Shape Memory Medical Celebrates Treatment of 1,500th Patient

SANTA CLARA, Calif.--(BUSINESS WIRE)--Shape Memory Medical Inc., developer of shape memory polymer devices for peripheral and neurovascular markets, announced today that its 1,500^th patient has been treated, marking a significant milestone for the Company’s portfolio of shape memory polymer embolotherapy devices – The IMPEDE® Embolization Plug Family and the TrelliX® Embolic Coil. The patient was treated by Thomas Maldonado, MD, Professor of Surgery, NYU Grossman School of Medicine and Director, of the Aortic Center at NYU Langone Health.

“We were excited to perform our first case using shape memory polymer technology, and in this particular case for the occlusion of the internal iliac artery for prevention of post-EVAR Type II endoleak,” said Dr. Maldonado.

Shape memory polymer is a new concept in medical devices, built on 25 years of polymer research and expertise initiated at Lawrence Livermore National Laboratory (LLNL) and further developed at Texas A&M University. Shape memory polymer features a porous, compliant polyurethane embolic material that enables conversion to organized thrombus followed by gradual healthy tissue formation. In 2009, Shape Memory Medical was formed to develop and commercialize devices for use in the peripheral and neurovascular embolization markets. An emerging alternative to traditional, bare metal embolization devices, shape memory polymer is soft and conformable, and the material is radiolucent which improves visibility of the surrounding anatomy during and after the procedure.

“This milestone is especially significant for Shape Memory Medical,” said Ted Ruppel, Chief Executive Officer. “This accomplishment is only the beginning of our plans for this emerging technology, with a product pipeline focused on the development of shape memory polymer solutions for aortic aneurysms and aortic dissection.” The Company is also pursuing research and development and corporate licensing partnerships for potential applications across multiple therapeutic areas such as aortic therapies, structural heart, biopsy, and drug delivery.

Since the launch of the IMPEDE Embolization Plug family in the US, Europe, and Japan and the TrelliX Embolic Coil in Europe, these novel devices have been used by vascular surgeons and interventional radiologists in over 25 countries. The growing body of evidence presented from the podium and in the literature has raised physician awareness and interest in the IMPEDE and TrelliX devices, including data from the TrelliX APEX Study and the IMPEDE EMBO Post Market Surveillance Study. The IMPEDE-FX RapidFill device is also currently being evaluated in a first in human safety and efficacy trial for a potential new indication for abdominal aortic aneurysm (AAA) sac management during elective endovascular aneurysm repair (EVAR). "Early AAA-SHAPE results are encouraging,” said Professor Michel Reijnen, MD, PhD, vascular surgeon at Rijnstate Hospital in Arnhem, the Netherlands and Principal Investigator, AAA-SHAPE Netherlands. “Shape memory polymer technology has the potential to improve post-EVAR sac regression, reduce secondary interventions, and reduce the burden for our patients as well as for healthcare systems.” The AAA-SHAPE trial is ongoing, with one-year results expected to be announced in 2023.

About Shape Memory Medical

Shape Memory Medical Inc. is dedicated to developing innovative therapeutic solutions with its proprietary shape memory polymers. Neurovascular embolization products include the TrelliX® Embolic Coil, which is CE marked for use in the EU. Peripheral embolization products include the IMPEDE® and IMPEDE-FX Embolization Plugs and IMPEDE-FX RapidFill® Device. In countries recognizing CE marking, the IMPEDE and IMPEDE-FX Embolization Plugs and the IMPEDE-FX RapidFill are indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature. In the United States, the IMPEDE Embolization Plug is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature, and the IMPEDE-FX Embolization Plug is indicated for use with the IMPEDE Embolization Plug to obstruct or reduce the rate of blood flow in the peripheral vasculature. The IMPEDE and IMPEDE-FX Embolization Plugs are PMDA approved in Japan. The TrelliX Embolic Coil and IMPEDE-FX RapidFill Device are not available in the United States or Japan.

For more information, visit www.shapemem.com.

For more information about the AAA-SHAPE Studies, please visit https://clinicaltrials.gov/ct2/home NCT04227054 and NCT04751578