding the European approval to market the PHOENIX TMR plus biologic delivery system, Chairman and CEO Joseph R. Kletzel, II stated, 'This initial approval will support the controlled launch of the PHOENIX system in Europe and other targeted international markets with clinicians who are providing advanced biologic and cell therapies to patients suffering from advanced heart disease. We intend to work closely with the initial centers to collect and publish data of interest about this advanced technology to clinicians, providers and patients in need.'
The company has previously reported the completion of the first clinical cases with the PHOENIX TMR plus biologic delivery system in Beijing by Dr. Feng Wan. In the initial cases, Dr. Wan used PHOENIX to deliver Ho: YAG laser energy in combination with a concentration of autologous bone marrow stem cells to areas of the heart that could not be bypassed.
Regarding the progress of the PHOENIX development plan Kletzel explained, 'We are working closely with researchers and the early clinical adopters of the PHOENIX technology to advance the clinical application in support of a full commercial launch. We are conducting basic and translational research in support of the advanced PHOENIX Combination Delivery System to assist clinicians in optimizing their therapeutic strategy and clinical outcomes. We will utilize the initial clinical information, along with the research results achieved with PHOENIX in determining the appropriate regulatory, reimbursement and commercial strategies in the U.S. going forward.'
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 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 or PMC 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; restrictions contained in our convertible debt obligations requiring the issuance of shares rather than repayment in cash; 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-K for the year ended December 31, 2005, the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2006, 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.
SOURCE Cardiogenesis Corporation
Source: PR Newswire (October 10, 2006 - 7:50 AM EST)
News by QuoteMedia
Looks good all-in-all
Cardiogenesis Announces Results for Second Quarter and First Half of 2006
Monday August 21, 4:56 pm ET
Company Is Current With SEC Filings, 2006 First Half Revenue Up 17% Over Prior Year
FOOTHILL RANCH, Calif., Aug. 21 /PRNewswire-FirstCall/ -- Cardiogenesis Corporation (OTC: CGCP - News), a leading developer of surgical products and accessories used in angina-relieving procedures, announced today that is current with all required SEC filings, including performance for the second quarter and the first half ended June 30, 2006.
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The Company reported that revenues for the second quarter of 2006 totaled $4.392 million, compared to $4.885 million for the same period in 2005, a decrease of 10%. The decrease in second quarter revenues compared to previous year resulted from reduced domestic capital sales and reduced sales outside the United States. For the first half of 2006, revenues increased by 17% to $9.241 million, from revenues of $7.875 million in the same period last year. The increase through the first six months of 2006 is due primarily to an 81% increase in capital sales and a 5% increase in revenue from disposables. During the second quarter of 2006 the company shipped 6 lasers and approximately 800 handpieces. For the first half of 2006, 12 lasers were shipped while handpiece shipments totaled approximately 1,700.
Chairman and Chief Executive Officer Joseph R. Kletzel, II said, "Revenue growth for the first half of 2006 is a result of the focus we have placed on our core TMR business. We plan to continue the top line growth in our core business through concerted efforts to increase utilization of our current installed base as well as continuing to leverage our competitive advantage with the SolarGen 2100s advanced TMR console to target prominent high volume cardiovascular programs both domestically and internationally."
Research and development costs decreased approximately $0.4 million for both the second quarter and first half of 2006 compared to the same periods in 2005. The decrease in the R&D expense for the three and six months ended June 30, 2006 was primarily due to certain product development expenses in the 2005 periods that did not recur in the current year periods.
Sales, general and administrative expenses decreased approximately $1.7 million for the second quarter and $2.0 million for the first half of 2006 compared to the same periods in 2005. The reduction in SG&A expenses for both the second quarter and first half of 2006 is primarily due to savings generated through the consolidation of sales territories, a reduction in marketing expenses including expenses for exhibitions and meetings and a $600 thousand legal settlement expense in the second quarter of 2005 which did not recur in the current year quarter.
Second quarter operating income was $49 thousand as compared with an operating loss of $1.634 million in the prior year quarter. The Company's net loss was $152 thousand for the second quarter of 2006 as compared with a net loss of $858 thousand in the prior year quarter. For the first six months of 2006 the Company recorded operating income of $266 thousand as compared with a $3.342 million loss from operations in the first half of 2005. The Company's net loss totaled $699 thousand for the first half of 2006 compared with a net loss of $3.669 million for the same period in 2005. The net loss includes non-operating, non cash interest and other charges primarily resulting from the valuation of warrants and derivatives related to the convertible debt financing completed in October 2004.
The Company also announced that it has taken specific steps to streamline the organization which it expects will result in savings in the range of $500 thousand to $750 thousand on an annualized basis. Kletzel noted, "We are aligning our organization to support the growth of our core business and to focus resources on identifying and pursuing platform extensions for our current product portfolio as well as potential new applications. We are committed to driving shareholder value through revenue growth and effective management of our cost structure."
The Company also announced that it is now current with all SEC periodic reporting requirements and that it expects to seek reinstatement of trading of the Company's stock on the OTC Bulletin Board as soon as reasonably practicable. "We will continue to focus the organization on operational performance and look forward to providing appropriate updates to our shareholders and investment community going forward," stated Kletzel.
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. Surgical products and accessories for the Company's minimally invasive Percutaneous Myocardial Channeling (PMC) procedure are currently being marketed in Europe and other international markets.
For more information on the Company and its products, please visit the Cardiogenesis company website at http://www.cardiogenesis.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 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 or PMC 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; restrictions contained in our convertible debt obligations requiring the issuance of shares rather than repayment in cash; 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-K for the year ended December 31, 2005, the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2006, 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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Source: Cardiogenesis Corporation
CGCP Cardiogenesis Announces Publication on Holmium:YAG TMR System in Prominent Scientific Journal
PR Newswire - March 7, 2006 7:31 AM (EDT)
Article Highlights Company's Advanced Minimally Invasive System, Potential When Combined with Biologic/Pharmacologic Agents
FOOTHILL RANCH, Calif., March 7, 2006 /PRNewswire-FirstCall via COMTEX/ -- Cardiogenesis Corporation (OTC Bulletin Board: CGCP), the market leader in surgical products and accessories used in angina-relieving Transmyocardial Revascularization (TMR) and Percutaneous Myocardial Channeling (PMC) procedures, announced today the publication of an Expert Review of Medical Devices focused on the Company's Holmium:YAG TMR system in the March edition of Future Drugs.
