Shape Memory Medical develops proprietary shape memory polymers and devices for endovascular markets. Its low-density, porous embolic polymer is crimped for catheter delivery and self-expands on contact with blood to form organized thrombus, offering vascular space-filling, radiolucency, low radial force, and stimulation of healing. Commercial products include the TrelliX embolic coil and the IMPEDE and IMPEDE-FX Embolization Plug families; the IMPEDE and IMPEDE-FX plugs are approved in multiple jurisdictions and the IMPEDE-FX RapidFill is an investigational device. The company reports devices approved in more than 25 countries, CE marking for certain products, and PMDA approval in Japan for the IMPEDE plugs; U.S. indications for IMPEDE products are specified and IMPEDE-FX RapidFill is currently limited to investigational use. The FDA has granted an IDE to begin a prospective, multicenter, randomized trial to assess IMPEDE-FX RapidFill with EVAR. Shape Memory Medical recently completed a $38 million Series C to support the pivotal AAA-SHAPE trial, further R&D, and expansion of sales and marketing. Shape Memory Medical develops polymer embolization devices, including IMPEDE peripheral and TrelliX neurovascular products, based on proprietary shape memory polymer technologies. The polymers are licensed from Lawrence Livermore National Laboratory and Texas A&M University. The company holds access to 45 issued and pending patents covering basic polymers and specific clinical uses. Proceeds from the recent financing will be used to accelerate regulatory, clinical, and commercialization activities for its peripheral and neurovascular product programs. Its IMPEDE and TrelliX products have not been approved or cleared by the FDA and are not commercially available. The company is based in Santa Clara, California.

Total raised

$52M

Funding rounds

2

Latest round

Series C

Latest activity

Mar 2024