Shape Memory Medical Inc., developer of proprietary shape memory polymer technology for endovascular embolization, announced the closing of a $10 million convertible note financing led by new investor August Global Partners (AGP), joined by fellow new investor Taiwania Capital.
The financing provides capital to support continued clinical development of the company’s aortic portfolio, including patient follow-up and data collection in the AAA-SHAPE Pivotal Trial, and advancement of the FLAGSHIP feasibility trial. Shape Memory Medical is backed by a global syndicate of healthcare investors that includes HBM Healthcare Investments (Cayman) Ltd., Earlybird Venture Capital, and WexMed II, LLC.
“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 evaluating the safety and effectiveness of the IMPEDE‑FX RapidFill® Device when used alongside endovascular aneurysm repair (EVAR) to proactively manage the abdominal aortic aneurysm (AAA) sac. The randomized, multicenter study recently completed enrollment and will follow patients for five years.
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FLAGSHIP (False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer) is a first-in-human clinical study evaluating Shape Memory Medical’s investigational False Lumen Embolization (FLE) System for treatment of aortic dissection false lumen. The study is designed to evaluate safety and preliminary signs of efficacy and will follow patients 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 platform utilizes a low-density, highly porous embolic material that is delivered through a catheter in a compressed form and self-expands upon contact with blood. The bioresorbable material is designed to promote organized thrombus formation, adapt to complex vascular anatomy, and maintain radiolucency to facilitate imaging during patient follow-up.
SOURCE: Businesswire
