ablation frontiers, atrial fibrillation catheter company, Cardiac Catheters, Atrial Fibrillation Treatment, RF Radiofrequency Ablation Technology, Atrial Fibrillation Clinical
 
Nominated Most Innovative Product
Clinical Studies Show Excellent Outcomes

News Room & Milestones

9/29/08 CONNECT Announces 2008 Finalists For Most Innovative New Product Awards Nominees Selected for Innovation in San Diego Technology and Life Sciences Sectors Pulmonary Vein Study Download Press Release
9/03/08 Catheter Ablation System for Atrial Fibrillation Shows Reduced Procedure Time, Remarkable Safety Profile and Excellent Outcomes in Two Clinical Studies Pulmonary Vein Study Download Press Release
06/24/08 Presentations at Cardiostim World Congress Focus Attention on a New Ablation Technology Pulmonary Vein Study Download Press Release
05/23/08 Presentations From Recent Heart Rhythm Society Meeting Validate the Safety and Efficacy of Ablation Frontiers Technology in 230 Patients Pulmonary Vein Study Download Press Release
Pulmonary Vein Study 04/24/08 Early Study Results Demonstrate Ability of Innovative RF Ablation Catheter to Quickly and Easily Isolate Pulmonary Veins in Atrial Fibrillation Patients Pulmonary Vein Study Download Press Release
03/27/08 New Multi-Electrode Ablation Frontiers Catheters and RF Generator Featured at American College of Cardiology Scientific Sessions New Multi-Electrode Ablation Frontiers Catheters Download Press Release
01/16/08 Speedy Procedures Demonstrate Excitement and Continued Interest in Novel Multi-Electrode Ablation System Novel Multi-Electrode Ablation System Download Press Release
01/16/08 FDA Grants Approval to Extend U.S. Enrollment and Clinical Trial FDA Grants Approval to Extend U.S. Enrollment and Clinical Trial Download Press Release
11/05/07 First Live Case Demonstrates New Technology and Faster Procedure First Live Case Atrial Catheter Ablation Shorter Surgery Download Press Release
07/17/07 $21.8 Million In Financing Financing Closed for Clinical Development $21.8 Million Download Press Release
12/19/06 CE Mark CE Mark Approved for Ablation Frontiers Inc. Download Press Release




9/3/08

Catheter Ablation System for Atrial Fibrillation Shows Reduced Procedure Time, Remarkable Safety Profile and Excellent Outcomes in Two Clinical Studies

CARLSBAD, California, September 2 /PRNewswire

Important Studies Presented at the European Society of Cardiology Continue to Bring Attention to Innovative Technology

Ablation Frontiers, Inc., announced today that two important studies, involving its innovative atrial fibrillation ablation products were presented by Dr. Lucas Boersma of the St. Antonius Hospital in Nieuwegein, Netherlands at the European Society of Cardiology (ESC) congress. One of the world's most prestigious scientific meetings for cardiologists, the ESC meetings took place from August 30 - September 3 in Munich, Germany.

Dr. Boersma's first study involved 45 patients with paroxysmal atrial fibrillation. Paroxysmal atrial fibrillation (PAF) is characterized by a rapid rhythm of the heart's upper chambers that starts suddenly and stops without the need for medical intervention, yet can provoke severe symptoms. All patients were treated with ablation therapy at the antrum of the pulmonary veins (PV) designed to electrically isolate them from the left atrial body. This therapy has previously involved long procedure times and often required elaborate and expensive imaging technology. Using the circular decapolar Pulmonary Vein Ablation Catheter (PVAC(TM)) and GENius(TM) Multi-Channel Radiofrequency (RF) energy generator from Ablation Frontiers, 100% of the veins were isolated in 97 minutes (+/- 32 minutes) with just 20 minutes (+/- 9 minutes) of fluoroscopy. No complications were observed and 82% of the patients discontinued anti-arrhythmic drug therapy and were free of atrial fibrillation 9 months (+/- 2 months) following a single ablation procedure.

"PV isolation is a therapy option that is appropriate for many PAF patients, but can be difficult and time-consuming to perform with previous technologies. More importantly, there has traditionally been a small but significant complication rate. The Ablation Frontiers system has overcome those challenges," stated Dr. Boersma. "Use of the GENius generator and a single PVAC catheter for mapping, ablating and confirming isolation reduces the risk of complications and streamlines the procedure by eliminating the need for elaborate mapping and imaging technology. And it is quite effective, in that 82% of the patients had no evidence of atrial fibrillation 9 months after their treatment. This is an important finding, since so many patients with paroxysmal atrial fibrillation are visiting their healthcare provider for help."

The second study presented involved patients with permanent or persistent atrial fibrillation (PPAF), a more severe form of the arrhythmia in which the heart's upper chambers consistently beat in a seemingly chaotic way at very high rates. Patients with PPAF do not respond to standard medications, and many of them have to contend with ongoing and sometimes debilitating symptoms.

