Liftoff with Keith Newman

Episode: Reinventing Back Surgery: Dr. Steve Falowski on SynerFuse’s Breakthrough in Chronic Pain Treatment

Date: December 16, 2025
Guests:

• Host: Keith Newman
• Guest: Dr. Stephen Falowski, MD, Director of Functional Neurosurgery at Argus Marathi Neurological Neurosurgical Associates of Lancaster

Episode Overview

In this episode, Keith Newman explores the fast-changing landscape of MedTech focused on chronic pain, particularly spine and back pain. The featured guest, Dr. Steve Falowski, discusses his role as a neurosurgeon, the burdens of chronic back pain, and the entrepreneurship behind SynerFuse—a startup aiming to revolutionize chronic pain management with innovative neuromodulation devices. Together, they look at why so many back surgeries leave patients suffering, where technology is taking the treatment, and what it means for the future of pain relief.

Main Discussion Points & Insights

1. The Immense Burden of Chronic Back Pain

• Chronic back pain is more prevalent than heart disease, cancer, and diabetes combined.
• Most common reason for work absenteeism is not a cold, but back pain.
  • Quote: "There are more people that suffer from pain than heart disease, cancer and diabetes combined." (Dr. Falowski, 00:00)

2. Limitations of Traditional Treatments

• Current treatments range from medication/physical therapy to spinal fusion surgeries.
• Spinal fusion helps some, but about 30% of patients suffer chronic pain post-surgery.
  • Quote: "About 30% of those patients will actually come out of the surgery in chronic pain...which is a staggering number..." (Dr. Falowski, 02:48)
• Those left in pain often cycle through medications (including opioids) and various therapies for years.

3. Breakthrough: Neuromodulation at the Time of Surgery

• Neuromodulation / spinal cord stimulation: Implanting electrodes on the spine (like a "pacemaker for the spine") to disrupt pain signals.
• Historically a last-resort therapy; now it offers 80–85% success rates for previously untreatable chronic pain.
  • Quote: "Imagine that you can control the electrode on your spine from your cell phone." (Dr. Falowski, 06:10)
• SynerFuse’s innovation: Place electrodes during the initial spine surgery (not years later), preventing chronic pain before it starts.
• Proof of concept: 20 patients, followed for a year—resulted in massive pain reduction, improved function, and reduced opioid use.
  • Quote: "...over 80% of the people improving...all their opioid use came down...disability got significantly improved..." (Dr. Falowski, 07:46)

4. Ideal Candidates and Scope

• Not limited to acute injuries—most patients have degenerative spine changes (arthritis).
• "If you live long enough, you're eventually going to degenerate your spine." (Dr. Falowski, 09:59)
• Potentially transformative for a huge population.

5. The Entrepreneurial Challenge

• Spine stimulator market dominated by giants like Abbott and Medtronic.
• SynerFuse (“David”) vs. these “Goliaths”—but a unique FDA pathway and novel timing (placing at original surgery) gives SynerFuse an edge.
  • Quote: "This is going to be a completely separate implant...implanted at the time of the initial spine surgery." (Dr. Falowski, 12:40)
  • "It’s a David and Goliath." (Dr. Falowski, 14:30)
• Early-mover advantage may lead to acquisition or shake up market forces.

6. Why Change the Approach Now?

• Frustration that patients waited 7–12 years in chronic pain before trying effective neuromodulation.
  • Quote: "What's always been disheartening...those patients aren't getting to me...until they've suffered in pain for seven to 12 years." (Dr. Falowski, 10:28)
• Combining surgery and neuromodulation leverages new technology and better patient selection for superior outcomes.

7. Scale and Rollout Challenges

• Number of spinal cord stimulators implanted annually has risen from ~10,000 to 50–70,000 over a decade.
• SynerFuse will commence a large U.S. study in 2026 (20–25 hospitals, 100+ patients).
  • Quote: "Within the next month or so...we’re going to launch the large US Study..." (Dr. Falowski, 23:14)

8. Cost and Healthcare Economics

• Chronic pain patients (post-fusion) often cost insurers $10,000/month for ongoing therapy and medications.
• Neuromodulation device: $10,000–$20,000 upfront, but potentially huge long-term cost savings.
  • Quote: "With these stimulators, there is what's considered a large upfront cost...but if you can decrease the amount they use moving forward, it would be a tremendous savings..." (Dr. Falowski, 24:38)

9. Wider Implications and Acceptance

• Requires buy-in from pain management specialists ("gatekeepers") and a cultural shift among both them and surgeons.
• Insurance coverage of spinal fusion is declining; improved results may restore trust in spine procedures.
  • Quote: "There was a New York Times article in 2016 that questioned, why are we still doing useless spine surgery?" (Dr. Falowski, 16:41)

10. The Role of AI in Next-Gen Therapies

• AI being used to refine stimulator programming for optimal outcomes—eventually leading to patient self-programming.
  • Quote: "With AI now...algorithms can read what the patient does their best on and start adjusting accordingly..." (Dr. Falowski, 29:22)

Notable Quotes & Memorable Moments

• "Pacemaker for the spine." (Dr. Falowski, 05:45 & 06:46)
• "If you live long enough, you're eventually going to degenerate your spine." (Dr. Falowski, 09:59)
• "Why are we waiting so long to get to these patients when we have a therapy that works so well?" (Dr. Falowski, 10:28)
• On competition: "It's a David and Goliath...But I think what's going to help [SynerFuse]...is their FDA approval will be specifically for this." (Dr. Falowski, 14:30)
• On innovation: "You control the electrode on your spine from your cell phone." (Dr. Falowski, 06:10)
• On patient impact: "Even in your 80s, you should not be living in chronic pain if we have therapies to help you." (Dr. Falowski, 31:35)
• On future of care: "With AI now...we're actually going to get to the point where we're going to have self-automated programming." (Dr. Falowski, 29:22)
• On personal motivation: "I'm very passionate about neuromodulation, the idea of stimulating nerves...I want people to know that these therapies work well." (Dr. Falowski, 32:10)

Timestamps for Key Segments

| Time | Segment | |----------|------------------------------------------------------| | 00:00 | Scale and reality of back pain in the population | | 02:39 | Overview of SynerFuse’s approach | | 05:45 | Innovations in neuromodulation | | 07:06 | Success rates and trial results | | 09:59 | Typical candidates and inevitability of degeneration | | 10:28 | “Aha” moment behind innovation | | 12:01 | Current industry landscape & entrepreneurial hurdles | | 14:30 | Competition with big MedTech players | | 16:41 | Scrutiny of spinal fusion and insurance coverage | | 18:13 | Impact of minimally invasive techniques | | 21:18 | What’s needed for widespread adoption | | 23:14 | Launching the large-scale U.S. study | | 24:38 | Cost comparison and healthcare implications | | 27:40 | Dr. Falowski’s journey into neurosurgery | | 29:18 | AI in device optimization | | 31:35 | Eligibility for older patients | | 32:10 | Parting thoughts: Passion for advancing the field |

Conclusion

Dr. Steve Falowski and host Keith Newman explore how SynerFuse is changing the paradigm for back surgery and chronic pain. Through smart integration of neuromodulation and spinal surgery, new technologies, AI-driven therapy optimization, and a nimble, startup mindset in a behemoth-dominated industry, they’re blazing a trail toward better pain relief for millions. Dr. Falowski’s passion, technical detail, and insider’s perspective deliver clear hope: the future of back surgery and pain management is less invasive, more personalized, and could remove years of needless suffering.