January 30, 2020
Financing Completed to Support Regulatory and Commercialization Progress of Emboline’s Embolic Protection Catheter
January 30, 2020—Emboline, Inc., developer of embolic protection technology for transcatheter aortic valve replacement (TAVR), announced the closing of a $5 million bridge round of financing from a number of existing and new investors. This financing is ahead of an expected Series C financing later this year.
According to Emboline, the new funds will support completion of CE Mark filing for the company’s Emboliner embolic protection catheter in preparation for the European commercial launch of the device and preparatory activities for a United States pivotal trial. This round of financing will provide working capital to make significant regulatory and clinical progress as the company finalizes its forthcoming Series C round.
The Emboliner device is intended to more reliably protect the cerebral system while also capturing noncerebral debris. The device is limited in the United States to investigational use.
The company advised that results from the SafePass 2 clinical study showed that Emboliner collects five times the amount of debris as seen in previous trials of commercial devices.
On January 15, the company announced completion of enrollment in the SafePass 2 clinical study of the Emboliner device for use with TAVR and advised that final data analysis is now underway for the full SafePass 2 study population. The data will be used to file for European CE Mark approval for the Emboliner in 2020. Additionally, the company will be seeking FDA approval to begin the pivotal United States clinical study.
Emboline advised that the 30-day results from the first 24 patients treated using the Emboliner device were presented at TCT 2019, the 31st annual Transcatheter Cardiovascular Therapeutics scientific symposium, held September 25–29 in San Francisco, California. The data showed no device-related adverse events, no device-related access site complications, 100% technical performance (successful access of the aortic arch with the delivery catheter, positioning across the aortic arch, retrieval and removal of the device), and debris capture and removal in 100% of patients. The study also examined the amount of debris collected from patients. An average of 250 particles of debris ≥ 150 µm in size were removed from each patient, with more than half of patients having debris ≥ 1 mm in size and one in four patients having debris ≥ 2 mm in size.
The Emboliner device is designed to provide total embolic protection of the brain and body during TAVR. The cylindrical nitinol mesh device covers the entire arterial bed (all three cerebral branches and noncerebral vessels) and contains an expandable access port through which TAVR devices are passed, enabling the device to capture and contain debris during the entire TAVR procedure. It requires no additional procedural access and minimal added procedural time, advised the company.