SAN JOSE, Calif.–(BUSINESS WIRE)–Shape Memory Medical Inc., developer of proprietary shape memory polymer technology for endovascular embolization, today 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.
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.
About August Global Partners
August Global Partners (AGP) is a Singapore-based independent fund management firm investing across the universe of healthcare and advanced manufacturing. Dedicated to the theme of “Living Better, Aging Better”, the AGP Healthcare Fund supports portfolio companies worldwide in areas such as precision medicine, AI-powered health technologies, and patient-centric care.
More information: www.augustglobalpartners.com
About Taiwania Capital
Taiwania Capital is a venture capital firm founded in August 2017 by Taiwan’s National Development Fund of the Executive Yuan in partnership with private enterprises. Currently, Taiwania Capital manages eight funds and focuses on investing in early- to growth-stage companies across Taiwan, the United States, Japan, Southeast Asia, and Central and Eastern Europe. Its mission is to connect Taiwan’s strong technology and biotech ecosystems with global innovation, while providing portfolio companies with strategic resources to support their growth and market expansion.
More information: www.taiwaniacapital.com
About Heal Venture Lab
Heal Venture Lab (HVL) is a Singapore-based healthcare venture builder focused on advancing innovative medical technologies and healthcare solutions across Asia-Pacific. HVL works with healthcare companies, investors, clinicians and strategic partners to support venture development, regional market access and cross-border growth.
With Singapore as its regional hub, HVL focuses on biomedicine, medical technology, diagnostics and other healthcare innovations addressing significant unmet clinical needs. The firm combines investment, strategic advisory, healthcare networks and market development capabilities to help promising companies expand across Asia-Pacific.
For more information, visit www.healventurelab.com.
About Shape Memory Medical
Shape Memory Medical Inc. is a California-based global medical device company advancing innovative therapies through proprietary shape memory polymer technology. The company’s products have received regulatory approvals in more than 40 countries, and its technology has been used in more than 3,500 patients worldwide. Building on its commercial embolization platform, Shape Memory Medical is expanding into aortic applications through multiple clinical development programs.
The company’s AAA-SHAPE Pivotal Trial is evaluating EVAR plus sac management using IMPEDE-FX RapidFill compared with stand-alone EVAR. Shape Memory Medical is also enrolling patients in FLAGSHIP, a first-in-human study evaluating its investigational False Lumen Embolization System for the treatment of aortic dissection.
For more information about AAA-SHAPE (Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion), visit www.clinicaltrials.gov (Study ID: NCT06029660).
For more information about FLAGSHIP (False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer), visit www.clinicaltrials.gov (Study ID: NCT06550986).
The IMPEDE and IMPEDE-FX Embolization Plugs and IMPEDE-FX RapidFill are CE Mark approved. The IMPEDE and IMPEDE-FX Embolization Plugs are approved in Japan and cleared for use in the United States. In the United States, the IMPEDE Embolization Plug is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature, and the IMPEDE-FX Embolization Plug is indicated for use with the IMPEDE Embolization Plug to obstruct or reduce the rate of blood flow in the peripheral vasculature. In the United States, IMPEDE-FX RapidFill is an investigational device, limited by Federal (or United States) law to investigational use.
For more information about Shape Memory Medical, visit www.shapemem.com.
Contacts
Shape Memory Medical Inc.
Ted Ruppel
408-649-5175
[email protected]