While bone fractures caused by injury usually have the ability to repair themselves, regeneration can be compromised by complex clinical conditions requiring additional and often invasive treatment.
Healing can be impaired by large bone defects resulting from aging, infection, tumor resection, trauma and skeletal abnormalities.
Osteoporosis, a disease resulting in brittle bones due to loss of bone tissue, affects an estimated 200 million people worldwide and causes over 8.9 million fractures per year. Until today, the gold standard of treating extensive bone loss has been an autologous bone graft procedure, involving the painful relocation of bone from one location in the patient’s body to another. Bones can also be held together by bone substitutes, including metal pins, screws and bars.
Haifa-based biotechnology company Bonus BioGroup, however, has developed a unique technology that promises to revolutionize the future of bone healing and is delivering promising clinical results.
Founded by Dr. Shai Meretzki and the late Prof. Avinoam Kaduri in 2008, the Tel Aviv Stock Exchange-listed company is behind the world’s first viable human bone graft manufacturing facility, where bone grafts are constructed ex vivo – outside of the human body – from the patient’s own live tissue.
BonoFill, the company’s unique method for growing a three-dimensional and high-density bone graft, requires the isolation of a unique kind of cell from the tissue with the ability to repopulate.
From that cell, a new bone is grown in a laboratory bioreactor mimicking the body’s physiological micro-environment. Within two weeks, a live and viable bone has grown and can be implanted back into the patient.
“Because every patient gets his own tissue and own cells back, the safety profile of this kind of therapy is very high,” Meretzki, chief executive and president of Bonus BioGroup, told The Jerusalem Post. “There is no immune reaction to the implant, never mind rejection. The body doesn’t know that the cells underwent a short cycle of two weeks outside the human body, and we see a very nice recovery and complete healing of the bone gap.”
When the company started working on tissue regeneration for large gaps between bones, they sought to precisely rebuild and implant the exact bone that was missing.
Yet instead of large bone gaps caused by trauma, the majority of patients actually suffer from large bone cavities with a small entrance hole caused by bone loss resulting from osteoporosis, infection and tumors.
“To overcome this, we grow the bone in thousands of tiny particles and then we can just inject those particles into the gap,” said Meretzki. “The bone is filled with tens of millions of cells that keep growing, and become bigger and solid within 24 hours. Filling the cavity with injectable bone reduces a painful operation of 15 hours into a treatment of 10 minutes, and within two months, the bone is healthy, alive, viable and active again.”
Bonus BioGroup’s technology, which boasts a long list of patents including exclusivity for the manufacturing and commercialization of live bone grafts in the United States, is currently undergoing two Phase II clinical trials in Israel for maxillofacial and orthopedic applications.
With positive results, the company expects to start a Phase III US Food and Drug Administration (FDA) trial at the beginning of 2020, with an outcome expected within two-and-a-half years. The company is also aiming to move its listing to the Nasdaq.
“All the patients we have treated within the orthopedic indications have suffered at least three bone graft failures in the past,”Meretzki said. “We take the hardest cases where people have already given up on them. They are all back on their feet or have full use of their hands. One patient, 13 months after he had a bone implant in his leg, completed the Ironman Triathlon.”
Meretzki believes that the technology will soon become the first line of treatment for large bone defects, a market worth approximately $8 billion today and set to grow as the world’s population ages.
“Within this field of generative medicine and tissue engineering, there aren’t any giants,” said Meretzki. “This has allowed us to file a very strong patent and to grow to be the giant of this field. I believe this field is the future of therapy. Currently you have medical devices and pharma but none of them actually heal you. Here we’re talking about a new medical approach that enables you to live longer and in good health.”