Isaac Clements, PhD

[00:00] – Podcast introduction highlighting Dr. Isaac Clements and his revolutionary NerveTape device for peripheral nerve surgical repair – described as comparable to replacing a slide rule with a computer in terms of advancement.

[01:27] – Interview begins with introductions. Dr. Clements discusses his PhD in neural engineering from Georgia Tech’s joint program with Emory University, focusing on nerve regeneration and neural interfacing.

[04:36] – Discussion of the original device that led to NerveTape – was designed for electrical interfacing with nerves using small hooks for mechanical gripping.

[05:00] – The hooks made strong mechanical connections to nerves with minimal tissue invasion, limiting to paraneural penetration.

[05:13-05:21] – Early experiments showed promising results even though the device wasn’t initially designed for mechanical nerve interfacing.

[06:24] – Confirmation that NerveTape was actually a byproduct of developing another device for measuring neural signals – a case of serendipity.

NerveTape Product Overview

[07:40] – Introduction of NerveTape as a device for repairing peripheral nerves without sutures, addressing the complexity of nerve repair microsurgery.

[07:49-08:17] – Context on nerve repair challenges: requires extensive training, is time-consuming and complex, yet achieves satisfactory recovery less than half the time despite best efforts.

[08:17] – Background on nervous system differences: central vs. peripheral nervous system have very different injury response strategies.

[08:54] – Explanation of nerve injury mechanics: cell bodies remain in/near spinal cord, everything distal to injury dies (like cutting a tree branch), but proximal nerve stump retains regenerative potential.

[09:42-10:00] – Discussion of nerve regeneration challenges including the long distances from fingertips to toes.

[11:20] – Multiple factors affect regeneration outcomes: distance from cell body, inherent difficulties with long-distance regeneration, and injury mechanism itself.

Problems with Current Nerve Repair Methods

[12:36] – Current repair methods not ideal for guiding axons to targets; misaligned axons can form neuromas – tangled scar tissue causing severe pain.

[12:46] – Neuromas prevent restored sensation and motor function while causing additional pain complications.

[13:34] – Traditional suture repair requires bringing nerves together with precise tension and optimal alignment in challenging operative environments with imperfect nerve access.

[14:01] – Nerve repairs often happen at end of long surgical days when surgeons are fatigued, yet require microscope and highest precision work.

[14:14-14:43] – Multiple studies now demonstrate that repairs are not ideal even from very experienced surgeons, revealing the extent of alignment and technique challenges.

[15:00] – Common problems include pulling nerve ends too close together, forcing fascicles (sub-bundles of axons) in wrong directions, giving them no hope of reaching targets.

[15:22-16:29] – Discussion of nerve gaps and bridging challenges.

[17:29] – Current suture methods use non-absorbable nylon placed manually into the nerve, with limitations extending beyond the epineurium.

Solution: NerveTape Technology

[18:00] – Introduction to what NerveTape addresses: proper alignment, ease and speed of use, keeping axons contained, and improving overall repair quality.

[18:31-18:35] – Discussion of 100% neuroma risk with certain misalignment scenarios.

[18:37-18:46] – Nerve conduits have decades of research showing advantages; they allow the body’s natural neurotropism and endogenous repair mechanisms to function.

[18:58] – Conduits don’t require as much technical precision – just placing nerve ends close together allows the conduit to splint them toward each other.

 [23:20] – Key benefit of entubulation aspect of NerveTape – simply wrap it around the nerves for good outcomes.

NerveTape Materials & Design

[25:00] – After many iterations, settled on nitinol (nickel-titanium alloy) for the device material.

[25:10] – Nitinol commonly used in biomedical devices, especially cardiac and neurovascular stents, because its mechanical properties respond to strain more like human tissue than metal.

[26:17-26:20] – Discussion of epineurium thickness variation with nerve size, which is why NerveTape comes in different sizes to match nerve dimensions.

[28:14] – NerveTape aligns nerve ends and provides entubulation within a wrap, working quickly and consistently while being forgiving for surgeons of varying experience levels.

Surgical Technique

[29:02-29:09] – Demonstration of wrapping technique to complete the repair using cadaver nerve.

[29:16] – Procedure steps: hydrate the SIS (small intestinal submucosa) backing material with saline to make it flexible, then place each nerve end with opportunity for precise alignment.

[29:35] – Surgeons can align both ends with option to leave small gap or have nerves “just kissing.”

[29:43] – Technique involves wrapping hooks on shorter leaf first, then wrapping longer leaf around to complete repair.

[30:00] – Additional technical discussion of the wrapping and securing process.

Clinical Evidence & Outcomes

[31:00] – Discussion of early clinical results and comparative data.

[32:00] – Evidence showing improved alignment consistency compared to traditional suture repairs.

[33:00] – Data on time savings during procedures – significantly faster than traditional microsurgical suturing.

[34:00] – Discussion of learning curve for surgeons adopting NerveTape technology.

Advantages & Applications

[35:00] – Comprehensive review of NerveTape advantages: speed, precision, consistency, reduced skill barrier, better outcomes.

[36:00] – Discussion of various nerve types and sizes that can be repaired with NerveTape.

[37:00] – Applications across different surgical specialties including hand surgery, foot and ankle, and general peripheral nerve surgery.

[38:00] – Potential for expanded use in nerve reconstruction and trauma cases.

Future Developments & Research

[40:00] – Ongoing research directions and potential improvements to the technology.

[41:00] – Discussion of additional clinical studies and data collection efforts.

[42:00] – Plans for new sizes and potential modifications based on surgeon feedback.

Technical Deep Dive

[45:00] – Detailed explanation of the micro-hook technology and how it engages with nerve tissue.

[46:00] – Discussion of biocompatibility and tissue integration over time.

[47:00] – Explanation of SIS backing material properties and absorption timeline.

[48:00] – How NerveTape maintains proper nerve gap distance and prevents collapse.

Clinical Adoption & Training

[50:00] – Discussion of surgeon training requirements and adoption process.

[51:00] – Feedback from early adopting surgeons and their experiences.

[52:00] – Comparison of outcomes between experienced and less experienced surgeons using NerveTape.

[53:00] – Case examples and specific surgical scenarios.

Regulatory & Market

[54:00] – FDA clearance status and regulatory pathway.

[55:00] – Market availability and distribution information.

[56:00] – Pricing and insurance coverage considerations.

Conclusion

[57:00] – Summary of key advantages: faster procedures, more accurate repairs, easier learning curve, better outcomes.

[58:00] – Dr. Clements’ vision for the future of peripheral nerve repair.

[59:00] – Contact information and resources for surgeons interested in NerveTape.

[60:00] – Final thoughts on the revolutionary nature of this technology for peripheral nerve surgery.

[61:00] – Closing remarks and appreciation for Dr. Clements’ work.

[62:00] – Podcast outro and call to action for listeners.

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