California: Shape Memory Medical Inc, a global medical device company based in California, has successfully secured a US$10 million convertible note financing. The financing was led by August Global Partners (AGP), a new investor, and joined by another new investor, Taiwania Capital. The funds are aimed at supporting the clinical development of the company's aortic portfolio, including patient follow-up and data collection in the AAA-SHAPE Pivotal Trial, as well as advancing the FLAGSHIP feasibility trial.
According to BERNAMA News Agency, the company is backed by a consortium of healthcare investors, including HBM Healthcare Investments (Cayman) Ltd, Earlybird Venture Capital, and WexMed II LLC. The financing round also received support from HEAL Venture Lab. Shape Memory Medical's President and CEO, Ted Ruppel, expressed satisfaction with the enrolment completion in the AAA-SHAPE Pivotal Trial and the progress made in FLAGSHIP. He emphasized the company's focus on generating clinical evidence to support the broader adoption of their shape memory polymer technology in aortic applications. Ruppel welcomed AGP and Taiwania Capital as investors and expressed gratitude for the ongoing support from existing shareholders.
The AAA-SHAPE Pivotal Trial is assessing the safety and effectiveness of the IMPEDE-FX RapidFill Device in conjunction with endovascular aneurysm repair (EVAR) to manage the abdominal aortic aneurysm (AAA) sac. The randomized, multicenter study has completed enrolment and plans to follow patients for five years.
Meanwhile, the FLAGSHIP trial is a first-in-human clinical study evaluating the False Lumen Embolisation (FLE) System for treating aortic dissection false lumen. This study aims to evaluate safety and preliminary efficacy indicators, with a two-year follow-up for patients.
AGP is an independent fund management firm based in Singapore, focusing on healthcare and advanced manufacturing investments. Taiwania Capital is a venture capital firm concentrating on early to growth-stage companies.