A New Hope for Degenerative Disc Disease: Dr. Jackie Weisbein's Role in the Groundbreaking Restore Trial

Oct 2

By Dr. Jackie Weisbein, DO, Double Board-Certified in Physical Medicine & Rehabilitation and Pain Medicine, Fellowship-Trained in Interventional Pain Management

Quick Insights

I'm honored to have treated the first patient in the Restore clinical trial evaluating VIA Disc NP™—a minimally invasive intervention designed to supplement and cushion degenerated discs for patients suffering from chronic discogenic low back pain. This landmark study may transform how we address the underlying causes of disc degeneration, not just the symptoms.

Key Takeaways

VIA Disc NP™ is a single injection designed to supplement the nucleus pulposus tissue and restore the disc's natural cushioning function.
The Restore trial is a rigorous, randomized, double-blind, sham-controlled study evaluating safety and efficacy in approximately 400 patients across 20 U.S. sites.
This treatment offers hope for those whose current options are limited to physical therapy, medications, opioids, or major spinal surgery.
Napa Valley patients now have access to cutting-edge clinical trials right here at home—no need to travel to San Francisco or Sacramento.

Why It Matters

For patients in Napa Valley and beyond who've exhausted conservative treatments for degenerative disc disease, VIA Disc NP™ represents a potential paradigm shift. Instead of masking symptoms or resorting to invasive surgery, this approach aims to restore the disc's natural cushioning function—offering real hope for lasting relief and improved quality of life.

Introduction

I'm thrilled to share some exciting news with my Napa Valley community: I recently treated the first patient in the Restore U.S. clinical trial, evaluating VIA Disc NP™ for patients suffering from lumbar discogenic pain associated with degenerative disc disease (DDD). As a double board-certified pain specialist and fellowship-trained interventionalist, I've dedicated my career to bringing the most advanced, evidence-based treatments to our region—and this milestone represents exactly that commitment.

Degenerative disc disease is one of the leading causes of chronic low back pain and disability worldwide. For so many of my patients—people like Mark from Vallejo or Lena from St. Helena—the current treatment landscape feels limited and frustrating. You've likely tried physical therapy, anti-inflammatory medications, maybe even injections or epidurals, only to find that the relief is temporary or nonexistent. And the thought of major spinal surgery? That's often too invasive, too risky, or simply not appropriate for your condition.

That's why VIA Disc NP™ is so promising. Developed by Vivex Biologics, this minimally invasive intervention is designed to supplement and cushion the disc itself—addressing the root cause of discogenic pain, not just masking the symptoms. The Restore trial will rigorously evaluate whether this single injection can provide meaningful, lasting relief for patients who've run out of good options.

If you're exhausted from "trying everything" and wondering what's next, this research may offer the hope you've been looking for.

What is VIA Disc NP™?

VIA Disc NP™ is an innovative nucleus pulposus allograft designed to supplement the nucleus pulposus—the gel-like center of your intervertebral disc that acts as a shock absorber for your spine. When this disc degenerates over time, it loses height, water content, and cushioning ability, leading to chronic pain, inflammation, and disability. For many patients, this pain is deep, aching, and relentless—made worse by sitting, bending, or lifting.

What sets VIA Disc NP apart is its approach: rather than removing or fusing the disc (as in traditional surgery), this treatment aims to restore the disc's natural function through a minimally invasive procedure. The allograft is processed from donated cadaveric disc tissue, then lyophilized and micronized into particles that can be delivered through a small instrument. In-vitro testing demonstrates that the transplanted nucleus pulposus tissue has the ability to absorb water similar to original nucleus pulposus tissue, potentially supporting the biomechanical function of the supplemented disc.

The procedure itself uses fluoroscopy imaging to guide a small instrument through Kambin's safe triangle—a well-established approach that minimizes risk to surrounding nerves—into the nucleus pulposus of the intervertebral disc. The VIA Disc NP allograft is then delivered into the target disc to support its cushioning function. It's an off-the-shelf allogeneic graft delivered in a proprietary container designed for consistent mixing in a fully closed system to reduce contamination risk.

In my practice, I see so many people who feel trapped between conservative care that isn't working and invasive surgery they're not ready for. VIA Disc NP™ is designed to fill that gap—offering a middle path that's both effective and less disruptive to your life.

