In Nina Tandon’s view, there have been two different phases of medical knowledge. “For so much of human history, medicine was about letting the body come to rest, because there was an assumed proportionality attributed to the body,” she has been quoted as explaining. “Then around the turn of the last century, humans started developing interchangeable parts (whether from donors, or made of plastic or metal), and also started thinking of bodies a bit more like machines.
“We’re each made out of 206 bones held together by 360 joints,” Tandon, Co-Founder and CEO of EpiBone, has said, “By the time we go through this lifetime, 75 percent of us will be living with parts in our body which we were not born with.”
While that percentage may seem high, consider all the things that count as ‘parts’ of bodies that are artificial today such as dental implants, pacemakers, joint replacements and more. “Bone is the most transplanted human tissue after blood,” Tandon explained, “And we’re replacing over a million joints every year in this country alone, just because of a couple millimeters of damaged cartilage.”
EpiBone, headquartered in Brooklyn, NY, is a company with 17 employees working on custom-growing living bones using a patients’ own stem cells with a mission to transform skeletal repair.
Since launching in 2014, the company has executed and hit major milestones such as a large animal study on the ramus-condyle unit in Yucatan minipigs; filed for multiple patents on perfusion bioreactor and other key IP; finished a GLP toxicology study on 200 immunocpmprised rates; completed a buildout of a GMP grade clean room facility to enable clinical trials; and completed 8 engineering runs for clinical trials.
“The next phase of medicine will entail learning how to fix and repair our own bodies using, well, our own bodies,” said Blake Adair, Chief of Staff at EpiBone.
Adair explained the process this way, “We start with a patient’s CT scan and a sample of fat tissues from which we extract adult stem cells, then we generate a custom scaffold and bioreactor based on the scans. Finally, the cells and scaffold are matured in the bioreactor, and results in a living ready-to-implant bone graft, which we hope will seamlessly integrates into a patient’s body. The value here is that it fits the defect area perfectly, it’s made of your own cells, and it’s alive so it can become a part of your own body in the most natural way possible.”
When ready, the stem cells are infused onto the bone scaffold and a personalized bone graft grows in the bioreactor in about three weeks, with the entire process taking only 5 weeks, according to the company. The expectation is that the new bone is then implanted into the patient’s body and the surrounding tissue seamlessly integrates with it. The custom size and shape ensure fit, and there’s no risk of rejection since it is made from the patient’s own cells.
“We are proud to be working on the cutting edge of what is currently possible in regenerative medicine, said Adair, adding, “In this new frontier we are tapping into and amplifying the body’s natural ability to heal itself, and offering patients an alternative to tissues that are in short supply, and unnatural inorganic implants.”
EpiBone manufactures its own bioreactors to deliver optimal flow rates through complex bone grafts. “Other companies either manufacture inert devices or cells without structure. Only at EpiBone do we do both.”
The company’s long-term vision is to unlock the healing potential of your own cells with an immediate focus on osteoarthritis and congenital craniofacial diseases, with future dreams of applying their technology to other joint replacements, tendons, and ligaments; followed by dental, cosmetics and soft tissue (fat) applications. “As part of our commitment to social good, we plan to develop orphan status products for patients with the highest unmet needs such as children who are afflicted with Treacher Collins,” he said.
By becoming a first-line product, the company believes they could have a radical impact on health outcomes, and thus creating a massive savings in the system with a reduction in future procedures that amount to an annual savings of $1.3B.
EpiBone is hoping to start human clinical trials in 2019.
In her closing comments, Tandon asks audiences to envision a future where all the extra parts our bodies needed are made not out of metal, not out of ceramic, not out of parts carved from other peoples’ bodies—but made out of ourselves.
EpiBone believes the 1st industrial revolution was about machines, the 2nd was about data, and as biology becomes the new data, wouldn’t it be great if the 3rd revolution was about life?