Shape Memory Medical | Top Medtech Startup 2022

MedTech Outlook Magazine

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

Ted Ruppel, President and CEO, Shape Memory MedicalTed Ruppel, President and CEO
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.

Early clinical data from AAA-SHAPE 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


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

Top 10 Medtech Startups - 2022

Company
Shape Memory Medical

Management
Ted Ruppel, President and CEO

Description
Shape Memory Medical stands alone in our development and vision for smart polymer advancement. Shape Memory Medical is reshaping clinical success through the science of smart polymer. We will continue to drive a cross-specialty portfolio to meet the demands of procedures today and tomorrow. We are the first medical device company to introduce an FDA-cleared medical device utilizing shape memory polymer (SMP) technology to a vascular market.

Shape Memory Medical News

Shape Memory Medical Announces First Patient Treated in the EMBO-Post Market Surveillance Registry in Germany

SANTA CLARA - Shape Memory Medical Inc., 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.
The patient was treated by Professor Dr. Götz Martin Richter, Chairman of the Clinics for Diagnostic and Interventional Radiology at the Center for Minimally Invasive Medicine, Klinikum Stuttgart, Germany, in cooperation with the Clinic for Vascular Surgery, Endovascular Medicine and Transplant Surgery in the Klinikum Stuttgart. Ted Ruppel, President and Chief Executive Officer of Shape Memory Medical Inc. said, “We would like to congratulate Professor Richter and the clinical study team at Klinikum Stuttgart for the first EMBO-PMS case in Germany. The addition of German sites accelerates our ability to evaluate the IMPEDE and IMPEDE-FX Embolization Plugs in a variety of uses within the peripheral vasculature.”
The EMBO-Post Market Surveillance Registry (EMBO-PMS) initiated at two centers in the United Kingdom and has now expanded to include up to ten centers in Germany, with a goal of treating up to 125 patients. Results thus far in the United Kingdom reflect treatment for conditions including Iliac artery aneurysm, type II endoleak after TEVAR, type Ib endoleak after EVAR, gluteal artery aneurysm, and splenomegaly. “We are pleased to participate in this important study and look forward to the follow-up from our treated patients,” said Professor Richter, Principal Investigator for EMBO-Post Market Surveillance German Registry.
Both the IMPEDE and IMPEDE-FX Embolization Plugs incorporate Shape Memory Medical’s novel shape memory polymer, a porous, radiolucent, embolic scaffold that is crimped for catheter delivery and self-expands upon contact with blood, that enables conversion to organized thrombus followed by gradual healthy tissue formation. Pre-clinical and clinical studies have shown that shape memory polymer offers effective and predictable space filling, stable clot formation for embolization, and progressive healing as the material is absorbed.
“We look forward to collaborating with colleagues from Germany to add to the experience within EMBO-PMS,” said Professor Robert Morgan, Consultant Vascular and Interventional Radiologist, St. George’s NHS Trust, London, UK and Principal Investigator, EMBO-Post Market Surveillance UK Registry. “We’re continuing to obtain data to support the safety and effectiveness of the IMPEDE devices across a variety of peripheral vascular anatomies with technical success and target vessel thrombosis achieved in all cases,” continued Morgan. Preliminary experience in EMBO-PMS is published in CVIR Endovascular 2021 Mar 9;4(1):29.