30 Best CEOs of the Year 2020 30 Best CEOs of the Year 2020 | Page 12

Pete O’Heeron, CEO: ‘Through Continued Discovery and Development in the Lab, SpinalCyte, LLC has Become a World Leader in Using Fibroblasts for a Number of Chronic Disease Pathways’ C “SpinalCyte was formed to develop a regenerative medicine cure for degenerative disc disease using human dermal fibroblasts to regrow the disc nucleus.” hronic Lower Back Pain afflicts an estimated 33 million people annually in the U.S. Over seven million of those people suffer from Degenerative Disc Disease. Aging baby boomers may double those numbers in the next two decades. Back pain is strongly associated with degeneration of the inter vertebral disc. Disc degeneration, although in many cases asymptomatic, is also associated with sciatica and disc herniation or prolapse. It alters disc height and the mechanics of the rest of the spinal column, adversely affecting the behaviour of other spinal structures such as muscles and ligaments. In the long term, it can lead to spinal stenosis, a major cause of pain and disability in the elderly. Degenerated disc incidence is rising with current demographic changes and an increasingly aged population. In light of the foregoing, we’re thrilled to present SpinalCyte, LLC. SpinalCyte’s invention provides a new and unique patented regenerative cell therapy for repairing the cartilage of the intervertebral disc (or any other articular cartilage). The method is based on using Human Dermal Fibroblasts (HDFs) which are forced to differentiate into chondrocyte-like cells in vivo through mechanical force, and the Intermittent Hydrostatic Pressure (IHP) critical for chondrogenic differentiation of fibroblasts. 12 SpinalCyte is a regenerative medicine company developing an innovative solution for spinal disc replacement using human dermal fibroblasts. Currently, SpinalCyte holds 57 U.S. and international issued patents and has filed for an additional 100+ patents pending. The company holds 157 U.S. and International Patents pending and issued across a variety of clinical pathways, including Disc Degeneration, Cancer, Multiple Sclerosis, Parkinson’s, Chronic Traumatic Encephalopathy (CTE), Diabetes, Liver Failure, and Heart Failure. Funded entirely by angel investors, SpinalCyte represents the next generation of medical advancement in cell therapy. The company was incorporated in 2008 and is headquartered in Houston, Texas. Pete O’Heeron, SpinalCyte, LLC CEO, spoke exclusively to The Silicon Review. Below is an excerpt. Why was the company set up? And how did you expand your company and its offerings over the years? SpinalCyte was formed to develop a regenerative medicine cure for degenerative disc disease using human dermal fibroblasts to regrow the disc nucleus. The human body has two cell sources which can regenerate into other tissues or organs, stem cells and fibroblasts. Through continued discovery and development in the lab, SpinalCyte has become a world leader using fibroblasts for a number of chronic disease pathways. Current pipeline products include Multiple Sclerosis, Parkinson’s, Cancer, Diabetes, and CTE (Football Head Injuries). Can you brief us about the history of your company? We began the company with one provisional patent to treat Degenerative Disc Disease using dermal fibroblasts to regrow the disc. We spent years in the lab and multiple animal trials before we were ready to advance into humans. Our first- in-human trial was a success and we saw 83% of the patients experience significant pain reduction. Over the years, our research developed other uses for fibroblasts and we’re currently developing a pipeline of clinical pathways including Diabetes, Cancer, Multiple Sclerosis, Parkinson’s, and CTE. What would you say was the single most influential factor in your business’ success? I always believe curiosity and determination are the most important factors in our success. We try to keep updated on all new clinical data being published. As you can imagine, the amount of innovation is growing both domestically and internationally. Staying at the forefront of scientific discoveries is focus for us. It’s curiosity and determination that takes us in new and promising directions. What are your three biggest accomplishments? My three biggest accomplishments are developing a proprietary surgical access system, developing a full cell