MINNEAPOLIS – (Business Wire) NeoChord, Inc., a venture-backed, Minneapolis-based medical technology company, announced today that it has enrolled the first patient in its European clinical trial. The trial, known as TACT (transapical artificial chordae tendineae) is being conducted in Germany, Denmark, Czech Republic and Norway.
“We are very pleased with the early results of this first procedure,” said Per Wierup and Sten Lyager Nielsen, the cardiac surgeons who performed the surgery. “The patient is an otherwise healthy, very active 47-year-old male who preferred to not have a sternotomy or cardiopulmonary bypass to fix his severe mitral regurgitation. The NeoChord approach has successfully treated his mitral regurgitation and potentially offers him a quick return to his military career and favorite hobby, scuba diving.”
Intra-operative transesophageal echocardiography (TEE) confirmed that the patient’s severe, eccentric mitral regurgitation was reduced to zero or trace mitral regurgitation. Giovanni Speziali, MD, the cardiac surgeon who is the primary inventor of the NeoChord device also attended the procedure. “These results, although early, are equivalent to what we obtain in traditional open heart surgery for correction of mitral regurgitation,” said Dr. Speziali.
The NeoChord procedure was developed to treat sub-valvular chordal damage – the primary cause of degenerative mitral regurgitation – via minimally invasive implantation of artificial chordae tendineae. The technology was developed by Speziali and other doctors at the Mayo Clinic and exclusively licensed to NeoChord.
“We’re very pleased to have achieved the first-in-man milestone and want to extend our very best wishes to the patient and his family,” said John Seaberg, CEO of NeoChord. “This successful outcome is the result of several years of hard work by our product development staff and our clinical advisors. I’m extremely proud of the extended NeoChord team.”
About NeoChord, Inc.
Based in Minneapolis, NeoChord is a privately-held, early stage medical technology company founded to advance the treatment of mitral regurgitation by commercializing a surgical device for minimally invasive surgical implantation of artificial chordae tendineae. For more information, visit: www.NeoChord.com.
About Degenerative Mitral Regurgitation (DMR)
DMR occurs when the leaflets of the heart’s mitral valve do not close properly, usually due to rupture or elongation of the chordae tendineae (chords) that control the leaflet’s motion. During pumping, the “leak” in the mitral valve causes blood to flow backwards (mitral regurgitation) into the left atrium, thereby decreasing blood flow to the body. Mitral regurgitation is a progressive disease that left untreated can result in atrial fibrillation, congestive heart failure, and death.
Forward-Looking Safe Harbor Statement
This press release contains certain “forward-looking statements,” as defined in the United States Private Securities Litigation Reform Act of 1995, that involve a number of risks and uncertainties. There can be no assurance that such statements will prove to be accurate and the actual results and future events could differ materially from management’s current expectations. Such factors include, but are not limited to, our limited history of operations; our losses since inception and for the foreseeable future; our lack of regulatory approval for our products, or significant delays in the completion of our clinical trials; our ability to timely commercialize our products; our dependence on third parties to initiate and perform our clinical trials; the need to obtain regulatory approval for any modifications to our products; physician adoption of our products; ongoing regulatory compliance; our dependence on third party manufacturers and suppliers; the successful development of our sales and marketing capabilities; our ability to raise additional capital when needed; our ability to attract and retain management and other personnel and to manage our growth effectively; potential product liability claims; potential healthcare fraud and abuse claims; and our ability to obtain and maintain intellectual property protection for our technology and products. We are providing this information as of the date of this press release and do not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.