You may know her. Helen is in her mid-50s and over the last few years she has lost her job as a specialist nurse, detached herself from social activities, doesn’t attend family functions anymore, suffers from anxiety, depression, insomnia and chronic pain. She barely leaves her home apart from her scheduled trips to the clinic, rarely sees her grand-daughter and can’t remember when she last went for a walk or a swim.
How did she get there? A non-healing wound on her ankle annihilated life as she knew it.
She is not alone. Far from it. All over the world, more than 100 million people suffer in silence, often despite receiving the best of care. No therapy reliably heals wounds, clinicians are at a loss, amputations are frequent, and millions of lives are at stake. Chronic wounds are so challenging that clinical success is often defined as a wound being contained, that’s how low the standard of care is.
So, in 2016 Amadeus decided to back an exceptional product designed to tackle this global health crisis head on. The technology is Natrox, a transformative therapy brought to market by Cambridge-based Inotec to heal the most difficult wounds at unprecedented speed.
Patients all over the world are already being treated successfully. 2020 will be a pivotal year. The company is announcing today its Series B funding and what Natrox holds for the future is remarkable.
A Time Bomb
Chronic wounds, those that exceed a 3-month healing process or fail to improve in a timely manner, present severe difficulties for individuals afflicted and a substantial financial burden for the healthcare industry. They may require several years to heal, and some remain unhealed for decades. Examples are diabetic foot ulcers, venous leg ulcers, pressure ulcers, non-healing surgical wounds, skin grafts or burns.
During this time, patients experience severe pain and emotional distress, reduced mobility and social isolation. Chronic wounds may result in disabilities after all available therapeutic interventions have been exhausted and an amputation is necessary – an outcome way more frequent than you might imagine: ulcers precede 85% of all amputations. In the US alone 85,000 amputations take place every year. Globally, non-healing diabetic ulcers lead to an amputation every 30 seconds, with amputees facing a 5-year mortality rate of up to 70%, more lethal than most cancers.
A rough prevalence rate for non-healing wounds in developed countries is 1-2% of the general population, similar to the prevalence of heart failure. This means that at any given time at least 100 million people in the world suffer from a chronic wound. More than 2 million Britons live with non-healing wounds and cost the NHS £5.5 billion annually – as much as the country invests in oncology. In the US, acute and chronic wounds cost Medicare up to $97 billion per year and affect 8 million people. The same story can be heard all over the world.
These numbers will only worsen. Aging populations, sedentary lifestyles, changing diets and obesity, rise in chronic conditions such as diabetes, coupled with inefficiencies in care, are fuelling a time bomb.
It is no surprise, then, that wound healing is receiving a lot of attention. The industry is consolidating rapidly with leaders looking to deepen and strengthen their portfolio through acquisitions. In 2019 alone, 3M acquired Acelity for $6.7 billion, Smith & Nephew bought Osiris Therapeutics for $660 million and Leaf Healthcare (undisclosed amount), Misonix picked up Solsys Medical for $97 million, Mölnlycke bagged M&J Airlaid, Urgo acquired Realm Therapeutics (Vashe) and so on. Overall there is an accelerating shift towards advanced products.
The Biology of Healing
Wound healing is a delicate thing. After a superficial wound, a myriad of systems are activated at the site in order to clear foreign material and to restore the normal structure of the skin. It requires the delivery of various inflammatory cells, chemokines, cytokines, matrix molecules, and nutrients to the wound site with a concordant increase in metabolic demand.
Any disturbance to this well-coordinated series of events can derail healing. For instance, when other pathologies come into play, a chronic wound can form. The underlying mechanism varies greatly, but includes factors influencing blood supply (peripheral vascular disease), immune function (such as immunosuppression or acquired immunodeficiency), metabolic diseases (such as diabetes), medications, or previous injury (such as radiotherapy). External factors, such as sustained pressure, temperature, and moisture, also play an important role.
An essential consideration in wound healing is continuous oxygen supply and oxygen tension in the wound bed. Wound healing requires oxygen to interact with numerous cytokines, supply the actively proliferating cells, as well as provide an effector for the neutrophil respiratory burst.
That’s where things start to break down. Most wounds will demonstrate a degree of hypoxia, or oxygen deficiency, due to tissue damage, and if oxygen demand continuously outstrips supply, compromised healing and chronicity kick in. Indeed, these effects seem to compound one another—in situations of low oxygen tension, not only will there be more necrotic debris to facilitate bacterial growth, but the primary mechanism of the immune system in combating these microbes is compromised.
Hypoxia, in addition to a pre-existing aggravating condition such as diabetes, leads to an increased time required for wound healing. Therefore, the availability of oxygen at the site of wounds is critical to the speed and quality of wound healing.
Looking beyond the wound itself, its very presence increases the entire body’s need for oxygen by 20% for a patient with a non-infected wound and 50% for a patient with an infected wound. Being mobile and autonomous is essential for recovery – and most patients aren’t because treatment options don’t allow it.
A large and growing array of dressings and therapies have been developed over the years. They range from collagen products, biological dressings, biological skin equivalents, keratinocytes, platelet-derived growth factor, platelet-rich plasma, silver products, intermittent pneumatic compression therapy, negative pressure wound therapy (NPWT), electromagnetic therapy, to hyperbaric oxygen (HBOT) chambers.
One can club these together in two groups:
- they either compensate for some – but not all – of the pathway disturbances induced by hypoxia (delivering only growth factors, or collagen for instance), or
- they address the problem of hypoxia but only deliver oxygen temporarily and/or in clinical set-ups. They require the patient to stay stationary for hours, usually with dressings removed to increase the diffusion.
None of the current approaches address the major bio-chemical and cellular pathways underpinning wound healing in their entirety. In addition to poor clinical efficacy, these treatments have low market penetration as they are cumbersome, complex to use, expensive, restrict care to the clinic and result in lifestyle and mobility limitations for patients.
A new approach is needed.
The thesis behind Natrox® is about fundamentals: to prevail in the global woundcare market, one must offer an all-round solution with significant workflow synergies that can easily integrate with existing clinical wound dressing practices, be patient centric, enhance nurse ease-of-use, and demonstrate high levels of effectiveness in wound healing. In other words, the ultimate therapy must –
- heal chronic wounds reliably,
- be adapted to home and community settings,
- be outcome- and value-based to fit new economic models,
- be versatile enough to fit all treatments and clinical pathways, and
- be wearable and discrete to allow continuous treatment, restoring mobility and patient autonomy
And that’s why Natrox® is now the new global standard in wound healing.
Led by Craig Kennedy, the company has brought together a seasoned executive management team and board who, together, launched nearly 20 wound care products and technologies and are behind some of the biggest success stories and exits in the industry.
The patented technology developed at Cambridge University, UK extracts moisture from the ambient air and converts it to oxygen, supplying pure humidified oxygen locally to the wound bed under any dressing at a continuous flow rate. Simply put, it creates a unique and constant oxygen-enriched environment at the wound area, accelerating the healing process.
Natrox® is setting new benchmarks: in clinical studies up to 90% of patients with acute and chronic wounds heal within 8-12 weeks. It is FDA 510(k) certified, CE (IIb) marked and already reimbursed in several markets.
Natrox® is the size of a mobile phone – light, portable, quiet. It cuts down the number of care facility or home visits as dressing changes are weekly. It is cost effective, less time consuming for the clinician and does not restrict mobility, unlike other active therapies, promoting a healthy lifestyle, and ultimately resulting in higher patient satisfaction and unmatched clinical efficacy.