Emboline Raises Funds for Further Development of the Emboliner Embolic Protection Catheter

January 5, 2021—Emboline, Inc. announced it completed raising more than $10 million in Series C funding from new and existing investors. The privately held medical technology company is focused on reducing stroke during transcatheter heart procedures.

The company’s Emboliner total embolic protection catheter is designed to capture and remove all debris from transcatheter procedures that would otherwise travel to the brain, kidneys, and other critical organs, reducing the incidence of stroke, cerebral ischemia, cognitive decline, and other adverse outcomes associated with procedure-related emboli. The Emboliner is not yet commercially available and is intended for investigational use only.

The company stated that the funds will be used to obtain initial commercial approval of the Emboliner and to launch its upcoming United States investigational device exemption clinical study, which are both anticipated in 2021.

The Emboliner is designed to capture and remove all debris generated during transcatheter heart procedures. The device is a cylindrical nitinol mesh filter with a proximal port to accommodate a transcatheter aortic valve replacement (TAVR) delivery catheter. It is delivered transfemorally and conforms circumferentially in the aortic arch to accommodate a broad range of patient anatomies. The Emboliner device provides protection for all three major cerebral aortic arch vessels as well the descending aorta.

Emboline advised that it recently completed the three-center, 31-patient SafePass 2 study of the Emboliner in New Zealand. In the study, the device met all primary endpoints for safety and technical performance when used during TAVR.

According to the company, the SafePass clinical program provided quantitative data on the overall magnitude of procedural debris generated by TAVR, suggesting that all TAVR procedures likely generate clinically relevant debris. Results were made available at TCT Connect, the 32nd annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held online October 14-18, 2020.

Sanjeevan Pasupati, MD, who is a cardiologist with Waikato Hospital in Hamilton, New Zealand, serves as Coprincipal Investigator for the study.

“In the SafePass 2 study, we found that the Emboliner works well and is easy to use,” commented Dr. Pasupati in the company’s announcement. “The device captured on average 280 particles of a clinically meaningful size (≥ 150 µ), and two-thirds of the procedures generated at least one particle ≥ 1 mm. We also found that embolic debris was generated by both balloon-expandable and self-expanding valve types used in the study. In the absence of embolic protection, the chances of a particular TAVR patient having a stroke is simply based on the probability of one of those particles going to a critical location in the brain.”