CyberHeart Inc.
This article was originally published in Start Up
Executive Summary
While no medical device start-up operates in a risk-free zone, CyberHeart is minimizing its risk by using core technology that is already proven in another therapeutic area, cancer. The start-up has licensed cardiac tissue ablation rights to Accuray Inc.'s CyberKnife robotic radiosurgery system, and intends to use it to develop a completely noninvasive approach for the large, unmet atrial fibrillation market.
Pioneering non-invasive radiosurgical cardiac ablation
707 Menlo Avenue
Suite 210
Menlo Park, CA 94025
Phone: (650) 470-0700
Fax: (650) 470-0701
Web Site: www.cyberheartinc.com
Contact: Patrick Maguire, MD, PhD, President & CEO
Industry Segment: Cardiology Devices
Business: Non-invasive treatment of cardiac dysrhythmias
Founded: March 2005
Founders: Thomas Fogarty, MD; Roderick A. Young, Chairman
Employees: 4
Financing to Date: Undisclosed
Investors: Private
Board of Directors: Thomas Fogarty; Roderick Young; Patrick Maguire
CyberHeart Inc. aims to develop a totally non-invasive, radiosurgery-based approach for treating cardiac dysrhythmias. The start-up believes that the delivery of a high dose of radiation that acts much like a surgeon’s scalpel will provide precise delivery of energy to the tissue while reducing complications seen in current catheter-based ablation procedures.
While no medical device start-up operates in a risk-free zone, CyberHeart is minimizing its risk by using core technology that is already proven in another therapeutic area, cancer. The company, which was formed in 2005 by device industry veterans Tom Fogarty and Rod Young, has licensed rights to Accuray Inc. ’s CyberKnife robotic radiosurgery system. In a deal signed in April 2007, the start-up obtained exclusive rights to Accuray’s technology for use in cardiac tissue ablation. Accuray will supply CyberHeart with radiosurgery equipment and stands to receive royalties on its eventual use. [See Deal]
CyberHeart’s ultimate goal is to develop the CyberKnife technology for the large, undermet atrial fibrillation market. AF, the most common cardiac arrhythmia, is an abnormal heart rhythm in the heart’s two upper chambers. It is characterized by disorganized, rapid electrical impulses in the sinoatrial node, which then result in irregular heartbeats. AF was once thought to be solely a quality of-life problem, with symptoms that include fatigue, chest pain, palpitations, labored breathing, syncope, and lightheadedness. However, we know now that it contributes significantly to cardiovascular morbidity and mortality.
Each year, AF affects an estimated 2.5 million people in the US, and more than five million worldwide. Currently, treatments range from medical management to surgical and non-surgical catheter-based ablation procedures. Drug therapies, which include anti-arrhythmic and rate control drugs, which are sometimes used with blood-thinning agents to reduce risks of clots, are reportedly only about 50% effective in treatment, moreover, they have many side effects.
Ablation procedures destroy the tissue of the atrium that is causing the disorganized, rapid electrical impulses that characterize atrial fibrillation. The resultant scars, or lesions from the ablation serve to interrupt the transfer of the chaotic impulses.
There are currently two surgical procedures for treating AF: surgical ablation and the Maze procedure. In the Maze procedure, small cuts are made in the heart. Scar tissue forms at the site of the cuts as the heart heals. Surgical ablation of cardiac tissue is performed either concurrent with an open-heart surgery such as coronary artery bypass grafting, or as a stand-alone procedure usually performed endoscopically, or via a keyhole approach. In surgical ablation, which requires a single incision into the heart’s left atrium, the surgeon created controlled lesions on the heart using either radiofrequency, microwave, or cryothermy energy.
Interventional electrophysiologists perform percutaneous catheter-based ablation procedures for cardiac dysrhythmias by inserting a catheter into a blood vessel in the groin or neck and using fluoroscopic imaging to navigate it to the heart. Once there, energy is directed to that tissue, wherein a small amount of it is destroyed.
