The following was provided while participating in the 2023 Destination Startup® Showcase.
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What We Do
For clinicians with patients who have wounds, particularly chronic wounds, GelSana is the hydrogel wound dressing company that provides products that improve wound healing by reducing inflammation and offering sustained drug delivery over time.
Affiliated Institution: Colorado School of Mines
Have we formed a company? Yes
Funding: Grant Funding, Angel Funding (including Self or Friends/Family), Venture Capital
Our Company and the Problem We Are Trying To Solve
Diabetes is a vast and growing health problem globally due to the rising prevalence of obesity. In addition to the systemic issues associated with this disease, a common and difficult complication is the occurrence of diabetic ulcers. These painful, infection-prone ulcers are very difficult to treat using current technologies and represent a significant under-met need in the marketplace. We have developed a proprietary hydrogel that prevents the foreign body response and can promote macrophage phenotypes associated with anti-inflammatory and pro-healing functions. These gels could have applicability across multiple wound types and uses beyond diabetic ulcers. GelSana’s first commercial hydrogel, Cleragel™, will target diabetic wounds; initial testing on diabetic wounds in mice have shown substantially decreased healing time and increased resultant healed tissue strength. As an added benefit, although not required, in the future these gels can be formulated to deliver therapeutics in a sustained manner over time, eliminating the need to continually reopen the wound bed and reapply ointments. GelSana’s hydrogels should decrease the need for wound dressing changes; in animal studies the dressing is never replaced for the duration of the study. These gels are anticipated to be a valuable tool to combat any wounds that are showing limited response to other healing solutions. Our first product will be registered with the FDA and launched in Spring 2023. The technology is protected by patents from Colorado School of Mines that have been licensed exclusively to GelSana.
Our Go-to-Market Strategy
We will begin early sales in Spring 2023 with key opinion leaders. We will also target large wound healing centers and podiatry offices. We will continue to work on this in the coming months prior to our end of March 2023 registration with the FDA. As our first key opinion leaders share their success with our product with their colleagues, we anticipate early sales volume will grow. We anticipate additional significant growth upon receiving approval to use the HCPCS code for reimbursement. With a Seed II fundraise, we are seeking to bring Sales & Marketing leadership onto our team at GelSana with a full-time hire. This person will be dedicated to making connections and initiating sales within wound care clinics and podiatry offices across the country and helping to establish and scale our early sales. The advanced wound care product market is controlled by competitors that include 3M, Smith+Nephew, Coloplast, and Cardinal Health. These companies provide a range of different wound dressings for advanced wound care, including hydrogels. The market is plagued with a multiplicity of different formulations, none of which have emerged as the market leader based on the similarity of their strengths and weaknesses including their inability to make a material impact on wound healing. GelSana is well positioned for capturing advanced wound care market share due to its unique and patented hydrogel technology that offers advantages over current wound dressing hydrogels.
How We Will Generate Revenue
Our company is heading fast to market with our first product Cleragel, and we anticipate achieving class I medical device regulatory filing for this product by end of March 2023, and we will then initiate early sales including with key opinion leaders and wound care clinics to further validate the product’s efficacy and benefit in humans and build a clinical database supporting claims of superiority. As these key opinion leaders share their success with our product with their colleagues, we anticipate sales volume will grow. Ultimately our exit strategy is to find an acquiror interested in selling our products with established sales channels, and who will likely also be interested in the sustained delivery aspect of our materials. An early exit could occur as soon as we have demonstrated the clinical and commercial value of the hydrogel product. Our revenue model shows a potential of over $300M in revenue by the year 2028. We have a product pipeline laid out that has four dressing formulations that would all be considered medical device products by the FDA which we intend to pursue first to get products to the market quickly. We also intend to pursue pre-clinical R&D for a biologic-containing hydrogel dressing that could directly compete with Smith+Nephew’s Regranex product, but the timeline is lengthier for this therapeutic product and it would ultimately require clinical trials before clinical adoption would be possible.
How We Will Benefit From Destination Startup®
We are seeking $3M total in a Seed II fundraise. This will be used to support early commercialization of our first product, Cleragel, as well as continued R&D efforts towards our product pipeline focused on the second product which will contain an antimicrobial agent. With this raise, we will be looking for additional team members and ultimately strategic partners. We anticipate entering into partnering agreements in about one year from now, and anticipate starting a series A raise next year for $7-10M. We are ultimately seeking early exit opportunities which may become apparent during our partnering discussions with large companies in the wound healing space.
Melissa Krebs, Ph.D. is CEO and Founder of GelSana and Associate Professor of Chemical & Biological Engineering at Colorado School of Mines. She has over 45 manuscripts on biopolymers for controlled therapeutic delivery and systems for regenerative medicine. Melissa’s lab at Colorado School of Mines developed these materials and she founded this company to commercialize and bring these promising materials to the clinic. On the Board of Directors are Mike Freeman, CEO of Innosphere Ventures, and Jim Kasic, Founder of Boulder iQ. Mike Freeman is responsible for Innosphere Ventures operations, finances, strategy, and execution. Jim Kasic is a senior executive with more than 30 years in the biomedical industry. We have a full-time PhD scientist on staff, Adam Rocker, that has been instrumental in developing Cleragel’s formulation, running our animal studies, designing the packaging, and coordinating the information transfer to Boulder iQ for Cleragel manufacturing. We have strong advisors on board including Joanna Money for business development; Jaron Ballentine for commercialization; Larry Blankenship for product development and revenue modeling; David Armstrong, a world-expert and a U.S. leading expert in diabetic foot ulcers for clinical advising; and John James, a surgeon that specializes in wound care in the Denver metro area specifically in the Centura Health System, a major hospital system in Denver. With the Seed II Fundraise we intend to bring Sales & Marketing Leadership into our team which we know that we will need for early commercialization of our first product.