(October 2014 – Topera was acquired by Abbott)
Topera, Inc. is a medical device company that produces a suite of advanced diagnostic tools for complex cardiac arrhythmias. Founded in 2012 on technology developed at the UC San Diego School of Medicine, Topera has set out to become a global leader in identifying the sources of arrhythmias to enable patient-specific solutions. It closed in on that goal with the January 2014 announcement of Food and Drug Administration approval to market its third-generation 3D Mapping System.
Serious cardiac arrhythmias such as atrial fibrillation (AF) and ventricular tachycardia are common maladies with devastating impacts. According to estimates from the Heart Rhythm Society, 6 million to 7 million people worldwide suffer from atrial fibrillation, and prevalence in the United States is projected to increase to 12 million by 2050. Unfortunately, these arrhythmias are complex and difficult to treat. Existing therapies are generic, one-size-fits-all remedies with mixed results.
Sanjiv Narayan, MD, PhD, a UC San Diego biomedical researcher and Veterans Administration (VA) Hospital cardiac electrophysiologist, came up with a new clinical approach while treating a patient who had undergone three failed procedures to correct his AF. Narayan believed the solution was to identify and target the mechanism sustaining the patient’s AF. Using his own prototype version of the Focal Impulse and Rotor Modulation (FIRM) mapping software, Narayan worked with his VA colleague Ruchir Sehra, MD, to identify a rotor in an area not usually targeted for treatment. Eliminating the rotor gave the patient long-term relief.
This breakthrough was the basis for the company’s formation and for the creation of the Topera RhythmView™ 3D Electrophysiological Mapping System. The mapping technology provides physicians with a diagnostic tool that, for the first time, pinpoints the unique patient-specific sources believed to be a sustaining mechanism of cardiac arrhythmias. Using the system, electrophysiologists can view a dynamic representation of the heart’s electrical activity. Once the sources of the arrhythmias are identified, clinicians can tailor effective patient-specific treatments.
Topera unveiled its 3D Mapping System in eight presentations at the 2012 American Heart Association (AHA) Scientific Sessions in Los Angeles, CA. An independent evaluation of the system was conducted at Indiana University, and results reported at the 2013 AHA Scientific Sessions showed that 80 percent of patients with persistent AF in the study achieved long-term relief after a single procedure.
Writing in the February 2013 Journal of Innovations in Cardiac Rhythm Management, editor-in-chief John Day, MD, said that “if this [Topera] technology pans out for atrial fibrillation, it could truly represent the holy grail of atrial fibrillation ablation. This discovery could be as significant as pulmonary vein isolation for the treatment of paroxysmal atrial fibrillation.”
In April 2013, Topera completed a $25 million Series C financing round led by global venture capital firm New Enterprise Associates, Inc. (NEA). The funding was primarily designated for the commercial launch of Topera’s RhythmViewTM WorkStation and FIRMapTM Catheter in Europe and the United States, and for extending the company’s research and development pipeline and clinical development program.
Justin Klein, MD, an NEA partner who joined Topera’s Board of Directors, said in the company’s announcement, “We have closely followed the rapidly changing field of atrial fibrillation … especially the opportunity to improve clinical outcomes and health economics through next generation 3D mapping. With its game-changing technology, extensive intellectual property, and commitment to rigorous clinical science, we believe Topera’s leadership in this field positions them well to build a valuable new franchise in electrophysiology.”
Arthur (Art) Taylor – President, COO, CFO
Ruchir Sehra, MD, MBA – Co-Founder and CMO
Rick Green – VP, Capital Sales & Marketing
Shane Brown -VP, Device Sales
Melissa Walker – (Acting) VP, Regulatory Affairs
Kristin Stokan – VP, Finance and Administration
Private funding – $31.5 million
Sanjiv M Narayan, MD, PhD,
Professor of Medicine in Residence
Co-Director, EP Fellowship Training Program
Director, VA EP Program