Two-year data from a European trial showed BioVentrix’s Revivent TC system significantly reduces left-ventricular volume and improves left-ventricular function in patients with heart failure following a myocardial infarction. The company expects to complete a US pivotal trial of the device in 2021 and launch the device in the US with funding from a planned initial public offering.

BioVentrix Inc. is developing a unique, minimally invasive approach to reshaping the heart’s scarred and enlarged left ventricle aimed at patients who develop ischemic heart failure following a heart attack. The company has made considerable headway with its technology, which offers an interesting balance between a catheter-based and surgical-based procedure; however, CEO Kenneth Miller, well aware of the pitfalls that have plagued earlier companies in this field, is taking a cautious approach to the US market.

As wearable medical devices become increasingly common for more and more complex applications, developers are facing questions are about the industry’s direction and how they will protect consumers.