Reasons to Invest

Investors, particularly non-specialists, are understandably cautious about developing strong investment theses in wound care because the space is crowded with many products and approaches and it can be difficult to assess the significance of differentiation claims. The following factors should make it easier to reach an investment decision in the case of OmegaSkin:

• The efficacy of skin substitutes that act as a scaffold or lattice to promote skin regeneration and wound healing has been well-established for decades. 
• OmegaSkin’s differentiation is that it is electrospun from soy protein isolate, rather than harvested from human or animal sources; electrospun scaffolds and soybean products have both been documented as advantageous for biomedical applications in numerous scientific publications.
• NeuEsse is the exclusive licensee of portfolio of patents from Temple University (where Peter I. Lelkes invented this technology) claiming Bioactive Proteins in Water-Soluble Soy Protein Isolates for wound healing.
• Regulatory risk is atypically very low because: (i) dozens and dozens of skin substitutes (made from various sources, including plants) have been routinely cleared by the FDA under the 510(k) pathways, without clinical data, due to precedents (predicates) and the excellent safety record of this class of products.
• The risk that our animal results will not translate to human patients is atypically very low because:  (i) OmegaSkin has demonstrated the ability to restore hair follicles and sweat glands (which are defining characteristics of mammalian skin), which to our knowledge may be unique among currently marketed skin substitutes; and (ii) a mechanical lattice made of ubiquitous soy has essentially no pharmacokinetic or pharmacodynamic elements to confound translation, unlike drugs (where clinical translation is a big concern).
• An over $500 million annual market currently exists in skin substitutes made from human or animal sources; OmegaSkin will not have to create a new product category or change existing medical practice (indeed it will simplify administration in many cases).
• Sales of current products represent only a single digit percent penetration of the addressable U.S. market, with an essentially virgin market for the rest of the world outside the most advanced economies, which means huge opportunities to penetrate underserved segments with the right product.
• Investors will additionally participate in having a major social impact, in expanding access to a potentially life- or limb-saving culturally sensitive advanced wound dressing for many millions more patients in the U.S. and around the globe at affordable prices, including those least able to pay:  given the projected highly favorable cost structure of OmegaSkin.
• The global protection of our IP mitigates risk from competition.