BioSig gets approval for U.S. sales of ablation surgery device

After a decade of publishing research reports and privately financing its science, California's BioSig Technologies announced Tuesday that the Food and Drug Administration has cleared its Minnesota-made medical device for sales in the United States. BioSig's device, known as the Pure EP System, is designed to improve the chances that ablations of the heart to treat atrial fibrillation (Afib) are successful, avoiding the need for future procedures. The device is being made by St. Paul-based contract manufacturer Minnetronix and refined in practice by physician-researchers at the Mayo Clinic. Tuesday's news of the FDA's 510(k) clearance for the Pure EP System came one day after the company announced closing on a $4.3 million private round of financing, bringing the company's total funds raised for the year to about $11 million. Substantially all of the investment proceeds came from existing shareholders in the company, BioSig said. Unlike many device startups in Minnesota and nationally, BioSig consciously avoided venture-capital (VC) funding out of concern that VC investors would never let the company spend as much time as was needed to fine-tune the system, company founder and CEO Kenneth Londoner said. "We decided to let the innovation take a little bit of a longer development path so we could have a more value-rich system to launch when we launched it," he said, noting that the idea for the device started in 2007. "VCs never would have given the company this amount of time to get the system to be fully optimized." The Pure EP System works alongside other devices in a procedure room where a patient is being treated for Afib with a technique known as ablation. Atrial fibrillation, the most common heart-rhythm disorder, happens when the heart beats erratically because of errant electric signals originating in specific cells in the heart tissue. This causes the heart to pump out less oxygenated blood than it should, and can contribute to the formation of clots in the blood that may travel to the brain and cause ischemic stroke. Electrophysiologists can treat Afib with a procedure called ablation, which intentionally creates scar tissue on the heart to block the Afib-causing signals. Doing so requires the physician to closely monitor electrocardiogram (ECG) readings in real-time during the ablation procedure. But in practice, these ECG readings can be filled with noise and interference caused by things like other machines in the room. The Pure EP system is designed to eliminate the noise from an ECG so the doctor can precisely see the effects of the ablation. The system captures information from the ablation catheter and then processes them. "We don't replicate the existing information systems. We are complementary," Londoner said. "And we can see signals nobody else can. … Subtle abnormalities which today [physicians] may confuse with a phantom signal or noise." BioSig has been developing and refining the system for more than a decade, including years of work with physicians at Mayo Clinic and other major medical centers. BioSig announced Tuesday that it has received marketing clearance from the Food and Drug Administration for Afib ablation procedures, based on preclinical studies with results published in eight different peer-reviewed papers. Londoner said that as the system begins to be used on human patients, the company and physician-researchers will develop controlled clinical trials to quantify the device's clinical effectiveness over time. "Our manufacturer, Minnetronix, has produced initial systems that will allow us to enter the market in the U.S. with selected sites," a BioSig spokesman said. The spokesman said the company partnered with JK Advisors, a San Diego firm led by Charles Austin, a former senior executive at Johnson & Johnson, to prepare for the commercial launch of the Pure EP system.