Of the few options available to End Stage Renal Disease (ESRD) patients, transplantation is the most cost effective and offers a relatively better quality of life. Yet, the supply of transplant organs falls far short of demand and as a result the transplant waiting list has continued to increase over the past few decades. American bio-science company Breonics’ Exsanguinous Metabolic Support (EMS) technology, which is a medical device that could repair donor organs and test their viability, aims to address the global transplant organ shortage, starting with kidneys (more than 80% of patients on the U.S. transplant waiting list were waiting for kidneys). The company is currently raising its Series A capital to fund clinical trials.
The demand for organ transplantation has increased worldwide over the past few decades due to increased incidence of organ failure. However the supply of organs for transplantation has remained relatively stagnant resulting in an escalating shortage of organs for transplantation over the past few decades. In the U.S. alone there were about 113,000+ patients on the national transplant waiting list as of July 2019, up from 23,198 in 1991 (representing a nearly five-fold increase), and every 10 minutes another person is added to the list. This is despite the number of donors increasing from 6,953 to 17,554, and the number transplants more than doubling from 15,756 to 36,529 during the same period.
Part of the reason for the stagnant transplant organ supply is due to the fact that under current medical standards of care, donors have to be free of certain illnesses, have to be below the age of 75, and donor organs have to be harvested within 30 minutes of death. However, of the more than 2.5 million annual deaths in the United States, just 2% occur under circumstances that meet this criteria; for instance the death takes place outside the hospital where the deceased’s organs could be preserved, or they suffer from conditions such as most cancers or certain incurable infections that make the organ unfit for donation. As a result, most organ donors in the U.S. are from living donors or from donation after brain death and this means that more than 95% of potential organs are not being considered for transplantation given the limitations of the current standards of medical care.
The desperate situation has spurred a search for solutions ranging from offering incentives for organ donation to development of technologies and methods to increase organ preservation. There is also a growing interest in using suboptimal organs from donors which are currently not considered for transplantation.
American bioscience company Breonics’ EMS platform offers a potentially ground-breaking solution towards addressing the global transplant organ shortage by expanding the window of opportunity for harvesting the donor organ. According to Breonics, under the 30-minute window, less than 4% of all mortalities in the U.S. are potential organ donors, but with their technology, the addressable market expands to at least 15%. Although the technology can be used for the repair and regeneration of lungs and livers, Breonics is initially targeting kidneys which has the biggest waiting list and is the most transplanted organ. 83.7% of patients on the U.S. transplant waiting list are waiting for kidneys.
And at 21,167 transplants performed in 2018, kidney transplants were the most performed transplants in the U.S. last year, far exceeding the 8,250 liver transplants performed the same year.
The opportunity is not limited to transplant patients but also to the dialysis population in the United States which is estimated at over 600,000 people as of 2016, as well as those newly diagnosed with End Stage Renal Disease (ESRD) which is estimated at over 120,000 according to the National Kidney Foundation; 30 million or 15% of the U.S. adult population was suffering from Chronic Kidney Disease (CKD) in 2017 according to National Center for Chronic Disease Prevention and Health Promotion, and of the 30 million U.S. CKD patients, about 0.4% or 120,000 patients are in Stage 4 which will likely pave the way for ESRD or total kidney failure which means they will likely need a transplant or dialysis in the near future. CKD is an under-recognized public health crises that causes more deaths than breast cancer or prostate cancer.
The incidence of ESRD has been on an upward trend in the United States which is the result of rising rates of diabetes and hypertension which are the two most common causes of kidney disease, according to data from the U.S. government’s Renal Data System. The prevalence of ESRD more than doubled between 1990 and 2015, from 727 ESRD patients per million U.S. residents in 1990 to 2,087 ESRD patients per million U.S. residents in 2015 according to the United States Centers for Disease Control and Prevention – Chronic Kidney Disease Surveillance System, United States.
There is no cure for ESRD and patients have three options: (i) no treatment which results in death; (ii) dialysis which generally has a negative impact on quality of life; and (iii) transplant which offers a relatively average longer life expectancy and better quality of life.
Dialysis is also more costly; the ESRD population in the U.S. represents 1% of the U.S. Medicare population, but they account for 7% of the Medicare budget. Medicare spending for ESRD patients stood at US$ 35 billion in 2016. 80% of this, equal to US$ 28 billion, was spent on hemodialysis care costs (approximately US$ 90,000 per patient annually). Spending for transplant patient care on the other hand stood at US 3.4 billion, equal to less than 10% of Medicare spend on ESRD patients. The U.S. government is reportedly exploring avenues to trim the relatively high cost associated with dialysis through measures such as improving care in the early stages of kidney disease, increasing access to kidney transplants and favor home dialysis over clinic-based dialysis treatment.
Transplantation is generally accepted to be superior not just in terms of cost effectiveness but also in terms of life for the patient. However, the biggest barrier limiting greater access to transplants is the supply of suitable donor kidneys. 12 people die every day (roughly 5,000 annually) waiting for a kidney transplant according to the National Kidney Foundation.
Breonics is addressing this pressing problem by broadening the criteria for organ donation by expanding the window of opportunity for harvesting the organ from the current 30 minutes, to two hours post mortem. Under current medical standards of care (SOC) transplant surgeons cannot transplant kidneys that have been exposed to warm ischemia for more than 30 minutes as the damage caused to the kidney due the lack of blood supply for more than 30 minutes could potentially harm the patient. This is why the organ donor pool in the U.S. is currently largely dependent on living donors or donation after brain death (DBD) which represents just a small fraction of deaths from traumatic injuries each year, approximately 4%, while organs from deceased by cardiac arrest are not considered because the damage caused to the organs as a result of prolonged lack of blood flow make them unusable. In contrast, brain dead patients are usually in an ICU on life support until they are declared brain dead by brain criteria, and thus their organs do not experience significant warm ischemic damage because the restriction of blood flow to the organs is only for a relatively shorter period of time, often in terms of minutes.
Breonics’ EMS technology can repair damage to organs that have been damaged from warm ischemia for up to two hours. Thus, with Breonics’ technology, the donor pool can be expanded to include the currently huge yet untapped pool of potential donors who died from cardiac arrest and uncontrolled brain deaths (such as from a stroke) because the transplant team can be called to hospital immediately after the time of death, obtain family consent as needed and still harvest the organs within the expanded window afforded by Breonics’ technology. The company’s EMS platform is the first technology that can be used to intervene after cardiac arrest and repair ischemically damaged kidneys and other organs for transplantation. Brenonics’ perfusate medical device can also assess the viability of the kidney prior to transplantation, thereby reducing discard rates due to false negatives. The U.S. reportedly discards 3,500 kidneys annually, and 17% of donated kidneys were discarded during the 10 year period between 2004 and 2014. The reason for the waste was because doctors in the U.S. were less inclined to using lower quality kidneys, however a panel of transplanted experts found that as many as 50% of the kidneys that were discarded could have been transplanted according to the National Kidney Foundation. The discard rate has only been increasing according to the study; in 2016, the discard rate reached 20%. Breonics has successfully resuscitated and repaired over 100 human kidneys that were discarded for being too damaged for transplant. The company estimates its technology has the potential to increase the number of kidneys available for transplant in the United States from the current 19,000+ to an additional 150,000 per year by 2021. Breonics will be reimbursed by the Organ Procurement Organization for every kidney Breonics successfully repairs, and provides for transplant which is guaranteed under the Renal Care Act of 1982.