SANTA CRUZ, Calif.--(BUSINESS WIRE)--Emboline™, Inc., developer of embolic protection technology for brain and body during transcatheter aortic valve replacement (TAVR), today 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.
The new funds will support completion of CE Mark filing for the company’s Emboliner™ Embolic Protection Catheter, preparation for the European commercial launch of the device, and preparatory activities for a U.S. pivotal trial.
“We are enthusiastic about the results from our SafePass 2 clinical study showing that Emboliner collects five times the debris of commercial devices, and are moving forward energetically to make it available for clinicians and patients as soon as possible,” said Emboline CEO Scott Russell. “This round of financing will provide working capital for us to make significant regulatory and clinical progress as we finalize our forthcoming Series C round.”
“2019 was a pivotal year for Emboline as we completed our SafePass 2 study with outstanding results,” said Emboline founder and chairman Amir Belson, MD. “It’s exciting to see that our concept of providing protection for both the brain and body is proving itself and demonstrating the potential to make the TAVR procedure even safer for patients. Our results in the clinic have validated the faith of our existing investors and triggered interest from a number of new investors who all strongly support the device and are eager to see it get it in the hands of the people who need it most.”
Debris generation during TAVR has been associated with a range of negative neurological outcomes for patients, ranging from a major stroke rate of approximately six percent,1 overall stroke rates as high as 22 percent,2 and new cerebral lesions in as many as 94 percent of patients.3
The novel 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 non-cerebral 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.
A video demonstrating use of the Emboliner is available to view here.
About Emboline, Inc.
Emboline, Inc., is a privately-held, emerging medical device company that has developed the Emboliner™ Embolic Protection Catheter, expected to be the first total embolic protection technology commercialized for TAVR and other interventional procedures with embolic risk. The novel Emboliner device is intended to more reliably protect the cerebral system, while also capturing non-cerebral debris. Emboline’s technologies are derived from intellectual property invented by Amir Belson, MD, founder of Neoguide Systems, Vascular Pathways, Zipline Medical, Qool Therapeutics, and other medical device companies.
CAUTION: Investigational Device. Limited by United States law to investigational use. Emboline, Emboliner and SafePass are trademarks of Emboline, Inc.
1. Pelligrini C, Rheude T, Trenkwalder T et al. One year VARC-2-defined clinical outcomes after transcatheter aortic valve implantation with the SAPIEN 3. Clin Res Cardiol 2019: 108(11);1258-1265.
2. van Mieghem N, et al. Filter-based cerebral embolic protection with transcatheter aortic valve implantation: the randomised MISTRAL-C trial. EuroIntervention 2016: 12;498-507.
3. Kapadia SR, Kodali S, Makkar R et al. Protection against cerebral embolism during transcatheter aortic valve replacement. J Am Coll Cardiol 2017: 69(4);367-377.