Future Drugs is a scientific publication based in the UK that provides healthcare practitioners and research professionals with objective cutting-edge information on exciting emerging trends in healthcare and advances in the major therapeutic areas through the Expert Review series.
Chairman and CEO, Michael J. Quinn commented on this prominent publication. "It is noteworthy to see recognition of the increasing clinical importance of the TMR therapy in a cutting edge scientific journal. This is a reflection of the substantial published body of evidence supporting the clinical significance of our Holmium:YAG TMR system, and our efforts in advancing the technology to improve patient outcomes. We are now completing the IDE feasibility trials with our minimally invasive PEARL surgical delivery systems, and have initiated our preliminary safety and feasibility trial with our advanced PHOENIX Revascularization Delivery System for the precise targeted delivery of biologic or pharmacologic materials to the Holmium:YAG thermoacoustic stimulated tissue zone surrounding our TMR channels."
The Expert Review article "Holmium:YAG laser system for transmyocardial revascularization" is authored by Keith B. Allen, MD of the Heart Center of Indiana. In his discussion of mechanism of action, the author highlights the more than 20 peer reviewed works published from researchers at Duke University Medical Center. He states, "Angiogenesis is the most likely mechanism of action responsible for clinical improvement following TMR, and research should be continued to find ways to augment this process."
Mr. Quinn stated, "We are taking the important next steps with TMR to increase its physiologic and clinical impact. Reducing the surgical injury required in delivering this powerful therapy with our minimally invasive PEARL Robotic and Thoracoscopic delivery systems is an important platform improvement. We are now leveraging our understanding of the thermoacoustic stimulated tissue zone created by our Holmium:YAG fiberoptic delivery system for the delivery of potent therapeutic agents to generate an even greater response. The PHOENIX combination delivery system provides the precise and targeted delivery of biologic or pharmacologic therapeutic agents directly into and around the thermoacoustic stimulated tissue zone."
In the Future Drugs article, the author cited the improved Kaplan Meier survival at 5 years achieved with the Cardiogenesis Holmium:YAG system (Annals of Thoracic Surgery. 78, 458-65 (2004)). Dr. Allen stated in his remarks, "Considering the increased operative and long term cardiac risks predicted by incomplete revascularization and the documented operative and long term benefits associated with adjunctive TMR in randomized patients with diffuse CAD, increased utilization of this therapy is warranted. In parallel, it is imperative that research continues into identifying growth factor, therapeutic or stem cell-based materials, which when coadministered may enhance these positive outcomes."
Mr. Quinn concluded, "We strongly agree with Dr. Allen's conclusion that the published results of TMR as a primary and secondary therapy supports increased utilization of TMR in the treatment of diffuse coronary artery disease. We are also focused on advancing the technology to make available our minimally invasive PEARL delivery systems and the PHOENIX combination delivery system to optimize patient outcomes."
4Q and Year End 2005 Results
Company Reports Second Consecutive Profitable Quarter and Highest Annual Revenue in Five Years
FOOTHILL RANCH, Calif., March 1 /PRNewswire-FirstCall/ -- Cardiogenesis Corporation (OTC Bulletin Board: CGCP - News), the market leader in surgical products and accessories used in angina-relieving Transmyocardial Revascularization (TMR) and Percutaneous Myocardial Channeling (PMC) procedures, announced results today for its fourth quarter and year ended December 31, 2005.
The Company reported that revenues in the fourth quarter of 2005 were $4.1 million compared to $5.2 million in the same period in 2004, a decrease of 22%. For the full year 2005, revenues increased by 6% to $16.3 million, from revenues of $15.5 million in the prior year. This revenue increase from 2004 to 2005 was fueled by a 14% unit handpiece growth.
Chairman and CEO Michael J. Quinn commented on the quarter and year-end results, "In 2005 we achieved our third consecutive annual revenue increase since 2002. This is significant progress, particularly when considering the momentum in procedural utilization of our TMR systems in 2005. Our increase in revenue year over year is a result of our continued progress in developing the TMR market, reflected in the 14% increase in annual handpiece sales," stated Quinn. "We are creating the future of TMR with our Advanced TMR Platform, including the SolarGen 2100s console, our Robotic and Thoracoscopic PEARL delivery systems and the PHOENIX Revascularization Delivery System."
Sales, general and administrative expenses for the fourth quarter of 2005 decreased by 8% as compared to the prior year period. Sales, general and administrative expenses for the full year 2005 increased approximately 19% from the prior year period to $13.5 million. The increase was primarily due to the sales and marketing expansion which occurred at the beginning of 2005, as well as the marketing expenses directly related to the initial clinical introduction of the Company's new minimally invasive product line.
Research and development costs for the fourth quarter of 2005 increased by 34% as compared to the prior year quarter and increased by 20% for the full year 2005 from the prior year. The increase resulted from costs incurred for the product development and study costs for the new minimally invasive TMR handpieces and the Company's investment in important research initiatives.
In August 2005, the Company initiated a restructuring effort to significantly reduce the expense base and cash requirements to support the TMR business. The effects of these changes significantly reduced operating expenses by 35% post-restructuring. Sales, general and administrative expenses post-restructuring decreased by 32% as compared to the first six months of the year and research and development expenses decreased by 34% post-restructuring as compared to the first six months of the year.
"In the second half of the year, we achieved significant progress operationally," Quinn commented. "We implemented an aggressive restructuring effort which resulted in five consecutive months of profitability immediately following the implementation. Management is committed to achieving revenue growth while operating on a lower expense base. The effect of our actions during the second half of the year produced two consecutive profitable quarters."
Quinn added, "With the improvement in our operations in the second half of the year, we were able to make three principle payments towards the convertible note, preventing further oversupply of our stock on the market. If our operating results continue on an upward trend, we remain committed to using our current cash funds, instead of issuing more stock, towards paying back the principal on the note."
