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A healthcare medical device company developing innovative mitral valve repair technology for use in high-risk patients with mitral regurgitation.
CLINICAL NEED
Serca Biomedical
“A Percutaneous Mitral Valve Repair Company”
Mitral regurgitation (MR) is leakage of blood backwards across the mitral valve from the ventricle into the atrium and is the most common form of heart valve disease in the U.S with moderate to severe disease affecting about 1-2% of the population. While there are several different subtypes of MR, there are two major types of the disease; degenerative, and functional. Degenerative MR results from a structural abnormality in some part of the valve itself (e.g. a damaged leaflet). Conversely, functional MR is generally caused by dilation of the mitral valve annulus such that the leaflets no longer close and seal, allowing blood to flow backwards through the valve. This often occurs as the result of a heart wall damage (ischemia) or an enlarged left ventricle, and is frequently associated with heart failure which has severe physiological consequences to the patient.
Today, mitral valve repair and / or replacement requires open-heart surgery with its inherent risks, expense, and extended recovery time. Open-heart surgery also requires cardiopulmonary bypass (CPB) with risk of thrombosis, stroke, and infarction. A percutaneous approach that avoids open heart surgery for patients too sick to tolerate the risks associated surgery is an unmet clinical need.
Today, mitral valve repair and / or replacement requires open-heart surgery with its inherent risks, expense, and extended recovery time. Open-heart surgery also requires cardiopulmonary bypass (CPB) with risk of thrombosis, stroke, and infarction. A percutaneous approach that avoids open heart surgery for patients too sick to tolerate the risks associated surgery is an unmet clinical need.
OUR MISSION
At Serca Biomedical we are passionate about developing the technology to deliver a percutaneous catheter-based annuloplasty system for use in high-risk patients to restore healthy mitral valve function.
Meet the Founder
Steve has over 25 years experience in medical device development at companies such as Baxter Healthcare, St. Jude Medical, Medtronic, and Mayo Clinic where he has led development teams from concept to commercialization. Steve has a graduate degree in Biomedical Engineering and 20 patents, seven issued in the field of percutaneous Mitral and Tricuspid repair.
Stephen Kuehn
Founder and CEO
Scott Maro
Maro & Associates, Inc.
Lead Designer