Kevin J. Tracey, MD

Kevin J. Tracey, MD, is president and CEO of the Feinstein Institutes for Medical Research at Northwell Health, a pioneer of Vagus nerve research and author of the recent book, The Great Nerve: The New Science of the Vagus Nerve and How to Harness Its Healing Reflexes.  A leader in the scientific fields of inflammation and neuroscience, his lab studies Vagus nerve stimulation and bioelectronic medicine. His contributions include first identifying the therapeutic action of monoclonal anti-TNF antibodies and discovering the specific reflex control of immunity by the nervous system, called the “inflammatory reflex.” These discoveries launched the new scientific field called bioelectronic medicine, which investigates the therapeutic applications of Vagus nerve stimulation to cure disease.

Dr. Tracey, a neurosurgeon, pursued studies of inflammation after the mysterious death of a toddler from sepsis who was in his care. His lab has since revealed molecular mechanisms of inflammation and identified the use of Vagus nerve stimulation to treat it. An inventor on more than 120 U.S. patents and the author of more than 450 scientific publications, he is among the most highly cited scientists in the world. He co-founded the Global Sepsis Alliance, is the author of Fatal Sequence (Dana Press) and is a national and international lecturer.

00:00 – 02:13: Introduction and Background

• Dr. Tracey introduced as “father of bioelectronic medicine”
• Neurosurgeon turned research CEO with 100+ patents
• Overview of Feinstein Institute: 1,000 full-time employees, 100 laboratories, part of Northwell Health system

02:13 – 05:00: Research Philosophy

• Discussion of holistic vs. reductionist approach to medicine
• Quote from colleague Sangeeta: “Everything cannot depend on one protein and one cell type”
• Emphasis on studying whole-animal systems rather than isolated components

05:00 – 09:35: The Inflammatory Reflex Discovery

• Origins in stroke research – unexpected finding that brain-injected anti-inflammatory drug also reduced body inflammation
• Discovery that signals traveled via Vagus nerve from brain to immune system
• Years of research to understand molecular mechanisms

09:35 – 13:38: Vagus Nerve Anatomy

• Two Vagus nerves (left and right) with 100,000 fibers each = 200,000 total “Vagus nerves”
• Each fiber has specific function in homeostatic reflex circuits
• Connects brain to heart, lungs, liver, GI tract, and other organs
• 1998 patent filing for electrical stimulation device concept

13:38 – 16:23: Clinical Application – Left Side Preference

• Historical preference for left-side implantation due to:
  • Reduced risk to recurrent laryngeal nerve
  • Lower arrhythmia complications
• FDA approval precedent established this standard

16:23 – 20:00: Device Generations and Side Effects

• Generation 1 devices: Continuous stimulation (5 min on/off), 5 milliamps current
• SetPoint device: 1 minute daily, 400-500 microamps, multivitamin-sized
• Significantly reduced side effects compared to older devices
• Comparison to biologic drug side effects (5-8% serious complications)

20:00 – 23:20: Mechanism vs. Pharmaceuticals

• Vagus nerve stimulation enhances natural evolutionary mechanisms
• Reduces TNF-alpha by 50-70% (not 100% like drugs)
• Avoids immunosuppression while maintaining natural immune function
• Evolution-tested approach vs. synthetic drug interventions

23:20 – 28:16: Cytokine Synergy and FDA Approval

• Multiple cytokine reduction (TNF, IL-1, IL-6)
• Cytokine synergistic effects – removing multiple reduces toxic interactions
• Recent FDA approval for rheumatoid arthritis announced
• 18-year development timeline with hundreds of millions invested

28:16 – 32:21: Future Applications

• Clinical trials planned/underway for:
  • Crohn’s disease and ulcerative colitis
  • Multiple sclerosis (with surprising remyelination effects)
  • Psoriatic arthritis
  • Diabetes
  • Neurodegenerative diseases (Alzheimer’s, Parkinson’s)

32:21 – 35:00: Vagus Nerve Mapping Project

• His colleague leading complete human Vagus nerve mapping
• NIH-supported consortium creating first complete fiber map
• Modern genetic and molecular tools replacing 19th-century sketches
• Goal: fiber-specific stimulation capabilities

35:00 – 38:47: Focused Ultrasound Innovation

• Non-invasive nerve stimulation via focused ultrasound
• Successful human trials targeting splenic nerve
• Reduced cytokine production in healthy volunteers
• Potential for skin-surface treatments

38:47 – 42:20: Patient Demand and Surgical Perspective

• 20,000+ patients applied for 242-person clinical trial
• Patients choosing surgical option over additional biologics
• One-hour outpatient procedure vs. lifetime of expensive, immunosuppressive drugs
• Comparison of surgical risks to medication side effects

42:20 – 45:53: Physician Education Needs

• New paradigm requiring behavioral change from physicians
• Rheumatologists not accustomed to surgical referrals for medical conditions
• Neurosurgeons unfamiliar with Vagus nerve for medical applications
• Book written to educate both patients and physicians

45:53 – 50:00: Variable Patient Responses

• Three expected outcome groups:
  • Complete remission (off all medications)
  • Partial improvement (still need some medication)
  • No significant benefit
• Individual patient factors affect outcomes
• Need for large-scale data to identify predictive factors

50:00 – 52:53: Device Programming Capabilities

• Programmable via wireless tablet interface
• Variables: duration (1-5+ minutes), frequency (daily to multiple times daily)
• Future studies on optimization for non-responders
• Deep understanding of mechanisms from 20+ years of research

52:53 – 55:00: Selective Fiber Stimulation

• Low current (400 microamps) targets most sensitive fibers
• Selective stimulation of anti-inflammatory pathways
• Minimal off-target effects compared to stimulating all 100,000 fibers

55:00 – 1:03:43: Non-Invasive Vagal Stimulation Discussion

• Heart rate variability and respiratory sinus arrhythmia mechanisms
• Semantic challenges in defining “Vagus nerve stimulation”
• 200,000 different fibers – which ones are being stimulated?
• Only two proven specific methods: surgical implant and focused ultrasound

1:03:43 – 1:06:31: Transcutaneous Auricular Stimulation

• TENS unit stimulation of ear (concha) region
• Possible auricular branch of Vagus nerve stimulation
• Clinical studies showing cytokine reduction
• Anatomical variation and multiple nerve overlap issues
• Correlation vs. causation concerns

1:06:31 – 1:08:44: Damaged Vagus Nerve Considerations

• COVID-19 causing Vagus nerve damage in some patients
• Self-help measures ineffective if nerve is damaged
• Long COVID patients showing Vagus nerve inflammation
• Need for implanted solutions in damaged nerve cases

1:08:44 – 1:10:36: Patient Access Information

• SetPoint Medical rolling out at specialized centers
• Northwell Health Center for Bioelectronic Medicine launched
• Patient navigator services available
• Website resources for potential patients

Special Offer: Save 15% Using Code “SBPOD” At Checkout

Special Offer: Save 15% Using Code “SBPOD” At Checkout