"Patients with PPAF represent an important but remarkably challenging subset of AF patients. Ablation Frontiers has the only ablation system expressly designed to treat these particular patients," continued Dr. Boersma. "This alone is a real breakthrough."

Fifty-one patients with PPAF were treated at 5 European centers using the GENius generator and PVAC, as well as two other anatomically-designed catheters from Ablation Frontiers -- the Multi-Array Septal Catheter (MASC(TM)) and Multi-Array Ablation Catheter (MAAC(TM)). Ablation therapy restored the heart to normal rhythm in 94% of the patients on the day of the procedure, with an average procedure time of 144 minutes (+/- 44 minutes) following transseptal puncture. Patients were followed for six months with a cumulative efficacy rate of 81%.

These excellent results align with the results presented recently at other leading scientific sessions from several other studies using Ablation Frontiers breakthrough technology.

"We are honored that a physician of Dr. Boersma's caliber and commitment is helping to demonstrate the value of our revolutionary technology with such studies," stated Keegan Harper, Chief Executive Officer of Ablation Frontiers. "The results from these and other studies continue to show the remarkable safety profile of this technology, and that procedure times can be reduced while improving clinical efficacy for all types of AF patients."

Ablation Frontiers is an emerging, venture-backed medical device company based in Carlsbad, California. Founded in 2004, Ablation Frontiers is dedicated to helping individuals suffering from AF and other cardiac arrhythmias. Working in concert with clinical experts in the field of ablation, the company is focused on developing and commercializing innovative products designed to make ablation procedures safer and less time consuming, thereby making it possible for more individuals to benefit from this life-bettering therapy. In 2006, Ablation Frontiers received the CE mark to begin marketing its system of unique ablation catheters and multi-channel RF generator in the European Union.

Distributed by PR Newswire on behalf of Ablation Frontiers, Inc.

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06/24/08

Presentations at Cardiostim World Congress Focus Attention on a New Ablation Technology

Ablation Frontiers, Inc. today announced that two studies reporting positive findings about its novel atrial fibrillation catheter ablation system were presented at this year's Cardiostim World Congress, a premier meeting for physicians that treat cardiac rhythm disorders.

Dr. Stefan Weber of the University Clinic at Regensburg, Germany, presented results of a study of 12 patients with paroxysmal atrial fibrillation (PAF). Using the company's PVAC(TM) (Pulmonary Vein Ablation Catheter) and GENius(TM) RF generator, Dr. Weber reported success in isolating 98 percent of pulmonary veins with a remarkably short average
ablation time of 84 +/- 9 minutes. The total time of radiofrequency (RF) energy needed to successfully isolate the pulmonary veins was 22.4 +/- 2.9 minutes.

"We found that mapping and ablation of the pulmonary veins using a single catheter, without 3D navigation or robotic steering, could be performed safely and effectively with short procedure times," stated Dr. Weber. "Thus, this system may be of high interest for all centers who would like to increase throughput for AF ablation."

The second study, led by Dr. Christoph Scharf and presented by Dr. Lam Dang of Klinik Im Park Hospital in Zurich, Switzerland, utilized the same novel catheter ablation technology in a total of 45 patients with long standing persistent AF. This study utilized two additional catheters from Ablation Frontiers, MASC(TM) (Multi-Array Septal Catheter) and MAAC(TM)
(Multi-Array Ablation Catheter) designed to find and ablate specific ablation targets called CFAEs (Complex Fractionated Atrial Electrograms). Six month follow up data was presented for 37 patients, with 78 percent free of AF after an average procedure time of 162 +/- 36 minutes. Dr Scharf noted the particularly low re-do procedure rate of 13.5% and the absence of left atrial flutters after the procedure.

"These early results are very promising and procedure times have been significantly reduced," stated Dr. Scharf. "Using unipolar:bipolar RF energy for the ablation is safer and more effective in our experience. This is an important aspect to this system, as tipped-catheters and conventional higher power RF generators have been associated with significant complications."

The company's innovative multi-electrode mapping and ablation catheters are used in conjunction with its duty-cycled radiofrequency (RF) generator. Each catheter's adaptable shape facilitates access to and good tissue contact with the left atrial regions that require ablation to terminate atrial fibrillation. The temperature controlled, power limited energy source was specifically designed to reduce the risk of complications seen with conventional higher-energy power sources.

"While isolation of the pulmonary veins can be effective in treating paroxysmal AF, long-standing persistent AF requires that other areas of the left atrium be specifically targeted. Conventional ablation technology offers only one therapeutic option for both disease states, which has produced moderate success, relatively high rates of complications, and long procedure
times. Ablation Frontiers' family of catheters delivers innovative solutions for treating both paroxysmal and long standing persistent AF patients," stated Keegan Harper, Chief Executive Officer of Ablation Frontiers. "We are very gratified to see our products working in both AF patient populations with high success rates, very low complication rates, and considerably
shortened procedure times."

