BSF Enterprise plc (LON:BSFA), the Main Market listed biotech company and owner of corneal tissue replacement company Kerato Ltd, has announced that Kerato Ltd has entered into a Heads of Terms agreement and research partnership with the University of Montreal in Canada.
BSF’s 100% owned Kerato is an independent company established to commercialise new innovations in tissue engineering towards in vitro and in vivo corneal use.
As part of this strategy, Kerato will work with the University of Montreal, combining tissue engineering expertise to further develop an in-situ gelling cornea that offers a novel treatment for corneal damage and full thickness perforations.
Corneas are the most frequently transplanted human tissue worldwide, with around 185,000 procedures per annum1. However, it is estimated that 55% of the world’s population do not have access to donor material1 with an estimated 12.7 million people worldwide waiting for a transplant2. The global artificial cornea and corneal implant market was valued at $ 421 million in 20213, of which Kerato estimates its serviceable market to be $37.6 million. The total market is expected to grow at 6.9% per annum to reach $ 767.5 million by 20303.
Kerato’s treatment combines host corneal stromal cells with a synthetic extracellular matrix protein sequence to support tissue healing and re-epithelialization of the surface of the eye. Administered via injections to repair damaged tissue rather than performing full transplant surgery, the treatment is expected to greatly reduce the complexity of procedures for many patients. This is expected to reduce time in hospital, decrease the likelihood of graft rejection, reduce costs for health service providers and result in better patient outcomes.
New tissue resulting from the treatment comprising the patient’s own stromal cells, is transparent and replicates the natural curvature of the eye. Stromal cells comprise the extracellular matrix that provide structural support for organs. Kerato’s Intellectual property and academic partners have previously demonstrated the critical role of corneal stromal cells in engineering a healthy extracellular matrix, and the impact that biomechanics can have on tissue regeneration.3
The partnership with the University of Montreal will build on the successful pre-clinical studies and academic work of Professor May Griffith, advancing the translation of the prototype corneal treatment and taking it through safety and efficacy studies, completing clinical trials and gaining regulatory approvals before launching on to international markets.
To de-risk this (as well as shorten time to market) the new approach will first be trialled in the veterinary space giving animal owners much greater access to complex corneal repair treatments.
Kerato’s aim is to commercialise its advanced intellectual property in tissue engineering and bio-engineered corneal products and accelerate progression toward clinical and veterinary trials. Two applications are being developed, an Implantable Medical Device and an Ocular Toxicity Testing Platform.
Sarah Greenhalgh, Managing Director at Kerato Ltd said: “This project with the University of Montreal marks the next step in the growth and development of Kerato’s corneal regenerative therapy technologies. Stromal stem cells significantly contribute to corneal clarity by replenishing damaged or aged keratocytes. We are excited to be working on a transformative treatment for the repair of corneal damage which can reduce costs for healthcare providers and support improved patient outcomes.”
1Gain P, Jullienne R, He Z, Aldossary M, Acquart S, Cognasse F, Thuret G. Global Survey of Corneal
Transplantation and Eye Banking. JAMA Ophthalmol. 2016 Feb;134(2):167-73. doi:
10.1001/jamaophthalmol.2015.4776. PMID: 26633035
2Gain P, Jullienne R, He Z, et al. Global Survey of Corneal Transplantation and Eye Banking. JAMA Ophthalmol.
2016;134(2):167-173. doi:10.1001/jamaophthalmol.2015.4776
3Artificial Cornea and Corneal Implant Market Report, 2030 (strategicmarketresearch.com), accessed 9/04/24
4Gouveia, R.M., Lepert, G., Gupta, S. et al. Assessment of corneal substrate biomechanics and its effect on epithelial stem cell maintenance and differentiation. Nat Commun 10, 1496 (2019). https://doi.org/10.1038/s41467-019-09331-6
BSF Enterprise is the parent to a portfolio of innovative subsidiary companies focused on developing and commercialising cell-based tissue engineering solutions to deliver sustainable outcomes across a variety of sectors.