As per an editorial in “The Indian Medical Journal of India” titled ‘Liver transplantation in India: Its evolution, problem and the way forward’, more than 2,00,000 people were dying in India every year from liver failure in the last decade. The statistics for other causes of liver failure such as cirrhosis, liver cancers etc are even higher. Approx 20% of alcoholics end up with cirrhosis of liver wherein transplant may be the only viable option. Non Alcoholic Fatty liver - Liver disease which also has Liver Transplant as treatment option has a prevalence of 20% in the population translating to several million in a population of 1.3 Billion.

As per experts in the Indian medical industry, 20,000 liver transplants are needed annually in India and in 2009 only 110 donors were available with various hospitals. This shows the huge demand-supply gap in the liver transplantation industry. Additionally, a liver transplant is estimated to cost between Rs 10 lakhs to Rs 45 lakhs in the first year and subsequently the costs for transplant maintenance is estimated to between 1.5 lakhs to Rs 3.0 lakhs per annum in India. Going by statistics, patients have a two year survival rate of approximately 78%. Thus liver transplantation is not entirely a satisfactory solution to liver failure. Liver transplantation might best be restricted to cases such as genetic diseases in children and similar conditions where liver regeneration is not likely with medical management alone. These considerations increase the imperative for the deployment of a clinically effective bio-artificial liver system.

The US scenario

Over 46,000 deaths annually from liver failure in the US and 160,000 hospital discharges where liver failure is the principal diagnosis. Other than liver transplantation, no new tools have been introduced in this particular area of medicine in many decades. Perhaps surprisingly, only about 6,500 transplants are available in the US due to a shortage of suitable organs. Over 17,000 patients are presently waiting on the liver transplant list in the US. The absence of a suitable alternative therapy means that many of these patients will die without receiving a transplant.

Four groups of patients have been identified in the US market totaling approximately 350,000 individuals who may benefit from up to 700,000 liver assist procedures using our system. These include patients in acute liver failure, those undergoing resection for primary or metastatic liver cancer and multiple organ failure. We estimate the dollar value of the US market at $7 billion.

Worldwide, the need is even greater. Driven primarily by the prevalence of viral hepatitis, liver failure is a leading cause of death in China and the Middle East. In China and Hong Kong as many as 150 million people may be chronically infected. Over 1,500,000 liver failure deaths occur annually worldwide.

Marketing Strategy

As in the US and Europe, India has formed a patient registry which seeks to provide a clearing house for information relating to transplantation. Also as in other markets, the Indian health care community has ample resources to identify the high quality, top-end medical facilities offering services in liver transplantation and liver medicine. These sources of information make it possible for patients to find their way to the best hospitals, which will also be the ones where VEBI will locate its operations.

The Bio-artificial liver system to be developed by VEBI will bear a cost of approximately 10 lakhs and as per the studies, no further maintenance will be required. This is expected to capture most of the market due to absence of any commercially viable substitute for the technology and unavailability of donors for liver transplantation.

Our product is an extracorporeal system, comprising a simple blood loop, which allows the equipment to continuously circulate a patient's whole blood through a bioreactor containing pig liver cells. A membrane barrier allows the pig liver cells to process the toxins accumulating in the blood as a result of liver failure but prevents direct contact with the patient’s blood. Procedures are expected to be 12 hours in duration and repeated 2-3 times during a given episode of liver failure. The clinical goal is to protect the patient's brain, heart, lungs and kidneys from the effects of the failing liver for a period long enough for the patient’s own liver to regenerate. The skills required to operate the system are not greatly different from those needed for kidney dialysis, a procedure performed millions of times per year around the world.

Our business model provides a breakthrough innovative technology, creating jobs and saving lives. We envision that the bioartificial liver bioreactors will be produced locally in each country for the benefit of its citizens.

It is our goal to make this potentially life-saving, cost-effective technology available globally.