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Corneal Regenerative Therapies
Corneal Regenerative Therapies
Corneal Regenerative Therapies

As the global population ages, vision impairment is an increasing concern, impacting physical, cognitive and mental health. Corneas are the most frequently transplanted human tissue worldwide, with around 185,000 procedures per annum, however it is estimated that 55% of the world’s population do not have access to donor material.

Approximately 12.7 million people globally are waiting for corneal transplants, and only 1 in 70 of those waiting are likely to receive the treatment that they need. There is a severe imbalance of access to human cornea tissue between developed and developing countries - with factors such as lower levels of economic and cultural sensitivities impacting the supply of donor corneas.

The development of medical devices and therapies providing novel alternatives to corneal transplantation, including corneal trauma /perforation repair, and addresses the global shortage of donor tissue for the treatment of corneal blindness.

Science


Our corneal regenerative therapies are the culmination of many years of academic research and collaborations with clinicians to understand how our technologies can be applied to solve medical challenges.

Our collaborators are known for their pioneering work in translational regenerative medicine and in-situ tissue regeneration. 

Our team have published extensively in tissue engineering and corneal biology.

Che Connon, Co-Founder of Kerato, and Managing Director of BSF Enterprise, commented:
"With 13 million people across the world waiting for a cornea replacement to transform their sight and quality of life, there is a global need for a solution.
Our plan at Kerato is to develop novel medical devices that can accelerate the use of lab-grown corneas as a medical solution." 

Medical Applications


The clinical applications of our medical devices are broad, ranging from perforations and ulcers to thinned-corneas and late-stage corneal disease.

Indications for use may include conditions where corneal glues have historically been used (to treat perforations, for instance), or where a full corneal transplant / Boston KPro is used.

Recovery from medical interventions using our products will be more straightforward and quicker, leading to better patient outcomes, and cost-savings for healthcare services and providers.

The Benefits


Effective early interventions

Effective early interventions for corneal trauma, and certain corneal infections and conditions mean that a full keratoplasty or corneal transplant are not subsequently required.

We will develop products that fit into the clinical pathway with little adjustment to standard clinical practice.

Recovery from procedures that use our medical devices should be faster and more straightforward than full cornea transplant, and complex follow-up should not be required.

Our medical devices will save health services money and lead to better patient outcomes and improved quality of life


2024 - Pre-clinical studies completed

Pre-clinical studies will be completed in Summer 2024

Timeline

For Medical Device

Kerato is currently working towards the launch of our first Medical Device.

To do this, we must implement GMP manufacturing and undertake Clinical Trials.

2024 - Pre-clinical studies completed

Pre-clinical studies will be completed in Summer 2024

2025 - Ethical approval

In 2025 we aim to have collated sufficient evidence to support ethical approval for our first clinical trials.
We will work with clinicians, hospitals and patient groups to design clinical studies that will benefit patients and support regulatory approvals.

Clinical Trials

2026 - Recruitment commences

Clinical trials will start in hospitals.

Patient follow-up will take place for a minimum of 18 months post medical device implantation

2025 - Ethical approval

In 2025 we aim to have collated sufficient evidence to support ethical approval for our first clinical trials.
We will work with clinicians, hospitals and patient groups to design clinical studies that will benefit patients and support regulatory approvals.

2028 - Regulatory approvals

Following completion of our clinical trials, we will generate evidence to support regulatory approval in our first target territory.

Medical Device launch

Launch Date 2029

Following regulatory approval, we will launch our medical device to the market, improving patients lives.

2028 - Regulatory approvals

Following completion of our clinical trials, we will generate evidence to support regulatory approval in our first target territory.

Want to learn more about what we do, and how we could work with your business or research group? Get in touch!
Investment Partner
Scientific Partner
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