Company Overview

Orthocell is an Australian regenerative medicine company dedicated to restoring mobility and regenerating soft tissue. Founded in 2006, Orthocell provides new approaches to the regeneration of tendon, cartilage and the repair of soft tissue injuries.

To date the company has successfully developed and commenced commercialisation of two autologous (using a patient’s own cells) cell therapies for the treatment of damaged and degenerated tendons (Ortho-ATI®), as well as damaged and degenerated cartilage (Ortho-ACI®). Orthocell has also developed, and is readying for registration, a collagen scaffold product (CelGro®) for the repair and reconstruction of soft tissue injuries, such as tendon tears and guided bone regeneration in dental and orthopaedic applications.

Orthocell is led by an experienced board and management team, which have been responsible for the development of the business. They have a successful track record of developing and commercialising new therapies that transform patients' lives.

A novel treatment with a strong and growing clinical evidence base

Orthocell’s Ortho-ATI® intervention uses a novel and highly advanced approach that utilises each patient’s own Tendon Progenitor Cells (TPC’s) to stimulate the formation of collagen and other connective tissue elements. Ortho-ATI® enables the accelerated healing of tendons, which are resistant to other existing therapies. It reduces pain and stiffness and increases strength, thereby greatly improving the patient’s quality of life.

Ortho-ATI® clinical trials and case studies have demonstrated significant pain reduction and functional improvement in a range of different tendons including, gluteal and Extensor Carpi Radialis Brevis (ECRB) (tennis elbow) tendons. Clinical data at up to 5 years post intervention continues to demonstrate significant improvement in pain relief and function.

Early commercialisation success

Orthocell has a licence to manufacture and market the Ortho-ATI® and Ortho-ACI® products in Australia and have treated more than 300 patients with each therapy to date. Awareness and support for the therapies continues to grow within the region with patients treated in Hong Kong, Singapore, New Zealand and Australia.

Promising new product and opportunity

Orthocell’s CelGro® collagen scaffold product is a promising new platform technology that provides the opportunity to enter the orthopaedic and general surgical markets for collagen scaffolds. CelGro® has many advantages over existing marketed naturally derived and synthetic scaffolds. Orthocell’s CelGro® scaffold is a unique collagen scaffold that is bio-compatible, bio-absorbable and biomechanically sound, allowing for multiple uses either on its own or in combination with autologous cells or growth factors. CelGro® exhibits a number of qualities that make it ideal for use as a tissue reconstruction and repair device.  Consequently this highly purified collagen construct has a wide and growing range of indications in orthopaedics, dental, general surgery, gynaecology, ENT, and soft tissue reconstructive interventions.

Established cGMP manufacturing facility and licence

Orthocell has established a quality controlled Good Manufacturing Processes (cGMP) facility in Perth qualified to international standard ISO 14644-1. This facility is licensed by the TGA to permit the manufacture of human tendon stem cells (tenocytes) and cartilage stem cells (chondrocytes) for the regeneration of damaged tendon and cartilage

Experienced team with successful regenerative medicine track record

Orthocell's Chief Executive Officer and Chief Scientific Officer both have unique experience in the regenerative medical industry, having been responsible for securing one of the first cell therapy products approved for the repair of cartilage in Australia and having led the sale of one of Australia’s first regenerative medical companies. The Board also features a number of experienced directors, including a world expert in orthopaedics, as well as directors with track records in developing and gaining FDA approval and CE marking for products in the life sciences and health care industry. The directors have also successfully sold Australian companies within the health care industry to US based acquirers.

 

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