Shape Memory Medical has raised $10m in convertible note financing led by August Global Partners, joined by new investor Taiwania Capital, to support continued clinical development of its aortic portfolio.
The funding will enable patient follow-up and data collection in the AAA-SHAPE Pivotal Trial and support the advancement of the FLAGSHIP feasibility study.
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HEAL Venture Lab also supported the transaction.
US-based global medical device company Shape Memory Medical develops proprietary shape memory polymer technology for endovascular embolisation.
The company is backed by a global syndicate of healthcare investors, including HBM Healthcare Investments (Cayman), Earlybird Venture Capital and WexMed II.
Shape Memory Medical reports that its products have received regulatory approvals in over 40 countries and have been used in more than 3,500 patients worldwide. It is now expanding its commercial embolisation platform into aortic applications through multiple clinical programmes.
Shape Memory Medical president and CEO Ted Ruppel said: “This financing strengthens our position as we enter a potentially transformative period for the company.
“With enrolment 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.”
The AAA-SHAPE Pivotal Trial is evaluating the use of EVAR plus sac management with IMPEDE-FX RapidFill, compared with standard EVAR alone.
Last month, the randomised, multicentre, open-label controlled study completed enrolment of 180 patients at 48 centres in the US, Europe and New Zealand, randomising participants in a 2:1 ratio. Patients will be followed for five years.
Primary endpoints include 30-day freedom from major adverse events, aneurysm rupture, perforation and conversion to open repair. Another endpoint is the proportion of patients achieving at least 10% aneurysm sac volume reduction without abdominal aortic aneurysm-related intervention through one year.
The FLAGSHIP study is enrolling patients in a first-in-human clinical trial evaluating the investigational false lumen embolisation system for treatment of aortic dissection false lumen. This study will follow patients for two years and is designed to assess safety and initial indications of efficacy.
Shape Memory Medical’s shape memory polymer platform employs a low-density, highly porous embolic material delivered in compressed form via catheter, which self-expands when in contact with blood.
The bioresorbable material is designed to promote organised thrombus formation, accommodate complex vascular anatomy and maintain radiolucency to aid imaging during patient follow-up.
August Global Partners partner Davian Sim said: “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 embolisation, 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.”
In December 2025, Shape Memory Medical secured the CE mark for its IMPEDE embolisation plug range as a Class III device under the EU’s Medical Device Regulation.
