Shape Memory Medical has announced that it has completed $38 million in Series C financing, which has been led by Earlybird Venture Capital, along with participation from both new and existing investors.
Shape Memory stated in a press release that its proprietary shape memory polymer is a low-density, porous embolic material that is crimped for catheter delivery. According to this press release, it is also self-expanding upon contact with blood for rapid conversion to organised thrombus. It is the company’s hope that this new technology will offer 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 US Food and Drug Administration (FDA) granted the company an investigational device exemption (IDE), which will allow it to begin a prospective, multicentre, randomised, open-label trial to determine the safety and effectiveness of the Impede-FX RapidFill device in improving abdominal aortic aneurysm (AAA) sac behaviour, when used with elective endovascular aneurysm repair (EVAR).
Ted Ruppel, chief executive officer and president of Shape Memory Medical said that “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”. Ruppel continued, adding that “the funds will support the execution of the AAA-SHAPE pivotal trial, a randomised 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 embolisation plug family of devices”.
Thom Rasche, partner at Earlybird Venture Capital and Shape Memory Medical board member added to Ruppel’s statement, commenting that “Shape Memory Medical’s approach to embolisation 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.”
