News & Events

Shape Memory Medical Inc. announced 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 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.

Shape Memory Medical Inc., developer of custom, proprietary shape memory polymers for the peripheral vascular and neurovascular markets, announced the first patient treated in Germany as part of the EMBO-Post Market Surveillance Registry, the Company’s prospective, multicenter, registry study of its IMPEDE and IMPEDE-FX Embolization Plugs when used for peripheral vascular embolization.

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.

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).

Shape Memory Medical Inc., developer of innovative therapies for cardiovascular and neurovascular markets, 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 its shape memory polymer embolization products and therapies.

Shape Memory Medical Inc. announced that it has received approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) to market its IMPEDE®-FX Embolization Plug in Japan.

Shape Memory Medical Inc., developer of innovative therapies for cardiovascular and neurovascular markets, announced CE Mark Approval for the IMPEDE-FX RapidFill Device, an expansion of the IMPEDE family of biodegradable peripheral vascular embolization plugs.

Shape Memory Medical Inc., developer of innovative therapies for cardiovascular and neurovascular markets, is pleased to announce and welcome Mary Dennehy as Vice President of Marketing. Mary will be responsible for driving the development and implementation of global marketing strategies and initiatives that support commercialization of its Shape Memory Polymer embolization products and therapies.

Shape Memory Medical Inc., developer of innovative therapies for cardiovascular and neurovascular markets, announced the initiation of AAA-SHAPE, the Company’s prospective safety study of the IMPEDE-FX Embolization Plug devices when used for abdominal aortic aneurysm (AAA) sac filling during elective endovascular aneurysm repair (EVAR). The study’s first procedure was performed by Andrew Holden, MBChB, an interventional radiologist and Andrew Hill, MBChB, a vascular surgeon at Auckland City Hospital in Auckland, New Zealand.

Shape Memory Medical Inc. announced today that its IMPEDE Embolization Plugs have been approved in Japan by the Pharmaceuticals and Medical Devices Agency (PMDA). Cosmotec, which is a Group Company of M3 Inc https://corporate.m3.com/en/ listed on the Tokyo Stock Exchange (TYO:2413), championed the approval process in Japan and is Shape Memory Medical’s distribution partner for all of its peripheral embolization products. The IMPEDE Embolization Plug is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature. It is available in three sizes, to treat vessels up to 10 mm in diameter. IMPEDE Embolization Plugs feature proprietary shape memory polymer (SMP) technology.

Shape Memory Medical is delighted to announce that the IMPEDE Embolization Plug, a member of its innovative line of vascular embolization products, has won one of the 2019 R&D 100 Awards (https://www.rd100conference.com/). These awards recognize the most promising new products, processes, materials, and software developed throughout the world and introduced to the market the previous year.

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. 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.

Shape Memory Medical Inc. announced today it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the IMPEDE-FX Embolization Plug. The IMPEDE-FX Embolization Plug is an adjunct to the IMPEDE Embolization Plug which previously received 510(k) clearance by the FDA and is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature. The IMPEDE-FX is available in three sizes, with the maximum device having an expanded diameter of 12 mm.

Shape Memory Medical Inc. announced today it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the IMPEDE Embolization Plug. The IMPEDE Embolization Plug is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature. It is available in three sizes, to treat vessels up to 10 mm in diameter.

Shape Memory Medical Inc. announced today the initial closing of its Series-B Preferred Stock financing. The round was led by HBM Healthcare Investments Ltd. Current investors, including affiliates of Wexford Capital LP and HBM-MedFocus Funds participated in this financing, and were joined by new investor Emergent Medical Partners.

Shape Memory Medical (formerly Shape Memory Therapeutics (SMT)) announced today the hiring of medical device industry veteran Ted Ruppel as President & CEO.