The Company generated income from operations of $388,000 and net income of $1,005,000 for the fourth quarter of 2005 and a loss from operations of $1.9 million and a net loss of $1.9 million for the full year 2005. The net loss includes non-operating, non-cash interest and other charges primarily resulting from the valuation of warrants and derivatives related to the convertible debt financing completed in October 2004.
During the fourth quarter of 2005, the Company shipped a total of 2 lasers, converted 2 evaluation lasers to sale and worldwide disposable shipments were 818 units. In 2005, a total of 37 lasers were shipped, 6 evaluation lasers were converted to sale and worldwide disposable shipments were 3,442 units. During the fourth quarter of 2004, the Company shipped a total of 6 lasers, converted 6 evaluation lasers to sale and worldwide disposable shipments were 806 units. In 2004, a total of 23 lasers were shipped, 11 evaluation lasers were converted to sale and worldwide disposable shipments were 3,018 units.
Quinn stated, "We are very encouraged by our results during the second half of 2005. We demonstrated the ability to drive disposables revenue and produce operating profit. We made significant progress in 2005 towards bringing our minimally invasive PEARL Robotic and Thoracoscopic tools to market, while also developing the TMR market as reflected in our 14% annual unit growth in disposable sales."
Quinn commented on the progress of the PEARL trials, "We are close to completion of the feasibility trials with our minimally invasive PEARL Robotic and Thoracoscopic trials. We expect to complete those trials in the near future and submit the required follow up data to the FDA. We are forecasting initial commercial sales of these products in the fourth quarter of this year."
Upcoming opportunities for the Company to highlight its minimally invasive PEARL delivery systems include: Louis A. Brunsting, III, M.D., an attending Cardiothoracic Surgeon at Centennial Medical Center, (an HCA facility in Nashville, TN) is invited to present his clinical TMR experience with the Cardiogenesis PEARL Robotic delivery system at the Advanced Cardiac Techniques in Surgery (ACTS) Meeting in New York in April; and, Gary S. Allen, M.D., Chief of Cardiothoracic Surgery at Osceola Regional Medical Center (Kissimmee, FL) will be presenting his early and midterm results with our PEARL Thoracoscopic delivery System at the International Society of Minimally Invasive Cardiothoracic Surgery (ISMICS) Meeting in June.
Regarding these developments, Quinn stated, "Cardiothoracic surgeons are excited about the advancements that we are bringing to market. In the completion of the required FDA feasibility trials, we are also developing the marketing tools to assist our surgeons with education of the medical and patient communities about these minimally invasive tools and techniques for delivering our significant and enduring therapy."
Quinn described the progress and plans for the Advanced TMR Platform. "In addition to completing the trials leading to commercialization of the minimally invasive PEARL delivery systems, we have made significant progress in the evaluation and application of our PHOENIX Revascularization Delivery System which combines the delivery of our Holmium: YAG TMR therapy with biologic or pharmacologic materials to enhance the overall physiologic and clinical response. We announced the successful completion of the initial clinical safety and feasibility cases earlier this quarter and are continuing to collect this important data in support of our PHOENIX program initiatives."
The Company is evaluating the potential for increasing the patient response to its Holmium: YAG therapy by adding precise biologic/pharmacologic delivery to the TMR procedure in the PHOENIX Revascularization Delivery System. Quinn explained, "The delivery of the pulsed Holmium: YAG energy through our proprietary fiberoptic delivery system stimulates the tissue surrounding the TMR channel with thermoacoustic energy. At the time of surgery, this initiates the body's own angiogenic response in and around the channels. It has been reported in the early clinical experience that delivery of biologics or pharmacologic materials to this stimulated myocardium can enhance the physiologic effect in tissue and contribute to improved regional and global ventricular mechanical function."
Dr. Marvin Slepian, the Company's Chief Scientific Officer and Director of Interventional Cardiology at the Sarver Heart Center at the University of Arizona in Tucson, commented on the PHOENIX system, "The phenomenon of combining Holmium:YAG TMR and biologic/pharmacologic therapies is analogous to the lighting of a match. The match is essentially the fiber of the Holmium:YAG laser delivery system, the spark is the addition of the biologic or pharmacologic agent and the resulting explosion is the robust angiogenic response resulting from the combination of the two in the thermoacoustic stimulated tissue zone."
"There is a tremendous amount of scientific and clinical interest in the potential for biologic/pharmacologic therapies for treating cardiovascular diseases," Quinn stated. "In the future, medical devices will primarily serve as delivery systems to optimize the effectiveness of innovative biologic/pharmacologic therapies. Our PHOENIX development program is focused on optimizing patient outcomes with the targeted, precise delivery of biologics/pharmacologics to the thermoacoustic stimulated tissue zone created with our Holmium: YAG TMR system."
The Company reported during January the FDA had approved the protocol for its PMC System. The protocol is a prospective, randomized, sham controlled, multi-center trial and will require approximately 400 patients. Regarding the trial status, Mr. Quinn explained, "We remain committed to achieving approval of our PMC technology in the United States. We expect to continue to be profitable based upon our growing TMR franchise, as we search for a corporate partner to help fund this significant PMC trial. We are fortunate to have a prominent group of respected cardiologists committed to supporting this important effort as soon as we have secured the necessary support."
It's very quiet in here
There's some history here, but lots has happened with CGCP that hasn't been mentioned here, just in case you are looking for information on this board to help with dd.
I've been lurking for some time and just decided to start posting. Of course, if I find that I am talking to myself, I'll probably get discouraged. However, it seems as if this board isn't quite dead yet, and maybe it can be revived.
Cardiogenesis(CGCP) Reports 2005 Third Quarter, Nine-Month Results
Thursday November 3, 7:30 am ET
Company Reports Profitable Quarter and 55% Increase in Revenues Over Prior Year Third Quarter
FOOTHILL RANCH, Calif., Nov. 3 /PRNewswire-FirstCall/ -- Cardiogenesis Corporation (OTC Bulletin Board: CGCP - News), the market leader in surgical products and accessories used in angina-relieving Transmyocardial Revascularization (TMR) and Percutaneous Myocardial Channeling (PMC) procedures, announced results today for its third quarter ended September 30, 2005.