Although the catheters used for these procedures are not currently approved for AF, the size of the catheter-based AF opportunity has attracted many companies to develop catheters that use radiofrequency, microwave, high-intensity focused ultrasound, or cryothermy as the energy source. Reportedly, catheter-based ablation procedures have 38 to 68% efficacy rates. These data combined with many other factors are driving interest in finding solutions for the unmet clinical need posed by AF.
CyberHeart proposes to meet this need by developing a catheter-free, completely non-invasive system. Its CyberHeart system will deliver energy to very discreet areas in the heart, specifically the atrium, and will ablate those areas or create a Maze-like lesion set, according to president and CEO Patrick Maguire. Maguire, the former president of cancer drug developer Targent Inc., joined CyberHeart in 2006. "If you believe that the energy can create an ablation lesion, and that right now it is delivered via catheter, we know now that the CyberKnife can deliver ablation lesions in very small, very sensitive areas. It is hopefully not a huge leap of faith to believe that it can be helpful in the heart," Maguire says.
He bases his opinion on Accuray’s experience in using the CyberKnife to treat tumors in various areas of the body with sub-millimeter accuracy. According to Accuray, the CyberKnife system uses continual image-guidance technology and computer-controlled robotic mobility to automatically track, detect, and correct for tumor and patient movement in real time throughout a procedure. Accuray’s experience with the CyberKnife has demonstrated that the technology is able to deliver energy with precision in very small and sensitive areas, such as in the brain stem, which controls respiratory and other vital functions. (See "Accuray: Building the Radiosurgery Market," IN VIVO, July 2007 (Also see "Accuray: Building the Radiosurgery Market" - In Vivo, 1 Jul, 2007.).)
The differences between the CyberHeart system and the other non-surgical ablation methods are more than the lack of a catheter, Maguire says, although that is a plus given that most complications of catheter-based procedures are reportedly due to the catheter itself. Robotic radiosurgery can precisely track and correct "on the fly" during the procedure for changes in motion and position of the area to be treated or targeted. With respect to the heart and the lung, the software allows the robot to move with the patient’s respiration and according to a cardiac rhythm cycle.
As for questions regarding the safety of using radiation in the heart, CyberHeart has data to show that the radiation effect has to do with the volume of the heart that you treat. The volume or area that CyberHeart’s system will be treating is less than the volume (less tissue) than radiofrequency catheter-based procedures, Maguire says.
CyberHeart is currently in discussions to pinpoint clinical strategy, the exact regulatory requirements, and need for clinical trials. It is considering either a general soft-tissue ablation labeling similar to the catheters currently being used, or a specific arrhythmia indication. If it goes the 510(k) route, using CyberKnife as the predicate device, it would receive general labeling for cardiac soft-tissue ablation. A specific arrhythmia indication such as atrial fibrillation or atrial flutter would require premarket approval, which the company could do simultaneous with the 510(k). Maguire believes the company will have a good feel for the direction of its clinical strategy by the end of 2007.
At the 28th annual scientific sessions of the Heart Rhythm Society held in May 2007, CyberHeart presented initial feasibility data for use of the CyberHeart technology. Reportedly, this early testing in swine showed minimal changes in surrounding tissue while producing focused electrophysiologic changes. The company plans additional presentations at the European Society of Cardiology Congress to be held in September 2007. It anticipates ongoing preclinical studies as it explores other anatomic substrates, which include atrial flutter and ventricular tachycardia. CyberHeart expects to begin first-in-man studies in approximately 18 months.
Those studies will be the focus of the company’s Series B funding. CyberHeart is currently operating on undisclosed seed funding. A Series A round of $7 million is in progress now and should close before the end of the third quarter of 2007, Maguire says.
The company’s goal for its technology is to bring two products to market: a software upgrade of the CyberKnife system installed base and a heart system only. At present, CyberHeart anticipates starting upgrading current CyberKnife centers in 2010. There are currently more than 100 such centers treating various cancers worldwide, and CyberHeart believes that these centers will want a dedicated heart unit for treatment.
The company will introduce the second, stand-alone heart system within a couple years after the 2010 upgrade. CyberHeart’s business plan is not to sell these units or sell software, but to install the units in the centers and charge on a per-patient, or "per-click" revenue model.—Mary A. Steinman