Shape Memory Medical Nets $38 Million in Financing

Shape Memory Medical Inc. has received a considerable infusion of capital, having raised $38 million in Series C funding.

Led by Earlybird Venture Capital, the financing round also attracted 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,” Shape Memory Medical President/CEO Ted Ruppel said. “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.” 
 
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. Shape Memory Medical has received U.S. Food and Drug Administration (FDA) granted investigational device exemption (IDE) approval 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).
 
“Shape Memory Medical’s approach to embolization is highly differentiated. At Earlybird Health, we support companies with breakthrough technologies and robust, positive patient outcomes,” Earlybird Venture Capital Partner and new Shape Memory Medical Board Member Thom Rasche stated. “With 35 million people worldwide affected by AAA, leading to 150,000-200,000 annual deaths due to rupture, Shape Memory Medical’s concepts for managing aortic aneurysms have the potential to be transformative in treating this condition.”
 
Shape Memory Medical Inc. develops therapeutic solutions with its proprietary shape memory polymers, with devices approved in more than 25 countries in Asia, the Middle East, Europe, the Americas, and Australia. 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. 
 
Founded in 1997, Earlybird Venture Capital identifies and backs early-stage companies on a pan-European basis and supports them through their growth and development phases, providing financial resources, strategic support, and access to an international network and capital markets. Earlybird invests out of independently-managed funds. Flagship funds with early-stage focus include Digital West (Western Europe), Digital East (Emerging Europe), and Health. Newer funds Earlybird-X (pre-seed in Western Europe and university spinoffs) and Growth Opportunities (a pan-Earlybird growth fund) offer even more agility. With €2 billion under management across all fund streams, nine IPOs, and 32 trade sales, Earlybird is one of Europe’s most established and active venture capital firms.