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The Company reported that revenues in the third quarter of 2005 were $4.4 million compared to $2.8 million in the same period in 2004, an increase of 55%. Revenues in the 2005 third quarter were fueled by a 14% increase in handpiece unit sales and a significant increase in laser revenue. The Company reported that 833 handpieces were shipped worldwide in the third quarter, the second highest quarterly handpiece sales performance in the last three years. For the first nine months of 2005, revenues increased by 20% to $12.3 million, from revenues of $10.3 million in the same period last year. This revenue increase through the first nine months of 2005 is fueled by 19% unit handpiece growth.
Chairman and CEO Michael J. Quinn commented on the third quarter results, "Our 20% growth in revenue through the first nine months of the year is built upon the foundation of increased utilization of TMR. We are encouraged by our progress in developing the TMR market, as reflected in our disposable unit growth. Review of our performance in the first nine months shows that our sales growth is resulting from our expanding the awareness and acceptance of TMR in the medical community as well as by increasing market share. Our Advanced TMR Platform, including the SolarGen 2100s console and Robotic and Thoracoscopic PEARL delivery systems are defining the future of TMR."
"Revenues of $4.4 million for the quarter represents the third highest quarterly revenue performance during the past 4 years," Mr. Quinn stated. "We are currently on a trajectory to achieve significant growth for the year in unit handpiece sales for the first time since 2000. Our efforts at developing the awareness and acceptance of TMR in the medical community are beginning to pay off. The combination of the long term data with our Ho:YAG system published in the Annals of Thoracic Surgery in 2004 combined with our Advanced TMR Platform is generating increased interest and adoption of TMR in the cardiothoracic community."
Sales, general and administrative expenses for the third quarter of 2005 were flat as compared to the prior year period. Sales, general and administrative expenses for the first nine months increased approximately 29% from the prior year period to $10.8 million. The increase was primarily due to the sales and marketing expansion which occurred at the beginning of 2005, as well as the marketing expenses directly related to the initial clinical introduction of the Company's new minimally invasive product line.
Research and development costs for the third quarter of 2005 decreased by 33% as compared to the prior year quarter and increased by 17% for the first nine months of 2005 from the prior year period. The increase resulted from costs incurred for the development and study costs for the new minimally invasive TMR handpieces and the Company's investment in important research initiatives.
Mr. Quinn described the development focus for the company related to the Advanced TMR Platform. "In response to the consistent request from leading clinicians around the world, we are developing advanced tools for the delivery of angiogenic therapeutics in and around the TMR channels," Quinn stated. "The published research from Duke and Columbia highlights the benefits of our proprietary Ho:YAG system in creating a stimulated zone of tissue around the TMR channels. The Ho:YAG thermoacoustic energy wave, as delivered through our proprietary fiberoptic delivery systems, penetrates the tissue surrounding the channel and initiates the body's own angiogenic response to provide neovascularization to the targeted ischemic area. The result, as published in research from Columbia and Duke, is a significantly greater amount of neovascularization around the TMR channels produced by the Cardiogenesis TMR system compared to other wavelengths and modalities."
"As the application of angiogenic therapeutics for the treatment of advanced heart disease advances to clinical practice, there is growing experience combining these materials with TMR. Our goal is to provide advanced tools to deliver angiogenic therapeutics into the Ho:YAG stimulated field of tissue surrounding the TMR channels, thereby multiplying the therapeutic effect to the patient," concluded Quinn.
In August, the Company initiated a restructuring effort to significantly reduce the expense base and cash requirements to support the TMR business. The effects of these changes significantly reduced third quarter operating expenses. Sales, general and administrative expenses for the third quarter decreased by 36% over the previous quarter and research and development expenses for the third quarter decreased by 49% over the previous quarter.
"In the third quarter, we achieved significant progress operationally," Quinn commented. "We increased our total revenue by 55% in the third quarter over the prior year quarter while restructuring the company in order to significantly reduce the expense base for our TMR business. We have made significant progress in reducing our expense base and have implemented a vigilant cost containment effort. The effect of these actions during the quarter produced operating income of almost half a million dollars. This is a big step in the right direction from the previous quarter and represents an improvement in operating income of $1.5 million."
Quinn added, "We are focused on strengthening the company financially. This includes an effort to prevent the ongoing oversupply of our Company's stock on the market as a result of the convertible note financing that we completed back in October 2004. If our operating results continue on the upward trend that we anticipate, we are committed to using our current cash funds, instead of issuing more stock, towards paying back the principal on the note."
The Company generated income from operations of $462,000 and net income of $807,000 for the third quarter of 2005 and a loss from operations of $2.3 million and a net loss of $2.9 million for the first nine months of 2005. The net loss includes non-operating, non-cash interest and other charges primarily resulting from the valuation of warrants and derivatives related to the convertible debt financing completed in October 2004.
Quinn stated, "We are very encouraged by our results in the third quarter. We demonstrated the ability to support revenue growth while reducing our expense base, thereby producing significant operating profit. We are committed to bringing new and innovative, angiogenic technology to the marketplace. With the exciting new minimally invasive cardiovascular tools added to our market basket, the Robotic and Thoracoscopic delivery systems, we are leading the way to the future of TMR. We are also making significant progress in educating the medical community on the significant and enduring patient benefits of TMR which has led to the increased adoption of the technology that we are seeing today."
During the third quarter of 2005, the Company shipped 9 lasers and worldwide disposable shipments were 833 units. This compares to the shipment of 5 lasers and worldwide disposable shipments of 731 units in the third quarter of 2004.
Conference Call
Cardiogenesis will host a conference call today to discuss the Company's results for its third quarter and year ended September 30, 2005. The call will take place at 12:00 p.m. EDT (Eastern) and will be broadcast live over the Internet. Those interested in listening to the live webcast of the conference call may do so by going to the Company's website at www.cardiogenesis.com.
Web participants are encouraged to go to the selected website at least 15 minutes prior to the start of the call to register and, if necessary, download and install any needed audio software. An online webcast replay of the call will be accessible at www.cardiogenesis.com for seven days starting shortly after the live webcast.
