Articles from Shape Memory Medical Inc.

Shape Memory Medical Inc., developer of custom shape memory polymers for endovascular applications, today announced enrollment of the first patients in FLAGSHIP, the Company’s prospective, single‑arm, open‑label first‑in‑human study evaluating its investigational False Lumen Embolization (FLE) System for the treatment of aortic dissection.

Shape Memory Medical Inc., innovator of the proprietary shape memory polymer technology for endovascular applications, announced that its IMPEDE® Embolization Plug product family has received certification as a Class III device under the European Union (EU) Medical Device Regulation (MDR) 2017/745. The IMPEDE Embolization Plug family, previously CE-marked under the Medical Device Directive 93/42/EEC (MDD), has now earned the more stringent EU MDR certification—achieved well in advance of the 2027 compliance deadline for Class IIb implantable and Class III devices.

Shape Memory Medical Inc., developer of the only commercially available volume-expanding shape memory polymer for endovascular embolization applications, announced it has reached 50 percent enrollment in its ongoing AAA-SHAPE Pivotal Trial, the Company’s prospective, multicenter, randomized, open-label trial to determine safety and effectiveness of the IMPEDE-FX RapidFill® Device to improve abdominal aortic aneurysm (AAA) sac behavior when used in conjunction with elective endovascular aneurysm repair (EVAR).

Shape Memory Medical Inc., the innovator of the only commercially available volume-expanding shape memory polymer for endovascular embolization applications, announced today that it has received approvals from both Singapore’s Health Science Authority (HSA) and Malaysia’s Medical Device Authority (MDA) to market the IMPEDE Embolization Plug, the IMPEDE-FX Embolization Plug, and the IMPEDE-FX RapidFill System. Getz Healthcare Pty Ltd, which is a member of the privately held Getz Group of Companies, has been instrumental in driving the approval process and serves as Shape Memory Medical’s distribution partner for its peripheral embolization portfolio.

Shape Memory Medical Inc., the innovator of shape memory polymer for endovascular applications, announced the completion of patient enrollment in the EMBO Post Market Surveillance (EMBO-PMS) Registry, the Company’s prospective, multicenter registry of the IMPEDE and IMPEDE-FX Embolization Plugs, and IMPEDE-FX RapidFill Device when used for peripheral vascular embolization.

Shape Memory Medical Inc., innovator of shape memory polymer for endovascular applications, today announced that its proprietary platform has been used to treat its 3,000th patient—a significant milestone in the company’s commercialization and clinical strategy. The patient was enrolled in the company’s AAA-SHAPE Global Randomized Controlled Pivotal Trial, which has now surpassed 25% enrollment. This achievement reflects strong clinical adoption and represents meaningful progress toward regulatory and market expansion objectives across the company’s product portfolio.

Shape Memory Medical Inc., developer of custom shape memory polymers for endovascular markets, announced that Edward “Ted” Ruppel, President and CEO, is scheduled to speak on Wednesday, March 19th, 2025 during the LSI USA Emerging Medtech Summit, an event that brings industry-leading executives and financiers together to further healthcare innovation.

Shape Memory Medical Inc., developer of custom shape memory polymers for endovascular markets, announced the first enrollment in Europe in the AAA-SHAPE Pivotal Trial, the Company’s prospective, multicenter, randomized, open-label trial to determine safety and effectiveness of the IMPEDE-FX RapidFill® Device to improve abdominal aortic aneurysm (AAA) sac behavior when used with elective endovascular aneurysm repair (EVAR). The patient was treated by Dr. Jan Heyligers, MD, PhD, consultant vascular surgeon, and Professor Dr. Patrick Vriens, MD, PhD, vascular surgeon, at Elisabeth TweeSteden Hospital in Tilburg, the Netherlands.

Shape Memory Medical Inc., developer of custom shape memory polymers for endovascular markets, announced the first patient treated as part of the AAA-SHAPE Pivotal Trial, the Company’s prospective, multicenter, randomized, open-label trial to determine safety and effectiveness of the IMPEDE-FX RapidFill® Device to improve abdominal aortic aneurysm (AAA) sac behavior when used with elective endovascular aneurysm repair (EVAR).

