Shape Memory Medical Raises $10 Million to Advance Aortic Clinical Programs
Shape Memory Medical Inc., a developer of shape memory polymer technology for endovascular embolization, has closed a $10 million convertible note financing led by new investor August Global Partners (AGP), with Taiwania Capital also participating as a new investor.
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The new funding will support the continued clinical development of Shape Memory Medical’s aortic portfolio, including patient follow-ups and data collection for the AAA-SHAPE Pivotal Trial, as well as the advancement of its FLAGSHIP feasibility trial. The company is backed by healthcare investors including HBM Healthcare Investments, Earlybird Venture Capital, and WexMed II.
"This financing strengthens our position as we enter a potentially transformative period for the company," said Ted Ruppel, President and Chief Executive Officer of Shape Memory Medical. "With enrollment recently completed in our AAA-SHAPE Pivotal Trial and continued progress in FLAGSHIP, we are focused on generating the clinical evidence needed to support the broader adoption of our shape memory polymer technology in aortic applications. We are pleased to welcome August Global Partners and Taiwania Capital as investors and appreciate the continued support of our existing shareholders as we advance these important clinical programs." The financing was supported by HEAL Venture Lab.
The AAA-SHAPE Pivotal Trial is testing the safety and effectiveness of the IMPEDE-FX RapidFill® Device when used with endovascular aneurysm repair (EVAR) to help manage abdominal aortic aneurysm (AAA) sacs. The randomized, multicenter trial has completed enrollment and will follow patients for five years.
FLAGSHIP (False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer) is a first-in-human study evaluating Shape Memory Medical’s investigational False Lumen Embolization (FLE) System for treating the false lumen caused by aortic dissection. The study will assess the device’s safety and early signs of effectiveness, with patients followed for two years.
“For decades, clinicians treating aortic aneurysms and dissections have relied on materials repurposed from other procedures, never engineered for the job. Shape Memory Medical set out to change that with a shape memory polymer platform engineered for embolization, designed to work alongside the stent graft and address a clear unmet clinical need,” said Davian Sim, Partner at August Global Partners. “With AAA-SHAPE fully enrolled and FLAGSHIP advancing, the company is at an inflection point, and the data ahead will define it. We look forward to working with Ted and the team through these milestones, and to supporting the company’s growth in Asia-Pacific as the platform expands globally.”
Shape Memory Medical’s proprietary shape memory polymer technology uses a lightweight, highly porous embolic material that is delivered through a catheter in a compressed form and expands when it comes into contact with blood. The bioresorbable material is designed to support organized blood clot formation, adapt to complex blood vessel structures, and remain transparent on imaging to make patient follow-up easier.