September - Following a meeting between the Medicines & Healthcare products Regulatory Agency (MHRA) and Edixomed, the MHRA confirmed that EDX110, when used as a wound care product, would be regulated as a Class III medical device.
August – Perfectus Biomed complete a further project for Edixomed, adding to the list of micro-organisms susceptible to EDX110 under the AATCC Test Method 100 procedure, including species with implications in dermatological conditions.
June - Prof Rob Allaker, Professor of Mucocutaneous Microbiology, Barts and The London School of Medicine & Dentistry, Queen Mary University of London confirmed that the EDX110 biofilm work, showing the activity of EDX110 against single and mixed species biofilms, and against drug resistant species, has been accepted for presentation at Eurobiofilms 2017.
May - Edixomed have retained the services of Professor David Lloyd BVetMed, PhD, FRCVS, DipECVD, Emeritus Professor of Veterinary Dermatology, The Royal Veterinary College. Professor Lloyd is advising Edixomed on the potential therapeutic applications of the nitric oxide system in livestock and companion animals and an appropriate research and development plan.
May - An independent analysis performed by Perfectus Biomed and utilising the FDA stipulated AATCC Test Method 100-2004, indicates that the Company’s lead product achieved the required bacterial and fungal reduction to support claiming “antimicrobial effectiveness” in both antibiotic sensitive and resistant organisms.
April - Edixomed is pleased to announce that their Chairman, Professor Chris Wood, has been elected as a Fellow of the The Learned Society of Wales. The Society acts as an independent source of expert scholarly advice and comment on matters affecting the research , scholarship and well-being of Wales and its people, and to advance public discussion and interaction on matters of national and international importance.
March - A major UK audit report is published, highlighting the continuing, critical unmet medical needs in patients with diabetic foot ulcers. The latest National Diabetes Foot Care Audit for England and Wales reports that more than 60,000 with diabetes in England are thought to have foot ulcers at any given time and that in 2014-15 the annual cost of diabetic foot disease to the NHS in England was estimated at £1 billion, in addition to the personal/social costs of reduced mobility and sickness absence.
March - Edixomed announce plans to support a pilot study using its innovative nitric oxide smart wound treatment to try and improve outcomes in Buruli ulcers, a debilitating skin condition affecting many thousands of children in West Africa and other parts of the world.
March – Edixomed receive Notice of Allowance from the United States Patent and Trademark Office for the patent application covering the current embodiment of their nitric oxide generating treatment system used in the diabetic foot ulcer study and other clinical programmes. A 2014 priority date gives the treatment system Intellectual Property Protection in the USA until 2034.
January – Edixomed retain Arc Bio Communications to develop programmes to connect and engage with medical, patient, scientific and investment communities.
November - “NHS Scotland proposed a fast track adoption of the nitric oxide dressing for the treatment of chronic ulcers as soon as it is granted marketing authorisation. NHS Scotland will provide a rapid Health Technology Assessment and support early uptake and further development in partnership with Edixomed.” – Andrew Fowlie, Innovation Team and Health Innovation Partnerships, Scottish Government Health and Social Care Directorates.
October – BBC Panorama reports on the health epidemic that is threatening to overwhelm the NHS. Type 2 diabetes is believed to cost the NHS £10.3 billion each year, with ten per cent of this budget spent on foot ulcers and amputations alone.
October – BBC Inside Out takes a close look at the diabetes epidemic that is sweeping the country and threatening to overwhelm the NHS, confronting the public with the reality of the huge number of amputations directly related to the disease.
October - Edixomed complete a series of analyses demonstrating the efficacy of the nitric oxide dressing in the prevention and treatment of fungal biofilms. The work was undertaken in conjunction with Professor Robert Allaker of The Blizard Institute, Queen Mary University of London.
September – The World Health Organisation publish their updated antimicrobial resistance fact sheet: Antimicrobial resistance is an increasingly serious threat to global public health that requires action across all government sectors and society.
September - All 193 UN member states have agreed to combat the proliferation of drug-resistant infections, estimated to kill more than 700,000 people each year. The UN secretary general, Ban Ki-moon, said antimicrobial resistance is a “fundamental threat” to global health and safety at the first general assembly meeting on drug-resistant bacteria.
June - The MHRA grants approval for Humanitarian Use of Edixomed’s Nitric Oxide dressing for a patient at the Royal Marsden Hospital, London with a non-healing post-surgical tumour resection wound, complicated by previous radiotherapy.
