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Orthocell has successful rotator cuff regeneration case study published

The regenerative medicine company is focused on regenerating mobility for patients by developing products for the repair of a variety of soft tissue injuries.

Orthocell Ltd - Orthocell announces successful rotator cuff regeneration case study published
The publication validates Ortho-ATI® as an effective solution to repair degenerate tendons

Orthocell Ltd (ASX:OCC) has had a successful case study focusing on its autologous tenocyte implantation (Ortho-ATI®) injection therapy to treat chronic degenerative rotator cuff tendinopathy published in the International Journal of Case Reports.

The case study was published by leading sports and exercise doctors Dr Bonnie McRae and Dr Hussain Khan and specialist Associate Professor Jane Fitzpatrick.

Orthocell managing director Paul Anderson said: “The positive case study supports the ongoing validation of Ortho-ATI® as a minimally invasive cell therapy to treat tendons that have failed to respond to conservative treatments and adds to the growing body of published data that supports Ortho-ATI® for the treatment of degenerate tendons.”

Paul Anderson.

Rotator cuff tendinopathy

Rotator cuff tendinopathy and tear, which manifests as severe shoulder pain, is a common and often difficult injury to treat and affects more than 50% of adults over 50 years of age.

Treating physician Associate Professor Jane Fitzpatrick said: “Rotator cuff tendinopathy is a common and debilitating injury that is often difficult to treat, especially in older patients who are less likely to benefit from surgery."

The current standard of care including corticosteroid, platelet-rich plasma (PRP) injections or surgery either lack an evidence base for long-term efficacy or suffer from variability in failure rates and full restoration.

Ortho-ATI® treatment process

A 77-year-old male patient suffered from chronic left shoulder pain for over three years and underwent numerous conservative treatment options including physiotherapy, injection therapy (prolotherapy) without success.

In 2016 the patient underwent Ortho-ATI® therapy commencing with a biopsy of his left patella tendon.

The patient’s tendon cells (tenocytes) were isolated and cultured at Orthocell’s TGA licensed manufacturing facility and injected into his rotator cuff and biceps tendon in the shoulder joint under ultrasound guidance.

Improved function

Pain and function improvement, including a return to gardening, was reported by the patient at the six-week post-implantation review and at eight months post-treatment (and a physiotherapy-led strength-based exercise program), the patient reported a return to sleeping normally, gardening and golf without pain.

Fitzpatrick said: “This case study highlights the exciting potential of Ortho-ATI® as a minimally invasive cellular therapy resulting in long-lasting improvements returning the patient to work and sport pain-free.”

At 12 months, the patient was completely symptom-free and had a complete range of movement with structural improvement in the tendon confirmed by repeat MRI.

Autologous tenocytes injected using ultrasound guidance.

Breakthrough in regenerative medicine

Ortho-ATI® is a world-leading breakthrough in regenerative medicine – a novel, cell therapy developed to treat chronic tendon injuries (tendinopathy/tendonitis).

Tendinopathy places a financial burden on the public health care system and treating physicians and insurers are constantly seeking advances in new treatments that are safe, effective and cost-efficient.

The current standard of care including corticosteroid, platelet-rich plasma (PRP) injections or surgery either lack an evidence base for long-term efficacy or suffer from variability in failure rates and full restoration.

Ortho-ATI® addresses these demands by enabling the accelerated regeneration of injured tendons, directly addressing the underlying cause of injury, replenishing degenerative tissue with healthy mature tendon cells (known as tenocytes).

Clinical validation

Ortho-ATI® has extensive clinical validation with published clinical data up to 4.5 years post-treatment in leading peer-reviewed journals (such as American Journal Sports Medicine), demonstrating durability and efficacy for treatment of degenerate tendons.

In studies conducted by Orthocell to date, Ortho-ATI® has been shown to be a cost-effective long-term, non-surgical solution for tendon injuries which are difficult to treat.

Orthocell is moving forward with clinical studies designed to assist in the US Food and Drug Administration (FDA) approval process.

Quick facts: Orthocell Ltd

Price: 0.355 AUD

Market: ASX
Market Cap: $65.57 m

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