FREMONT, Calif., June 6, 2011—SeptRx, an emerging medical device company that is developing the SeptRx® Intrapocket PFO Occluder (IPO)—a platform for the percutaneous transcatheter closure of a heart defect known as patent foramen ovale (PFO)—announced today that the company has received $2.7 million in a ‘Series A’ financing led by NDC (Nitinol Devices & Components) Inc. The cash infusion is intended to “carry us through CE mark registration,” said Scott Russell, President and CEO of SeptRx.
The SeptRx® Intrapocket PFO Occluder has already completed a successful 11-patient first-in-human (FIH) clinical trial. SeptRx’s FIH trial was the first and only PFO device trial to demonstrate 100% closure and 100% safety (out to 3 years). A larger European clinical trial is nearly underway: InterSEPT (In-tunnel SeptRx European PFO Trial), 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,” says Mr. Russell. “Unfortunately, the stroke burden will very likely increase in the coming decades. Given that as many as 20% 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% 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.
SeptRx, Inc. is an emerging medical device company that is developing the SeptRx® Intrapocket PFO Occluder (IPO), a platform for the percutaneous transcatheter closure of a heart defect known as patent foramen ovale (PFO).
NOTICE: The SeptRx® IPO is not approved for sale in any regulatory jurisdiction. Further, it is not yet available for investigational use or commercial sale in the U.S.