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Early Study Results Demonstrate Ability of Innovative RF Ablation Catheter to Quickly and Easily Isolate Pulmonary Veins in Atrial Fibrillation PatientsAblation 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
New Multi-Electrode Ablation Frontiers Catheters and RF Generator Featured at American College of Cardiology Scientific Sessions
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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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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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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.
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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.
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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.
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