Gail Naughton, Chairman and CEO of Histogen talked about regenerative medicine at www.bio2devicegroup.org event.
Naughton began by sharing the history of regenerative medicine. So what is regenerative medicine? It is the process of replacing or regenerating human cells, tissues or organs to restore or establish normal function and it holds promise for regenerating damaged tissues and organs. It was an exciting discovery earlier that if you grow cells in a 3D environment, instead of a plastic cup then they become tissues and form functional epidermis, said Naughton. This would require tremendous cross-functional effort between bio-engineers and surgeons.
Earlier technology was based on allogenic fibroblasts obtained from neonatal foreskins, from routine circumcisions. The focus was on wound healing because of fewer complications due to topical applications. The stem cell technology responded to wound environment and secreted numerous growth factors. One of the first companies in this space was TransCyte that focused first on facial burns and then on diabetic foot ulcers. It showed excellent and persistent wound healing and was very exciting. However, cool technology does not translate into reimbursement. At the time, wound healing was a low paid proposition. Ischemic wounds occur as a result of blocked blood flow to medium and small vascular beds in the body. It was found that stem cells cure ischemia and restore blood vessels. Between 1996 and 2000, there were various companies targeting ischemic wound healing, including Integra, TransCyte, Apligraf, and Dermagraft. There was a lot of hype but still not much success in getting reimbursement. Additionally, these products had low shelf life and required to be stored in freezers. It took several years before the realization that cost of amputations and other procedures far outweighed the cost of these technologies.
During that time, Advanced Tissue Sciences licensed NouriCel product line to SkinMedica for skin care applications. Then Inamed licensed rights for human collagen product applications from Advanced Tissue Sciences. The company was later bought by Allergan for $375 million. Increased collagen secretion, even when topically applied, had positive effect on decreasing anti oxidants. One of the lessons learned was, that the path to generating revenues was through cosmetic and aesthetic applications. Skin care was an exploding market and consumers were willing to pay.
Allogenic stem cell technology, particularly from neonatal foreskins was making way for many skincare options. Next to come was autologus stem cell technology with cells derived from person’s own blood, to reduce major complications due to body’s immune response. Recombinant proteins derived from the expression of recombinant DNA within living cells, offered further options. Cytori Therapeutics Celution System had a proprietary centrifuge device that enabled access to adult adipose-derived stem and regenerative cells (often from liposuction and other procedures) for later cosmetic use. Cytori technology automated and standardized the extraction, washing, and concentration of the patient’s ADRCs for present and future clinical use.
Australia based Avita offered point of care cell treatment with great application for burns. Avita’s ReCell Spray-on Skin is a rapid, autologous cell harvesting, processing, and deliver technology that allows surgeons to treat burns and other skin problems using patient’s own cells. This real time technology accelerates healing, minimizes scar formations, eliminates tissue rejection, and reintroduces pigmentation to the skin. Again it becomes apparent that revenue generation is easier for aesthetic applications. Fibrocell Science is another exciting company with autologus fibroblast technology. Fibroblast cells that are responsible for production of collagen, a protein that gives the skin its strength and elasticity and extracellular matrix proteins, are most common cells of connective tissue. Autologous fibroblast cells derived from individual’s body are used for variety of aesthetic applications. Regardless of the fact that people may or may not need autologous technology for wrinkle removal, the marketing is working, said Naughton. People are happy to get a jar or “customized” skin cream for almost $500.
Naughton’s company Histogen is also currently focusing on aesthetic applications, particularly on skin and hair growth. Conditions that make the embryonic environment special was a moment of major insight and excitement, said Naughton. Histogen has proprietary technology that mimics the low oxygen, low gravity embryonic environment. These hypoxic human dermal fibroblasts HDFs are derived from similar embryonic conditions that lead to production of vital proteins and growth factors. From this process, Histogen extracts two products, a soluble human cell conditioned media (CCM) and an insoluble human extracellular matrix (hECM). With one technology, two formulations, Histogen sees ahead a variety of applications to address a broad range of markets, said Naughton. Before and after pictures of wrinkles and hair growth showed clearly the impact of Histogen technology and raised tremendous excitement among the attendants. Histogen raised $10M in Series A round and is currently raising Series B, to support upcoming clinical trials and scaled up manufacturing.