Atrial fibrillation (AF) is a common and devastating cardiac rhythm disorder in which the heart's upper chambers beat in an extremely fast and chaotic rhythm. Symptoms may include palpitations, dizziness and shortness of breath. AF can present in different forms, including paroxysmal, in which the abnormal rhythm starts and stops on its own, or long-standing persistent, which does not stop on its own and cannot be stopped with currently available medical treatments (drugs or cardioversion). Left untreated, AF patients are at an increased risk for stroke and may also develop heart failure or other
cardiac disorders.

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05/23/08

Presentations From Recent Heart Rhythm Society Meeting Validate the Safety and Efficacy of Ablation Frontiers Technology in 230 Patients

Novel Catheter Ablation System also delivers remarkably shorter procedure times

CARLSBAD, Calif., May 23 /PRNewswire/ -- Ablation Frontiers, Inc. today announced that four presentations at the Heart Rhythm Society's 2008 Scientific Sessions reported positive early results using its novel Catheter Ablation System, and that these findings aligned well with each other and supported previous experience from the field.

The company's innovative multi-electrode mapping and ablation catheters used in conjunction with its duty-cycled radiofrequency (RF) generator were the subject of four presentations (AB9-3, AB9-5, PO5-17, and PO6-32). Three of these reports examined early outcomes using the advanced ablation system to treat atrial fibrillation (AF) patients in commercial procedures throughout Europe, while the fourth presentation focused on the feasibility phase for a US-based clinical study.

"In more than 1,000 commercial cases in Europe our technology has been very safe, highly effective and reduced procedures to well under 2 hours. Our commercial experiences are nicely substantiated by the four Presentations given at HRS," stated Keegan Harper, CEO of Ablation Frontiers, Inc. "The results presented also align well with each other,
With a total of 230 patients showing no adverse events, approximately 80 percent efficacy, and average procedure times ranging from 85 to 129 minutes."

The largest study included 132 patients with paroxysmal AF and was presented by Dr. Lam Dang of the Klinik Im Park in Zurich, Switzerland. He reported a procedure time of 129 +/- 36 minutes with no device-related complications. At the time of presentation, 80 percent of patients with 6 month follow-up were free from AF and had discontinued drug therapy.

Dr. Lucas Boersma of St Antonius Hospital in Nieuwegein, The Netherlands presented two abstracts that studied 85 patients with paroxysmal AF who were treated with the Ablation Frontiers system. These presentations demonstrated a 100 percent acute success rate, no peri/post-procedure complications up to 7 days, and procedure time of 85 +/- 33 minutes. Of those patients monitored at the 6 month follow-up date, 83 percent were free of AF and off anti-arrhythmic drugs.

A smaller study of 20 patients with permanent AF was presented by Dr. Gregory Michaud, Director of the Center for the Advanced Management of Atrial Fibrillation at the Brigham and Women's Hospital in Boston. This data represented procedures performed by 12 first-time operators as part of the feasibility phase of a US clinical trial called TTOP-AF, or the Tailored Treatment of Permanent AF, which is currently enrolling patients. Dr. Michaud reported that 96 percent of patients experienced a procedural success rate with no complications reported. At 6 months follow up, 75 percent of patients were in sinus rhythm, free of AF. After receiving early data from this group of patients, the Food and Drug Administration (FDA) allowed commencement of the pivotal TTOP-AF trial in the US.

"These early reports are extremely promising," noted Dr. Boersma, "and we are hopeful that long-term data will maintain consistency with the results presented. As physicians, we are excited about the remarkably close alignment of these safety and efficacy outcomes, with greatly reduced procedure times, in both the paroxysmal and permanent AF populations."

Atrial Fibrillation is a common and devastating cardiac rhythm disorder in which the heart's upper chambers beat in an extremely fast and chaotic rhythm. Symptoms may include palpitations, dizziness and shortness of breath. AF can present in different forms including paroxysmal, in which the abnormal rhythm starts and stops on its own, or permanent, which does not stop on its own and cannot be stopped with currently available medical treatments (drugs or cardioversion). Left untreated, AF patients are at an increased risk for stroke and may also develop heart failure or other cardiac disorders.

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04/24/08

Early Study Results Demonstrate Ability of Innovative RF Ablation Catheter to Quickly and Easily Isolate Pulmonary Veins in Atrial Fibrillation Patients

Ablation Frontiers, Inc., today announced that data on the first five patients enrolled in a study involving its novel RF ablation catheter and generator were presented by Dr. Stefania Riva at the 7th Annual Session of the Italian Association of Arrhythmology and Cardiac Pacing on April 3, 2008 in Milan. The patients, two of whom presented with permanent atrial fibrillation and three with paroxysmal atrial fibrillation, underwent successful pulmonary vein isolation without any reported complications. Procedure times averaged 32 minutes and after three months median follow-up (range: one to five months), four of five patients were in sinus rhythm.

