EpiBone

EpiBone is a biomedical engineering company that is currently in the process of reconstructing human bone growth for use in surgical operations. EpiBone will allow patients to grow bones with the use of their own stem cells in order to create a patient-specific product. These specialized bone grafts can simplify surgery, provide exact repair, and shorten recovery times.^[1] EpiBone has animal-tested its product and is currently waiting for FDA approval to begin testing with humans. It was created by its current CEO, Nina Tandon.^[2]

Benefits

EpiBone can improve existing factors of surgery, including recovery times, foreign body implantation, regeneration, and bone repair accuracy. EpiBone can also lead to a decreased amount of surgeries possibly saving trillions of dollars per year.^[3]

• Exact Defect Repair – A precise size and shape is formed for the specific patient, so an accurate bone graft is made. This makes bone replacement surgery more effective because the body is getting exactly what it needs. In today's surgical repairs, bone grafts or replacement bones are not as precise and accurate because they are not made specifically for the patient's needs.
• No More Foreign Body Implantation – EpiBone's bone grafts are made from the patient's own stem cells, so foreign body complications are eliminated. Two of the most common types of bone grafts used today are allografts, grafts made from a deceased donor's bone, and autografts, grafts made of bone from another part of the patient's body. According to the Musculoskeletal Transplant Foundation, there are more than nine hundred thousand allograft transplants each year in the United States. EpiBone will be able to decrease that number all while providing a solution without having to cut out bone from any other human.
• Tissue Regeneration – Tissue regeneration can help create better drug formulations, decrease human and animal lab testing, and create personalized treatments. Medicine can become more specialized to do specific functions.^[4] Today's medicines are very useful for a variety of functions but also include many side effects that can cause conflict to its user. Tissue engineering can help restore original tissue functions that no longer work in the body due to failure. This means that tissue engineering can help us outlive the failure of our organs or bones.^[5]
• Shorter Recovery Times – Recovery times are shortened because only one surgical operation is needed to replace a damaged bone. Other alternatives, like an allograft, may require multiple surgeries just to acquire the replacement bone. Also, EpiBone grafts skip the process of molding to the body because they are made to take over the exact size and shape of the damaged bone. Other replacement bones have to adjust to how the body uses them, which causes longer recovery times.

Process of creation

With the use of technology, EpiBone is able to create a reconstructed bone graft. This process goes through five major steps which are: scanning the defect, collecting the stem cells, placing the cells into the bioreactor, and allowing the cells to develop and grow.

1. CT Scan – EpiBone starts the bone reproduction process with a CT Scan. The patient will undergo this scan so EpiBone can receive a complete picture of the bone defect's exact size and shape.
2. Stem Cells – EpiBone retrieves stem cells from the patient's fat tissue. EpiBone uses multipotent stem cells, which are capable of developing into multiple tissues and bone.
3. Bioreactor – The mulitpotent stem cells are placed into a bioreactor, which simulates conditions inside the body.^[6] This allows the stem cells to begin growth. EpiBone uses the frames of animal bone and cartilage to influence the shape of which the stem cells grow. The bioreactor makes EpiBone have the potential to build patient-specific bone grafts for craniofacial and orthopedic reconstructions.^[7]
4. Cell Development – The cells develop into a customized, living implant in three to four weeks. Cells naturally mature to form strength and shape.

Progress

So far, EpiBone has tested its product on pigs. They have tested on pigs because their head size and mechanics of chewing are similar to humans. EpiBone built a temporomandibular joint, a complex bone in the system of a jaw, to truly test how useful their productivity.^[8]

EpiBone is waiting for approval to being testing on human bone.

Obstacles

• FDA – Animal testing has shown that EpiBone's technology works, but FDA approval is needed to begin human testing. It is unknown how long it will take to receive approval from the FDA. Human trials were set to begin in 2015, but without approval, no further testing can be made.
• Cost – The cost of a single EpiBone graft will be very expensive ranging from $10,000 to $15,000. The cost is about three to four times as the cost of traditional procedures because of the patient-specific design of each graft. This means that EpiBone first has to gather support from many investors in order to pay for the processes to begin.

Background

Nina Tandon is the CEO and co-founder of EpiBone. She possesses ten years of experience in tissue engineering and over eight years of experience in bioreactor design. She attended Columbia University, MIT, and McKinsey. She possesses the goal to create an alternative for human implantation.^[9]

References