Cardiogenesis(CGCP) Reports 2005 Second Quarter Results
Wednesday August 10, 7:30 am ET
Company Reports Record Handpiece Sales and 45% Increase in Revenue Over Prior Year Quarter
FOOTHILL RANCH, Calif., Aug. 10 /PRNewswire-FirstCall/ -- Cardiogenesis Corporation (OTC Bulletin Board: CGCP - News), the market leader in surgical products and accessories used in angina-relieving Transmyocardial Revascularization (TMR) and Percutaneous Myocardial Channeling (PMC) procedures, today announced results for its second quarter ended June 30, 2005.
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The Company reported that revenues in the second quarter of 2005 were $4.9 million compared to $3.4 million in the same period in 2004, an increase of 45 percent. Revenues in the 2005 second quarter were fueled by a 38% increase in handpiece unit sales and as well as a significant increase in laser sales. The Company reported a record 1,025 handpieces shipped worldwide in the second quarter, the highest quarterly handpiece sales performance in the last four years. Domestic handpiece shipments increased by 17% and international handpiece shipments increased considerably to 173 units compared to 12 units in the prior year quarter. For the first six months of 2005, revenues increased by 6% to $7.9 million, from revenues of $7.4 million in the same period last year.
Chairman and CEO Michael J. Quinn commented on the second quarter results, "Our strong revenue performance was supported by an increase in disposable units and a good quarter for capital sales, and we're pleased with the significant growth in TMR disposable units achieved both domestically and internationally. $4.9 million for the quarter represents the second highest quarterly revenue performance during the past 4 years. We are seeing the initial benefits from our renewed international sales efforts, with a five fold increase in international sales compared to the prior year quarter. This is the result of establishing new distribution relationships in four targeted markets during the second quarter."
Quinn stated, "Our success in significantly growing our TMR business in the second quarter is based upon: the market acceptance of our new SolarGen 2100s TMR console; the progress we are making in educating the medical community on the significant and enduring patient benefits of TMR as well as patient selection; and the growing interest of surgeons in learning the newest minimally invasive cardiovascular tools, the Robotic and Thoracoscopic PEARL delivery systems. We are leading the way to the future of TMR in providing surgeons with tools that are advancing the practice by addressing the concerns of patients and their doctors about the invasiveness of traditional surgical procedures."
"We are especially encouraged by the interest level being expressed by hospitals around the country in utilizing their Intuitive Surgical da Vinci Robot for advanced cardiovascular procedures, including robotic TMR with the Cardiogenesis system," Quinn explained. "The first robotic TMR procedure completed at Centennial Hospital in Nashville by Dr. Louis A. Brunsting III utilized our Robotic 5.0 PEARL delivery system, the SolarGen 2100s console and the Intuitive Surgical da Vinci Robotic system. The procedure went as planned, and the patient was discharged angina free from the hospital just two days post procedure. This advanced procedure represents a dramatic improvement in the patient experience in regards to both hospitalization and total recovery time. This is especially true when compared to the previous bypass operation most of these patients have experienced, or even when compared to the initial TMR procedures completed through a thoracotomy."
Sales, general and administrative expenses increased approximately $1.6 million from the prior year period to $4.3 million due primarily to increased headcount from sales and marketing expansion. Sales, general and administrative expenses in the first six months increased approximately $2.4 million from the prior year period to $8.1 million. In addition to the sales and marketing expansion, the company incurred higher costs attributed to an increased presence at trade shows and higher marketing expenses due to the initial clinical introduction of the Company's new minimally invasive product line. Research and development costs increased by $309,000 to $687,000 for the 2005 second quarter from the prior year quarter and increased by $368,000 to $1 million for the first six months of 2005 from the prior year period. The increase resulted from costs incurred for the development and study costs for the new minimally invasive TMR handpieces and the Company's investment in important research initiatives.
The Company generated a loss from operations of $1 million and a net loss of $858,000 for the second quarter of 2005 and a loss from operations of $2.7 million and a net loss of $3.7 million for the first six months of 2005. The net loss includes non-operating, non-cash interest and other charges primarily resulting from the valuation of warrants and derivatives related to the convertible debt financing completed in October 2004.
In addition to the progress made on the clinical implementation of the minimally invasive TMR delivery systems, the Company has made important progress with new product programs, including the development initiative for a TMR PLUS biologic delivery system. This advanced development program will take advantage of our proprietary holmium: YAG delivery technology, which acutely stimulates the tissue surrounding the transmural laser channels with a wave of thermo-acoustic energy.
Mr. Quinn explained, "The precise pulsed delivery of our low power Ho:YAG wavelength to the myocardium creates a fertile region of stimulated tissue surrounding the channel. This is the region of tissue that has been shown to grow new micro vessels resulting in improved perfusion and regional mechanical function in controlled studies of chronic ischemic myocardium. We are working with research and clinical experts to developing tools for express biologic delivery in this fertile region immediately upon completion of the TMR channels. As the field of therapeutic angiogenesis approaches clinical viability, Cardiogenesis intends to provide advanced surgical delivery system options for optimizing patient outcomes utilizing our proprietary Ho:YAG TMR system in conjunction with delivery of biologic solutions. This will include advanced versions of our minimally invasive TMR delivery systems."
"In the second quarter, we achieved significant progress on our top line revenue," Quinn commented. "We increased our total revenue by 45% in the second quarter compared to the prior year quarter. We are taking steps to support our continued revenue growth while drastically reducing our expense base moving forward. Our focus is on achieving consistent quarter to quarter profitability. In order to accomplish this, we have restructured the company in order to create a reduced break-even goal which requires a rigorous cost containment effort and a focus on new products and projects that will directly contribute to this goal in a timely manner."
During the second quarter of 2005, the Company shipped 20 lasers and worldwide disposable shipments were 1,025 units. This compares to the shipment of 3 lasers and worldwide disposable shipments of 742 units in the second quarter of 2004.