The procedures were conducted using the PVAC Pulmonary Vein Ablation Catheter and multi-channel GENius Generator for Ablation Catheters. The PVAC was used for both mapping and ablating during the procedures. "The use of a single mapping and ablation catheter has streamlined and simplified the procedure," stated Dr. Stefania Riva.

Atrial Fibrillation is a common and devastating cardiac rhythm disorder in which the heart's upper chambers beat extremely fast and in an apparent chaotic rhythm. Symptoms include palpitations, dizziness and shortness of breath. Left untreated AF patients are at an increased risk for stroke and may also develop heart failure or other cardiac rhythm disorders. AF is most frequently treated with drug therapy but recent surgical advances targeting the electrical isolation of the pulmonary veins (near the left sided upper chamber) have demonstrated success at eliminating the rhythm disorder. While results of these surgical techniques hold promise, the invasiveness of the procedures makes them challenging, time consuming and subject to complications.

"The lack of perioperative and postoperative complications is of key importance," stated Dr. Riva. "As of this date, one patient in our study with paroxysmal AF has stopped taking all anti-arrhythmic medications. While our study is still underway, I find these interim results quite encouraging."

Ablation Frontiers, Inc. is pioneering new technology designed to make AF ablation safer for patients, faster and easier for physicians, and more appropriate for a broader spectrum of patients. Older ablation approaches are often considered only for those patients with paroxysmal AF, the mildest form of the disease.

"We are very much encouraged by these interim results and sincerely thank Dr. Paolo Della Bella, Chief of the Arrhythmology Department at the University of Milan's Institute of Cardiology and one of the authors along with his colleagues for their outstanding work in this study and their dedication to finding a cure for AF," stated Keegan Harper, Chief Executive Officer of Ablation Frontiers. "These preliminary data show the promise of the Ablation Frontiers technology for patients with either permanent or paroxysmal atrial fibrillation. This early report aligns well with anecdotal data from other clinics in Europe. We are very pleased with the resonance this new device is finding in the clinical community."

About Ablation Frontiers
Ablation Frontiers is an emerging, venture-backed medical device company based in Carlsbad, California. The company received $21.8 million Series C financing in June 2007, led by the Novartis Venture Fund, to drive clinical development and market expansion for their novel Cardiac Ablation System. Founded in 2004, the company is focused on developing and commercializing innovative products for the treatment of cardiac arrhythmias. In late 2006, Ablation Frontiers received the CE Mark to begin marketing in the European Union with its portfolio of anatomical-based catheters and a multi-channel RF generator.

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03/27/08

New Multi-Electrode Ablation Frontiers Catheters and RF Generator Featured at American College of Cardiology Scientific Sessions

CARLSBAD, Calif., March 27 /PRNewswire/ -- Ablation Frontiers, Inc., a privately held medical device company, announced today that a poster at the American College of Cardiology (ACC) Scientific Sessions in Chicago would feature results from a study using its Cardiac Ablation System. The poster presentation (1008-94) was also recently published as a "Cardiac Arrhythmias" abstract in the March supplement to the Journal of the American College of Cardiology, which is distributed to cardiologists globally. The poster will be on display at the ACC Scientific Sessions on Sunday, March 30th.

"This System was designed to make atrial fibrillation ablation procedures safe and efficacious, while reducing procedure time and complexity," stated Dr. Andrew Grace of Papworth Hospital in Cambridge, United Kingdom. "We will be able to treat all types of atrial fibrillation with this novel technology, including paroxysmal, persistent, and chronic." Dr. Grace, one of the study investigators and a co-author of the poster, is a practicing cardiologist at the UK's largest cardiothoracic hospital. Dr. Grace added, "Since the system is still fairly new, long-term results continue to be evaluated. We are pleased to be able to present the first published data for this system at the ACC."

Atrial fibrillation (AF) is a common rhythm disorder, in which the heart's upper chamber beats in a rapid, chaotic manner often causing the body's heart rate to be very fast. A patient is often left with symptoms of tiredness, weakness, and lightheadedness. The risk of stroke is much higher in this population. Until recently, treatment has been with drug therapy designed to lower the heart rate and blood thinners for stroke prevention. Over the last 15 years, pioneering work has led researchers to now treat the disease by identifying the cardiac cellular origin, delivering energy through a catheter to destroy that portion of heart tissue thus changing the electrical pathways causing the arrhythmia. Known as AF ablation, it is anticipated that 50,000 procedures will be performed in the United States this year.

A current guidance document from the UK's National Institute for Health and Clinical Excellence (NICE) has estimated that ablation procedures can prevent recurrence of atrial fibrillation in up to 80 percent and reduce mortality by more than 50 percent in this patient population.

While AF ablation procedures can be curative and appear quite promising, current technology makes it time-consuming, tedious, and difficult to perform for even the most skilled and experienced of operators.

