In the U.S. alone, there are over 100 million chronic wound visits every year. By 2020, the general wound care market is expected to hit about $20.5 billion. Maryland’s Gemstone Biotherapeutics aims to address this market with a highly tunable, novel biosynthetic wound healing product that is heading towards FDA review. Now with a 2019 Maryland Stem Cell Research Fund (MSCRF) grant award they are drawing a lot of attention as a company to watch in the regenerative medicine space.
Gemstone, founded in 2013, is a pre-clinical research and development company established with in-licensed technology from Johns Hopkins University and seed capital provided by local angel investment group Gamma3. Its lead pipeline product is moving toward FDA IND submission in early 2019 and is based upon materials technology invented by Johns Hopkins’ Dr. Sharon Gerecht, who remains a key adviser to the Gemstone team.
Gemstone’s novel biosynthetic material has the potential to offer patients what CEO Dr. Emily English calls, “healing plus.” English, who became CEO in 2018 and is a former senior scientist and program manager at the Johns Hopkins University’s Applied Physics Laboratory, added: “When we use the term regenerate…we’re talking about tissue that comes back without scarring, with restoration of hair follicles and sebaceous glands and with all of the normal structures you’d expect to see in healthy, living skin.”
“Scarring is a significant problem across many different areas of medicine…and so there’s always a hunt on for technology that offers the promise of robust regeneration.”
The company’s lead technology offers the promise of such robust regeneration and will seek FDA approval as a medical device. It will target the dermatology space first, specifically acute wound care resulting from abnormal mole removal, skin cancer surgery, and biopsies. In the U.S. alone over 30 million excisional procedures are done every year. These wounds are notoriously difficult when it comes to returning skin to its original healthy, scar-free state.
Gemstone’s novel approach aims to return skin to normalcy faster, reducing the stress and shame that often accompanies such procedures executed in highly visible areas. Gemstone believes its technology will eventually replace the need for complex Dermatology closure procedures.
“The power of our technology lies in its flexibility,” stated English. “A way we like to explain our technology is this: it’s like putting two lego bricks together in a certain ratio and you get one structure, like a house. If you want to add another room, you can attach another set of legos. Essentially the chemistry we use operates in much the same way: We have an ‘A’ material and a ‘B’ material and we can add something to that mix to customize it to, for example, fully treat an acute surgical wound or a chronic wound like a diabetic foot ulcer.”
“Many of the current wound treatments are good at what they do, but have the limitation of being natural materials that lack flexibility. Our product is a manufactured biosynthetic, which allows us to add therapeutics or cells to address different indications,” continued English.
Gemstone’s product will eventually be commercialized as a sterile patch that can be easily cut to size and will match the skin’s thickness. The material is applied into the void created by a burn or surgery.
“We are laser focused on getting our lead product to the market,” stated English. “We feel our diversity of experience and commitment to the highest quality science will get us there.”
A signal of its company-to-watch status, English and Gemstone recently received a commercialization award of approximately $300,000 from the Maryland Stem Cell Research Fund, which was established in 2006 by the state of Maryland and is currently administered by Columbia, Maryland’s TEDCO.
The organization plans to use the stem cell award to enhance its pipeline by customizing the core material to achieve better efficacy for severe burns.
“The steps Gemstone Biotherapeutics is taking towards providing medical solutions is transformational, and a true representation of what we look to support through the Fund,” said Dr. Dan Gincel, executive director of TEDCO’s Maryland Stem Cell Research Fund. “Their development of clinically relevant technologies and subsequent research efforts help to further TEDCO’s mission of growing the life sciences ecosystem here in Maryland.”
“TEDCO has been very helpful connecting us to resources in the community and the MSCRF team was extraordinarily helpful during the award proposal process. Both organizations helped us tremendously and we are very appreciative,” said English. “We’re looking forward to reconnecting with everyone at the stem cell symposium at the end of the month.”
TEDCO’s annual stem cell symposium will be held this year on October 30th at the Hotel at the University of Maryland. You can learn more and register here.
English, who was recently named to The Daily Record’s 2018 Leading Women list, added, “We’re a startup that’s so close to developing a solution for scar-free skin regeneration. The possibility of achieving that is so exciting to us.”
With its novel biosynthetic technology nearing FDA review, another topical wound treatment in the early pre-clinical phase, the MSCRF award, community support and access to lab space and equipment at Johns Hopkins University, Gemstone is primed to transform wound care and improve the lives of millions of patients across the U.S.