With synthetic mesh now largely withdrawn, and native tissue repair alone associated with high recurrence rates, clinicians have been left with limited tools to support prolapse repair.
SmartFem exists to fill that gap, offering a graft solution that is:
Help designed in collaboration with leading Australian clinicians, we work with healthcare professionals who share a commitment to advancing pelvic floor surgery and improving the outcome experience for women.
SmartFem provides the Victoria Graft System, an intraoperative autologous graft solution. It is:
The system follows a known Class IIa regulatory pathway and is manufactured under clinical conditions to support adoption in both private and public hospitals.
SmartFem’s development pathway has been deliberate and data-informed of preliminary findings:
Proof of concept demonstrated in 100+ patients
Clinical use in >100 women with over 85% showing successful support at 12 months
More than 400 patients treated with no reported adverse events
Product launch and new independent clinical evaluations underway.
Our filed patent, “Scaffold for soft tissue augmentation and reinforcement”, covers the core technology and is undergoing submission in key global markets.
Founder and Chief Medical Officer
PhD, MD, MMIS, FRANZCOG
Dr Fariba Behnia‑Willison is a fully accredited gynaecological surgeon and pioneer in female pelvic regenerative treatment, such as the use of PRP. She introduced single-incision laparoscopic techniques to Australia and performed the world’s first single-incision mesh hysteropexy.
Chief Financial Officer (CFO)
BE, MEng, PhD
Khosrow is a technology and quantitative finance executive with more than 25 years of experience developing high-performance trading, analytics, and risk management systems. He holds a PhD in EECS from University of California, Berkeley, a Bachelor of Science in Electrical Engineering from Purdue University, and holds both CFA and FRM designations. Khosrow previously served as CTO and CRO at Laurion Capital Management and held senior leadership roles at Goldman Sachs, Morgan Stanley, and Bear Stearns. At SmartFem Biotech, he supports strategic growth, operational planning, and U.S. market expansion initiatives.
Operations Manager
BE, MEng, PhD
Dr Pouria Aryan is a biomedical engineer and research manager with extensive experience across both industry and academia. He specialises in translating engineering innovation into clinically meaningful, patient-centred solutions. With a background spanning mechanical engineering, and biomedical research, Dr Aryan brings a unique interdisciplinary perspective to the development and implementation of advanced medical technologies.
Research Manager
BMid, MMid, PhD
Dr Mahshid Taheri is a clinical researcher with a strong background in clinical trials, data analysis, and medical writing. She leads SmartFem’s research and clinical affairs, supporting evidence generation, ethics approvals, and post-market surveillance activities for the VGS. With a focus on scientific integrity and regulatory alignment, Mahshid ensures that SmartFem’s clinical strategy is robust, ethical, and aligned with global best practices in women’s health innovation.
Senior Consultant
BS
David Kaysen is an experienced MedTech executive and strategic advisor with more than 40 years of leadership across medical devices, diagnostics, biopharmaceuticals, and healthcare software companies. He has served as CEO, President, Board Member, and advisor for multiple healthcare ventures, with deep expertise in commercialization, fundraising, FDA pathways, and women’s health. As former President and CEO of Uroplasty, he helped drive the company’s growth and global market expansion prior to its strategic acquisition. At SmartFem Biotech, David supports corporate strategy, commercialization, and growth initiatives for the Victoria Graft System and future regenerative technology platforms.
Senior Consultant
BS, PhD
Dan Mooradian is a medtech executive, innovator, and strategic advisor with more than 30 years of experience developing and commercializing breakthrough medical technologies. He holds a PhD in experimental pathology from Wayne State University and is named on more than 100 patent filings worldwide. Dr. Mooradian has held senior leadership roles at Boston Scientific, Synovis Life Technologies, and Kerecis, where he served as CTO prior to its acquisition by Coloplast. At SmartFem, he supports strategic initiatives across technology development, intellectual property, and U.S. commercialization.
Avio Medtech Consulting is a U.S.-based medical technology consulting firm with extensive expertise in FDA regulatory strategy, quality systems, product development, clinical and commercialization planning, and operational support for emerging and growth-stage medtech companies. Founded and led by experienced medical technology executives and entrepreneurs, Avio works closely with innovative healthcare companies to accelerate product development, navigate complex regulatory pathways, reduce commercialization risk, and support successful market expansion. As a strategic advisor to SmartFem, Avio supports the company’s FDA regulatory planning, U.S. market-entry strategy, commercialization initiatives, and broader development activities for the Victoria Graft System (VGS) and SmartFem’s autologous regenerative technology platform for women’s health and pelvic floor repair.