"Despite the great promise of ablation therapy, the technical challenges of positioning the catheter in a safe and reliable manner have been quite daunting," commented Keegan Harper, Chief Executive Office of Ablation Frontiers. "Conventional methods have made the procedure possible, but not repeatable and available to all clinics. We believe our novel multi-electrode catheters and duty-cycled radiofrequency generator will bring proven safety and efficacy benefits to many more patients around the world."

About Ablation Frontiers
Ablation Frontiers is an emerging, venture-backed medical device company based in Carlsbad, California. The company received $21.8 million Series C financing in June 2007, led by the Novartis Venture Fund, to drive clinical development and market expansion for their novel Cardiac Ablation System. Founded in 2004, the company is focused on developing and commercializing innovative products for the treatment of cardiac arrhythmias. In late 2006, Ablation Frontiers received the CE Mark to begin marketing in the European Union with its portfolio of anatomical-based catheters and a multi-channel RF generator.

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01/16/08

Speedy Procedures Demonstrate Excitement
and Continued Interest in Novel Multi-Electrode Ablation System

Carlsbad, CA, USA – Jan 16, 2008 – Ablation Frontiers, Inc., a privately-held medical device company, announced today a successful series of catheter ablations using the company’s Tip-Versatile Ablation Catheter™ (T-VAC).  Dr. Vince Paul of the St. Peter's Hospital in Chertsey, United Kingdom is one of three leading European sites that have been evaluating this new multi-electrode linear ablation catheter since November 2007.  He performed four ablation procedures for atrial flutter, a potentially dangerous irregular heart rhythm.  
 
Diagnosed with typical atrial flutter, an arrhythmia originating from the upper chambers of the heart, the patients had all suffered from periodic episodes of -palpitations, dizziness, or fatigue. "I would often get lightheaded and notice my heart was racing,” said one patient who had tried several medications unsuccessfully for this “short circuit” of the heart’s normal rhythm.

Performed in a cardiac catheterization laboratory, the T-VAC is inserted through a vein in the patient’s leg and traversed into the heart.  Dr. Paul then moved the catheter tip in the heart until he identified the precise area of cardiac tissue responsible for the irregular heart rhythm. Simultaneously applying radiofrequency (RF) energy to all six T-VAC electrodes with the Ablation Frontiers GENius™ RF Multi-Channel generator, Dr Paul was able to create “lesions” approximately 30mm in length.  These lesions modify the cardiac tissue to block the abnormal electrical conduction.  For one patient, a single ablation created in just 90 seconds completely blocked the short circuit.  Another two patients required only two or three ablations to fix their arrhythmia.  All four patients were successfully treated and left the Catheterization Laboratory with a normal heart rhythm.

After the final procedure of the day, which lasted 20 minutes, Dr. Paul said, “With the T-VAC and GENius generator I could create a long contiguous lesion without having to drag the catheter along the surface of the heart.  I am very pleased with this novel design, which allows for potentially shorter & safer linear ablations.”  Dr. Paul represents one of approximately 10 physicians that will utilize the catheter during an upcoming introduction period.

Having received the CE Mark for the T-VAC in September 2007, Ablation Frontiers will feature the T-VAC at the Boston Atrial Fibrillation Symposium, taking place January 17-19, 2008 at the Seaport Hotel and World Trade Center.  The T-VAC is expected to be launched into the broad European market in the second quarter of 2008. 

Ablation Frontiers CEO, Keegan Harper said, “the T-VAC will be a strong  complement to our other product offerings and allow us to offer advanced treatment to all patients needing an ablation therapy whether it be in the right or left side of the heart.  The T-VAC will also enable treating physicians to perform ablation procedures in substantially less time than what is currently possible.”

 Federal Law limits these devices to investigational use in the United States.

About Ablation Frontiers
Ablation Frontiers is an emerging, venture-backed medical device company based in Carlsbad, California.  The company received $21.8 million Series C financing in June 2007, led by the Novartis Venture Fund, to drive clinical development and market expansion for their novel Cardiac Ablation System. Founded in 2004, the company is focused on developing and commercializing innovative products for the treatment of cardiac arrhythmias.  In late 2006, Ablation Frontiers received the CE Mark and actively markets its portfolio of anatomical-based catheters and a multi-channel RF generator in the European Union.

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01/16/08

FDA Grants Approval to Extend U.S. Enrollment and Clinical Trial

Ablation Frontiers Uses Novel Technology in Treatment of Chronic Atrial Fibrillation Patients

Carlsbad, Calif. -- January 16, 2008 - Ablation Frontiers, Inc. today announced the expansion of enrollment in the first ever U.S. Investigational Device Exemption (IDE) clinical trial for interventional treatment of chronic atrial fibrillation (AF).  Approval from the US Food and Drug Administration (FDA) to proceed with the pivotal phase of the study is based on the review of an initial feasibility segment completed in August 2007.  Completion of the clinical trial, which will compare the safety and efficacy of tailored ablation therapy against traditional pharmaceutical regimens, will support a pre-market approval (PMA) application to the FDA.

