Praful Shah, have met with him several times to discuss GelSana. Tim Jones, work with him through Innosphere. Bud Rockhill, work with him through Mines Entrepreneurship / Venture Center

Potentially. However, our valuation and terms have been set by our lead investor, Innosphere Ventures.

This round is an equity priced round.

$8,500,000

These funds we are raising for this second seed round will be used for early commercialization of our first product, Cleragel. Specifically they will support us finishing our manufacturing work, performing our biocompatibility testing, supporting one new hire in commercialization, attending conferences to promote our first product, R&D supplies, Corporate and IP legal fees, and general insurance / office support / rent requirements.

Melissa Krebs, Ph.D., CEO, [email protected], https://www.linkedin.com/in/melissa-krebs-ph-d-09aa1531/ , Melissa Krebs, Ph.D. is CEO and Founder of GelSana and Associate Professor of Chemical & Biological Engineering at Colorado School of Mines. She is a Board Member of Colorado Bioscience Association, and she is also a Faculty Member of the Gates Center for Regenerative Medicine at University of Colorado School of Medicine, and an Adjunct Associate Professor in Ophthalmology at University of Colorado School of Medicine as well. 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 wound-healing materials and she founded GelSana to commercialize and bring these promising materials to the clinic.

Mike Freeman, Board of Directors, [email protected], https://www.linkedin.com/in/mikeafreeman/ , Mike Freeman as CEO is responsible for Innosphere Ventures operations, finances, strategy, and execution. Innosphere Ventures is the longest-standing and most successful commercialization program in the state of Colorado, and served as GelSana’s lead investor for both a pre-seed and seed round of fundraising. They are also leading the Seed II fundraise.

Jim Kasic, Board of Directors, [email protected], https://www.linkedin.com/in/jim-kasic-2792046/ , Jim Kasic is a senior executive with more than 30 years in the biomedical industry. Jim is able to assist with the design process and regulatory applications and approvals, he has a strong track record of growing startups and securing funding, and he has experience guiding sales and marketing teams globally.

Adam Rocker, Ph.D., Scientist, [email protected], https://www.linkedin.com/in/adam-rocker-a401b649/ , Adam Rocker is lead Scientist at GelSana, with a PhD in Bioengineering and expertise in developing biomaterials as drug delivery systems for enhanced tissue regeneration with a focus in angiogenesis in particular. He has prior experience in R&D at GE Healthcare and Thermo Fisher Scientific.

Joanna Money, Ph.D., Advisor for business development, [email protected], https://www.linkedin.com/in/joanna-joey-money-1933404/ , Joey is a Corporate Development executive, successful in developing and driving strategic growth and operations. Strong operational and relationship management experience in biopharma, bio-based chemical and biotechnology companies, specializing in building value through product commercialization as well as structuring, negotiating and executing lucrative partnering and licensing deals.

David Armstrong, MD, PhD, Clinical Advisor, [email protected], https://www.linkedin.com/in/dgarmstrong/ , Dr. Armstrong is Professor of Surgery with Tenure at the University of Southern California. Dr. Armstrong holds a Master of Science in Tissue Repair and Wound Healing from the University of Wales College of Medicine and a PhD from the University of Manchester College of Medicine, where he was appointed Visiting Professor of Medicine. He is founder and co-Director of the Southwestern Academic Limb Salvage Alliance (SALSA). He has more than 640 peer-reviewed research papers in dozens of scholarly medical journals as well as over 100 books or book chapters.

Kathleen Schaum, Advisor for Reimbursement Strategy, [email protected], https://www.linkedin.com/in/kathleen-d-schaum-9964b14/, Kathy Schaum is a nationally recognized wound /ulcer management reimbursement strategy consultant and educator, with 50+ years of industry experience, who shares reimbursement expertise with manufacturers, medical professionals, investment firms, advisory boards, wound management organizations, and marketing/sales professionals.

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.

