Kensana Health Targets Calciphylaxis

Calciphylaxis by the Numbers

Calciphylaxis is a serious disease in which calcium accumulates in small blood vessels of the fat and skin tissues. This accumulation causes blood clots, painful skin ulcers, and for 50% of diagnosed patients it leads to certain death.

Expanding on the above, calciphylaxis has an incredibly poor prognosis with 1-year mortality rates between 45% and 80%. Thus far, most patients respond poorly to any traditional therapies available to them and infections soon develop, which is the leading cause of death.

Calciphylaxis is primarily seen in patients suffering from Kidney Disease, most often in patients with advanced renal failure. The latest data indicates the occurrence of calciphylaxis in dialysis patients ranges from 0.04% to 4%, and that rate has been rising significantly over the last decade. From 2007 onwards, it is estimated that 3.7 to 5.7 per 10,000 chronic hemodialysis patients were developing this disease.

Chronic Kidney Disease (CKD) is a growing, global public health priority that is associated with markedly high morbidity, mortality and excess health-care costs. In 2017, a total of 850 Million people were estimated to be living with Chronic Kidney Disease, which was twice the estimated prevalence of diabetes worldwide. CKD is the third fastest growing cause of death globally and is projected to become the fifth commonest cause of years of life lost by 2040.

If we crunch the numbers it means that ~400,000 patients with Kidney Disease world-wide will develop calciphylaxis.

See Kensana Health's Phase III Calciphylaxis Trial

Real People are Behind Every Statistic

A spotlight on Diabetes Mellitus

According to 2021 data from the International Diabetes Federation, 537 Million adults (20-79 years) are living with diabetes worldwide. That is nearly 1 out of 10 individuals who are diagnosed with either type 1 or type 2. The Western Pacific contributed 206 Million cases in 2021 alone. The number of adults with diabetes in this region is predicted to rise to 260 Million by 2045, an increase of 27%. This number is frighteningly larger if we include the fact that 1 in 2 adults living with diabetes are currently undiagnosed.

20% (107.4 Million) of these diagnosed individuals will develop wounds. It is estimated that every 30 seconds a leg is amputated due to diabetes. Unfortunately, diabetic foot ulcers are not the only concerns that arise for these patients, but a full spectrum of wound classes can manifest.

In 2021, diabetes was responsible for 6.7 Million deaths, which can be calculated as 1 death every 5 seconds. Not only is this toll hard on the individual and their families, it is an incredible burden on our healthcare system, which in the last few years, has seen a considerable influx of short and long-term patients leading to significant wait times for doctors and elective surgeries. This year alone, diabetes has caused at least 966 Billion Dollars (USD) in health expenditure – a 316% increase over the last 15 years.

Diabetes can reduce the ability of the skin to heal itself and this is due in part to an under-functioning endocannabinoid system leading to an immune system deficiency. For many diabetics, the number of immune fighter cells sent to heal wounds, and their ability to take action, is often reduced. If your immune system can’t function properly, wound healing is slower and the risk of infection is higher.

For a diabetic, even the smallest of cuts on vulnerable areas of the body such as feet can develop into serious wounds that can lead to infection. About 15% of people who have diabetes develop foot ulceration and it usually begins with a cut, graze, scratch, or blister.

Wounds related to diabetes are so prevalent that 55% of all wounds in Dr Maida’s trial were diabetes related.

Dermatologic diseases associated with diabetes

Generalized Granuloma Annulare
Lichen Planus
Hidradenitis Supparativa
Skin Infections

Skin manifestations strongly associated with diabetes mellitus

Acanthosis Nigricans
Diabetic Dermopathy
Diabetic Foot Syndrome
Diabetic Foot Ulcer
Diabetic Thick Skin
Scleroderma-Like Skin Changes
Limited Joint Mobility
Scleredema Diabetocorum
Necrobiosis Lipoidica
Bullosis Diabeticorum

Non-specific dermatologic signs and symptoms

Ichthyosiform Changes of the Shins
Acquired Perforating Dermatosis
Eruptive Xanthomas
Diabetes-Associated Pruritus
Huntley’s Papules (Finger Pebbles)
Keratosis Pilaris
Pigmented Purpuric Dermatoses
Palmar Erythema
Periungual Telangiectasias
Rubeosis Faciei
Yellow Skin and Nails

Cho et al 2018, Labib et al 2022, Shaw et al 2010,
Patel et al 2019, Tee and Yap, 2017

World-wide Wound Estimates

In 2020, Dr. Chandan K. Sen published an updated version of his Human Wound Estimates using available world-wide data. His calculations for the United States were incredibly alarming.

“Medicare cost projections for all wounds ranged from $28.1 to $96.8 billion, including costs for infection management, among which surgical wounds and diabetic ulcers were the most expensive to treat.1 Furthermore, outpatient costs ($9.9–$35.8 billion) were higher than inpatient costs ($5.0–$24.3 billion), possibly because of an increase in outpatient wound treatments that are currently provided.1 Despite these alarming statistics, the investment in research support is not on par with the threat of these debilitating health issues.2,3 Diabetic foot ulcers (DFUs) (30.5%), for example, have a comparable 5-year mortality rate to cancer (31%), which has remain unchanged since 2007 and yet funding for studies related to these life-threatening complications remains significantly lower than that for cancer research.”

It is estimated that by the year 2060, the elderly population of the United States will be over 77 million, of which 3% of this population will have open wounds. It is evident that chronic wounds will be an “Increasingly persistent problem in this population” (Sen 2021) in the future.

  • ~7,000,000 people are estimated to be affected by chronic wounds in the United States

  • The global advanced wound care market is projected to reach $18.7 billion by 2027, growing at a Compound Annual Growth Rate (CAGR) of 6.6% over the analysis period 2020–2027.

  • China is projected to reach a market size of $4 billion by the year 2027 with a CAGR of 10% and Japan and Canada are expected to make noteworthy growths at 3.6% and 5.8%, respectively, over the 2020–2027 period.

  • In Asia Pacific, Australia, India, and South Korea are predicted to drive an increase to $2.6 billion by the year 2027.

Foot Ulcers

Data was collated from some of the most reputable online sources for the most “Comprehensive analysis of its kind” (Sen 2021), which included more than 800,000 subjects from 33 countries. The annual incidence of foot ulcers globally were found to be between 9.1 and 26.1 million. The data shows that the diabetic foot ulcer market is expected to have a positive 6.8% CAGR between 2019 and 2026, with an estimated valuation in excess of $11 billion by the end of 2026.

Venous Ulcers

The global treatment market for venous ulcers is expected to reach $4.8 billion in 2026 with a CAGR of 6.4% from 2019 to 2026. Approximately 80 Million people globally between the ages of 18-64 are suffering from a venous ulcer. Compression therapy is currently the most common method of treating this disease, accounting for 62% of the market share in 2018.

“Emerging advanced wound dressings are expected to be competitive with compression therapy in this market.” (Sen 2021)

Acute Wounds

The most current data for acute wounds is drawn from a statistical brief from hospital-based ambulatory surgery and hospital inpatient settings in 2014. Acute wounds resulted in 17.2 million hospital visits. The majority (57.8%) of these visits occurred in hospital-owned outpatient settings, while 42.2% were inpatients.

“The development of novel and practical concepts to prevent and treat these wound infections is key to effective wound management.” (Sen 2021)