Having received FDA approval to enter the pivotal phase of the trial in the fourth quarter of 2007, several patients have already been randomized into the study.  Initial US treatment sites included The Lahey Clinic and Medical Center in Burlington, Massachusetts. Their first patient, with a three year history of continuous AF, was successfully treated and returned home the next day with a normal heart rhythm. After the two-hour and ten-minute procedure, Dr. Gregory Michaud had the following enthusiastic comment, ”I am really excited about this new technology. It has two advantages that are immediately apparent. One, the catheters are simpler to use than the traditional “point-by-point” catheters, thus reducing the time it takes to complete complex left atrial procedures. Second, the depth of the radiofrequency energy lesions is controllable, which makes damage to collateral structures, such as the esophagus, less likely.”

The Ablation Frontiers Cardiac Ablation System, being evaluated in this clinical study, was developed under the guidance of Drs. Fred Morady and Hakan Oral, at the University of Michigan.  Designed to be a versatile tool kit for mapping and ablating areas of the heart where AF is most prevalent, the Cardiac Ablation System combines a novel radiofrequency (RF) energy source with a series of anatomically-designed catheters.  The Ablation Frontiers system is also unique because it does not require expensive 3D navigation or robotic steering equipment that can make these types of procedures longer and more complicated. 

About the TTOP AF Trial
The study, known as the Tailored Treatment of Permanent Atrial Fibrillation (TTOP AF), uses an approach that allows cardiologists to customize their treatment strategy and potentially shorten procedure times, improve patient outcomes, and reduce recurrence of the disease. "The pivotal phase of the TTOP AF trial is designed to demonstrate the clinical safety and efficacy of our Catheter Ablation System as compared to current drug options," said Ablation Frontiers’ Chief Executive Officer, Keegan Harper.  "Based on positive clinical outcomes of our multi-center European study, as well as our ongoing commercial experience in Europe, we believe that the TTOP AF trial will show striking clinical benefits made possible by our technology. We have already demonstrated in numerous procedures in Europe that we can greatly reduce procedure times with our technology.”   

Patients will initially be randomized into two treatment groups; one group receiving ablation therapy, and the other group – called the control arm – receiving commonly used drug treatments. For every two patients initially receiving an ablation, one will be randomly assigned to the control arm.  The trial allows patients in the control arm to receive an ablation if they do not respond to drug therapy. At the conclusion of the study, Ablation Frontiers will submit a Pre-Market Approval (PMA) application to the FDA for marketing the Catheter Ablation System in the US.

About Atrial Fibrillation
Atrial fibrillation remains the most commonly diagnosed cardiac arrhythmia, or irregular heart rhythm, affecting approximately ten million people worldwide.  As the U.S. population ages, it is likely that the incidence of AF will dramatically increase over the next several decades, with an estimated six percent of the current U.S. population over age 60, and ten percent of the population over age 80, affected by the condition.  AF is a leading cause of stroke and when left untreated can significantly reduce quality of life and lead to stroke, heart failure and death.

Patients with AF today are generally treated with pharmaceutical drug regimens or surgery in more severe cases.  Currently, no minimally invasive, catheter-based procedures have been approved by the FDA to treat AF, although an estimated 50,000 procedures will be performed this year.  The currently available “tip catheter” approaches are based on a decade-old technology originally designed to treat irregular heart rhythms other than AF.  

About Ablation Frontiers
Ablation Frontiers is an emerging, venture-backed medical device company based in Carlsbad, California. The company received $21.8 million Series C financing in June 2007, led by the Novartis Venture Fund, to drive clinical development and market expansion for their novel Cardiac Ablation System. Founded in 2004, the company is focused on developing and commercializing innovative products for the treatment of cardiac arrhythmias.  In late 2006, Ablation Frontiers received the CE Mark to begin marketing in the European Union with its portfolio of anatomical-based catheters and a multi-channel RF generator.

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11/05/07

First in the World Live Case using New Technology Demonstrates Shorter Procedure Time

Ablation Frontiers, Inc. Participates in the Heart Rhythm Congress 2007 Live EP Cases in Birmingham, UK

Carlsbad, CA, USA – Nov 5, 2007 – Ablation Frontiers, Inc., a privately-held medical device company, announced today its successful first public broadcast of a procedure using the company’s novel Catheter Ablation System on October 31st, 2007. Performed by Dr. Lucas Boersma of the St. Antonius Hospital in Nieuwegein, The Netherlands, the System was used to isolate heart tissue causing a potentially dangerous irregular heart rhythm. The process was transmitted to an audience of heart specialists in Birmingham, United Kingdom, as part of the 2007 Heart Rhythm Congress. Professor John Morgan of the Southampton General Hospital – a member of the Heart Rhythm Congress organizing committee – accompanied Dr. Boersma in performing the procedure.

