Shape Memory Medical Receives CE Mark for the TrelliX® Embolic Coil System

Shape Memory Medical Inc. announced today it has received CE mark for its TrelliX® Embolic Coil System. The TrelliX Embolic Coil System is intended to obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. CE-marked indications include: Intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, arterial and venous embolizations in the peripheral vasculature. The TrelliX Embolic Coil System features proprietary shape memory polymer (SMP) technology.

As of today, the TrelliX Embolic Coils have been used in more than 30 neurovascular interventions, including aneurysms (seven were large or giant), fistulas, and dissections. Dr. Gyula Gal, from Odense University Hospital in Denmark, remarked "In my experience, the SMP offers significantly higher thrombogenicity than bare-metal platinum coils, which often leads to rapid thrombosis of the lesions. In the majority of the cases, thrombosis continued after the treatment was finished, leading to better results at angiographic follow-up than at the end of the procedure. This is rare, especially for the large and giant aneurysms." Dr. Gal, who performed a majority of the clinical cases, will be presenting a selection of his cases at the World Federation of Interventional and Therapeutic Neuroradiology Conference in Naples, Italy this week.

Dr. Aquilla Turk, from Prisma Healthcare Upstate Network in South Carolina, reviewed the data on the initial cases and commented "The clinical outcomes are similar to those observed with bare platinum coils, but the angiographic outcomes are superior, with a durable occlusion at 6 months."

Commenting on this regulatory approval and ongoing clinical usage, Shape Memory Medical's President and CEO, Ted Ruppel, said, "We believe the TrelliX Embolic Coil is a game-changing product, particularly for medium to giant aneurysms, that may offer significant advantages in neurovascular and peripheral vasculature applications. The lack of SMP imaging artifact allows physicians to more easily visualize occlusion during the procedure, which makes it unlike any other embolic coils on the market today. Preclinical results also show rapid conversion to organized thrombus throughout the SMP porous embolic scaffold, followed by collagen deposition, and without chronic active inflammation."

Bart Balkman, Shape Memory's Chief Commercial Officer added "We are excited to offer TrelliX to the European market. The TrelliX coils featuring our SMP, are a significant advance in technology for more difficult aneurysms and will benefit many patients and physicians."

The TrelliX Embolic Coil System contains proprietary Shape Memory Polymer technology. SMP technology was initially researched and developed at Lawrence Livermore National Laboratory and Texas A&M University. Shape Memory Medical was founded to develop and commercialize solutions for a variety of clinical applications using this novel technology. The SMP technology is a porous polymeric material capable of changing from a smaller, catheter-deliverable shape to a "memorized" larger, conformable shape in response to the body when implanted. The company continues to develop innovative materials and therapies, including neurovascular applications as well as the peripheral vascular applications. Shape Memory Medical has licenses to 30 issued patents for its SMP technology, as well as 40 patent applications in process alongside multiple FDA cleared and CE marked products currently available for use.

About Shape Memory Medical

Shape Memory Medical Inc., based in Santa Clara, California, is committed to developing multiple medical therapies with their novel shape memory polymers. Products include IMPEDE® and IMPEDE® FX devices for peripheral embolization applications, and the TrelliX® Embolic Coil for neurovascular applications. The company's TrelliX® Embolic Coils have not been cleared or approved by FDA, and are not commercially available in the United States. For more information, visit www.shapemem.com.