Leading regenerative medicine and 3D bio-printing company Koligo Therapeutics will list on the Australian Securities Exchange at the end of March via an Initial Public Offering (IPO). Koligo is the only company in the world dedicated to the wide distribution of pancreatic islets—the cells that make insulin to regulate blood sugar—for treating pancreatitis. India has the highest incidence of pancreatitis in the world with more than at 120 cases per 100,000 people.
Koligo is also developing and commercialising a range of 3D bio-printed tissue and other regenerative medicine products to help address serious conditions such as diabetes, liver failure, neurological diseases, metabolic disorders, and genetic disorders.
Koligo is already at revenue stage with a product Kyslecel qualified for sale in the United States and generating A$1.6m revenue in the first 14 months from a limited number of initial hospital customers. Matthew Lehman, Chief Executive Officer explains, “Kyslecel is an autologous (using the patient’s own cells) pancreatic islet cell transplant therapy used to treat chronic or recurrent acute pancreatitis.”
Chronic pancreatitis is a debilitating and painful condition and India has the highest incidence of it in the world. It is a long-standing inflammation of the pancreas that alters the organ’s normal structure, gets worse over time and leads to permanent damage. It eventually impairs a patient’s ability to produce enzymes to digest food. “There are no pharmacological, endoscopic, or surgical options for treatment and up to 80% of patients are on high doses of potent opioids to manage the pain. Nearly one-in-five of these patients becoming addicted,” he says.
Koligo works with qualified partner hospitals to remove a patient’s pancreas. It is transported to Koligo’s FDA-registered labs in Louisville, Kentucky, where the patient’s islets are isolated and prepared into Kyslecel. The Kyslecel is then transported back to the patient’s hospital to be infused back into the patient’s liver.
Koligo aims to launch Kyslecel V2.0 in mid-2019. This will have an extended shelf life, allowing longer transport times to a wider region and potential international operations (subject to regulatory requirements).
India, with its large number of pancreatitis sufferers, is a key market Koligo plans to enter.
“This is a major procedure with a significant difference to the quality of life of recipients. Eighty five percent of patients experience improved quality of life. Two in three patients have some islet function. And one-in-three can expect to be insulin-free after three years. The TPIAT procedure also greatly reduces the risk of type 3c diabetes (brittle diabetes) that can occur if a total pancreatectomy alone is done.”
Patented 3D bio-printing
Koiligo is developing a pipeline of regenerative medicine products utilising a patented 3D-V bio-printing platform and will be the only 3D bio-printing business on the ASX, and one of very few publicly-traded 3D bio-printing companies globally.
“Koligo will transform human cell and tissue transplant with our 3D-V bio-printing. We will create 3D biodegrable bio-printed spheroids which contain a patient’s stromal vascular fraction cells and/ or micro vascular fragments and pancreas islets. The 3D structure allows better oxygen and blood flow for more effective grafting of transplants. These spheroid ‘scaffolds’ allow improved function of the cell or tissue after transplant and safely biodegrade,”says Lehman.
“With this 3D-V bio-printing technology we will engineer tissue products for the treatment of pancreatitis, type 1 diabetes, other pancreatic diseases, liver failure, neurological diseases, metabolic disorders, and genetic disorders. Each is a multi-billion-dollar market.”