REG - BSF Enterprise PLC - Kerato Limited - Update

BSF EnterpriseAnnouncement

22/02/2024 07:00

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RNS Number : 0086E  BSF Enterprise PLC  22 February 2024

22 February 2024

BSF Enterprise PLC

("BSF" or the "Company")

 

Kerato Limited - Update

 

BSF (LSE: BSFA), (OTCQB: BSFAF), the Main Market listed biotech company and
owner of pioneering UK-based tissue engineering company 3D Bio-Tissues Ltd
(3DBT) and corneal tissue replacement company Kerato Ltd, provides an update
on the technical and commercial development of Kerato.

Kerato Update

BSF's 100% owned Kerato was recently established as an independent company to
commercialise 3DBT's advanced intellectual property in lab-grown human corneal
products and accelerate the progression toward clinical trials.

Kerato uses cells and collagen to produce corneas in the laboratory that are
comparable to those of human donors. The Company has a dedicated commercial
team and has recently appointed a Managing Director, Sarah Greenhalgh, to
oversee the development of product offerings and the execution of the product
and sales strategy.

Two applications are being developed for Kerato's bioengineered biomimetic
corneas that address the global shortage of donor human corneas for medical
and research applications. Currently, 50 per cent of the world does not have
access to human donor corneas, with 13 million people on the waiting list for
replacements.

Implantable Medical Device

The Implantable Medical Device will focus on solutions in two key areas. The
first will be a corneal stroma equivalent, with >100μm thickness.
Anatomically, located between the outer epithelium and the inner endothelium,
the stroma is the thickest layer of the cornea and plays a pivotal role in
normal visual function.

The second focus will be on developing corneal fillers, providing stable
treatments for corneal thinning or misshaping, to enable refractive surgery,
or correct refractive errors including myopia and hyperopia, as well as
bioactive patches to support the repair of damaged corneas following injury or
surgery.

Kerato is currently working on a timeline to launch the Medical Device in
2028. This gives sufficient time for optimising the standard operating
procedures and implementing GMP manufacturing over the next 18 months before
commencing Clinical Trials in 2026. There are a number of grant funding
streams that Kerato has identified to help finance the clinical trials.

Kerato is looking to directly work with clinicians, supplying a transformative
medical device for the artificial cornea and corneal implant market valued
today at $422m with a Compound Annual Growth Rate (CAGR) of 7.4 per cent 1 
(#_ftn1) .

Ocular Toxicity Testing Platform

Building on a strategic relationship with one of America's largest consumer
goods companies, which successfully evaluated Kerato's lab-grown corneas as
potential alternatives in testing the safety and efficacy of their wide range
of chemical and pharma products, Kerato is now developing a new Ocular
Toxicity Testing Platform, named Keratox ™, to enable companies to test and
understand a range of ocular toxicity endpoints through a sustainable and
cost-effective method.

The platform will provide an in-house, high throughput solution that can be
incorporated into existing R&D pathways, providing an early indication of
a formulation's ocular toxicity profile with reference to the United Nations
Globally Harmonized System of Classification and Labelling of Chemicals. This
enables companies to "fail fast", thereby supporting innovation. Globally, the
in vitro toxicology testing market is worth over $12bn with a CAGR of 12 per
cent 2  (#_ftn2) .

The Company is currently working to enhance tissue optimisation and undertake
user testing before launching the platform to market in 2026.

Che Connon, 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 two-fold: develop novel medical devices that can accelerate the use
of lab-grown corneas as a medical solution; and provide an Ocular Toxicity
Testing Platform that can support innovation as global corporations continue
to invest heavily in new products that rely upon improved safety testing."

 

Sarah Greenhalgh, Managing Director of Kerato, commented: "Our aim at Kerato
is to develop and supply new technologies for corneal production. Our Ocular
Toxicity Testing Platform will be transformative in this respect, as we
provide a new testing method that can be seamlessly implemented within
existing R&D pathways and scaled, helping to meet the growing global
demand for an alternative and sustainable process."

 

For further enquiries, please visit www.bsfenterprise.com
(http://www.bsfenterprise.com/)  or contact:

 BSF Enterprise PLC                       Via SEC Newgate below
 Geoff Baker - Executive Director

 Che Connon - CEO & Director

 Shard Capital (Broker)
 Damon Heath                              0207 186 9000

 Isabella Pierre                          0207 186 9927

 SEC Newgate (Financial Communications)
 Bob Huxford                              020 3757 6882

 Elisabeth Cowell                         BSF@secnewgate.co.uk

 George Esmond

 

ISIN of the Ordinary Shares is GB00BHNBDQ51

SEDOL Code is BHNBDQ5.

 

Notes to Editors

BSF Enterprise PLC (BSF) is focused on unlocking the next generation of
biotechnological solutions - using cell-based tissue engineering to help
generate cultured meat, lab-grown leather, as well as human corneas, collagen
growth and skin substitutes, as part of a radical transformation to deliver
sustainable solutions across a variety of sectors.

 

It owns 100% of 3D Bio-Tissues (3DBT), a tissue engineering with
patent-protected IP that is already producing human corneas for testing to
help restore vision to millions of people. Building on this success, it aims
to produce the UK's first high quality lab-grown meat and leather from its
laboratory in Newcastle, transforming the meat-production industry and the
leather industry towards an ethical and sustainable practice.

 

BSF aims to deliver growth to shareholders through the continued
commercialisation of 3DBT's IP, which has multiple applications, as well as
through M&A. It aims to deveolop a suite of technologies that underpins
the development of tissue templating for corneas, meat and leather, and
license out the IP to manufacturers, wholesalers and distributors to help
manufacture the products at scale.

 

 1  (#_ftnref1) Artificial Cornea and Corneal Implant Market Size & Share
| 2028 (theinsightpartners.com)
(https://www.theinsightpartners.com/reports/artificial-cornea-and-corneal-implant-market)
accessed 20/02/24

 2  (#_ftnref2) Exploring Opportunities in the In-Vitro Toxicology Testing
(globenewswire.com)
(https://www.globenewswire.com/en/news-release/2023/09/25/2748557/28124/en/Exploring-Opportunities-in-the-In-Vitro-Toxicology-Testing-Market-Drug-Discovery-and-Personalized-Medicine-on-the-Horizon.html)
accessed 20/02/24

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