Epilepsy therapy innovations start with an idea. So how does it go from that to a device that can be safely used in patients? In this episode of Seizure Diaries, our conversation is centered around the medical device regulatory process, offering a behind-the-scenes look at how safety, evidence, and patient protection guide every step of development.

​​Joining the conversation is Tim Marjenin, Vice President and Head of Neurology Regulatory Affairs at MCRA. Drawing on his experience at the U.S. Food and Drug Administration, he shares insight into the regulatory landscape and how it intersects with clinical research.

Listeners are introduced to the structure of medical device regulation in the United States, including how laws, FDA regulations, and guidance documents shape the pathway for bringing new technologies to market. The discussion explains device classifications, the unique Humanitarian Device Exemption pathway, and the collaborative relationship between companies, regulators, and clinical experts. Together, these elements illustrate the extensive planning, testing, and documentation required to demonstrate that a device is safe and effective.

Key takeaways emphasize the central role of risk-benefit evaluation, the multidisciplinary teams involved in reviewing devices, and the importance of communication and transparency, especially for families considering participation in clinical trials.

The episode highlights how rigorous oversight and thoughtful decision-making aim to ensure that new therapies are developed responsibly while maintaining a strong focus on patient well-being.

Listeners will hear:

• How a medical device moves from concept to regulatory approval

• The role of Congress, the FDA, and guidance documents in device oversight

• Differences between device classes and what they mean for safety requirements

• What the Humanitarian Device Exemption pathway is and when it's used

• How FDA review teams evaluate safety, effectiveness, and risk-benefit balance

• Why strong communication between companies, regulators, and families matters

• Considerations for parents and caregivers when evaluating clinical trial participation

More about Cadence Neuroscience:

Cadence Neuroscience is currently developing an investigational BTS [Biomarker Targeted Stimulation] device therapy for the treatment of drug-resistant focal epilepsy, based on pioneering work performed by researchers at Mayo Clinic. Learn more at cadenceneuro.com.

This episode focuses on clinical experience and research insights. While no specific studies were cited, the organizations and technologies below provide helpful context for listeners who want to learn more.

Resources mentioned in this episode:

• MCRA

• FDA | Medical Devices

• FDA | CDRH

• FDA | FD&C Act

• iqvia.com

What does it take to move epilepsy care forward, from understanding the brain's biomarkers to developing therapies that could change patients' lives? In this episode of Seizure Diaries, our conversation explores the intersection of clinical care, research, and engineering innovation through the work of neurologist and researcher Dr. Greg Worrell and his long-standing collaboration with Cadence Neuroscience. Together, they discuss how scientific curiosity and patient-centered care are driving new possibilities in epilepsy treatment.

Listeners gain background on the unique challenges of epilepsy, particularly drug-resistant epilepsy, where traditional medications may not provide adequate seizure control. The discussion highlights the role of Mayo Clinic's research environment, advances in neuromodulation, and the importance of identifying measurable brain biomarkers to guide therapy. The episode also traces the origins of biomarker targeted stimulation and the collaborative work that continues to shape emerging technologies.

Key takeaways center on how innovation happens in real clinical settings, the value of cross-disciplinary collaboration, and the growing potential of data, sensing technology, and personalized treatment approaches. The conversation reinforces a central theme: progress in epilepsy care depends on combining engineering advances with deep clinical insight and a sustained focus on improving quality of life for patients.

Listeners will hear:

• An overview of the challenges in treating drug-resistant epilepsyHow neuromodulation works and why biomarkers matter

• The role of Mayo Clinic's research culture in advancing therapies

• The origin story of biomarker targeted stimulation

• Real-world patient impacts and success stories

• Future directions in sensing technology, data, and personalized care

More about Cadence Neuroscience:

Cadence Neuroscience is currently developing an investigational BTS [Biomarker Targeted Stimulation] device therapy for the treatment of drug-resistant focal epilepsy, based on pioneering work performed by researchers at Mayo Clinic. Learn more at cadenceneuro.com.

This episode focuses on clinical experience and research insights. While no specific studies were cited, the organizations and technologies below provide helpful context for listeners who want to learn more.

