FREMONT, CA -- (MARKET WIRE) -- 05/25/06 -- Cardima, Inc. (OTCBB: CRDM) today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) marketing clearance for the new Cardima Ablation System, which ablates cardiac tissue during heart surgery using radio frequency (RF) energy. This system is expected to be used primarily by surgeons performing cardiac surgery using standard hospital laparoscopic as well as thorascopic techniques.
The Cardima Ablation System uses three components: commercially available surgical radio frequency generators; the new Cardima Surgical Ablation Probe with a linear array of multi-electrodes and adjacent thermocouples using the core technology similar to the Company's REVELATION® series ablation micro-catheters; and a novel energy management device called the INTELLITEMP®, which uses a temperature feedback feature to apply RF energy to single or multiple electrodes on the probe simultaneously. The new surgical ablation probe includes a specially designed stabilizer suction device with an illuminated tip for better visibility, which is clipped to the electrode array to maintain electrode-tissue contact during hands free ablation.
"I am pleased to see the long development for the Cardima Ablation System come to a successful completion," stated Gabriel Vegh, chief executive officer of Cardima. "The new Cardima Surgical Ablation Probe has the potential to effectively compete with devices on the market designed to replicate the highly successful surgical Maze procedure. We are evaluating potential marketing and distribution strategies for the Cardima Ablation System."
-------------------- " Cash is King " Posts: 1102 | From: NJ | Registered: Mar 2006
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joe, since you already have some shares in this. you think i should get in, not enough volume? thanks
Posts: 4071 | Registered: Dec 2005
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pre-opening news is always tough. no chance to beat the big guys in. I like those after opening news releases where the playing field is alot more level .... imo
-------------------- " Cash is King " Posts: 1102 | From: NJ | Registered: Mar 2006
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Exerpt from the forcast released on 5/5/06, the last paragraph scares me off of this one. The chart and news say otherwise, could be a breakthrough product for them and get the stock value back up to the .75 range. Will play it short with $1k. ----------------------------------------------- The following discussion should be read in conjunction with our consolidated financial statements provided in this annual report on Form 10-K. Certain statements contained herein may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks, uncertainties and other factors that could cause actual results to differ materially, as discussed more fully herein.
The forward-looking information set forth in this annual report is as of the date of this filing, and we undertake no duty to update this information. More information about potential factors that could affect our business and financial results is included in the section entitled "Risk Factors" of this annual report.
OVERVIEW
Since our incorporation in November 1992, we have developed, produced and sold a variety of micro-catheters, including those for the diagnosis of VT. Since 2001, however, our efforts have primarily focused on developing differentiated products that diagnose and treat AF, including our REVELATION(R) Tx micro-catheter for use in the EP market, and our SAS for use in the surgical market. Our EP products allow for the mapping (diagnosis) and ablation (treatment) of the two most common forms of cardiac arrhythmias: atrial fibrillation and ventricular tachycardia. Arrhythmias are abnormal electrical heart rhythms that adversely affect the mechanical activities of the heart and can significantly affect a person's quality of life and potentially can be fatal. We have developed micro-catheter-based systems designed (i) to locate and provide more extensive and less traumatic access to arrhythmia-causing tissue for diagnosing the arrhythmia, referred to as mapping, and (ii) to restore normal heart rhythms by isolating and/or blocking the arrhythmia-causing tissue using radio frequency energy, referred to as ablation. Our micro-catheters incorporate multiple electrodes at the distal end to record electrical signals for mapping and, with certain micro-catheters, to transfer radio frequency energy for tissue ablation, allowing physicians to both map and ablate arrhythmias using the same micro-catheter. Our micro-catheters are designed with variable stiffness guidewire technology and a highly flexible distal tip to allow more extensive and less traumatic access to the chambers and vasculature of the heart. In addition, all of our micro-catheters are disposable, single-use products that we believe can be adapted to and used with conventional ECG-recording systems and with existing compatible radio frequency generators, eliminating the need for significant new investment in capital equipment by hospitals.
More recently, we have leveraged our proprietary technologies for treating AF into the development of products for the surgical market. On January 29, 2003, we received notice from the FDA that it had approved for commercialization of our SAS for use in cardiac surgery. This new system connects the Cardima Surgical Ablation Probe, a deflectable multi-electrode linear array micro-catheter technology, to a commercially available electrosurgical radio frequency generator through the INTELLITEMP(R), a multi-channel radio frequency, or RF, energy management device. This system allows surgeons to direct RF energy through any combination of up to eight probe electrodes simultaneously into cardiac tissue, a feature which can significantly reduce the time required to perform an ablation-based "maze" procedure. Since September 2003, the SAS has been utilized on a limited basis to treat AF as an adjunct procedure to valve replacement. In the first quarter of 2004, the SAS was utilized in two less invasive cases for the treatment of AF, opening the door to the prospect of the SAS technology being broadly used in a stand-alone procedure to treat AF. We do not currently plan to market our SAS ourselves, and are currently seeking to sell or otherwise consummate a strategic transaction for this system.