The 60-year old male patient was diagnosed with paroxysmal atrial fibrillation (AF), a recurrent electrical “short circuit” in one of the upper heart chambers, approximately 2 years ago. In March 2007, however, his diagnosis worsened to persistent atrial fibrillation, defined as AF which is sustained beyond seven days. He has suffered from episodic heart palpitations and dyspnea – all common symptoms of this arrhythmia. "I would often be out of breath and sometimes feel my heart beating much faster than normal,” said the patient.

The minimally-invasive procedure was performed in the Cardiac Catheterization Laboratory. Dr. Boersma began by inserting the Pulmonary Vein Ablation Catheter (PVAC™) into the patient’s right leg and maneuvering up to the heart by way of a large vein. The multi-electrode circular tip catheter was used to diagnose and treat the cardiac tissue responsible for the irregular heart rhythm, which was located in the left atrium of the heart, near the pulmonary veins. Simultaneously applying radiofrequency (RF) energy to all of the electrodes with the Ablation Frontiers GENius™ generator, Dr Boersma created a number of circular “lesions” that blocked the short circuit – a procedure known as Pulmonary Vein Isolation or PVI. The patient left the Catheterization Laboratory with a normal heart rhythm.

During the procedure, Dr. Boersma isolated all four pulmonary veins in approximately 38 minutes, or 50 minutes from the first venous access. Afterwards he commented, “With this game changing technology I can create a contiguous, circular lesion without having to drag the catheter along the surface of the heart. This greatly simplifies a once complex procedure. The novel design also allows me to perform the procedure with a single catheter for mapping and ablation. After having treated many patients with this technology I have documented substantially reduced procedure times as well as reduced complications from what I would normally expect to see.” On Tuesday, the day before the procedure, Dr Boersma presented his results with the PVAC as part of a presentation entitled, “New developments and insights into Atrial Fibrillation ablation therapy”. In his initial experience, Dr. Boersma reported 100% acute success – confirmed pulmonary vein isolation – with an average total procedure time of 96 minutes.

Professor Morgan noted, “We have successfully used this catheter in a large number of patients at Southampton General Hospital and experienced reduced procedure times without any major complications. We are very happy with the design of both the catheter technology and the RF generator.”

Ablation Frontiers has been distributing the PVAC and GENius™ RF Generator to a select number of European centers since receiving the CE Mark in December 2006. As part of the company’s “toolbox” approach for ablation of all types of arrhythmias, Ablation Frontiers also distributes the Multi-Array Ablation Catheter™ (MAAC), Multi-Array Septal Catheter™ (MASC), and Tip-Versatile Ablation Catheter™ (T-VAC).

Atrial fibrillation remains the most commonly diagnosed cardiac arrhythmia, or irregular heart rhythm, affecting approximately ten million people worldwide. Because AF is a disease that increases with advancing age, with an estimated six percent of the current U.S. population over age 60 and ten percent of the population over age 80 affected by the condition, and the increasing average age of the U.S. population, it is likely that the incidence of AF will more than double over the next several decades. AF is a leading cause of stroke and when left untreated can significantly affect quality of life and lead to stroke, heart failure and death.

Federal Law limits these devices to investigational use in the United States.

About Ablation Frontiers

Ablation Frontiers is an emerging, venture-backed medical device company based in Carlsbad, California. Founded in 2004, the company is focused on developing and commercializing innovative products for the treatment of cardiac arrhythmias. In late 2006, Ablation Frontiers received the CE Mark and actively markets its portfolio of novel anatomical-based catheters and a multi-channel RF generator in the European Union and other international markets. To learn more about the company, visit www.ablationfrontiers.com.

About the Heartbeat Education Centre

The Live Cases were hosted by the Heartbeat Education Centre, Southampton, which is equipped with high specification audiovisual facilities. This capability enables simultaneous transmission of multiple “screenshots” from up to 7 catheter laboratory suites with simple and effective mechanisms for audience operator interaction and participation. The demonstrations were intended to show the physician audience in Birmingham some of the newest technologies available for atrial fibrillation (AF) ablation.

First Live Case Atrial Catheter Ablation Shorter Surgery Download Press Release

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Cardiac Ablation Catheter Company for Atrial Fibrillation
07/17/07

Ablation Frontiers Closes $21.8 Million Financing Round to
Drive Clinical Development and Market Expansion

CARLSBAD, July 17, 2007 – Ablation Frontiers, Inc., a privately-held medical device company focused on developing novel treatments for irregular heart rhythms, recently announced the close of a $21.8 million Series C financing led by the Novartis Venture Fund. Additional new investors included Affinity Ventures, Hexagon Investments and Trellis Health Ventures.  Previous backers Versant Ventures, Aberdare Ventures, and Pequot Ventures also participated in the round.