Resources mentioned in this episode:

• www.mayoclinic.org/departments-centers/neurology

• neurovista.us

• www.mayoclinic.org/biographies/worrell-gregory

Today's conversation centers on when cutting-edge neuromodulation meets compassionate, team-based pediatric care. In this episode, the Seizure Diaries hosts welcome Dr. Scott Perry, Director of the Jane and John Justin Institute for Mind Health at Cook Children's Hospital, for a deep dive into the evolving world of epilepsy surgery, neuromodulation, and patient-centered decision-making.

Learn how Dr. Perry and his team are helping families navigate complex diagnoses, evaluate treatment options, and harness technology to improve outcomes.

Dr. Perry shares his professional journey from aspiring astronaut to leading pediatric neurologist, offering insight into the multidisciplinary approach that powers Cook Children's Neuroscience Center. He discusses how collaboration across neurology, psychology, psychiatry, developmental pediatrics, and rehabilitation supports holistic care, and why big data and collaborative research networks like the Pediatric Epilepsy Research Consortium are shaping the future of epilepsy treatment.

Through stories and statistics, Dr. Perry explains how earlier surgical referrals, detailed evaluations, and the rise of stereo EEG (SEEG) are changing what's possible for children with intractable epilepsy.

Listeners will hear:

• How neuromodulation, epilepsy surgery, and genetic insights intersect in pediatric care

• The critical role of parents and caregivers in informed decision-making

• The value of individualized treatment

• Ongoing efforts to shorten the path from diagnosis to intervention

More about Cadence Neuroscience:

Cadence Neuroscience is currently developing an investigational BTS [Biomarker Targeted Stimulation] device therapy for the treatment of drug-resistant focal epilepsy, based on pioneering work performed by researchers at Mayo Clinic. Learn more at cadenceneuro.com.

Resources & Links Mentioned in This Episode

• cookchildrens.org/services/neurosciences

• perc-epilepsy.org

• childneurologyfoundation.org

Epilepsy affects millions of people worldwide, yet access to accurate information, supportive care, and innovative therapies can be hard to find.

In this episode of Seizure Diaries, hosts Kent Leyde and Doug Sheffield of Cadence Neuroscience sit down with leaders from the Epilepsy Foundation to discuss how lived experience, groundbreaking research, and patient-driven data are shaping the future of epilepsy care.

Bernice "Bee" Martin Lee, Epilepsy Foundation CEO, shares her personal journey with epilepsy and her vision for ensuring no one faces epilepsy alone. Chief Research and Innovation Officer Caitlin Grzeskowiak, PhD also joins to explain how data collection, research collaboration, and innovative platforms like Empowered are creating real-world impact for patients, caregivers, and clinicians alike.

Together, they reveal how advocacy, science, and technology intersect to improve quality of life and accelerate progress. This discussion combines personal stories with cutting-edge initiatives and sheds light on how collective effort is driving change in the epilepsy space.

Listeners will hear:

• Bernice's personal journey with epilepsy and how it shapes her leadership

• How the Epilepsy Foundation is tackling health equity and stigma

• Caitlin's path from genetics research to data-driven advocacy

• The launch of Empowered, a patient-centered data platform

• How technology, shared databases, and chatbots are improving access to information

• Upcoming opportunities like the Epilepsy Shark Tank and startup accelerator

More about Cadence Neuroscience:

Cadence Neuroscience is currently developing an investigational BTS [Biomarker Targeted Stimulation] device therapy for the treatment of drug-resistant focal epilepsy, based on pioneering work performed by researchers at Mayo Clinic. Learn more at cadenceneuro.com.

Resources & Links Mentioned in This Episode

• Epilepsy Foundation – Main website for education, advocacy, and community resources: epilepsy.com

• Empower(ed) Platform – Learn more under About Us, Research & Funding on epilepsy.com

• Shark Tank Innovation Program – Pitch competition for epilepsy-focused innovations: epilepsy.com/sharktank

• My Seizure Diary – Digital tool for tracking seizures and treatments: epilepsy.com/learn/seizure-diary

• Chatbot "Sage" – AI assistant for trusted epilepsy information (available on the epilepsy.com homepage).