May – NHS Choices report on a new review calling for global action to tackle the antibiotic resistance crisis to prevent a post-antibiotic future. The review panel, chaired by economist Jim O'Neill, warns that without global action, antibiotic resistance will become a "devastating problem" by 2050.
May - The MHRA grants approval for Humanitarian Use of Edixomed’s Nitric Oxide dressing for named patients with sickle cell ulcers, not responding to any other treatments at Accelerate CIC Wound Care Centre, Mile End Hospital, London.
April – Diabetes UK launch pop-up designer shoe shop, Amp Shoes, in London. With 135 shoes on display, each represents one of the 135 diabetes-related amputations taking place in England each week.
March - A series of experiments are completed demonstrating the efficacy of Edixomed’s NO-generating solution in prevention and treatment of antimicrobial biofilms. The work was undertaken in conjunction with Professor Robert Allaker of The Blizard Institute, Queen Mary University of London.
January - Dr Hugh Munro joins Edixomed as Chief Scientific Officer. Hugh is an accomplished polymer scientist with an extensive background in product development. Hugh is author/co-author of circa 80 peer reviewed publications and Inventor/co-inventor of 17 USPO and 12 EPO granted patents.
January - Edixomed begin a research collaboration with the University of the West of England, Bristol (UWE), to develop and assess an extended range of nitric oxide dressings.
January - Edixomed complete a series of analyses demonstrating the efficacy of the nitric oxide dressing in the prevention and treatment of biofilms, including many multi-drug resistant variations and poly-microbial biofilms. The work was undertaken in conjunction with Professor Robert Allaker of The Blizard Institute, Queen Mary University of London.
December – Edixomed announces the final patient in its ProNOx1 study, the randomised controlled study in diabetic foot ulcers, has completed their final visit and the study has now officially closed.
August - Dr Waleid Akabat joins Edixomed as Senior Analytical Scientist. Waleid brings extensive experience in analytical science within the pharmaceutical industry to Edixomed.
June - Edixomed announced today that it has reached the targeted number of patients for ProNOx1, its randomised controlled clinical study of the wound dressing in diabetic foot ulcers. The study has successfully recruited 60 evaluable patients in each arm of the study, and aims to show the advantages of the NOx generating dressing over standard of care.
May – Edixomed presented a study update at The International Symposium on the Diabetic Foot (ISDF). The ISDF is held every four years with over 1200 attendees and a faculty comprising the world’s leading diabetic foot specialists.
February – Edixomed announce the 10th and final site is now open in ProNOx1 study. The study is now recruiting in London, Dundee, Edinburgh, Glasgow, Leeds, Wakefield, Preston, Manchester, Salford and Nottingham.
February – Edixomed is awarded a SMART award from Scottish Enterprise. Scottish Enterprise awarded Edixomed £100,000 to support its research into the nitric oxide technology and the development of a commercially viable transdermal pharmaceutical delivery product.
November – An update of ProNOx1 was one of only ten abstract submissions selected for oral presentation from more than 280 approved posters at Wounds UK.
October - Edixomed’s presented a ProNOx1 study update at the Diabetic Limb Salvage Conference (DLS) in Washington DC. Highly regarded as one of the world’s finest limb salvage events, DLS brings together over 800 lower limb specialists.
May - Edixomed’s presents a diabetic foot ulcer study update at the 15th Malvern International Diabetic Foot Conference. Almost 300 physicians, surgeons, podiatrist, orthotists and nursing staff from Europe, US, Asia and New Zealand attended. Professor Mike Edmonds from King’s College Hospital, a Principal Investigator for the ProNOx1 study commented, “The outcomes are very encouraging at this stage. Longstanding diabetic foot ulcers are an area of great unmet need and we are heartened when a new treatment comes along that appears to work well”.
January - NOVAP, Edixomed’s Phase I/II study of the NOx generating technology in mechanically ventilated patients for the reduction of ventilator associated pneumonia (VAP) opens for recruitment at Barts Health NHS trust. Chief Investigator Professor Charles Hinds is very excited by the technology and believes it has the potential to reduce the incidence of this life threatening treatment complication.
January - Edixomed’s novel NOx generating wound dressing was short-listed for the prestigious Scottish Life Sciences Innovation Award.
December - Edixomed opens its 2nd study site, Canniesburn Regional Plastic Surgery and Burns unit, Glasgow, in ProNOX2 - the superficial partial thickness wounds study.
November – Edixomed opens its 4th study site in ProNOx1 - the diabetic foot ulcer study. The study is open at Ninewells Hospital, Dundee; Edinburgh Royal Infirmary; Southern General Hospital, Glasgow and King’s College Hospital, London.