Conference Call
Cardiogenesis will host a conference call today to discuss the Company's results for its second quarter and year ended June 30, 2005. The call will take place at 12:00 p.m. EDT (Eastern) and will be broadcast live over the Internet. Those interested in listening to the live webcast of the conference call may do so by going to the Company's website at www.cardiogenesis.com.
Web participants are encouraged to go to the selected website at least 15 minutes prior to the start of the call to register and, if necessary, download and install any needed audio software. An online webcast replay of the call will be accessible at www.cardiogenesis.com for seven days starting shortly after the live webcast.
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. Surgical products and accessories for the Company's minimally invasive Percutaneous Myocardial Channeling (PMC) procedure are currently being marketed in Europe and other international markets.
For more information on the Company and its products, please visit the Cardiogenesis company web site at www.cardiogenesis.com or the patient and physician website at www.heartofnewlife.com. heartofnewlife.com is a resource for patients and physicians which provides medical information on TMR
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 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 or PMC 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-K for the year ended December 31, 2004, the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2005, 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.
CARDIOGENESIS CORPORATION
CONDENSED AND CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
(unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
2005 2004 2005 2004
Net revenues $4,885 $3,376 $7,876 $7,417
Cost of revenues 925 518 1,530 1,071
Gross profit 3,960 2,858 6,346 6,346
Operating expenses:
Research and
development 687 378 1,037 669
Sales, general and
administrative 4,307 2,724 8,051 5,652
Total operating
expenses 4,994 3,102 9,088 6,321
Loss from
operations (1,034) (244) (2,742) 25
Non-operating income,
net 176 (20) (927) (22)
Net income
(loss) ($858) ($264) ($3,669) $3
Net income (loss) per
share -
basic and diluted ($0.02) ($0.01) ($0.09) $0.00
Shares used in
per share computations
Basic 42,808 41,279 42,356 40,885
Diluted 42,808 41,279 42,356 41,404
CARDIOGENESIS CORPORATION
CONDENSED AND CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)
June 30, December 31,
2005 2004
ASSETS
Cash and cash equivalents $2,258 $4,740
Accounts receivable, net 3,133 3,578
Inventories 2,964 1,782
Property and equipment, net 602 601
Restricted cash 2,539 2,884
Other assets 1,940 2,098
Total assets $13,436 $15,683
LIABILITIES AND SHAREHOLDERS' EQUITY
Accounts payable, accrued
liabilities, and other
liabilities $3,945 $2,675
Deferred revenue 583 658
Secured convertible term note
and related long term
obligations 7,981 7,615
Shareholders' equity 927 4,735
Total liabilities and
shareholders' equity $13,436 $15,683
CGCP-Needs a little tune up before earnings! imo
CEO Quinn said the qrt. that will be reported august 10th 2005 was shaping upto to be a barn burner of a qrt. and that kit sales was at a record pace Ceo stated that at last conference call and also imo. lasers will also be a record selling qrt. along with revenues and gross business profit,kit sales and great news for the pmc pma will be the dessert maybe topped with business partner for pmc pma protocol as CEO also stated they was in talks with a pharma/medical device company for protocol "my guess is Johnson & Johnson's" i also have a hunch that cgcp does indeed have business partner for protocol for pmc pma but also for sales and marketing cgcp products in the USA and Europe.CGCP ALREADY has a business partner in Canada for both pmc "pmc is angio plasty version of tmr & there are over 600k performed each year in the USA alone" Canada just approved all of cgcp products and Europe newly deployed sales force markets both tmr and pmc........all adds upto consecutive profitable qrt's for cgcp til at least 2008 imo. and better than cgcp 4th qrt. of 2004 of gross business profit of $1.4 million and the 1st qrt. of 2004 was just hamper due to cms panel that turned out to be positive,EDWARDS "PLC PARTNER" STATED THAT SALES WAS DEFERRED FROM ONE QRT. TO ANOTHER DUE TO CMS PANEL AT EDWARDS RECENT CONFERENCE CALL
http://stockcharts.com/gallery/?CGCP
Cardiogenesis to Announce 2005 Second Quarter Results on August 10, 2005 Conference Call
Wednesday July 27, 7:30 am ET
FOOTHILL RANCH, Calif., July 27 /PRNewswire-FirstCall/ -- Cardiogenesis Corporation (OTC Bulletin Board: CGCP - News), a leading developer of surgical products and accessories used in angina-relieving procedures, announced that it will release its financial results for the second quarter ended June 30, 2005, before the market opens on Wednesday, August 10, 2005. That same day, at 12:00 p.m. EDT (9:00 a.m. PDT), Cardiogenesis' senior management will host a conference call which will be broadcast live over the Internet to discuss the Company's results for the quarter and comment on the current progress of the business.
ADVERTISEMENT
Those interested in listening to the live webcast of the conference call may do so by going to the Company's website at www.cardiogenesis.com. Webcast participants are encouraged to go to the website at least 15 minutes prior to the start of the call to register and, if necessary, download any needed audio software. A replay of the call will also be accessible at www.cardiogenesis.com for seven days starting shortly after the live webcast.
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. Surgical products and accessories for the Company's minimally invasive Percutaneous Myocardial Channeling (PMC) procedure are currently being marketed in Europe and other international markets.
For more information on the Company and its products, please visit the Cardiogenesis web site at www.cardiogenesis.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 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 or PMC 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-K for the year ended December 31, 2004, the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2005, 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.
