Shape Memory Medical
Changing the Paradigm of Medical Therapies with SMART materials

In 2004, Dr. Duncan Maitland led an initial study funded by a 5-year NIH grant to investigate polymers for treating aneurysms with a focus on shape memory polymers. These smart polymers showed promise in early prototypes, as foam-coated metal coils with extremely low density which enabled them to undergo substantial changes in volume (up to 100x) and be easily delivered via a microcatheter. In January of 2008, Dr. Maitland continued developing smart polymers for this application at Texas A&M University (TAMU). A year later in 2009, Dr. Maitland founded Shape Memorial Medical Inc. as a medical device company that commercializes smart polymer-based innovations.

Shape Memory Medical is the first company to use this smart polymer for embolization.

In 2015, Ted Ruppel, joined the company as President & CEO, with decades of experience in the endovascular industry, tasked with bringing these unique embolization products to commercialization.

“This novel, biodegradable shape memory polymer showed unprecedented healing and faster conversion to stable collagen than standard coils in animal studies, leading to occlusion without chronic inflammation,” says Ted Ruppel.
Since the launch of the IMPEDE Embolization Plug family in the US, Europe, and Japan and the TrelliX Embolic Coil in Europe, these innovative devices have been used by vascular surgeons and interventional radiologists in over 25 countries.

Continued development of the applications of smart polymer is underway in the Company’s prospective firstin- human safety study, AAA-SHAPE -(Abdominal Aortic Aneurysm Sac Healing And Prevention of Endoleaks).
This multicenter study has completed enrollment of 35 patients from the Netherlands and New Zealand. “With the AAA-SHAPE Safety Study, we aim to show smart polymer’s unique progressive healing properties will create new opportunities to solve the most vexing aortic problems. Post-EVAR aneurysm failure to regress remains a significant unmet clinical need associated with higher long-term all-cause mortality. Early clinical data from AAASHAPE suggests our device agnostic solution has reduced abdominal aortic aneurysm sac diameter and volume at both 6 month and 1 year time points, as compared to standard EVAR” explained Ruppel.

Shape Memory Medical’s smart polymers are already a disrupting technology within the greater medical market and promise to have continued impact on embolization procedures for patients. The future of Shape Memory Medical is bright, not only with continued focus on embolization, but also new therapeutic opportunities on the horizon, such as structural heart, oncology, and drug delivery.

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://clinicaltrialsgov
/ct2/homeNCT04227054 and NCT04751578