The advanced wound care product market is competitive and controlled by large 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. 3M sells Tegaderm Hydrogel Wound Filler (propylene glycol and guar gum). Smith+Nephew sells Intrasite gel (carboxymethylcellulose and PEG), and Regranex, platelet-derived growth factor in cellulose gel, however, this product has had mixed clinical results. Cardinal Health sells Aquaflo (polyurethane). Coloplast sells Purilon (carboxymethylcellulose and alginate). 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. Unlike competing products, the materials which our hydrogels are comprised promote an anti-inflammatory environment. Future formulations of the gels will stabilize and sustain delivery of therapeutics to the wound environment, offering a major advantage over existing products and preventing the need for continual repeated application, making it easier for the patient and more cost effective. These formulations represent a rich R&D pipeline for GelSana.

For our first product, Cleragel, we are intending to apply to use an existing HCPCS code for reimbursement as a hydrogel wound dressing. We will do this after FDA registration of Cleragel. Subsequent products will have different reimbursement strategies depending on therapeutic incorporated and format.

We will file Cleragel as a class I medical device with the FDA by the end of this year, 2023.

The market is very crowded, however we have strong differentiated technology and strong, defensible IP surrounding this technology.

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 Fall 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.

We anticipate raising a Series A in one year to support growth beyond early Cleragel sales. This funding will be used to support more formal clinical outcome measures for Cleragel, pushing a second medical device product to market (hydrogel + antimicrobial), and for pre-clinical research for a drug-device combination product to support an IND application.

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 with additional data on other products in our pipeline.

We will begin early sales in Fall 2023 with key opinion leaders. 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 an existing HCPCS code for reimbursement of our hydrogel product. At this time we can approach durable medical equipment (DME) suppliers and negotiate contracts for adding our Cleragel product into their sales catalogues.

With this 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. They will also seek partnerships with durable medical equipment (DME) suppliers to ultimately scale our sales even further.

We have licensed the IP from the Colorado School of Mines; we have finalized the formulation and format and packaging of our first product which is now well underway with a contract manufacturing organization; we have completed key animal studies demonstrating the capability for this formulation to heal diabetic wounds in mice 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 engaged and contracted with our CMO, Boulder iQ, for this first product, and we are well underway in the manufacturing process, heading towards FDA registration later this year. We have recently been awarded 2 Phase I SBIRs, one from NIH for preclinical work on a drug/device combination product, and another from AFWERX (Air Force) for DOD customer discovery towards DOD use of our hydrogels in various wound care settings. We also have non-dilutive funding from State of Colorado supporting the manufacturing of our Cleragel product. We have won numerous awards over the past two years, including awards in 4 pitch competitions (netting $34.5k total in awards), being named “Most Innovative Emerging Wound Care Product Company” by Global Health & Pharma in 2022”, and with Melissa Krebs being named 2023 MedTech CEO of the Year (Colorado) by Acquisition International.

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. The lifetime incidence of ulcers in persons with diabetes is between 19-34% [1]. Worldwide, every year between 10-26 million diabetic patients will develop a diabetic ulcer [1]. The financial burden of this is extreme, representing $78 billion annually in the U.S. alone [2]. These ulcers lead to 80% of non-traumatic amputations in the U.S.; every 20 seconds a limb is lost to a diabetic ulcer. The mortality rates after diabetes-related amputations exceed 70% at 5 years for all patients, and exceed 74% at 2 years for patients on dialysis.

In addition to diabetic foot ulcers, decubitus ulcers or pressure ulcers occurring in elderly/bedridden patients represent another 2.5 million cases in the U.S. annually [3]. These pressure ulcers are similarly difficult to treat, subject to infection and represent a major financial burden and care problem for patients and geriatric facilities.

These are just two examples of wounds we can make substantial impact with, there are many other types of wounds including chronic and acute, surgical incisions, burns, scars, and so forth.

1. Diabetic Foot Ulcers and Their Recurrence, Armstrong, D., et al, The New England Journal of Medicine, 2017, 376, 2367-75
2. Five year mortality and direct costs of care for people with diabetic foot complications are comparable to cancer, Armstrong D, et al, Journal of Foot and Ankle Research, 2020, 13
3. Agency for Healthcare Research and Quality, US Department of Health and Human Services, https://www.ahrq.gov/patientsafety/settings/hospital/resource/pressureulcer/tool/index.html