GelSana engineers novel polymer materials for chronic wound care that are highly differentiated from the competitive field. We have developed proprietary polymers that evade the foreign body response, have anti-inflammatory capabilities, and repel bacteria. These materials will have applicability across multiple wound types in both the chronic and acute spaces. GelSana’s first commercial product, Cleragel™, will target various types of wounds including diabetic wounds; testing on diabetic wounds in mice and pigs have shown substantially decreased healing time. As an added benefit, these gels can be formulated to deliver therapeutics in a controlled 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, provide cost savings to clinics, and reduce pain for patients. These gels are anticipated to be a valuable tool to combat any wounds that are showing limited response to other healing solutions. GelSana has raised venture capital as well as secured non-dilutive funding from state of Colorado (OEDIT), NIH, and AFWERX (Air Force). 

Chonic wounds impact 1 in 38 adults in the U.S. One example of a chronic wound is a diabetic ulcer, with impaired healing due to high inflammation and poor vascularization. Lower extremity ulcers alone cost $78B in the U.S, and precede 84% of all diabetic lower extremity amputations. Current standard of care does not address chronic inflammation and reduced vascularization, two primary factors associated with poor healing. Half of chronic wounds become infected which can lead to amputation, and unfortunately in the U.S. a patient loses a limb every 20 seconds due to a chronic infected wound. There is an unmet need for innovative wound care products that reduce inflammation, repel bacteria from the wounds, and promote improved and accelerated wound healing.

To date we have raised a total of $5.5M in funding, with $2.5M from non-dilutive grant funding and $3M from investors. We have licensed the IP from the Colorado School of Mines; we have finalized the formulation and format and packaging of our first product; we have completed key animal studies demonstrating the capability for this formulation to heal diabetic wounds at the rate at which healthy animals heal and we have conducted a head-to-head trial in these animals against lead competitor products and found improved healing with our material. We have brought manufacturing in-house and are preparing for FDA registration of both our facility and our first product Cleragel by end of this year / early 2026. As a Class I medical device, Cleragel will be able to be used clinically immediately upon FDA registration. Recently we were selected to participate in MedTech Innovator 2025 cohort (only 65 companies are selected out of over 1500 applicants worldwide). Our work has been peer-reviewed by others in various capacities and deemed exciting and novel, including being  awarded SBIR grants from NIH NIDDK, Air Force AFWERX, and Colorado OEDIT. 

Our company is heading fast to market with our first product Cleragel; we anticipate achieving class I medical device regulatory filing for this product by late 2025/ early 2026, 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, and as we use the initial human studies to approach new centers for sales, we anticipate sales volume will grow. We anticipate launching in the European market by mid-2027. Ultimately our exit strategy is to find an acquirer 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 first product Cleragel.

The advanced wound care product market is controlled by competitors that include large companies such as 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 polymer technology that offers advantages over current wound dressings. Cleragel directly addresses current market limitations by offering enhanced durability in both dry and moist conditions. Unlike hydrogels, it maintains its structural integrity, requiring fewer dressing changes. Additionally, Cleragel is anti-inflammatory, repels bacteria, and may reduce pain, making it a more versatile and effective solution.

Cleragel will first make an impact in treating diabetic foot ulcers (DFUs), a chronic and costly wound type. From this base, GelSana will expand Cleragel’s indications to include venous leg ulcers, pressure ulcers, surgical incisions, trauma injuries and burns — scaling across wound clinics, hospitals, long-term care, and burn centers. A soft launch is planned for 2025–2026, with full US commercialization in 2027 and European expansion to follow. In 2026, we will focus on clinical studies with our KOLs to ultimately drive clinical adoption. These clinical studies will demonstrate: performance & handling in covering difficult-to-treat wounds, pain reduction, and wear time and reduced dressing changes. Also in 2026 we will focus on marketing and presentations at conferences, and hire a sales leader and US sales representatives to assist with direct sales to wound care clinics and podiatry offices. Later we will expand sales through distribution contracts, and we also plan to launch in Europe in mid-2027 to further drive sales and strategic interest.