SKIN.L Regulatory News (SKIN)

AIM share code: SKIN

29 July 2019

Integumen PLC

("Integumen" or "Company")

Integumen collaboration with Irish Government supported tcbb RESOURCE, the University of Limerick, Epitheal and Cellulac to expand wound care division

Development of CBD infused chronic wound care and burns products

Integumen today announces the expansion of its wound care division, LifeScienceHub Ltd (Wound pHase), as it extends its license technology agreement (RNS 16 July 2018) with Cellulac plc (9.35% owned by Integumen), to include the refinement of medical grade hemp-derived cannabidiol ("CBD") for infused wound dressings in collaboration with the University of Limerick, Department of Chemical Sciences and the Irish Government suppported, Research Centre for Resource Efficiency ("tcbb RESOURCE").

The expanded division will utilise Labskin's CBD testing expertise and participate through the proposed Interreg North-West Europe collaboration with multiple partners including University of Limerick and Epitheal Limited Ireland, using Cellulac's new SoniqueFlo enzyme and engineering installation in tcbb RESOURCE's facilities in Thurles, Ireland to process and refine medical grade hemp-derived CBD to create private-label CBD infused chronic wound and burns dressings.

Wound pHase already has a strong IP portfolio for an innovative chronic wound dressing that notifies the patient or care giver as to the stage of healing without the need to remove the dressing. In addition it is developing a LabskinTattoo for UV sunscreen; it does this by changing colour based on the changing acidity of the wound, enabling assessment of the wound healing conditions without exposure to external bacteria through frequent dressing changes. The Company believes that the addition of CBD, with its known anti-inflammatory and pain relief properties, will contribute to a faster recovery.

Gerard Brandon, CEO of Integumen, commented:

"Following the success over the past year of building the Labskin division into a sustainable revenue generating business, management can now turn their focus on to the potentially lucrative Wound pHase division. Management believe that with their experience of building a 43 country contract production, sales, marketing and distribution channel in wound care whilst at Alltrael Pharmaceutical plc in 2003, Wound pHase has the potential to rapidly build a white-label offering.

With a growing demand for CBD infused products for their anti-inflammatory and pain relief properties, we believe that our expertise in skin wound repair and burns treatment at Wound pHase, in addition to the testing capabilities of Labskin and commercial knowledge of Integumen's management team, our unique CBD infused pain-relieving wound dressing for chronic wounds will be well received in this growing multi-billion dollar global market."

CBD and Pain Relief:

The human body makes its own version of CBD compounds called endocannabinoids with two receptors CB1 and CB2. They operate like neurotransmitters, switching on and off nerves. These, in turn, spark or dampen the electric pulse that creates thoughts, behaviours and movements. Tetrahydrocannabinoil ("THC"), the psychoactive substance that creates a high has a strong affinity to CB1, whereas CBD, with less than 0.2% THC does not typically interact with CB1 but can trigger a response to the body's endocannabinoids. Researchers, including Dr Joseph Cheer, a neurobiologist at the University of Maryland who specialises in cannabinoids, suggest that CBD switches off electrical pulses associated with pain by tweaking the amount of calcium that can get inside the body's nerves1.

Labskin has already successfully tested CBD demonstrating anti-microbial and anti-inflammatory effects in skin-care with the Company's STOER For Men cosmetics products, and is currently testing CBD infused female hygiene products at the Company's Labskin test facility in York, UK.

Wound Care Growth:

The incidence of chronic wounds is growing with approximately 1-2% of the USA population sustaining chronic wounds during their lifetime, leading to approximately 6.5 million incidences at an annual cost of approximately US$25 billion. In Europe, wound management costs approximately €6650-€10,000 per patient and consumes 2-4% of European healthcare budgets.

Patients with diabetes are also at high risk of wound infections. Approximately 387 million people have diabetes, and this number is predicted to increase by 205 million by 20352.