Ablation Frontiers has developed an innovative portfolio of devices for treating dangerous arrhythmias without the use of expensive, complicated imaging systems or robotics.  The company recently announced the launch of commercial operations in the European Union after their Catheter Ablation System received the CE Mark.  Currently, the company has focused their efforts on the treatment of atrial fibrillation – the most common type of abnormal heart beat – and is supporting clinical trials in the Unites States and Europe to demonstrate safety and efficacy in curing the disease.  A proven treatment for atrial fibrillation has been described as a major unmet medical need, with market estimates of approximately $2 billion. 

The capital raised in this round will be dedicated to Ablation Frontiers’ investigational device exemption (IDE) clinical trial in the United States, as well as expanding commercial operations around the world.  According to CEO Keegan Harper, "We are pleased with the results of this financing, which represents a step-up in the company’s valuation, as well as the confidence of an accomplished team of new and repeat investors. This funding will help us accelerate market growth internationally while driving clinical activity for our recently-initiated IDE study.” 
“We are pleased to have led this round of investment in Ablation Frontiers” said Steven Weinstein, Managing Director at the Novartis Venture Fund.  “We are impressed with the company's product portfolio, experienced management team and remarkable pace of adoption in early commercialization.” As a result of this financing, Mr. Weinstein will join the Ablation Frontiers Board of Directors
About Ablation Frontiers
Ablation Frontiers is an emerging, venture-backed medical device company based in Carlsbad, California.  Founded in 2004, the company is focused on developing and commercializing innovative products for the treatment of cardiac arrhythmias.  In late 2006, Ablation Frontiers received the CE Mark for its Cardiac Ablation System consisting of a portfolio of anatomical-based catheters and a multi-channel radiofrequency (RF) generator.

About Novartis Venture Funds
Founded in 1996, Novartis Venture Funds currently manages over $550 million in committed capital. As a financially driven corporate life science investor, the Novartis Venture Fund invests in those companies which have the potential to lead the next innovation wave in our core therapeutic fields or explore new business areas that will be critical to patient care. Since its formation, Novartis Venture Fund has invested in more than 50 companies in the biotech and medical device sectors. The Novartis Venture Funds team of nine investment professionals located in Basel Switzerland and Cambridge, MA brings together extensive expertise in life sciences and venture capital. For more information, visit www.venturefund.novartis.com.

Financing Closed for Clinical Development $21.8 Million Download Press Release

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Cardiac Ablation Catheter Company for Atrial Fibrillation
12/19/06

CE Mark Approved for Ablation Frontiers Inc. ABLATION FRONTIERS ANNOUNCES CE MARK FOR
NOVEL CARDIAC ABLATION CATHETERS

Regulatory Approval Clears Path Towards European Commercialization

Carlsbad, CA, December 19, 2006—Ablation Frontiers, Inc., developer and manufacturer of three-dimensional catheters for the treatment of atrial fibrillation (AF) announced today that it has received the CE Mark for its Cardiac Ablation System consisting of a portfolio of 3 catheters and a novel RF energy delivery system. CE Mark certification allows the company to initiate use of its system throughout the European Union and other International markets that recognize the CE mark.

Ablation Frontiers proprietary devices are used to treat tissue in the right and/or left atrium of the heart during an AF ablation procedure. Unlike traditional technologies used for this procedure, Ablation Frontiers Inc. has invented and developed a portfolio of custom catheters, for use with standard Fluoroscopy imaging, designed for the atrial anatomy along with a custom RF energy delivery system to tailor lesions for the individual needs of the patient. The Company’s percutaneous cardiac catheters are inserted through a vein in the leg of the patient and advanced into the right and/or left atrium. Each of the catheters is designed to map and using radiofrequency energy, ablate specific target sites through either single selected or multiple channels simultaneously.

This results in a significant reduction of time required for the procedure and increased accuracy for the physician due to the stabilizing nature of the three-dimensional catheters. Traditional ablation can take up to 6 hours or greater. The Ablation Frontiers portfolio of catheters and RF energy system allows physicians to tailor the ablation therapy to suit the needs of each patient.

“It’s truly exciting to be at the forefront of new technology to treat atrial fibrillation that is curative rather than palliative,” stated Keegan Harper, CEO of Ablation Frontiers.  “We are very pleased with the results of our European clinical trials and are looking forward to the launch of our technology into the European and key international markets”,

Ablation procedures are used to treat cardiac arrhythmias, such as Atrial Fibrillation. AF is an uncontrollable, rapid heartbeat that can lead to serious complications like strokes or Heart Failure. Globally, in excess of 10 million people are afflicted with AF. During the Ablation procedure, a catheter is inserted into a specific area of the heart. Energy is directed through the catheter to small areas of the heart muscle that permit the abnormal heart rhythm. This energy "disconnects" the pathway of the abnormal rhythm.

The Cardiac Ablation Technology System provides a catheter-based solution to AF that is appropriate for most hospital facilities when performed by a cardiac electrophysiologist.

Ablation Frontiers is a privately held company that was founded in 2004.

CE Mark Approved for Ablation Frontiers Inc. Download Press Release

 

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