--------------------------------------------------------------------------------
Source: Cardiogenesis Corporation
Mag,It should only get better this week heading into earnings the following week Aug.10 http://stockcharts.com/gallery/?CGCP
CGCP .64 - CARDIOGENESIS CP (OTCBB)
Date Open High Low Last Change Volume % Change
07/29/05 0.5800 0.6500 0.5800 0.6400 +0.0500 149003 +8.47%
Composite Indicator
Trend Spotter TM Buy
Short Term Indicators
7 Day Average Directional Indicator Buy
10 - 8 Day Moving Average Hilo Channel Buy
20 Day Moving Average vs Price Buy
20 - 50 Day MACD Oscillator Buy
20 Day Bollinger Bands Buy
Short Term Indicators Average: 100% - Buy
20-Day Average Volume - 117025
Medium Term Indicators
40 Day Commodity Channel Index Buy
50 Day Moving Average vs Price Buy
20 - 100 Day MACD Oscillator Buy
50 Day Parabolic Time/Price Buy
Medium Term Indicators Average: 100% - Buy
50-Day Average Volume - 119094
Long Term Indicators
60 Day Commodity Channel Index Buy
100 Day Moving Average vs Price Buy
50 - 100 Day MACD Oscillator Sell
Long Term Indicators Average: 33% - Buy
100-Day Average Volume - 114207
Overall Average: 88% - Buy
CGCP chart looks good also http://stockcharts.com/gallery/?CGCP
Interesting read CGCP By: scomasun
29 Jul 2005, 06:46 PM EDT
Msg. 1953 of 1955
Jump to msg. #
CEO Quinn said the qrt. that will be reported august 10th 2005 was shaping upto to be a barn burner of a qrt. and that kit sales was at a record pace Ceo stated that at last conference call and also imo. lasers will also be a record selling qrt. along with revenues and gross business profit,kit sales and great news for the pmc pma will be the dessert maybe topped with business partner for pmc pma protocol as CEO also stated they was in talks with a pharma/medical device company for protocol "my guess is Johnson & Johnson's" i also have a hunch that cgcp does indeed have business partner for protocol for pmc pma but also for sales and marketing cgcp products in the USA and Europe.CGCP ALREADY has a business partner in Canada for both pmc "pmc is angio plasty version of tmr & there are over 600k performed each year in the USA alone" Canada just approved all of cgcp products and Europe newly deployed sales force markets both tmr and pmc........all adds upto consecutive profitable qrt's for cgcp til at least 2008 imo. and better than cgcp 4th qrt. of 2004 of gross business profit of $1.4 million and the 1st qrt. of 2004 was just hamper due to cms panel that turned out to be positive,EDWARDS "PLC PARTNER" STATED THAT SALES WAS DEFERRED FROM ONE QRT. TO ANOTHER DUE TO CMS PANEL AT EDWARDS RECENT CONFERENCE CALL
http://stockcharts.com/gallery/?CGCP
http://ragingbull.lycos.com/mboard/boards.cgi?board=CGCP&read=1953
Amen brother, Amen. Revenue is king and they need to make up for last quarters slide with a brilliant Q.
B K
NoBody said they have a great future this is a gamble.
I am currently at about break even, a little in the black.
PMC ????? in a nut shell is the factor.
Revenue in the US will be huge or it will sink the company like a led zepplin.
I Believe in the procedure
This is a better solution. IMHO
All that being said you are correct. Show me the revenue!!
Good luck
Please tell me why you believe there is a great future. I question:
1. Their Offshore Financing Deal which makes many companies with similar arrangements circle the bowl.
2. One quarter up and one quarter down track record. Smacks of loading customers up and poor management.
3. Do they have the cash to pay for the clinical trial that they have been working on? Should cost $3-5 million dollars.
4. The last 3 years have brought declining sales of capital, flat usage levels and more net losses.
I want to believe in them but.......
B K
This is an odd stock.
The company has a real future. finally
Getting approvals finally.
Increasing sales and revenue.
The basic problem is they are off the radar screen.
It is time for the company to do a little self promotion.
Yes CGCP should!!
Anybody Here!
This should climb back to the $1 range soon JMHO
Hweb...this is from the 10k.
Total non-operating expense of $1,816,000 increased $1,779,000 or 4808% for the year ended December 31, 2004 when compared to $37,000 for the year ended December 31, 2003. This increase is primarily due to non-operating, non-cash charges recorded in 2004 in relation to the Secured Convertible Term Note ("Note") issued in October 2004. These non-operating, non-cash charges resulted from mark to market charges on derivatives and warrants and interest and debt issuance costs associated with the Note. Since the fair value of the warrants and derivatives is tied in large part to our stock price, in the future, if our stock price increases between reporting periods, the warrants and derivatives become more valuable. As such, there is no
way to forecast what the non-operating, non-cash charges will be in the future or what the future impact will be on our financial statements.
Does anyone have an idea how this will play out?
Jason
Jason, CGCP had a great Q4 if not for those non-cash charges from the October financing. I was unable to find out how much (if any) of a charge will recur in Q1. Seems to depend on the stock price. Any ideas?
Conservative est....(a little blue sky numbers guessing)... I think CGCP can net .750m/qtr or $3m for 2005. Current MC is about 25m giving a forward pe of 8.3 with revs conservatively at $21m...(apx 30% increase). Peers are selling for PE's exceeding 30...so if we give CGCP a conservative PE of 20 we should see $1.80 per share. This value guessing does not consider rev from the Pearl Delivery System...which according to the company will sell at higher prices than the Solar Gen2100 laser..with equal or higher margins. I think the catalyst for this stock to trade above $1.00 in the short term is for FDA approval to be announced of the Pearl System. And as we all know from listening to the CC last month the announcement of FDA approval should occur "Very soon".
In summary, given a quarter like the last one or better...and FDA approval I think we could see a share price of $3.00 or better.
I have had to average down in this position recently...due to my assumption of the stock breaking out above .70 after the 4th qtr and CC. It didn't happen...I am down to an av of .59 now and hoping for the best of course. But I think my guesses above are not to far off. We should be slapping each other on the back sometime this year.
Jason
CGCP i expect this to be around a buck or higher in 3months.My avg is in the high 50's & haven't sold a share.Good Luck Jerry
Listened to the CC, or the first 40 mins until I got cut off.
Since Nobody reads this board. I want to make a crazy statement.
If this stck is not back over $1 in 3 months I will give up investing. I got a freaking cavity from that CC. They could not have made that call any sweeter if they poured suger on it.
last minute profit taking before the CC.
I believe we will go higher after CC.
This will be the first time in a long time that they have good news.
New sales products
approvals
projections
increased revenue
JMHO
Back to $1 after the CC
CC Today anybody out there???
Wish i had some more cash today,could have added more before thursday! http://biz.yahoo.com/prnews/050118/latu055_1.html
Does anyone have any background info on Quinn? The home website doesn't offer one and a basic search resulted in a million Michael Quinns with no middle initial....Thanks in advance.
