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FILTERLEX

Full-Body Embolic
Protection Device for TAVI

New York, NY Accepting International Investment

Pitch DeckThe MarketThe CompetitionThe Team

AT A GLANCE

IP: PCT submitted in Sep. 2016, received exceptionally positive search report and written opinion

Status: Pre-clinical

Filterlex Medical Ltd. was founded in June 2015 to develop a novel, full-body embolic protection device to reduce the risk of stroke and related embolic complications during left-heart interventional procedures.

UNIQUE FEATURES

  • Provides full-body embolic protection
  • No additional arterial access required
  • Performs deflection, capture and removal of embolic particles
  • Easy and intuitive deployment and retrieval
  • Protects aorta surface
  • Stable and safe device anchoring
  • No interference to procedure devices
  • Applicable for a variety of procedures

THE MARKET

The worldwide TAVI market is estimated to surpass $5.5B by 2020. Additional major markets include TMVR (estimated at five times of the TAVI market) and AF Ablation (1.2M procedures annually). The total addressable market for Filterlex is valued at over $5B.

THE NEED

During catheter-based, left-heart procedures such as TAVI, embolic particles are often released to the blood flow. Particles migration to the brain may cause a spectrum of neurological defciencies, from cognitive impairment to debilitating stroke. Emboli released to distal organs may result in acute kidney injury and ischemia.

THE PRODUCT

The Filterlex device is a next-generation full-body embolic protection device, easily and intuitively deployed and retrieved. The device is securely positioned in the aorta, protects its surface while facilitating a seamless TAVI procedure. Its distinctive, triple action design provides a full-body embolic protection by deflecting, capturing and removing embolic particles. Uniquely, it requires no additional arterial access and does not interfere to the procedure workflow.

THE COMPETITION

Claret Medical

Sentinel, overall funding estimate – $41M. FDA clearance 510k De-novo in June 2017, CE since Jan. 2014.

Keystone Heart

TriGuard, overall funding estimate – $25M. FDA, 510K, undergoing IDE trial, CE since Sept. 2013.

ICS

Emblok, early clinical-stage.

Protembis

ProtEmbo, early clinical-stage.

The Team

Ms. Sigal Eli - CEO

Entrepreneur, inventor and interventional cardiology imaging expert with extensive experience in TAVI procedures, a former clinical and training specialist at a medical imaging company.

Mr. Eyal Teichman - CTO

Entrepreneur, mechanical engineer and CTO with over 25 years of R&D experience with extensive experience in implantable devices in the cardiovascular feld.

Giora Weisz, M.D. - Chairman of Advisory Board

Director of Interventional Cardiology at Montefore Medical Center, and faculty of the Cardiovascular Research Foundation in New York, NY.

Mr. Ron Davidson – Active Board Member

Seasoned executive with 20 years’ experience in managing and accelerating companies in the healthcare feld, led two companies to successful exits

Dr. Shimon Eckhouse – Chairman

Founder and investor of numerous medical technology frms. One of Israel’s leading medical entrepreneur and the owner and Active Chairman of Alon MedTech Ventures incubator