Shape Memory Medical | Top Medtech Startup 2023

MedTech Outlook Magazine

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

Ted Ruppel, Shape Memory Medical | Medical Tech Outlook | Top Medtech StartupsTed 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.

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.

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

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 IMPEDEFX 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/homeNCT04227054andNCT04751578

Top 10 Medtech Startups - 2023

Company
Shape Memory Medical

Management
Ted Ruppel, President and CEO

Description
Shape Memory Medical, is a leading medical device company. They specialize in the development of innovative and advanced materials with shape memory properties, offering solutions for various medical applications such as embolization, vascular occlusion, and other minimally invasive procedures.

Shape Memory Medical News

Shape Memory Medical Completes $38 Million in Financing to Advance Endovascular Embolization

SANTA CLARA, Calif: 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..
“With this financing, we are well positioned to accelerate the clinical and market development of shape memory polymer technology for aortic and peripheral vascular markets,” said Ted Ruppel, president and CEO of Shape Memory Medical. “The funds will support the execution of the AAA-SHAPE Pivotal Trial, a randomized controlled study comparing EVAR plus sac management with IMPEDE-FX RapidFill to stand-alone EVAR. The funding will also support the research and development of our product pipeline, and the expansion of sales and marketing strategies to address the increasing demand for our commercially-available IMPEDE Embolization Plug family of devices,” continued Ruppel.
The Company’s proprietary shape memory polymer is a low-density, porous embolic material that is crimped for catheter delivery and self-expands upon contact with blood for rapid conversion to organized thrombus. The technology offers unique properties including vascular space-filling, radiolucency, low radial force, and stimulation of the immune response and healing system. The company recently 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 the safety and effectiveness of the IMPEDE-FX RapidFill® Device in improving abdominal aortic aneurysm (AAA) sac behavior, when used with elective endovascular aneurysm repair (EVAR).
Thom Rasche, Partner at Earlybird Venture Capital and the newest addition to the Shape Memory Medical Board commented, “Shape Memory Medical’s approach to embolization is highly differentiated. At Earlybird Health, we support companies with breakthrough technologies and robust, positive patient outcomes. With 35 million people worldwide affected by AAA, leading to 150,000-200,000 annual deaths due to rupture, Shape Memory Medical’s innovative concepts for managing aortic aneurysms have the potential to be transformative in treating this condition.”