Shape Memory Medical Raises $10M for Aortic Trials

Shape Memory Medical has closed a $10 million convertible note financing. The round was led by new investor August Global Partners (AGP) and joined by fellow new investor Taiwania Capital.

The financing will support clinical development of San Jose, Calif.-based company’s aortic portfolio, including follow-up and data collection for the AAA-SHAPE pivotal trial and advancement of the FLAGSHIP feasibility trial. The company is backed by HBM Healthcare Investments, Earlybird Venture Capital, and WexMed II.

Shape Memory Medical develops therapies through proprietary shape memory polymer technology. The platform uses a porous, bioresorbable embolic material delivered in compressed form that self-expands upon contact with blood. It promotes organized thrombus formation, conforms to complex vascular anatomy, and remains radiolucent for follow-up imaging.

Building on its commercial embolization platform, the company hopes to expand into aortic applications through several clinical development programs.

The AAA-SHAPE trial is evaluating IMPEDE-FX RapidFill with EVAR to proactively manage the AAA sac. The randomized study has completed enrollment and will follow patients for five years. FLAGSHIP is a first-in-human study of the company’s investigational False Lumen Embolization system for aortic dissection, assessing safety and preliminary efficacy over two years.

Early this year, the company announced it had received EU MDR approval for its family of Impede embolization plugs.

Comments from Shape Memory Medical and AGP

Ted Ruppel, president and CEO, Shape Memory Medical: “This financing strengthens our position as we enter a potentially transformative period for the company. 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.

Davian Sim, partner, AGP: “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. 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.”