09 Jul Biotherapy Services Limited (BTS) receive a follow-on investment of £1.5m
Biotherapy Services Limited (BTS) receive a follow-on investment of £1.5m continued support of ongoing clinical trials for its regenerative wound care treatment.
- The funds will be used to support the clinical development of their patented treatment for Diabetic Foot Ulcers (“DFUs”).
- Diabetes affects 3.7m people across the UK, one in four will suffer a DFU.
- Biotherapy Services Limited has recently been awarded a UK Innovation Passport.
Biotherapy Services Ltd (BTS), a Portfolio company of the Foresight Group (“Foresight”) are pleased to announce they have received a £1.5m follow-on investment to support the clinical development of RAPIDTM Biodynamic Haematogel, currently in phase 2b/3 clinical trials for the treatment of DFUs.
Co-founded in 2013, BTS specialise in autologous regenerative techniques and have developed a wound care treatment with published results in healing severe DFUs, resulting in 13 of 15 patients (86.7%) at high risk of limb loss avoiding amputation[1]. Originally marketed as a medical device, the treatment has since been reclassified by the UK’s regulatory body, the MHRA, as a medicinal product requiring the appropriate clinical trials to demonstrate safety and efficacy, and progress to market authorisation.
Diabetes affects 3.7m people across the UK, one in four of whom will suffer a DFU. Currently this results in 169,000 DFUs being treated annually by the NHS. Chronic ulcers, defined as those which do not resolve in 12 weeks, go on to cause 11,000 amputations per annum, and cost the NHS £935m in 2017 alone. Diabetes accounts for 10% of the entire NHS budget and this is forecast to increase as the number of diabetes sufferers in the UK grows to 5.1m by 2025, up c.38% and it’s hoped this treatment will help address the significant quality of life impact that a DFU can have on diabetic patients’ lives.
BTS has recently been awarded an Innovation Passport by the authorising bodies including the Medicines and Healthcare products Regulatory Agency (“MHRA”) and the National Institute for Health and Care Excellence (“NICE”), under their recently launched Innovative Licensing and Access Pathway (“ILAP”) scheme[2]. This was granted in recognition of the high unmet clinical needs of patients affected by DFUs, with compelling early phase data to indicate potential benefit of RAPIDTM Biodynamic Haematogel to patients.
Broadening its clinical development, BTS have progressed into other areas which would benefit from similar technology such as patients impacted by non-healing wounds (pressure ulcers, deep sternal wounds, post-operative wounds, and palliative care). This is an area of high unmet clinical need and currently represents a market worth over £5.6bn in the UK[3]. Longer term, the Company is planning to expand its technology and expertise across diverse clinical areas such as hair re-growth, scar reduction and prophylaxis of wound infection for high-risk procedures.
Commenting on the additional funding,
James Rickard, Chief Scientific Officer (Acting MD) Biotherapy Services said: ” The whole team are really excited to receive the additional funding from Foresight allowing the business to expand RAPID-1 our Clinical trial and generate the outcome data sooner accelerating the treatment towards routine clinical practice. We hope RAPIDTM Gel can go a long way towards addressing the unnecessarily high amputation rate of patients suffering from DFUs.”
John Chiplin, Chairman of Biotherapy Services said: ” We are delighted to continue to receive the support of Foresight, which has enabled Biotherapy Services Ltd to develop and continue to commercialise a range of therapies that will be truly therapeutically disruptive in improving the lives of patients living with chronic wounds and reducing the burden on both the NHS and globally”.
Nick Mettyear, Investment Manager at Foresight, added: “The recent Innovation Passport award for RAPIDTM Gel is a significant step forward in the Company’s journey to offering a new treatment option for DFU, a debilitating and costly condition. Foresight is excited to continue to support a truly revolutionary approach to the problem of chronic non-healing wounds.”
[1] Martin T, Kyriakides CK, Sarkar S. Platelet Rich Plasma (PRP) is an Adjunct for the Accelerated Closure of High-Risk Diabetic Foot Wounds. British Journal of Surgery Feb 2015 102; S2: p24 https://doi.org/10.1002/bjs.9770
[2] https://www.gov.uk/guidance/innovative-licensing-and-access-pathway
[3] Guest JF, Fuller GW, Vowden P. Cohort study evaluating the burden of wounds to the UK’s National Health Service in 2017/2018: update from 2012/2013. BMJ Open. 2020 Dec. https://bmjopen.bmj.com/content/10/12/e045253
Learn more about the RAPIDTM Biodynamic Haematogel, currently in phase 2b/3 clinical trials