When one door closes, another opens, and sometimes it leads to unexpected breakthroughs. In the latest episode of talk is biotech!, Guru Singh, Founder and CEO of Scispot, sits down with Negin Ashouri, founder and CEO of FemTherapeutics, to explore her journey from Iran to Canada and how an immigration hurdle set her on a path to reshape women's healthcare.

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The Path to Biotech Innovation

Negin’s story begins in Iran, where she excelled in robotics and electrical engineering. She planned to continue her education in the U.S., but the Trump travel ban disrupted those plans. Instead, she found a new home in Canada, where the biotech ecosystem embraced her ambitions. This detour led her to discover a passion at the intersection of healthcare and technology, setting the stage for a career in biotech innovation.

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Tackling an Overlooked Women's Health Crisis

One in three women suffers from pelvic organ prolapse, yet treatments have barely evolved in over 60 years. FemTherapeutics is on a mission to change that. The condition significantly affects quality of life, but it’s been historically underfunded and overlooked in medical device innovation. Negin and Guru discussed how FemTherapeutics is addressing this gap with practical, patient-focused solutions.

Current Treatment Challenges:

• A 50% failure rate in traditional pessary devices
• Lack of customization for individual anatomical differences
• Surgical interventions often result in complications, like those highlighted in the documentary Bleeding Edge

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3D Printing Technology for Personalized Solutions

FemTherapeutics is redefining the pessary device using 3D printing technology. Their approach leverages advanced measurement tools for precise anatomical assessment and customizable designs that adapt to each patient's unique needs. While personalized 3D printing initially seemed promising, Negin explained how high costs and scalability issues prompted the team to develop standardized models that still offer superior comfort and efficacy.

Their medical device innovation uses biocompatible materials that enhance comfort while reducing complications. Guru and Negin explored how this combination of precision and accessibility could transform the lives of millions of women worldwide.

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Navigating Regulatory Challenges

Bringing a medical device to market is no small feat, especially for startups. FemTherapeutics faces stringent FDA and Health Canada regulations, which can be more demanding for smaller companies compared to established players like Medtronic. Negin emphasized the importance of meticulous preparation, from benchtop testing to in-human studies, and the need to work with experienced regulatory advisors.

Despite these hurdles, Negin shared how strategic collaborations and careful documentation have helped FemTherapeutics progress toward FDA approval.

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Breaking Barriers as a Female Founder

As a female leader in biotech entrepreneurship, Negin’s journey has been marked by both challenges and victories. Fundraising in the biotech space is tough, and being a woman adds another layer of complexity. Early on, Negin faced skepticism from investors who claimed she was "too early," but her persistence paid off. FemTherapeutics secured pilot programs with hospitals, providing both validation and revenue streams to support growth.

Guru and Negin discussed how women founders often navigate unique obstacles in the biotech world, but with resilience and a clear vision, they can drive meaningful change.

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The Canadian Advantage in Biotech

While the U.S. offers vast market opportunities, Negin and Guru highlighted Canada’s benefits for biotech startups. Lower operational costs, generous government funding, and access to top talent make Canada an ideal hub for early-stage research. However, scaling often requires tapping into the larger U.S. market, a balance FemTherapeutics is navigating as they expand.

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Looking Ahead: The Future of FemTherapeutics

FemTherapeutics is more than just a medical device company. It’s a testament to the power of persistence and biotech innovation. By combining technical expertise with a deep understanding of patient needs, Negin and her team are paving the way for better, more accessible treatments in women’s health.

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Watch the Podcast

Want to dive deeper into Negin Ashouri's journey? Watch talk is biotech! Episode 2 on YouTube and discover how FemTherapeutics is using 3D printing technology and biotech innovation to transform women’s health.

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Listen to the Podcast

Prefer listening on the go? Stream talk is biotech! Episode 2 on Spotify. In this episode, Guru Singh and Negin Ashouri discuss the challenges of biotech entrepreneurship, navigating regulatory hurdles, and breaking barriers as women founders.

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