• AWS Health Data Lake – Partner powering the Epilepsy Foundation's Empower platform.

• Across Matrix / Greenlight – Technology partners enabling EHR integration for Empowered.

• Aurelius – Licensing partner connecting de-identified patient data with pharma/biotech.

Support & Helplines

• Epilepsy Foundation Helpline: 1-800-332-1000 (24/7 support)

• Live Chat Helpline: Accessible through epilepsy.com

What does it take to prevent a tragedy that many don't even know could happen? How do we empower families and caregivers to better support those living with epilepsy? And why is awareness around SUDEP—Sudden Unexpected Death in Epilepsy—so urgently needed?

This episode of Seizure Diaries tackles these essential questions and more in a powerful and informative conversation. Hosts Kent Leyde and Doug Sheffield of Cadence Neuroscience welcome their very first guest, Tom Stanton, President of The Danny Did Foundation.

Tom shares the heartbreaking story of his nephew Danny's passing from SUDEP—a turning point that led to the foundation's mission to increase awareness, support families, and advocate for real change in epilepsy care.

Listeners will hear:

• Danny's story, told by his uncle, Tom
• challenges and improvements in SUDEP awareness
• technological advances in seizure detection
• support systems for the caregiver burden
• ways to get involved and support the cause
• the importance of patient awareness
• how the Foundation is addressing critical gaps in education and communication around epilepsy, while championing both innovation and compassion

This episode sheds light on how knowledge and collaboration can save lives. Tom discusses the importance of empowering families with resources, building stronger bridges between clinicians and advocates, and ensuring that no family facing epilepsy has to navigate it alone.

More about Cadence Neuroscience:

Cadence Neuroscience is currently developing an investigational BTS [Biomarker Targeted Stimulation] device therapy for the treatment of drug-resistant focal epilepsy, based on pioneering work performed by researchers at Mayo Clinic. Learn more at cadenceneuro.com.

The Danny Did Foundation:

Learn more about The Danny Did Foundation and how to support the organization at their website: https://www.dannydid.org/about-danny-did/.

Mentioned in this episode:

AES - American Epilepsy Society

AAN - American Academy of Neurology

Dravet syndrome - Dravet Syndrome Foundation

Welcome to the very first episode of Seizure Diaries, where science meets hope in the fight against epilepsy. In this premiere conversation, listeners are introduced to the urgent and evolving world of epilepsy treatment, particularly for those who live with drug-resistant seizures.

This episode sets the stage for what's to come—groundbreaking ideas, expert voices, and a deep commitment to changing lives through advanced neurological care.

Listeners will hear:

• the science behind neuromodulation

• real-world needs in current epilepsy treatment

• how Cadence is working to bridge gaps in treatment with new therapies

This episode provides a foundational understanding of how collaborative research and cutting-edge technology are opening new possibilities for seizure control—and why this work matters now more than ever.

More about Cadence Neuroscience:

Cadence Neuroscience is currently developing an investigational BTS [Biomarker Targeted Stimulation] device therapy for the treatment of drug-resistant focal epilepsy, based on pioneering work performed by researchers at Mayo Clinic. Learn more at cadenceneuro.com.

Cadence Neuroscience is developing investigational medical technologies that have not been approved or cleared by the U.S. Food and Drug Administration (FDA) or other health authorities. Any forward-looking statements reflect current expectations and are subject to risks and uncertainties. Actual results may differ materially. This information is for educational purposes only and does not constitute medical advice or investigational device promotion. Patients should consult qualified healthcare providers regarding diagnosis and treatment options.

Currently, these investigational technologies are only accessible through participation in a clinical trial. To learn more about these investigational technologies and how to access them, talk with your qualified healthcare provider or visit www.clinicaltrials.gov.

For those living with epilepsy, a life without seizures truly is freedom.

In this podcast, hosts Cadence Neuroscience CEO Kent Leyde and Chief Scientific Officer Doug Sheffield discuss their work toward ending epileptic seizures.

From their own innovative medical technology to other advances in the field, Kent and Doug's conversations with guests investigate the impact epilepsy has and the work being done locally and globally to ensure every person lives a seizure-free life.