Shape Memory Medical has closed a $10 million convertible note financing to advance clinical development of its shape memory polymer technology for aortic disease. New investor August Global Partners led the financing, with Taiwania Capital also participating as a new investor.
The company is additionally backed by healthcare investors including HBM Healthcare Investments, Earlybird Venture Capital and WexMed II.
The capital will support continued patient follow-up and data collection in Shape Memory Medical’s AAA-SHAPE Pivotal Trial and advancement of its FLAGSHIP feasibility study.
AAA-SHAPE is evaluating the safety and effectiveness of the company’s IMPEDE-FX RapidFill Device when used alongside endovascular aneurysm repair to proactively manage the abdominal aortic aneurysm sac.
The randomized multicenter study recently completed enrollment and will follow patients for five years.
FLAGSHIP is a first-in-human trial evaluating Shape Memory Medical’s investigational False Lumen Embolization System for treating the false lumen associated with aortic dissection.
That study is designed to evaluate safety and preliminary signs of efficacy and will follow patients for two years.
Shape Memory Medical’s polymer technology uses a low-density, highly porous embolic material delivered through a catheter in compressed form.
The material self-expands upon contact with blood and is designed to promote organized thrombus formation, adapt to complex vascular anatomy and preserve radiolucency for follow-up imaging.
Shape Memory Medical’s products have received regulatory approvals in more than 40 countries, and its technology has been used in more than 3,500 patients worldwide.
IMPEDE-FX RapidFill remains investigational in the U.S.
KEY QUOTES:
“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.”
Ted Ruppel, President And CEO Of Shape Memory Medical
“With AAA-SHAPE fully enrolled and FLAGSHIP advancing, the company is at an inflection point, and the data ahead will define it.”
Davian Sim, Partner At August Global Partners