Jason
I like it
The trend is now our friend.
2 New products.
New sales rep. Push back to $1 is on.
Cardiogenesis Names Lee S. Langford Vice President, General Manager of Central Area
Tuesday February 8, 7:30 am ET
Accomplished Sales Leader Taking Helm of Expansion Division
FOOTHILL RANCH, Calif., Feb. 8 /PRNewswire-FirstCall/ -- Cardiogenesis Corporation (OTC Bulletin Board: CGCP - News), the international market leader in surgical products and accessories used in angina-relieving Transmyocardial Revascularization (TMR) and Percutaneous Myocardial Channeling (PMC) procedures, announced today that Lee S. Langford, 31, an accomplished medical device sales professional and manager, has joined the Company as Vice President, General Manager of the Company's expansion Central Area, effective immediately. He will report directly to Chairman and CEO Michael J. Quinn.
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Prior to joining Cardiogenesis, Langford, from 2002-04 worked for Given Imaging, first as a Capital Sales Representative, then as a Regional Manager. Prior to that, from 2000-02 he excelled as a sales representative with Imagyn Medical Technologies in their surgical and oncology divisions. Langford is a graduate of the U.S. Military Academy (West Point) and served as a commissioned officer in the U.S. Army (Ranger Infantry Officer), attaining the rank of Captain.
Michael J. Quinn, Chairman and CEO stated, "Lee is an impressive sales professional and manager. Our senior management has direct experience in working with Lee in previous medical device companies, and has proactively recruited him to this important general management position. Lee joins our Company at an exciting time, with the roll out of the TMR PLUS advanced platform, including the celleratOR platelet rich plasma preparation (PRP). These initiatives received significant attention and interest at the recent Society of Thoracic Surgeons Meeting in Tampa."
Quinn also commented on the decision to add a fifth business unit to the organizational structure at this time. "The effective expansion of our U.S. salesforce is a critical component of our growth strategy for 2005. Lee possesses both the selling and leadership skills to immediately contribute to and help lead the effective expansion of the sales team. The addition of Lee to the management team at this time is important to us in ensuring our achievement of aggressive operating goals in 2005 and going forward."
Langford will immediately assume all operating responsibilities related to the Central Area of the U.S. sales organization.
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. Surgical products and accessories for the Company's minimally invasive Percutaneous Myocardial Channeling (PMC) procedure are currently being marketed in Europe and other international markets.
For more information on the Company and its products, please visit the Cardiogenesis company web site at www.cardiogenesis.com. Or the patient and physician website at www.heartofnewlife.com. heartofnewlife.com is a resource for patients and physicians which provides medical information on TMR.
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 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 or PMC 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-K for the year ended December 31, 2003, the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2004, 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.
Contact: Cardiogenesis Corporation
Michael Quinn, Chairman & Chief Executive Officer, 714-649-5000
--------------------------------------------------------------------------------
Source: Cardiogenesis Corporation
CardioGenesis to Participate in International Meeting of Society of Thoracic Surgeons
Thursday January 20, 7:30 am ET
Company Launching Advanced TMR PLUS Platform to Cardiothoracic Surgeons
FOOTHILL RANCH, Calif., Jan. 20 /PRNewswire-FirstCall/ -- CardioGenesis Corporation (OTC Bulletin Board: CGCP - News), the market leader in surgical products and accessories used in angina-relieving Transmyocardial Revascularization (TMR) and Percutaneous Myocardial Channeling (PMC), today announced it will be exhibiting at the 41st annual meeting of The Society of Thoracic Surgeons (STS) held January 23 - 26 in Tampa. The Company will be formally launching its recently FDA approved advanced laser console for TMR, the SolarGen 2100s and their new celleratOR PRP system for point of care preparation of platelet rich plasma (PRP).
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Chairman and CEO, Michael J. Quinn commented, "These are the first new products we will be launching to our cardiothoracic customers in over two years. We have worked closely with leading innovative clinicians in developing our advanced TMR PLUS platform, including the recently FDA approved SolarGen laser system. We are excited to be formally launching it to the international audience that attends the STS." Quinn added, "We will also be introducing our celleratOR PRP system, providing the patient's own platelet concentration from a small centrifuge system. This product has achieved significant penetration in several other surgical specialties, and we are excited to be bringing it to the cardiovascular market."
The Company is supporting an educational symposium in conjunction with the STS Meeting. The presentations will include: Robotic and thoracoscopic minimally invasive TMR procedures; PRP in cardiac applications; and the FDA approved SynCardia CardioWest Temporary Artificial Heart (TAH-t) to be presented by Jack G. Copeland, MD of the University of Arizona Health Sciences Center. The symposium will be held in the Tampa Marriott Waterside Hotel, Meeting Room 6 with Dr. Copeland opening the program at 6:30 PM. For clinical attendees to the symposium, the Company will be providing the opportunity to win a scholarship in 2005 to the Course on Non-Sternotomy Cardiac Surgery with Randall K. Wolf, MD at the University of Cincinnati. The Company is supporting this advanced practice course, which includes training on thoracoscopic TMR.
"Having proven the significant and enduring benefits of TMR, we have focused on bringing advanced devices and tools to expand the eligible patient population. We are excited to be going into the STS, our biggest meeting of the year, with strong momentum from the end of 2004 and a series of new products to introduce at the meeting," explained Quinn. "We have an opportunity to drive revenue growth in 2005 with these new products, with more to follow soon."
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. Surgical products and accessories for the Company's minimally invasive Percutaneous Myocardial Channeling (PMC) procedure are currently being marketed in Europe and other international markets.
For more information on the Company and its products, please visit the CardioGenesis company web site at www.cardiogenesis.com or the patient and physician website at www.heartofnewlife.com. Heartofnewlife.com is a resource for patients and physicians which provides medical information on TMR.
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 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 or PMC 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-K for the year ended December 31, 2003, the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2004, 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.
For further information, please contact Michael J. Quinn, President and Chief Executive Officer, +1-714-649-5050, or Richard Lanigan, Senior VP, Marketing, +1-714-649-5024, both of CardioGenesis Corporation.
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