Collaboration partners

Labskin (Innovenn Ltd - wholly owned subsidiary of Integumen)

Integumen's laboratory grown human skin testing services. Specifically developed to host harmful bacteria on simulated human skin. It is the best testing platform for antimicrobial products, such as anti-dandruff shampoos and anti-acne creams, anti-aging, anti-fungal, UV sun exposure, toxic shock, and drug delivery through the skin, which cannot currently be carried out in vivo (animal models) due to ethical constraints of testing harmful bacteria.

Wound pHase (Life Science Hub (UK/IE) Limited - wholly owned subsidiaries of Integumen)

Lifesciencehub's lead technology is a pH diagnostic tool, Wound pHase, which has applications in the staging of chronic non-healing wounds, such as diabetic foot ulcers and venous stasis ulcers. Wound pHase is a polymer film in disc form which is applied to a wound and surrounding skin in the same way as a traditional hydrogel dressing. Responding to the acidity/alkalinity of the wound, the disc changes colour within five minutes of application. The colorimetric response of the disc to the wound indicates the acidity/alkalinity of the wound bed. Given that the pH of a chronic wound determines the ability of the wound to heal, Wound pHase allows caregivers to monitor the changing state of a wound, andtherefore vary the appropriate treatment regime.

Cellulac plc (9.35% owned by Integumen) - www.cellulac.com

A patented oil extraction pricess that excludes the use of high temperature solvents, developed over 16 years with capacity of between 4 and 1,000 tonnes per hour. Has already been installed at commercial scale for extraction of Omega 3 with EU and US clearance for human consumption. Extraction rig has been installed at tcbb RESOURCE facility in Thurles, Ireland specifically for this extraction process. 

Dept. Chemical Sciences, University of Limerick - www.ul.ie

Using laboratory and pilot scale processing facilities to test and optimise the yield of selected product from characterised feedstocks. The goal of this project is to extend the development of novelty industrial and commercial products through optimising the process variables for particular feedstocks or products such as CBD from hemp.

Epitheal Limited - www.epitheal.com

Epitheal is a science driven dermatology company, researching and developing formulations to promote healthy skin focusing on conditions using natural compounds as the basis of their research such as salicylic acid. Epitheal also focus on the varying application of natural compounds treating a wide range of diseases worldwide

tcbb RESOURCE - Irish Research Centre for Resource Efficiency CLG - www.tcbbresource.ie

tcbb RESOURCE is an Irish Government supported not-for-profit, test-bed for bio-based innovation - scale-up, demonstration and pilot technology for resource recovery and renewable gas and collaborates with higher-education research groups, enterprises and state agencies in publicly-funded programmes to support industry in the transition towards a low-carbon economy.

1. https://www.pbs.org/newshour/science/is-cbd-legal-heres-what-you-need-to-know-according-to-science

2. https://doi.org/10.1016/j.tibtech.2018.04.004

Contacts:

About Integumen:

Integumen is a vertically integrated business, collaborating their Labskin technology platform with partners in artificial intelligence, clinical research, medical device and life science. These collaborators are building their own technology on top of the Labskin AI backbone. Labskin allows skin-care, health-care, pharmaceutical manufacturers and cosmetic companies to test their products on human-like skin in a real-world environment with full access to multiple state-of-the-art partner technologies.

The Company combines data analytics with access to therapeutic operational expertise and offers solutions to our clients, from regulatory approvals, right through to marketing fully tested ingredients that have been certified on our Laboratory grown living human tissue.

Notes to Editors:

CBD (Cannabidiol) oil is an extract from the Cannabis Sativa plant. Hemp-derived CBD is produced from the seeds of the plant, and does not contain the psychoactive ingredient Tetrahydrocannabinol (THC) or does so only in trace amounts. This differentiates hemp-derived CBD oil from CBD Oil produced from flowers, leaves and stalks of the plant (which are higher in THC content). CBD products which contain less than 0.2% THC concentration are legal in the UK.