Winston-Salem, NC-based Precise Bio, a regenerative medicine company that is working on advancing the use of bio-printed tissue and organs to patients, recently launched a dedicated ophthalmology business unit to support attainment of near-term opportunities in the ophthalmology arena as it builds a portfolio of programs in additional indications.
The company has developed what it calls a 4D bio-fabrication platform technology that comprises cell expansion, bio-materials, processes, and printing technology. According to Aryeh Batt, co-founder and CEO of Precise Bio, the company is the first to transplant a 3D-printed corneal graft in animals. This new business unit will be dedicated to advancing the technology to human patients, he said.
"It's really taking two paradigms that have developed over the years, 3D printing has matured and regenerative medicine has reached many milestones, bringing them together brings us the capability to bring it to the patients, bring it to the market," Batt told MD+DI.
He said the company has been focused from the beginning on the ophthalmology field for various reasons. For one, the eye is a good match for 3D printing because eye tissue is structured layer by layer, which is the way 3D printers work. Second, Batt said, the eye is easy to measure so if a bio-fabricated technology is implanted in the eye, the company will know right away if it's working or not. The implanted tissue can be replaced and removed, making it a reversible procedure, Batt said, which speaks to the safety of the technology.
"The regulatory path fairly simple, and in general, the ophthalmology field is an arena that knows how to look in an innovative way at new technologies," Batt said.
“There has been great excitement among physicians and commercial organizations about our disruptive technology to create eye-related tissues and its potential to transform the treatment of serious ophthalmic diseases and conditions,” Batt said. "Based in part on the requests and suggestions from these key audiences, we are currently pursuing different ophthalmic programs, two of which are being undertaken with collaborators."
Establishing a business unit dedicated to realizing this potential will support the company's future financing strategies and ensure that our financial resources are aligned with the tremendous power of our technology and intellectual property in a market with an estimated cumulative value of $10 billion.”
“Precise Bio’s technology has the potential to truly transform the treatment of serious diseases, and to address the unmet needs in corneal replacement and other indications, which cannot be met by the limited number of donor tissues and organs,” said Shay Soker, PhD, a professor at the Wake Forest Institute of Regenerative Medicine and a co-founder of Precise Bio. “The company’s technology overcomes multiple challenges in scalable, reproducible manufacturing of bio-printed tissues and organs, and positions Precise Bio for leadership in the field of regenerative medicine."
The company is on the verge of moving forward from a basic R&D stage and pre-clinical studies to the clinical stage in the near, Batt told MD+DI. He said the technology offers the hope of being able to press a button on a computer and quickly print out an implant using the patient's own cells, which not only solves the problem of having to wait for a donor but also reduces the likelihood of rejection.
Batt said the company expects to be ready for first-in-human studies in 2020, or perhaps as early as the end of 2019. The reason Precise Bio considers its technology to be 4D printing instead of 3D printing is that there is a maturing phase involved, Batt said. Down the road, the company plans to establish other business units and pursue indications outside of the eye, such as in cardiology, orthopedics, and skin.