Shape Memory Medical – a developer of custom shape memory polymers for endovascular markets – announced 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, and Emergent Medical Partners II, L.P.
The company’s proprietary shape memory polymer is a low-density and porous embolic material that is crimped for catheter delivery and self-expands upon contact with blood for rapid conversion to organized thrombus. And the technology offers unique properties including vascular space-filling, radiolucency, low radial force, and stimulation of the immune response and healing system.
Shape Memory also 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 it used with elective endovascular aneurysm repair (EVAR).
KEY QUOTES:
“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.”
“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.”
- Ted Ruppel, president and CEO of Shape Memory Medical
“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.”
- Thom Rasche, Partner at Earlybird Venture Capital and the newest addition to the Shape Memory Medical Board
