Startup Cardio Firm Receives Series A Funding

SeptRx, a startup medical device company based in Fremont, Calif, recently received its Series A round of funding, totaling $2.7 million. The funding was led by Nitinol Devices & Components Inc.

The company is developing the Intrapocket PFO Occluder (IPO)—a platform for the percutaneous transcatheter closure of a heart defect known as patent foramen ovale (PFO).

The cash infusion is intended to carry the company through CE mark registration, according to Scott Russell, President and CEO of SeptRx.

The Intrapocket PFO Occluder already completed a successful 11-patient first-in-human clinical trial, which was the first and only PFO device trial to demonstrate 100 percent closure and 100 percent safety (out to 3 years), according to the company. A larger European clinical trial is nearly underway, from which data will be used to apply for CE marking. The trial will be conducted at two investigation sites: Frankfurt, Germany, and Massy, France.

“Stroke is a worldwide burden, the second most common cause of death and the most common cause of disability internationally,” said Russell. “Unfortunately, the stroke burden will very likely increase in the coming decades. Given that as many as 20 percent of all strokes can be attributed to PFO, SeptRx believes that we can have a significant impact in reducing this unacceptable threat. We intend that our Series A funding will advance SeptRx through regulatory hurdles in Europe and position us for initial commercialization efforts there.”

PFO is a tunnel-like defect connecting the right atrium with the left atrium. A remnant of fetal circulation, it usually seals itself within a few months after birth. Unfortunately, in about 25 percent of the population the PFO does not fully close and may allow blood (and emboli) to pass directly between the right and left atria. The presence of a PFO has been identified as a contributing factor in cryptogenic stroke, chronic migraine, decompression sickness, and obstructive sleep apnea. A PFO contributes to these conditions by providing a pathway for emboli (blood clots, air bubbles) in the venous system to reach the arterial system by passing directly from the right atrium to the left.