United Health Products (UHP) (OTCPK: UEEC) today announced that 2019 was a pivotal year for the company in which it:
- Successfully completed human clinical trial of HemoStyp®, an Oxidized Regenerated Cellulose that is patented through Oct 2029 (US Patent 8,557,874 Oct 15, 2013), for the healthcare and wound care sectors on 236 WIRB (Western Institutional Review Board) approved and consented patients. Surgeries consisted of Level 1 and Level 2 bleeds on the Lewis bleeding scale for abdominal, cardiovascular, thoracic and vascular surgeries. An independent statistical review confirmed the non-inferiority and superiority of HemoStyp over Surgicel, the market leader for hemostatic agents.
- Submitted a Premarket Application (PMA) for Class III approval to the FDA for HemoStyp in early October, with the final module submission in early November. The PMA program confirms the safety and efficacy of a product. If approved, UHP expects that HemoStyp will be authorized for use in surgical procedures in abdominal, cardiovascular, thoracic and vascular surgeries per UHP's PMA filed Instructions For Use. HemoStyp's PMA application falls under SUBCHAPTER H--MEDICAL DEVICES PART 878 -- GENERAL AND PLASTIC SURGERY DEVICES. Subpart E--Surgical Devices Sec. 878.4490 Absorbable hemostatic agent and dressing. An absorbable hemostatic agent or dressing is a device intended to produce hemostasis by accelerating the clotting process of blood. It is absorbable; is intended for internal surgical use; and, is classified as a Class III device. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=878.4490
- Conducted a preclinical animal study to assess the effect of HemoStyp on the bone. The company conducted the animal study to evaluate the suitability of HemoStyp in contact with bone in the chronic swine model, and to validate HemoStyp for this application. This study and indication is independent of the current PMA application and will potentially allow UHP access to a new and significant market opportunity. The study results determined that there was no adverse pH effect on the bone and surrounding tissue. UHP believes that these preliminary results demonstrate the safe application of HemoStyp in orthopedic procedures. These results need to be confirmed by human clinical trial in order to confirm safety and efficacy prior to obtaining FDA approval.
- Commenced the process of relocating the majority of its manufacturing to a United States facility. Once fully operational, the facility will be capable of manufacturing up to 20 million square inches of HemoStyp gauze monthly. Additional formulations of the HemoStyp product designed for the specialized human surgical market will also be produced at this facility. UHP is onshoring its production operations to improve its order response time, reduce freight costs and improve scalability.
- Filed a patent application in August 2019 covering methods of forming and using a hemostatic material, and more specifically, methods of forming and using a hemostatic hydrocolloid that is formed into a gel, foam or spray used to control bleeding and oozing from a variety of wounds. Upon approval of the new patent, this will allow for the HemoStyp hydrocolloid to act as a conduit to transfer other properties associated with the treatment of wounds within the hydrocolloid.
Completed a safety and efficacy animal study for its HemoStyp hydrocolloid product, for which it filed a patent application. If the patent is granted and FDA approval is obtained, HemoStyp could then be bundled as a suite of multiple products for surgical and wound care applications. The study, A Safety and Efficacy HemoStyp Hydrocolloid Test, was done by creating bilateral femoral arteriovenous fistulas in swine. HemoStyp thrombin hydrocolloid was applied to the anastomosis suture line on one side for the cessation of bleeding, while the market leading competitive product was applied to the anastomosis suture line on the opposite side for the cessation of bleeding. Time to cessation:
Animal 1: HemoStyp Hydrocolloid Product 35 Seconds; Competitive Product 1 Min 25 Seconds
Animal 2: HemoStyp Hydrocolloid Product 35 Seconds; Competitive Product 1 Min 55 Seconds
Animal 3: HemoStyp Hydrocolloid Product 25 Seconds; Competitive Product 2 Min 20 Seconds
UHP is also working on two other complementary HemoStyp-based products that could potentially be added to its surgical product suite.
- Appointed Dr. Gerry Abate, MD as Chief Medical Director. Dr. Abate, a cardiologist, is a former Executive Director of Medical Affairs for Fortune 500 Company Quest Diagnostics, where he directed a Medical Affairs group that includes eight clinical franchise medical directors (oncology, genetics, women’s health, cardiovascular-metabolism, neurology, infectious disease/inflammation), HEOR team, publications group, MSLs, genetic counselors and project management. Dr. Abate’s responsibilities will include direct oversight with the Company’s PMA submission and all clinical and product data.
In January 2020 the company expects to meet with the FDA as part of the normal PMA application process. In addition, in February 2020 management members will travel to China to complete the relocation of the manufacturing operation to Maryland. The entire relocation process, including the installation and testing of production equipment, is expected to take approximately two months.
Lastly, UHP has advanced its discussions to negotiations with well positioned candidates interested in acquisition of the company or partnerships that allow penetration into the surgical markets.
About United Health Products
United Health Products develops technology, manufactures and markets patented hemostatic products for the healthcare and wound care sectors. The product, HemoStyp, is derived from oxidized regenerated cellulose. HemoStyp is an all-natural product designed to 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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United Health Products, Inc.