Why Degenerative Disc Disease is So Challenging

Lumbar degenerative disc disease is incredibly common, especially as we age. But knowing it's common doesn't make it any less frustrating or debilitating. The pain from DDD is often described as a constant, deep ache in the lower back that can radiate into the hips and legs. It's made worse by activities we do every day—sitting at a desk, gardening, picking up grandchildren, or even just standing for too long.

For someone like George, a retiree in Sonoma County who loves working in his vineyard, this kind of pain doesn't just hurt—it steals your identity and independence. And the current treatment options? They're often inadequate:

Physical therapy and exercise: Helpful for some, but many patients plateau or find that pain limits their ability to participate fully.
Medications: Anti-inflammatories and pain relievers can help temporarily, but they don't address the underlying degeneration—and long-term opioid use carries serious risks.
Injections: Epidural steroid injections can provide relief, but the effects are often short-lived and don't restore disc function.
Surgery: Spinal fusion or disc replacement can be effective, but they're invasive, carry significant risks, and require long recovery periods.

This is why I'm so excited about VIA Disc NP™. It's designed to overcome the limitations of these traditional approaches by directly addressing the disc itself—restoring its cushioning ability without major surgery.

The Restore Trial: Rigorous, Evidence-Based Research

As someone who trains other physicians and serves as President of Women Innovators in Pain Management, I'm deeply committed to evidence-based medicine. That's why I'm proud to be one of 20 clinical sites nationwide participating in the Restore trial—and even more honored to have treated the first patient in this groundbreaking study.

The Restore trial is designed to the highest scientific standards:

Randomized, double-blind, sham-controlled: Approximately 400 adults with DDD will be randomly assigned in a 2:1 ratio to receive either a single injection of VIA Disc NP™ or a sham needle placement procedure. Neither the patient nor the evaluating physicians will know which treatment was received, ensuring unbiased results.
Rigorous endpoints: The primary endpoint is the proportion of participants achieving at least a 30% reduction in back pain (measured on the Visual Analogue Scale) at 12 months—what we call a "minimal clinically important difference" (MCID). Secondary endpoints include overall pain scores and functional improvement measured by the Oswestry Disability Index.
True sham control: By using a sham procedure—where a needle is inserted through the skin and muscle but does NOT penetrate the disc—rather than just comparing to "usual care," this trial can more precisely measure the benefit attributable to VIA Disc NP™ itself. This rigorous approach maintains blinding and preserves the integrity of placebo control.
Crossover option: At 12 months, participants in the sham group with continued symptoms may cross over to receive VIA Disc NP™, ensuring that everyone has the opportunity to potentially benefit from this treatment.

Dr. Tim Deer, the National Principal Investigator, said it best: "I'm optimistic that the results will provide level 1, high quality evidence consistent with outcomes observed in previous prospective studies." For patients like you, this means that if VIA Disc NP™ proves effective, you can trust that the evidence backing it is as strong as possible.

You can learn more about the trial details and eligibility criteria at ClinicalTrials.gov.

What This Means for Napa Valley Patients

One of the most rewarding aspects of my practice is bringing cutting-edge treatments to our local community. For too long, patients in Napa, Yountville, St. Helena, and the North Bay have had to travel to major academic centers in San Francisco or Sacramento to access the latest clinical trials and innovative therapies. But that's changing.

By participating in the Restore trial, I'm able to offer my patients access to a potentially game-changing treatment right here at Napa Valley Orthopaedic Medical Group. This means:

Convenience: No need to drive hours for appointments or procedures.
Continuity of care: You're treated by a physician who knows your history, understands your goals, and can coordinate all aspects of your care.
Personalized attention: As a boutique practice, you'll receive the individualized, compassionate care you deserve—not just a number in a large hospital system.
Support through the process: Vivex Biologics provides a comprehensive patient access program to help with prior authorization and reimbursement, making the process as smooth as possible.

If you're living with chronic discogenic pain and feel like you've run out of options, I encourage you to reach out. While not everyone will be a candidate for the Restore trial, I'm committed to exploring every available avenue to help you reclaim your life from pain.

Who Might Be a Candidate for the Restore Trial?

While the Restore trial has specific inclusion and exclusion criteria, in general, you might be a candidate if:

You're between 22 and 85 years old.
You've been diagnosed with moderate to severe lumbar degenerative disc disease affecting one or two levels.
You're experiencing chronic low back pain that has lasted six months or longer and hasn't responded to at least three months of conservative care.
Your pain is moderate to severe (VAS score between 40-90mm) and significantly impacts your function (ODI score between 40-80).
You have a positive sustained hip flexion test and demonstrated intolerance to sitting.
You haven't had previous lumbar spine surgery at the affected levels.
You're looking for a minimally invasive alternative to major spinal surgery.
You want to participate in cutting-edge research that may help others in the future.