September - Edixomed’s randomised, controlled clinical study in superficial partial thickness wounds (ProNOx2) opens at the internationally renowned St Andrew’s Centre for Plastic Surgery and Burns, Chelmsford, the first of 2 sites.
June - The first patient is enrolled into Edixomed’s 140 patient randomised, controlled clinical study of the NOx generating wound dressing in diabetic foot ulcers (ProNOx1) at Kings College Hospital diabetic foot clinic. The diabetic foot clinic at Kings College Hospital, run by Professor Mike Edmonds, was the first of its type in the world to offer multi-disciplinary treatment for diabetic foot problems.
March - Edixomed gains approval from the MHRA and NRES for its 140-patient randomised, controlled clinical study of the NOx generating wound dressing in diabetic foot ulcers (ProNOx1).
March - Edixomed were invited, as past winners, to represent the Small Business Research Initiative at the Innovation Expo 2013. Edixomed presented the science and data behind the NOx generating technology at this prestigious congress to an audience of lead investigators, innovators and investors.
February - Edixomed are awarded a Strategic Research Project Grant from Barts and The London Charity. The grant will fund a phase I/II study of the NOx technology in increasing transdermal passage of local anaesthetics.
September - Edixomed clinical team present, as invitees of UKTI, at the 5th International Wound Dressings Conference in Beijing.
September - Carl Daintree has been appointed as Director of Operations. Carl has almost 20 years of experience in the biotech industry. Carl has run his own consultancy servicing the biotech industry. Carl has a wealth of experience in operations, regulatory procedures, market entry, sales and marketing.
June - The Medical Research Council awarded Edixomed with a grant of over £250,000 to investigate whether the NOx producing technology, when administered to mechanically ventilated patients, can reduce the incidence of ventilator associated pneumonia. Currently, as the most prevalent nosocomial infection in Critical Care Units (CCUs), VAP accounts for more than half of all CCU-acquired infections.
April - Both Alida Capital International and the Scottish Investment Bank added further investment in Edixomed Limited.
April - Justin Barnes appointed to Board of Directors.
April - Syd Hanna appointed to Board of Directors.
July - The Small Business Research Initiative for Healthcare (SBRI Healthcare) is an NHS England initiative, championed by the newly formed Academic Health Science Networks (AHSNs), who aim to promote UK economic growth whilst addressing unmet health needs and enhancing the take up of known best practice. Edixomed wins £400,000 share of £1.5M Small Business Research Initiative (SBRI) Competition funding.
June - The Medical Futures Innovation Awards is the world's most prestigious fora and catalyst for innovation in healthcare and lifesciences. Edixomed’s NOVAP system using nitric oxide to prevent Ventilator associated pneumonia received the Overall Winner for Respiratory Innovation Awards.
March. Alida Capital International (ACI) is a prominent Scottish business angel syndicate focused on investing in Scotland's life sciences sector, specifically biotech and pharmaceutical companies and have invested in Edixomed.
Improved healing and outcomes for diabetic foot wounds with a nitric oxide generating dressing
Harrogate - November 2014
Joanne Stewart, Joanne McCardle, Matthew Young, Michael Edmonds, Brian Kennon, Carl Daintree, Lynsey Beall, Graham Leese.
The ProNOx1 study now has 26 evaluable patients. In this analysis, the NOx dressing demonstrated a statistically significant decrease (p‹0.05) in wound size, with 50% of the NOx dressing patients having a wound of less than 10% of its original size, compared to only 16.6% in the standard of care group. Moreover, the dressing has exhibited a £64,000 saving in the treatment of serious adverse outcomes as a result of lower incidence.
A Clinical Study of A Nitric Oxide Dressing for Healing Diabetic Foot Ulcers: Promising Early Results
Washington DC - October 2014
Joanne Stewart, Matthew Young, Michael Edmonds, Brian Kennon, Carl Daintree, Graham Leese.
An early analysis of the data was performed, comparing the area of the wound at baseline to that of the wound after 12 weeks of treatment or until completely healed, whichever was earlier. In the group treated with the NOx dressing 50% of the patients had a wound of less than 10% of its original size compared to 16.6% in the standard of care group giving a statistically significant difference.
A controlled trial of the effects of local NO/NOX application on microcirculatory blood flow and oxygen tension in the skin of patients with Sickle cell disease.
Sweden, 2nd – 5th June 2005
Telfer P, Ekwebelem TC, Heath M, Radfar M, Tucker AT. European Hematology Association 10th Annual Congress, Stockholm, Sweden, 2nd – 5th June 2005.
