BioSig Technologies, Mayo to collaborate on heart data system

The Mayo Clinic has signed a long-term collaboration agreement with a Minnesota medical device maker whose product is supposed to give heart doctors a more precise view into causes and effective treatments for deadly cardiac problems.

BioSig Technologies, based in Golden Valley, announced a 10-year agreement with Mayo Clinic. It allows BioSig staff and Mayo heart doctors to work jointly on existing and new applications for a device called the Pure EP System, which is intended to provide more-detailed heart data during a procedure.

The Pure EP, which is not yet approved in the U.S., is supposed to clearly decipher high-frequency signals in cardiac electrograms that can tell doctors which cells in the heart are causing arrhythmias, and whether they have been successfully burned away after an "ablation" procedure. Other systems on the market use older technology that won't detect all the same frequencies.

"You can get some bad-acting cells that take over for the heart's natural pacemaker. And you do this diagnostic mapping procedure to figure out where they are, and then you use ablation to kill those cells," BioSig CEO Greg Cash said Monday. The Pure EP System "allows you to identify the so-called bad-acting cells, and then it also allows you to see if you have ablated them — killed the cells — so that they won't cause arrhythmias any longer."

In a note to investors in January, Cash said the company was "highly confident" BioSig will get FDA clearance to sell the device in 2017, following submission of a 510(k) application this summer.

BioSig is a 15-employee company that has raised about $25 million in private funding since its inception in 2009. Last year it struck an agreement with St. Paul-based contract designer and manufacturer Minnetronix to complete the design and development for the first version of the Pure EP system, with an estimated completion date of this September.

Mayo and BioSig have been working closely together for years, although the relationship hit a speed bump when BioSig published its news release about the business arrangement without first getting it cleared by Mayo. The news release called the relationship a "strategic partnership," but Mayo officials refer to such an arrangement as a "collaboration," which is less involved than a partnership, said Mayo spokeswoman Duska Anastasijevic.

Cash acknowledged the misunderstanding about the news release, and emphasized that the two entities are collaborating on the Pure EP System.

Cash declined to talk about the financial terms of the collaboration, except to say it would last for a decade and that it was expected to result in the creation of jointly held intellectual property. Under the deal, two Mayo doctors will contribute knowledge, ideas and clinical support for new applications and features for the device.

"It's a sharing of ideas. We have ideas, they have ideas, and then we decide jointly if this is something we want to prototype or ... file patents on," Cash said.

BioSig stock, traded on the Over The Counter market, closed down nearly 6 percent on Monday, at $1.45 per share.