Henderson, Nevada – April 2, 2019 – United Health Products, Inc. (OTCQB: UEEC), manufacturer and marketer of HemoStyp, a patented hemostatic gauze for the healthcare and wound care sectors, today filed its Form 10-K for the year ended December 31, 2018. The 10-K may be viewed on EDGAR on the Securities and Exchange Commission website at: https://www.sec.gov/edgar/searchedgar/companysearch.html.
Douglas K. Beplate, President and CEO said, "2018 was the most important year to date in our company's development: we shifted our corporate focus to achieving FDA Class III approval for our products in human surgical applications. We believe that gaining access to this $3.4 billion segment of the hemostatic gauze market is the best path to creating value for our shareholders and so we have devoted our resources fully to that objective. In parallel with this effort we are working closely with our financial advisory, Société Générale, to conduct a review of strategic alternatives, including the possible sale of the company, to maximize shareholder value."
In February 2018, the Company completed and submitted to the U.S. Food and Drug Administration ("FDA") all materials relevant for the pre-market approval ("PMA") for HemoStyp under the FDA's new and innovative CtQ Pilot-Program as a Class III application for internal surgical procedures. The CtQ Pilot Program was created to identify products that have a chemical makeup of demonstrated safe interaction with the body - as evidenced by years of prior product usage and studies - to be approved for Class III internal surgical use. The FDA reviewed UHP's HemoStyp as one of the participants for the program.
The Company's 2" x 4" Trauma Gauze™ product was selected as the feature component for a new Advanced Wound Care Kit for Dick's Sporting Goods. With today's environment, when the unexpected can happen anywhere, both in the wild and in urban areas, having an advanced trauma kit can be the difference between survival and tragedy. The HemoStyp pouches have been included under the Field and Stream label and have been available in their stores nationwide since February 2018.
In January 2018, the Company's distribution partner, Quantum Health Group, filed an application for Class III use in general internal surgical procedures with the Ministry of Food and Drug Safety ("MFDS") in South Korea. The Ministry of Food and Drug Safety provides the vision of "Safe Food and Drug, Healthy People, Well-being Society," and making extensive efforts to safeguard consumers and promote the public health by ensuring the safety of all foods, drugs, cosmetics, herbal medicines, and medical devices. Quantum received a response requiring additional data and testing. The Company intends to respond to the request and complete its application following the expected FDA Class III approval.
In March 2018, the Company obtained Class III and CE mark approval for HemoStyp in the European Economic Area (EEA). The EEA comprises the 28 European Union members and certain other countries. Accordingly, HemoStyp was approved for use in internal surgical procedures in more than 30 countries. This approval expired in August 2018, and a new application will be prepared in conjunction with the new CE standards for Class III following the expected FDA Class III approval. The EEA approval was granted following the provision of all required documentation to the relevant regulatory agencies. The CE marking- CE is an acronym for the French term "Conformité Européenne"- certifies that a product has met EEA health, safety, and environmental requirements, which ensure consumer safe. Manufacturers in the EEA and abroad must meet CE marking requirements where applicable to market their products in Europe. A manufacturer who has gone through the conformity assessment process may affix the CE mark to its product. With the CE marking, the product may be marketed throughout the EEA and certain other countries with a population of exceeding 517 million and a GDP exceeding $17 trillion.
In July 2018, the Company announced that it had been accepted as a Walmart.com supplier, and would offer two HemoStyp wound care products for online retail sale, Hemostrips® Hemostatic Bandages and Boo-boo Strip Hemostatic Bandages.
On August 8, 2018, the Company announced that its protocol submission for human testing has been reviewed by the FDA in furtherance of its efforts to achieve Class III approval for the product in the U.S. This FDA review has been provided to the Institutional Review Board (IRB) for protocol and hospital site approval. UHP started the human trial study in November. The IRB is a committee that is independent of the FDA, and that is formally designated to approve, monitor, and review biomedical and behavioral research involving humans. The purpose of the IRB is to assure that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study. The Company's human trial protocol calls for the application of HemoStyp in abdominal, cardiovascular thoracic and vascular surgical procedures to control bleeding sites. Prior to finalizing its human trial protocol, UHP submitted a Q-Sub - a request for FDA review — to the FDA, in conjunction with its previously filed Class III PMA submission application.
The IRB approved HemoStyp human trial is a prospective, non-inferiority, multi-center, randomized, open-label trial to observe HemoStyp in the management of bleeding during surgery; and, to assess the efficacy and safety of HemoStyp as an adjunct for management of secondary hemostasis in an operative setting. Our independently developed protocol has established endpoints for bleeding control.
We expect that the human trials will be the final step in obtaining FDA PMA Class III approval for HemoStyp. We have recruited a team of leading surgeons to conduct the study, and our lead investigator has successfully conducted over 20 medical device studies in the past. We aim to complete this final regulatory stage as part of our strategy to supply the domestic and international hemostasis surgical markets.
On October 25, 2018, the Company announced that, in connection with the FDA PMA Class III approval process for HemoStyp, UHP has been contacted by several medical technology companies that are active in the surgical equipment and hemostatic products sectors, and who expressed an interest in the Company's products and business strategy. In response to these inbound contacts, and to maximize shareholder value, the Company's board of directors has determined to conduct a review of strategic alternatives, which include a potential sale of the Company, joint venture or other commercial partnership, or a standalone growth plan. To assist in this review, the Company has retained Société Générale to serve as financial advisor to the Company, and it has retained the law firm of Ruskin Moscou Faltischek PC to assist in the strategic review. There can be no assurances that any specific transaction will occur as a result of the retention of these firms. .
About United Health Products Inc.
United Health Products Inc. (UHP) develops, manufactures, and markets patented hemostatic gauze, for the healthcare and wound care sectors. The product, HemoStyp, is derived from regenerated oxidized cellulose. HemoStyp is an all natural product designed to absorb exudate/drainage from wounds to help control bleeding. UHP is focused on identifying new markets and applications for its products and expanding its current markets. UHP currently sells a suite of hemostatic products to the dental, veterinary and retail markets.
For more on United Health Products, Inc. visit: www.unitedhealthproductsinc.com
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Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This news release may contain forward-looking information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements that include the words "believes," "expects," "anticipates" or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the Company to differ materially from those expressed or implied by such forward-looking statements.
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