Our team

EL: Aaron Huang, ahuan111@ucr.edu

CO EL: Dr. Dmytro V. Zagrebelnyy, dmytro.zagrebelnyy@ucr.edu

IM: Dr. Eric Gosink, eric.gosink@ucr.edu

TL: Dongwei Sun, dsun027@uce.edu

PI: Huinan Liu, huinanliu@engr.ucr.edu 

Our solution

Our polymeric composite conduit aims to bridge and repair damaged spinal cords, providing neurosurgeons with greater precision, eliminating secondary surgeries, and improving neural regeneration.
Instead of using nerve transplants to make immediate connections in treatments, we are manufacturing a biodegradable, synthetic tube for spinal (and potentially peripheral) nerve surgeons to operate with greater precision, avoid additional surgeries, and improve nerve regeneration via temporary structural support. The biodegradability is tunable so the tube can be customized for cases of varying severities. Formulating the synthesis process will help alleviate donor issues and eliminate graft-related biological risks. 

Commercialization Timeline and Deliverables

We developed our commercialization plan timeline into four phases. Phase I (Year 1), apply for PFI and SBIR 1 to Assess Safety; Phase II (Year 2-3), SBIR 2A to verify if the benefits meet expectations in small animal models; Phase III (Year 4-5), SBIR 2B for large animal models; Phase IV (Year 6), seeking for financial support for FDA approval and clinical trials. 
For the next stage. we would plan to perform in vivo animal study to evaluate the nerve recovery performance. With promising results, we will plan to move on to clinical trials and collaborate with our early adopters. Simultaneously, we will collaborate with medical facilities and other surgery centers to see if there are unmet needs.

Ecosystem map of our RegeSpine product

Our customers include spinal nerve surgeons, the hospital chief officers, and the supply chain officers (decision makers and economic buyers) in the hospital. These are the personnel that will be involved in the distribution and implementation of the device after going through the regulatory pathway, but the demand for the device is dependent on the assessments reported to the medical boards, medical centers, the FDA, and other surgeons by our beneficiaries.

Broader Impacts

Our product will lead to next-generation medical implants that promote spinal cord and peripheral nerve regeneration and eliminate secondary surgeries for implant removal. This product will improve the quality of life for patients who suffered damaged nerves and mobility by disease or trauma and reduce overall healthcare costs. Especially, it will provide alternative solutions to patients who are in urgent demand of autografts and allografts transplants. Our biodegradable polymeric nerve scaffold will further progress the field of regenerative medicine by allowing more physicians to participate in research as it alleviates the pressure from intense medical care routines and extensive treatments.

Fundamental research already conducted under previous awards

Our previous research studied biomaterials and related applications related to neural fields. We fabricated full biodegradable conductive polymer-coated magnesium (Mg) microelectrodes for neural recording, which exhibited 5 times higher charge storage capacity (CSC) than the standard platinum (Pt) microwire [7, 8, 9]. Those biodegradable Mg microelectrodes showed promising mechanical properties for load bearing and biodegradability in the human body. The conductive poly(3,4-ethylene dioxythiophene) (PEDOT) coating reduced the degradation rate of Mg microwires [10]. In addition, we found coated Mg microwire exhibited improved cytocompatibility through in vitro study with Human embryonic stem cells (hESCs), which can potentially differentiate into many cell types of interest (e.g., neurons) for regenerative medicine. We also disclosed a patent which incorporated Mg wires into biocompatible nanocomposite scaffold to provide both directional and biological cues for the neuro regeneration [12].

[7] Zhang C*, Wen TH, Razak KA, Lin J*, Xu C*, Seo C**, Villafana E**, Jimenez H**, and Liu H. Magnesium-based Biodegradable Microelectrodes for Neural Recording. Materials Science and Engineering: C. Volume 110, May 2020, 110614. Accepted 12/26/2019. DOI: 10.1016/j.msec.2019.110614.
[8] Zhang C*, Wen TH, Razak KA, Lin J*, Villafana E**, Jimenez H**, and Liu H. Fabrication and Characterization of Biodegradable Metal Based Microelectrodes for In Vivo Neural Recording. MRS Advances. Volume 4, Issue 46-47 (Soft Materials and Biomaterials). pp. 2471-2477. Published online by Cambridge University Press, July 16, 2019. DOI: 10.1557/adv.2019.302.
[9]. Zhang C*, Driver N*, Tian Q*, Jiang W*, and Liu H. Electrochemical Deposition of Conductive Polymers onto Magnesium Microwires for Neural Electrode Applications. Journal of Biomedical Materials Research Part A. [Epub ahead of print] March 9, 2018. DOI: 10.1002/jbm.a.36385. (PMID: 29520971)
[10] Sebaa M*, Nguyen TY*, Dhillon S*, Garcia S*, and Liu H. The Effects of Poly(3, 4-ethylenedioxythiophene) (PEDOT) Coating on Magnesium Degradation and Cytocompatibility with Human Embryonic Stem Cells for Potential Neural Applications. Journal of Biomedical Materials Research Part A. Online First, 3/5/2014. DOI: 10.1002/jbm.a.35142. (PMID: 24677580)
[11] Sebaa M*, Dhillon S*, Liu H. Electrochemical Deposition and Evaluation of Electrically Conductive Polymer Coating on Biodegradable Magnesium Implants for Neural Applications. Journal of Materials Science: Materials in Medicine. 24(2): 307-316, 2013. DOI: 10.1007/s10856-012-4796-y, Online First, 10/27/2012. (PMID: 23104085)
[12] Patent: Bioresorbable Device for Neural Injury Repair. Tech ID: 31798 / UC Case 2013-514-0 (https://techtransfer.universityofcalifornia.edu/NCD/31798.html)