For patients like Lena, who's been told "your MRI shows some degeneration" but hasn't found relief with standard treatments, or Mark, who's skeptical after so many failed therapies, this trial represents a real chance at answers and relief. Every candidate undergoes a thorough evaluation to ensure they're appropriate for the study—and even if you're not eligible, we'll work together to find the best treatment plan for your unique situation.

You can review the complete eligibility criteria on the trial's ClinicalTrials.gov page.

Understanding the VIA Disc NP Procedure

For those considering participation in the trial, it's helpful to understand what the procedure involves. The VIA Disc NP procedure is performed as a minimally invasive, outpatient procedure—meaning you can go home the same day. It's typically performed in either a hospital outpatient department or an ambulatory surgery center.

During the procedure, I use fluoroscopy (real-time X-ray imaging) to carefully guide a small instrument through Kambin's safe triangle—an anatomical corridor that allows safe access to the disc while avoiding the spinal nerves. Once positioned correctly within the nucleus pulposus of the affected disc, the VIA Disc NP allograft is delivered to supplement the degenerated tissue. The treatment can be performed at one or two levels, depending on your specific condition.

What I appreciate about this approach is its elegance: we're not removing tissue, not fusing bones, not implanting hardware. We're simply supplementing what's been lost, allowing the disc to better perform its natural function of cushioning and supporting your spine.

For more technical information about the procedure, you can visit the VIA Disc NP website.

Support Beyond the Procedure

I know that one of the biggest concerns patients have—especially those who've dealt with insurance denials or complicated prior authorizations in the past—is whether treatment will be covered. Vivex Biologics has established a comprehensive patient access program designed to support both patients and physicians through the reimbursement process.

The program provides:

A secure online portal for prior authorization and appeal requests
Electronic benefits verification
Prior authorization and appeal submissions
Real-time case updates and communication
Access to reimbursement tools and coverage policy information

The goal is to provide full transparency and help patients take control of the process. While I can't guarantee coverage—every insurance plan is different—my team and I work closely with the Vivex patient access team to support you through every step.

My Commitment to Innovation and Excellence

As a double board-certified physician in Physical Medicine & Rehabilitation and Pain Medicine, and fellowship-trained in Interventional Pain Management, I've built my career on staying at the forefront of pain medicine. I regularly teach other physicians about advanced procedures, serve in national leadership roles, and actively participate in clinical research—all because I believe my patients deserve the very best, most current care available.

Treating the first patient in the Restore trial is a milestone I'm incredibly proud of, but it's also a reflection of my broader commitment: to bring hope, function, and comfort back to people who've been struggling for too long. Whether it's through clinical trials like this one, advanced procedures like Intracept or SI-BONE fusion, or personalized wellness planning, my goal is always the same—help you get back to living your life.

For more information about my practice and the full range of treatments I offer, visit my website.

Conclusion

The Restore trial represents an exciting frontier in the treatment of degenerative disc disease and chronic discogenic pain. As the physician who treated the first patient in this landmark study, I'm honored to be part of research that may transform how we care for people suffering from this debilitating condition. VIA Disc NP™ offers a minimally invasive approach that addresses the root cause of disc degeneration—not just the symptoms—potentially providing lasting relief for those who've felt out of options.

If you're living with chronic low back pain, exhausted from treatments that haven't worked, and worried there's nothing left to try, please know: you're not alone, and you're not out of hope. As a double board-certified physician in Physical Medicine & Rehabilitation and Pain Medicine, fellowship-trained in Interventional Pain Management, and President of Women Innovators in Pain Management, I'm committed to bringing the most advanced care to our Napa Valley community.

Whether you're interested in learning more about the Restore trial or exploring other treatment options, I'm here to help. You don't have to live in pain—there are real options. Schedule your consultation today to explore personalized pain management solutions.

For more information about VIA Disc NP™ and the science behind it, visit viadiscnp.com or vivex.com.

This article is for educational purposes only and should not be used as a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified healthcare provider with any questions you may have regarding a medical condition or treatment options. Never disregard professional medical advice or delay in seeking it because of something you have read in this article.