Fluid Biomed Milestones

Award acknowledges a company that has shown significant achievement within the marketplace and Alberta’s business community through strong performance or a leadership role

Fluid Biomed Inc. is commercializing the first polymer-based brain stent to cure aneurysms. The company’s team of neurosurgeons, scientists, and engineers have designed the world’s first hybrid polymer-metal flow-diverting stent to cure this deadly disease. Uniquely constructed of dissolving polymer and metal, this innovative medical device provides a scaffold to allow better healing and visualization of blood vessels.

Accepting this award, Co-founder and CEO, Dr. John Wong said ”As a young company, Fluid Biomed is incredibly humbled and proud to be recognized as BioAlberta‘s 2023 Company of the Year. It has been inspiring to first witness and now become a valued participant in the exponential expansion of the provincial life sciences ecosystem. Kudos to all of us as we grow the nexus of intellect, infrastructure, and investment in Alberta to create the next generation of medical technologies that will save lives around the world. Thank you!”

First-in-Human Clinical Safety Trial is Successfully Launched using ReSolv™, the Unique Polymer-Based Flow-Diverting Stent Designed to Treat Brain Aneurysms

Company Advisory Board Expands to Include Respected Medical Key Opinion Leader and Medtech Entrepreneur

CALGARY, AB, June 1, 2023 /CNW/ – Fluid Biomed Inc., a medical device company developing ReSolv™, the world’s first hybrid polymer-metal flow-diverting stent to treat brain aneurysms, announces the international launch of REDIRECT, its first-in-human clinical trial. Phase 1 of this technical feasibility and safety study has begun with successful device implantation without adverse effect in human subjects at the pre-determined 30-day time point and recruitment is on-going.

Dr. John Wong, neurosurgeon, company co-founder and Chief Executive Officer, said “We view this first clinical demonstration in multiple patients of our revolutionary stent, as the next leap in brain aneurysm treatment that combines science, engineering, and medicine. Surmounting the formidable challenges to capture this milestone as a young company with remarkable efficiency of resources and time, is a testament to the dedication, creativity, and tenacity of our talented team, both individually and collectively. We look forward to achieving even more alongside our next financing partners.”

Dr. Alim Mitha, neurosurgeon, company co-founder, President, and Chief Technology Officer, said, “It is incredibly gratifying and exciting to witness years of careful scientific work from our affiliated biomedical engineering laboratory culminate in a transformative medical device. Our unique hybrid polymer-metal technology may be the foundation of an extremely versatile platform that can address the treatment of aneurysmal disease in its broadest scope. Whole new strategies of therapy may open as a result.”

Fluid Biomed also announces new company advisors: Professor Ajay Wakhloo, renowned neuroradiologist and stent pioneer; and Michael Wallace, serial entrepreneur and medical industry leader. “Leveraging the decades of experience from these enviable additions to our advisory board, will help us establish the next generation of neurovascular tools to aid physicians worldwide in the battle against brain aneurysms and stroke,” says Wong.

Certification validates company commitment to medical device quality and safety

Fluid Biomed Inc., developer of the world’s first bio-resorbable stent to cure brain aneurysms, announces it has received ISO 13485:2016 certification, the internationally recognized benchmark for Quality Management Systems (QMS) specific to medical devices.

“Fluid Biomed is committed to better health and quality of life through innovation, and we are developing unique life-saving technologies that are safe and effective,” said Dr. John Wong, Chief Executive Officer. “Although a young company, the team has individually and collectively dedicated themselves to nurturing and supporting a culture of quality focused on continuous improvement.  We’re so proud to share that our Quality Management System has been independently audited by the leading national standards body, BSI, and is now certified to the rigorous and exacting requirements of ISO 13485:2016.”

ISO 13485 is the prevailing process-based QMS standard for the medical device industry around the world. Fluid Biomed holds certificate number FM 762811 and its QMS complies with the standards of ISO 13485:2016 for the design and development of intracranial stents and associated delivery components.

Company unveils new name to convey its focus on medical device innovation

Fluid Biotech, a life sciences company based in Calgary, Alberta, Canada that is pioneering stent technology, is rebranding itself to Fluid Biomed, to emphasize its focus on medical device innovation as it accelerates towards clinical trials.

“Fueled by our previous over-subscribed seed financing round, we’ve made tremendous progress as a young firm in the pre-clinical testing of our flagship product: the world’s first polymer-based flow-diverting stent to cure the deadly disease of brain aneurysms,” states company co-founder and CEO, Dr. John Wong. “The new company name aligns with our mission of developing the next generation of stents to improve patient well-being and will help us harmonize with strategic medical device manufacturers and financial partners as we enter the next exciting phase of growth”. All other facets of the company remain unchanged and the transition is anticipated to be complete by end of Q1 2022.