Based: Palo Alto, CA
CEO: Edward Kerslake
The Scoop: Topera uses next-generation 3-D analysis and mapping to detect the source of atrial fibrillation, atrial flutter, and atrial and ventricular tachycardia. There are two components: the RhythmView workstation loaded with software, and the FIRMap mapping catheter with dozens of electrodes. FIRMap is expanded into the atrium and makes contact with the surrounding atrium walls, capturing signals that are processed to create detailed images of the electrical flows in the heart.
What Makes It Fierce: Topera's approach reflects an enormous advance over the standard of care, which relies more on an "anatomic approach" and a series of tests that give clinicians a more limited picture. The California company's imaging technology is so much more detailed than what is out there that it gives electrophysiologists a better understanding of the disease and its points of origin. With that detailed map in hand, it is designed to guide more targeted treatment, whether it is ablation, freezing or another option.
"The hard part is knowing ... which part of the atrium should be targeted for the therapy," CEO Edward Kerslake told FierceMedicalDevices. "Today it is shooting in the dark, but occasionally hitting the target."
Topera's imaging advance has already attracted the attention of at least one major investor. Earlier this year, the 28-employee company secured a $25 million Series C financing led by none other than New Enterprise Associates. NEA, based in Menlo Park, CA, was the top biotech venture capital firm in 2012 and it unveiled a $2.6 billion fund in fall 2012, in an era when med tech VCs, and venture investments, continue to decline. An unnamed "strategic industry partner" also participated in the round, a party Kerslake declined to name.
Kerslake had plenty of good things to say about NEA, however, lauding the firm's status with Topera as a vital investor and partner.
"They are a very good team," he noted. "I was impressed with the level of due diligence they did."
Kerslake also remained coy about the company's previous funding, though he described it as essentially angel financing, in part, from "former medical device CEO, CTOs or those with cardiac franchises that would understand the market."
"This most recent round was the most significant," he added.
What To Look For: Over the coming months, Topera is focusing on regulatory approvals and prepping its product for an eventual commercial launch. It has FDA 510(k) clearance in the U.S. for its RhythmView workstation but is awaiting a similar signoff for the FIRMap catheter. Kerslake said the commercial version of the workstation/software allows for atrial mapping in about 30 seconds, up from 10 minutes in earlier versions of the system.
Meanwhile, the company is waiting for European approval for both products. If all goes well, Topera hopes to have RhythmView and FIRMap cleared and ready to launch before the end of 2013. The milestones, Kerslake said, will be sweet.
"It is pretty satisfying," he said, explaining it is as if "the world had been flat and we are demonstrating now the world is round, ... doing what people said we couldn't do."
Many young med tech companies become acquisition targets once they bring a product to market. But Kerslake insisted that won't happen to Topera in the immediate future.
"I can't build a company based on somebody else's choices," Kerslake said. "We are in love with the technology and are all enjoying the company, and see no reason to look for an exit at this time."
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VC giant NEA backs Topera in $25M Series C
-- Mark Hollmer (email | Twitter)