A 10-year-old boy from Connellsville, Pennsylvania burned over 30% of his body, with his leg being burned to the bone. The leg required 360 skin grafts, and doctors thought he would never be able to walk again. This 10-year-old boy is now the Founder & CEO of NeuEsse — Joe Connell.
NeuEsse Inc. is a medical device company that has created a human skin substitute from soy protein. Our mission is to enhance outcomes and quality of life for patients who have suffered wounds, burns, skin disrupting ulcers, and other skin/epidermal injuries.
This is more than business. We bring hope to those suffering.
- Research at Carnegie Mellon University offers great promise for delivering stem cells and growth factors
- Exclusive licensee of portfolio of patents from Temple University
- Sustainable, vegan-friendly soybean skin substitute products
- Full thickness wound study shows healing with minimal scar
- BoomStartUp pitch competition winner (Health & Wellness)
In adults, skin accounts for ~16% of total body weight and covers a surface area of ~22 square feet (2 square meters). In a lifetime, most people will damage their skin, some more severely than others: trauma, surgery, burns and chronic wounds and ulcer treatment.
Wound care encompasses responding to a number of different needs, from staunching bleeding to providing an immediate physical barrier to cleaning and debriding the wound bed to fighting infection to promoting wound closure to reducing scarring and restoring skin appendages such as hair follicles and sweat glands.
Patients face numerous problems in today's field of therapies.
- Unavailable — skin substitutes need donors, lengthy lab preparation, costly special handlings, storage and delivery.
- Unaffordable — most current skin substitutes are too costly for serious wounds and burns.
- Unacceptable — cultural or religious sensitivities to sources of material (cadavers, embryonic materials, cows or pigs) block access to patients around the globe.
We believe there is an urgent need for an effective, potentially life- or limb-saving, culturally sensitive skin substitute at affordable prices.
Imagine an affordable, off-the-shelf, plant-based dressing that is applied directly into the wound bed, absorbs the wound exudate, and provides a structure that supports native tissue healing.
The skin substitute, OmegaSkin, utilizes water-soluble soy protein isolate to generate a high-tech extra-cellular matrix or scaffold. Once applied, OmegaSkin gradually integrates into the host's dermis while acting as a scaffold for new skin to grow.
- Full thickness wound healing — minimal to no scarring and intact hair follicles with sweat glands.
- Regenerative — soybean plant-based protein generates an extracellular matrix for wound closure.
- Affordable — we believe it could be less expensive to manufacture and scale.
- Safety — less propensity for cross infection or contamination than sources from animal or cadaverous sources.
HOW WE'RE DIFFERENT
The novelty of OmegaSkin, compared to prior skin substitutes that act as a scaffold to promote healing, made from human or animal products, is that OmegaSkin is made from a plant source — purified soybean protein isolates that are commercially available as food.
Otherwise, OmegaSkin likewise acts as a mechanical scaffold to promote healing, and thus the company is working towards having it regulated as a Class II medical device that may be marketed pursuant to a 510(k) clearance.
- Doesn't require refrigeration
- No special storage needs
Studies in animal models indicate that electrospun soy-based wound matrices are gradually degraded and integrated into the host's dermis while acting as a scaffold for new skin to grow. In preclinical trials, OmegaSkin offered superior closure in full-thickness wounds with minimal to no scarring and saw regrowth of intact hair follicles and sweat glands.
Because of the integration into the host's dermis, the repaired skin will typically retain pigmentation of the patient and match better the original skin color or tone.
We aim to create a significant revenue stream through bids and contracts with hospital purchasing agents. NeuEsse believes the product has greater efficacy than present competition yet costs orders of magnitude less to produce.
Management believes OmegaSkin has the ability to under-bid the price of any competitor yet the hospital or wound clinic will enjoy the same rate of insurance reimbursement. Direct sales to physician offices and hospitals may benefit from this same scenario.
NeuEsse is targeting a variety of wound care markets. The list below is not all-inclusive to just these markets, but they are common markets where the wound care products could be very useful.
Rising incidence of chronic diseases such as diabetes, cancer, and other autoimmune disorders is anticipated to increase the incidence rate of chronic wounds in the U.S. Factors such as antimicrobial resistance, unhealthy & sedentary lifestyles, and tobacco & alcohol consumption is contributing to rising prevalence of non-communicable diseases. We believe the failures of present wound healing therapies will drive hospital admissions for treatment.
Increasing prevalence of chronic wounds in the geriatric population and growing demand of outpatient wound care services is expected to drive the growth of wound care centers market during the forecast period.
However, this process cannot be performed in a warzone where immediate treatment including debriding, bleeding cessation, applying anti-infection measures followed by coverage and protection of the injury, and evacuation to the next proper facility.
Our leadership: expertise backed by experience
Use of Proceeds
If the offering's maximum amount of $1,069,999 is raised:
|Use||Value||% of Proceeds|
|Manufacturing & Inventory||$250,000||23.4%|
|CE Marking for European Sales||$150,000||14.0%|
This is an offering of Common Stock, under registration exemption 4(a)(6), in NeuEsse Inc.. This offering must raise at least $10,000 by November 8, 2022 at 11:59pm ET. If this offering doesn’t reach its target, then your money will be refunded. NeuEsse Inc. may issue additional securities to raise up to $1,069,999, the offering’s maximum.
If the offering is successful at raising the maximum amount, then the company’s implied valuation after the offering (sometimes called its post-money valuation) will be:
These financial statements have been reviewed by an independent Certified Public Accountant.
The Offering Statement is a formal description of the company and this transaction. It’s filed with the SEC to comply with the requirements of exemption 4(a)(6) of the Securities Act of 1933.
We’re also required to share links to each of the SEC filings related to this offering with investors.
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Be sure to understand the risks of this type of investment. No regulatory body (not the SEC, not any state regulator) has passed upon the merits of or given its approval to the securities, the terms of the offering, or the accuracy or completeness of any offering materials or information posted herein. That’s typical for Regulation CF offerings like this one.
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The information contained herein includes forward-looking statements. These statements relate to future events or to future financial performance, and involve known and unknown risks, uncertainties, and other factors, that may cause actual results to be materially different from any future results, levels of activity, performance, or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties, and other factors, which are, in some cases, beyond the company’s control and which could, and likely will, materially affect actual results, levels of activity, performance, or achievements. Any forward-looking statement reflects the current views with respect to future events and is subject to these and other risks, uncertainties, and assumptions relating to operations, results of operations, growth strategy, and liquidity. No obligation exists to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.
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