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

“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.”

About Shape Memory Medical

Shape Memory Medical Inc. is dedicated to developing innovative therapeutic solutions with its proprietary shape memory polymers, with devices approved in more than 25 countries spanning regions 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. Caution: IMPEDE-FX RapidFill is an investigational device, limited by Federal (or United States) law to investigational use. For more information, visit www.shapemem.com.

About Earlybird Venture Capital

Earlybird Venture Capital focuses on European technology companies. Founded in 1997, Earlybird identifies and backs exceptional early-stage companies on a pan-European basis and supports them through their growth and development phases – providing financial resources, strategic support, plus access to an international network and capital markets. Earlybird invests out of a family 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 & university spinoffs) and Growth Opportunities (a pan-Earlybird growth fund) offer even more agility. With EUR 2 billion under management across all fund streams, 9 IPOs, and 32 trade sales, Earlybird is one of Europe’s most established and active venture capital firms.

More information on www.earlybird.com, LinkedIn and X.