The physiological impact of nitric oxide (NO) and the enzymatic pathways for synthesis via nitric oxide synthase have been clearly established for many years since the pivotal work of Furchott, Ignarro and Murad (Nobel Prize, 1998). Nitric oxide is a key modulator of biological function in man.
Diabetic microvascular vasodilator response to a novel NO/NOx generating system.
Tucker AT, Das R, Coppack S, Peacock J. Recent Advances in Cardiovascular Disease, London Hypertension Society 15th Annual Symposium, Royal College of Surgeons London, United Kingdom, 25th May 2004. British Journal of Clinical Pharmacology 2004,58(6): 681-681.
Endothelial dysfunction has been implicated as a principal initiating factor in the pathogenesis of diabetic microvascular complications and is characterised by the reduced bioavailability of nitric oxide (NO). In addition to the classically described loci of production such as the vascular endothelium and leucocytes, an alternative non-enzymatic system has been recently developed...
A novel method for delivering nitric oxide therapy to the skin of human subjects. Clinical Science
Hardwick JBJ, Tucker AT, Wilks M, Johnson A, Benjamin N. 2001;100:395-400. ISSN: 0143-5221.
Nitric oxide (NO) is a mediator of essential biological processes, including vasodilatation, antimicrobial activity and wound healing. A chemical system using sodium nitrite and ascorbic acid has been developed which generates significant amounts of NO. The originally described system was messy and impractical, and the high acidity may cause pain and further tissue damage in ulcerated skin. To overcome this, a selectively permeable, hydrophilic polyester co-polymer membrane system (Sympatex™) has been identified that can be placed between the NO-generating chemicals and the skin.
Effect of a nitric oxide generating system on microcirculatory blood flow in the skin of patients with Raynaud’s Syndrome.
Tucker AT, Cooke ED, Pearson RM, Benjamin N. Lancet 1999;354(9191):1670-5. ISSN: 0140-6736.
Patients with Raynaud’s syndrome have abnormal digital vasoconstriction, which may be secondary to impaired synthesis of, or impaired sensitivity to, nitric oxide. We studied the effect on microcirculation of a nitric-oxide-generating system applied topically to the finger and forearm of healthy volunteers and patients with primary Raynaud’s syndrome.
Acidified Nitrite Preparations In The Treatment Of Infectious Diseases.
London - March 2005
Tucker AT, Barnes N. SET for BRITAIN, UK National Science Week, House of Commons, London, United Kingdom, 14th March 2005.
Respiratory disease is the leading cause of death worldwide. According to the World Health Organisation, out of annual 50.5 million deaths, 9.4 million (18.7%) were due to respiratory diseases (4.3 million to lower respiratory tract infections, 2.2 million to chronic obstructive pulmonary disease (COPD), 1.96 million to tuberculosis, and 0.95 million to cancer of the trachea, bronchus and lung) . In the United Kingdom, respiratory disease has overtaken coronary heart disease as a principle cause of death, costing the NHS £2.5 billion a year and utilising 2.8-million hospital beds annually.
Study of a combined percutaneous local anaesthetic and nitric oxide generating system for venepuncture.
Tucker AT, Makings E, Benjamin N. Anaesthesia 2002;57(5):429-434. ISSN: 0003-2409.
Nitric oxide (NO) may be generated and delivered into the skin via a novel system of sodium nitrite and ascorbic acid. This placebo-controlled, double-blind trial compared the analgesic properties of this system alone when supplemented with lidocaine. the pain of dorsal hand vein cannulation was assessed in 100 volunteers. The NO-generating system was prepared by mixing two gels, the first KY jelly™ and sodium nitrite (10 w/v), the second KY jelly™ and ascorbic acid (10% w/v). NO-generating gel was the placebo treatment, and when combined with lidocaine (final concentration 5%), formed the active treatment.
Formulation and validation of a novel solution of nitric oxide for delivery to the respiratory tract.
Tucker AT, Barnes NC, Johnston A, Elston WJ, Watson D, Wilks M, Rahman M, Rehman M. Brit Journal of Clinical Pharmacology 2007, 63(6): 781-781.
ß-adrenoreceptor antagonists (ß-blockers) reduce the peripheral systolic blood pressure response to exercise but could have less effect on central systolic blood pressure because of effects on heart rate and/or vascular tone influencing the relationship between central and peripheral blood pressure. In addition, studies in ß2-adrenoreceptor knock out mice suggest that ß2-receptors play a role in determining the haemodynamic responses to exercise through the modulation of myocardial contractility and peripheral vascular resistance.