S4 Medical Corp. has raised $5 million to take its medical device through regulatory approvals and into production, likely by mid-2024.
The investment, which was led by an undisclosed "multinational strategic corporation," is part of S4 Medical's Series B funding round and includes an option to acquire the company if milestones are met, CEO Bill Fuller told the Cleveland Business Journal.
The financing will support the U.S. and European regulatory approval of S4 Medical's Esolution device, as well as manufacturing scale-up for a potential commercial launch of the device in 2024, the company said Wednesday.
The Chagrin Falls, Ohio-based startup has developed an "elegant approach" to protecting the esophagus from thermal damage during cardiac ablation procedures, said Fuller, who has cofounded or led other medtech startups in the Cleveland area, including Centerline Biomedical Inc.
Cardiac ablation is a procedure that scars heart tissue to block irregular electrical signals, such as those that cause atrial fibrillation, an arrhythmia that can lead to an increased risk of stroke or heart attack.
Injury to the esophagus during ablation procedures "can lead to a rare but fatal complication," said Dr. Emile Daoud, S4 Medical's chief medical officer, in a statement.
Daoud, who also is section chief of electrophysiology at Ohio State University Wexner Medical Center in Columbus, Ohio, is a prolific inventor and has been working on a fix for esophageal injury during ablation for a couple of decades, Fuller said.
Ablation injury to the esophagus is such a serious issue that companies have spent billions trying to solve this problem with newer, complicated and expensive ablation methods," Fuller said.
S4 Medical's Esolution is a "simple device" that uses suction and deflection to move the esophagus aside during ablation procedures, Fuller said.
The global atrial fibrillation device market is projected to reach $3.6 billion by 2030 and is estimated to be growing at an annual rate of more than 13%, according to a report by Market Research Future.
"This new funding and strategic relationship is a major step toward realizing our goal of improving ablation patient outcomes on a worldwide scale," Bill Baumel, managing director of the Ohio Innovation Fund and an S4 Medical director, said in a statement.
Ohio Innovation Fund invested "north of $1 million" in S4 Medical's first institutional round of fundraising in 2020, Baumel told Columbus Business First, a sister publication of the Cleveland Business Journal.
The medical device developer has raised more than $12 million, including its recent funding, since 2018, Fuller said.
Reporter Carrie Ghose of Columbus Business First contributed to this report.
