United Health Products Stock

United Health Products, Inc. (UHP) develops, manufactures, and markets a patented hemostatic gauze for the healthcare and wound care sectors.

The company's gauze product, HemoStyp, is a neutralized, oxidized, regenerated cellulose ('NORC') derived from cotton and designed to absorb exudate/drainage from superficial wounds and help control bleeding. The company is in the process of seeking regulatory approval to sell the company's Hemostyp product line into the U.S. Class III and European Union CE Mark surgical markets.

HemoStyp Gauze Products

HemoStyp hemostatic gauze is a natural substance created from chemically treated cellulose derived from cotton. It is an effective hemostatic agent registered with the FDA for superficial use under a 510(k) approval obtained in 2012 to help control bleeding from open wounds and body cavities. The HemoStyp hemostatic material contains no chemical additives, thrombin, collagen or animal-derived products, and is hypoallergenic. When the product comes in contact with blood it expands slightly and quickly converts to a translucent gel that subsequently breaks down into glucose and salts. Because of its benign impact on body tissue and the fact that it degrades to non-toxic end products, HemoStyp does not impede the healing of body tissue as compared to certain competing hemostatic products. Laboratory testing has shown HemoStyp to be 100% absorbable in the human body within 24 hours, compared to days or weeks with competing organic regenerated cellulose products. A human trial conducted in 2019 and 2020 demonstrated the effectiveness of HemoStyp in vascular, thoracic and abdominal surgical procedures.

HemoStyp hemostatic gauze is a flexible, silk-like material that is applied by placing the gauze onto the bleeding tissue. The supple material can be easily folded and manipulated as needed to fit the size of the wound or incision. In surface bleeding and surgical situations, the product quickly converts to a translucent gel that allows the physician or surgeon to monitor the coagulation process. The gel maintains a neutral pH level, which avoids damaging the surrounding tissue. In superficial bleeding situations, HemoStyp can be bonded to an adhesive plastic bandage or integrated into a traditional gauze component to address a broad range of needs, including traumatic bleeding injuries and prolonged bleeding following hemodialysis.

Potential Target Markets

The company's HemoStyp material is cut to several sizes and configuration and marketed as HemoStyp Gauze. The company's potential customer base includes, without limitation, the following: Hospitals and Surgery Centers for all Internal Surgical usage (in the event the company obtain FDA Class III approval); Hospitals, Clinics and Physicians for external trauma; EMS, Fire Departments and other First Responders; Military Medical Care Providers; Hemodialysis centers; Nursing Homes and Assisted Living Facilities; Dental and Oral & Maxillofacial Surgery Offices; and Veterinary hospitals.

Primary Strategy

The company's HemoStyp technology received an FDA 510(k) approval in 2012 for use in external or superficial bleeding situations and there is an opportunity for HemoStyp products to address unmet needs in several medical applications that represent attractive commercial opportunities. The company's extensive laboratory testing and the company's completed human trial indicate that the HemoStyp technology could successfully compete against established Class III market participants, and could gain a significant market share.

In 2018, the company made the decision to focus its efforts and resources on accessing these Class III markets to maximize the value potential of the company's HemoStyp products. The Class III PMA process required a substantial investment of time and resources so the company made the strategic determination to pause the company's sales and marketing to non-Class III markets in order to devote the company's full attention to the PMA process. In the fourth quarter of 2021, with the company's PMA application largely complete and under review by the FDA, the company re-engaged with certain consumers and distributors of 510(k) hemostatic products with the objective of developing a revenue channel in this market going forward. The company's primary market focus for this initiative includes the first-aid, dental surgery and emergency medicine sectors.

In the anticipation of receiving a Class III PMA (which cannot be assured), the company is evaluating paths to rapidly grow its revenue and profits in all potential market segments, with the intention of maximizing shareholder value.

The company has been contacted by several medical technology companies that are active in the surgical equipment and hemostatic products sectors, and who have expressed an interest in the company's products and business strategy. In response to these inbound contacts, the company has held discussions to evaluate the potential commercial partnerships in anticipation of an FDA decision on the company's Class III PMA application.

Patents and Trademarks

The company's NORC technology is protected through patents filed with the U.S. Patent and Trademark Office, which protection runs through 2029. In 2020 and 2021, the company filed additional U.S. and International patents that protect the use of the company's NORC technology in a gel or hydrocolloid formulation.

On January 21, 2021, the U.S. Patent Office provided notification of publication of the company's patent application for the method of forming and using a hemostatic hydrocolloid. This publication does not imply any assurance of the receipt of the patent but establishes an obligation of any party that seeks to use the applicable method to pay royalties for the right to do so. The patent application for this process remains pending as of the date of this filing.

On February 11, 2021, the company was notified that its application to establish global patent protection for the process of creating and deploying a hydrocolloid (or gel) format of its HemoStyp technology was accepted for publication under the procedures of the Patent Cooperation Treaty ('PCT'), an international patent law treaty which provides a unified procedure for filing a patent application in most foreign countries. The company previously filed provisional patent applications for the company's HemoStyp hydrocolloid process in 2020. In January 2022, the company initiated steps to register its hydrocolloid patent in the European common market and in additional foreign countries where the company intends to commercialize any future HemoStyp gel formats. The company can give no assurance that foreign registration of the company's patents will be granted in any of these jurisdictions.

The company has registered trademarks for the following product formats: Boo Boo Strips, The Ultimate Bandage, Hemostrips, CelluSTAT, and Nik Fix.

Research and Development Expenditures

For the year ended December 31, 2022, the company incurred $624,564 research and development expenditures.

History

The company was founded in 1997. The company was incorporated in 1997. It was formerly known as United EcoEnergy Corp. and changed its name to United Health Products, Inc. in 2010.