We have generated revenues of approximately $21.3 million from inception to December 31, 2005. Prior to January 1997, these revenues were generated primarily in Europe and Japan from sales of our PATHFINDER(R) and TRACER(R) micro-catheter systems for diagnosing VT and our REVELATION(R) micro-catheter system for diagnosing AF, as well as ancillary products such as the VENAPORT(R) guiding catheters. Since 1997 and the U.S. FDA's clearance of certain of our products, sales in the United States consist primarily of our PATHFINDER(R) and REVELATION(R) lines of micro-catheters for diagnosing VT and AF, respectively. To date, our international sales have been made through our small direct sales force, which currently consists of one sales consultant, and distributors who sell our products to physicians and hospitals. European sales consist primarily of the REVELATION(R) Tx, REVELATION(R) T-Flex and REVELATION(R) Helix micro-catheters for treatment of AF following receipt of CE Mark for those products in December 1998, December 2001 and November 2002, respectively.
We have experienced significant operating losses since inception. We expect that our operating losses will continue for the foreseeable future as we continue to invest substantial resources in product development, pre-clinical and clinical trials, seeking regulatory approval, sales and marketing and manufacturing. Because our cash resources are extremely limited, we must raise additional capital in the immediate future in order to continue to pursue FDA approval for our REVELATION(R) Tx micro-catheter system, seek to sell or otherwise consummate a strategic transaction involving our SAS, and otherwise continue operations.
-------------------- "Man who excels at putting worm on hook is Master Baiter" Posts: 678 | From: Boise, Idaho | Registered: Nov 2005
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this sux, i had an open order at .055 but didn t think it was dippin back, now it s at 99
Posts: 27 | From: florida | Registered: Mar 2006
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+267% from the website alert I saw this morning. They had another that gained 74% so far today. Their Tuesday alert hit a trading high of +314% .... unreal
-------------------- " Cash is King " Posts: 1102 | From: NJ | Registered: Mar 2006
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sold some at .097 to get back my capital..riding free shares at the moment...Joe...since you seem to be following this one...what is your exit? i am trying to decide if it is going to go much higher... decisions decisions...
-------------------- #1 Rule: Protect your capital! #2 Rule: Never fall for the BS on the boards! Posts: 8890 | Registered: Jan 2006
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I bailed at .095, I've learned the hard way not to get greedy. There's another one out there every day. Hence my motto, " Cash is King ". Besides no one is going to hold anything going towards the Holiday weekend.
-------------------- " Cash is King " Posts: 1102 | From: NJ | Registered: Mar 2006
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-------------------- The difference between genius and stupidity is that genius has its limits Posts: 10204 | From: NYC | Registered: Mar 2006
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$6B market ALL TO THEMSELVES. There's NO cracking open the chest. Tell me what patient or what doctor won't prefer this approach to existing procedures ?
This is why investors waited so anxiously for news of FDA approval over the years and many gave up when CRDM went to the OTC. Well guess what ? CRDM is BACK !
"Cardima, Inc. developed the linear ablation REVELATION Tx system for treating atrial fibrillation. Since atrial fibrillation afflicts an estimated 2 million people in the United States and approximately 4.5 million people worldwide, the Company believes it is a potential $6 billion market that is poorly served by current treatment alternatives. The REVELATION Tx microcatheter system is a minimally invasive, single-use system with the potential of curing atrial fibrillation, and is believed by the Company to be at least two years ahead of other development-stage ablation therapies in the approval process. Phase I and II data with the REVELATION Tx microcatheter system have demonstrated safety and promising efficacy. The Company is targeting FDA approval for the REVELATION Tx by the end of calendar year 2002. The Company's REVELATION Helix received CE mark approval in December 2001 with initial market launch in the European Union in the first quarter of 2002." http://72.14.209.104/search?q=cache:VXP7_hW5NtIJ:sec.edgar-online.com/2002/09/19 /0001012870-02-00382...
CRDM .06+120% Makes HISTORY: FDA approval of Cardiac Ablation device.
Over 8 years in the making. Fell from Nasdaq to OTC. Now the sun is shining for this company:
Market Cap:$5.58M * .055/sh wAs over $6/sh in 1998
Article for Cardima Inc (OTC BB:CRDM) 9:00 AM most recent headlines
-------------------- The difference between genius and stupidity is that genius has its limits Posts: 10204 | From: NYC | Registered: Mar 2006
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no doubt 10 i made the mistake of not getting into this in the am , almost 400 friggin % wtg people
Posts: 742 | From: SOUTH CARRIBEAN | Registered: Mar 2006
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