CelGro® pre-clinical study validates high quality nerve repair

• Results indicate CelGro® facilitates regeneration of severed nerves returning them to normal nerve structure avoiding the need to use damaging sutures
• Provides critical data demonstrating the restoration of normal nerve architecture which is not possible to be obtained from human clinical trials
• Reinforces human clinical trial results indicating CelGro® guides and supports nerve regeneration
• Further human nerve clinical trial results expected in Q3 CY2019

Perth, Australia; 25th July 2019: Regenerative medicine company Orthocell Limited (ASX:OCC, “Orthocell” or the “Company”) is pleased to announce positive pre-clinical results for the use of CelGro® in enhancing repair of severed peripheral nerves. The new results provide evidence of CelGro® restoring nerves to their normal or pre-injured structure, which is not possible to be examined as part of the current human nerve regeneration trial.

Orthocell Managing Director Paul Anderson, said: “We are thrilled with the animal study results, indicating CelGro® facilitates high quality nerve repair. The results reinforce the initial patient outcomes previously reported from our current human clinical study demonstrating return of sensation and muscle function in affected limbs following CelGro® nerve regeneration treatment. Restoring normal nerve structure is critical for regaining mobility, function and quality of life.”

Repair of damaged peripheral nerves often involves reconstructive surgery and the use of sutures/stitches to reconnect the nerve ends. This traditional method has shown to result in suboptimal sensory and functional patient outcomes. Sutures are unable to seal the nerve, thus incapable of preventing leakage of important intraneural fluids from the regenerating nerve. Furthermore, nerve suturing is technically demanding to apply for direct repairs and often induce detrimental scarring that impedes healing and functional recovery.

In this pre-clinical study, Dr Pletikosa showed that use of CelGro® for peripheral nerve repair in rats induced a complete regeneration of nerve fibres which were indistinguishable from normal nerve histology. The findings were supported by early recovery of nerve sensory and muscle functions. CelGro® showed superior outcomes in restoration of nerve structure and functional recovery when compared to the traditional direct suturing nerve repair technique.

Dr Zoran Pletikosa, said: “CelGro has shown to produce superior outcomes in restoration of nerve structure and functional recovery when compared to traditional techniques. I am very pleased with the performance of CelGro in this study and excited by its potential.”

Pre-Clinical Study Results
Orthocell conducted this preclinical animal study to demonstrate at a microscopic level that the company’s collagen medical device CelGro® produces superior nerve repair in severed peripheral nerves when compared to the traditional (direct suture) repair method.

The pre-clinical study was conducted with 30 rats across three study groups (Control; Direct suture method and CelGro® repair method). Motor and sensory outcomes were measured at multiple time points. Summary results of the study included:

• CelGro® maintained alignment of nerve ends during reconnection
• Suturing caused scarring and fibrosis impeding nerve growth leading to disordered nerve alignment and inferior repair – refer to Figure 1: Comparing Histology of Nerve Tissue
• CelGro® promoted nerve growth allowing normal nerve alignment resulting in a repair indistinguishable from normal nerve – refer to Figure 1: Comparing Histology of Nerve Tissue
• CelGro® repaired nerves showed a 30% greater transmission of electrical impulses and corresponding muscle function
• CelGro® repaired nerves showed return to normal sensory function (responses to mechanical and thermal stimuli) 2-3 weeks faster than sutured nerves

These results indicate CelGro® can accelerate and augment the repair of damaged or severed nerves compared to suturing. Tensionless and sutureless repair of peripheral nerves is of significant clinical interest to the surgical community (eg. Orthopaedics and neurosurgery) because of the potential improvements in efficacy and efficiency of surgical procedures. Tensionless and/or sutureless repair will reduce surgery time and the risk of additional trauma to soft tissue through the use of sutures. This study also further validates the versatility of the CelGro® platform technology and the potential to extend Orthocell’s medical device product range.
CelGro® Human Nerve Regeneration Trial
Recently Orthocell announced that the first four patients successfully completed participation in the CelGro® nerve regeneration clinical trial. Following surgery with CelGro®, patients experienced an 83% improvement in muscle power of affected limbs and had returned to work, sport and normal daily activities. A short video explaining how CelGro® supports nerve repair can be found here. https://www.orthocell.com.au/celgro-nerve-1

The company is in the process of gathering further patient data and will provide a clinical update in 3Q CY2019.

About the CelGro® Platform
CelGro® is a collagen medical device platform for soft tissue regeneration and repair applications, manufactured by Orthocell at its quality-controlled Good Manufacturing Practices (GMP)-licensed facility in WA.

Orthocell has received market authorisation (CE Mark) of CelGro® in the EU for dental bone and soft tissue applications. The CE Mark allows CelGro® to be sold within EU countries, validates CelGro®’s quality manufacturing and product performance, and provides a strong foundation for indication expansion and regulatory approvals.
CelGro® has also been shown to improve tissue growth and repair in clinical studies using CelGro® to augment repair of the rotator cuff tendon within the shoulder, to guide bone regeneration in the jaw and to assist in the rejoining of severed, or damaged peripheral nerves. CelGro® is a customisable collagen medical device with numerous competitive advantages over existing synthetic and biologic tissue repair devices, particularly in the areas of cell compatibility, tensile strength and the promotion of quality tissue repair.

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About Orthocell Limited
Orthocell is a regenerative medicine company focused on regenerating mobility for patients by developing products for the repair of a variety of soft tissue injuries. Orthocell’s portfolio of products include TGA-licensed cell therapies Autologous Tenocyte Implantation (Ortho-ATI®) and Autologous Chondrocyte Implantation (Ortho-ACI®), which aim to regenerate damaged tendon and cartilage tissue. Orthocell is moving forward with clinical studies designed to assist in the US (FDA) approval process and has completed its pre-IND meetings with the FDA. The Company’s other major product is the CelGro® platform technology, a collagen medical device which facilitates tissue repair and healing in a variety of orthopaedic, reconstructive and surgical applications. Orthocell recently received European regulatory approval (CE Mark) for CelGro®. The collagen medical device can now be marketed and sold within the European Union for a range of dental bone and soft tissue regeneration procedures and is being readied for first approval in the US and AUS.

For more information on Orthocell, please visit www.orthocell.com.au or follow us on Twitter @Orthocellltd and LinkedIn www.linkedin.com/company/orthocell-ltd