Shape Memory Medical Inc., developer of custom shape memory polymers for endovascular markets, announced today that it has completed $38 million in Series C financing led by Earlybird Venture Capital and with the participation of new and existing investors, including HBM Healthcare Investments (Cayman) Ltd., WexMed II LLC, HBM-Medfocus LLC, and Emergent Medical Partners II, L.P..

Shape Memory Medical Inc. announced today that it has entered into a sublicense agreement with a strategic global medical device company. Under the agreement, Shape Memory Medical will sublicense its proprietary shape memory polymer technology for a narrow high-growth indication outside of Shape Memory Medical’s endovascular and neurovascular focus, in return for an upfront license payment, and future milestones and royalties. While pursuing this and other potential sublicense opportunities, Shape Memory Medical remains committed to the clinical and commercial development of its proprietary technology within its core business – aortic, peripheral vascular, and neurovascular embolization.

Shape Memory Medical Inc., developer of custom shape memory polymers for endovascular markets, announced that one-year data from the AAA-SHAPE Safety Trial will be presented during the 50th Annual VEITH Symposium in New York City on Tuesday, November 14, 2023.

Shape Memory Medical Inc., developer of custom shape memory polymers for endovascular markets, announced that the Food and Drug Administration (FDA) granted investigational device exemption (IDE) for the company to begin a prospective, multicenter, randomized, open-label trial to determine safety and effectiveness of the IMPEDE-FX RapidFill® Device to improve abdominal aortic aneurysm (AAA) sac behavior when used with elective endovascular aneurysm repair (EVAR).

Shape Memory Medical Inc. announced today that it has entered into a sublicense agreement with a global MedTech market leader. Under the agreement, Shape Memory Medical will sublicense its proprietary shape memory polymer technology for a narrow indication in a therapeutic area outside of Shape Memory Medical’s cardiovascular, endovascular and neurovascular focus, in return for an upfront license payment, and future milestones and royalties. While pursuing this and other potential sublicense opportunities, Shape Memory Medical remains committed to the clinical and commercial development of its proprietary technology within its core business – aortic, peripheral vascular, and neurovascular embolization.

Shape Memory Medical Inc., developer of shape memory polymer for peripheral and neurovascular markets, announced the publication of results from the Company’s prospective, open-label, single-arm, safety study of the IMPEDE Embolization Plug in peripheral vascular embolization. The study was published this month in the peer-reviewed journal, Vascular, ahead of print.

Shape Memory Medical Inc., developer of custom, proprietary shape memory polymers for the peripheral vascular and neurovascular markets, announced preliminary six-month results from the AAA-SHAPE Safety Trial. Data will be presented during the 49th Annual VEITH Symposium in New York City on Tuesday, November 15, 2022.

Shape Memory Medical Inc., developer of custom, proprietary shape memory polymers for the peripheral and neurovascular markets, announced the completion of patient enrollment in AAA-SHAPE, the Company’s prospective, multicenter early feasibility safety study of the IMPEDE-FX RapidFill® Device when used for abdominal aortic aneurysm (AAA) sac management during elective endovascular aneurysm repair (EVAR).

Shape Memory Medical Inc., developer of shape memory polymer devices for peripheral and neurovascular markets, announced today that its 1,500th 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.

Shape Memory Medical Inc., developer of innovative therapies for cardiovascular and neurovascular markets, announced the initiation of AAA-SHAPE Netherlands, the Company’s prospective, multicenter early feasibility study of the IMPEDE-FX RapidFill® Device when used for abdominal aortic aneurysm (AAA) sac management during elective endovascular aneurysm repair (EVAR). The Dutch study’s first procedure was performed by Professor Michel Reijnen, MD, PhD, vascular surgeon at Rijnstate Hospital in Arnhem, the Netherlands.

Shape Memory Medical Inc., developer of innovative products for cardiovascular and neurovascular therapies, is pleased to announce and welcome Anthony Lipp as Chief Commercial Officer. Anthony will be responsible for driving the development and implementation of global sales strategies of the company’s shape memory polymer embolization products and therapies.