Activist letter to the FDA, suggesting United Health Products (UEEC) has the wrong regulatory path

To: FDA Division of Industry and Consumer Education

Date: August 28, 2019

RE: HemoStyp PMA Class III submission from United Health Products Inc.

Dear Sir/Madam,

We are writing this note to inform you that United Health Products Inc (Stock ticker: UEEC) may have chosen an incorrect regulatory approval path for its HemoStyp hemostatic gauze 510K submission. From the Company’s July 10 PR announcement:

“Human Clinical Trial

HemoStyp is under study in the surgical setting, with the intent to seek a pre-market approval (PMA) as a Class III, 510K device from the FDA. It expects to complete enrollment and all surgical procedures for its human clinical trial on or around mid-July 2019.”

When we reviewed the technical info page from the Company’s website we found claims of substantial pharmaceutical activity of the HemoStyp material, as shown below (highlighted emphasis ours):

“Efficacy

HemoStyp® Hemostatic Gauze is an essential ingredient in expediting hemostasis. Research has demonstrated that PPT and PT are both decreased (clotting time accelerated) with the presence of HemoStyp® Hemostatic Gauze in the wound. It is useful in both pathways.

The intrinsic pathway is initiated by the activation of factor XII to its enzyme form, factor XIIa. As HemoStyp® dissolves and comes in contact with iron in red blood cells, it forms negatively charged colloidal particles that promote the activation of blood coagulation factor XII. Unlike most other materials used for hemostasis, HemoStyp® increases blood viscosity even in patients with coagulation defects.
Injury to the blood vessel lining and contact of blood with tissues outside the vessel stimulates thrombin production.Thrombin causes platelet aggregation. Platelets exposed to thrombin secrete their granules and release their contents into surrounding plasma. Thrombin also initiates a reaction leading to a fibrin clot. In research studies, the texture and initial solid state of HemoStyp® slowed the blood flow and reduced the time in which thrombin was released into the wound. This increased platelet and whole blood adhesion rates, thereby improving hemostasis speed and function.
The enzyme form of clotting factor XII (factor XIIa) catalyzes the conversion of factor XI to its enzyme form (factor XIa). Factor XIa catalyzes the conversion of factor IX to activated form factor IXa in a reaction that requires calcium ions. Factor IXa assembles on the surface of membranes in complex with factor VIII. The factor IXa/ factor VIII complex requires calcium to stabilize certain structures on these proteins associated with their membrane-binding properties. Factor Xa forms a complex with factor V on membrane surfaces in a reaction that also requires calcium ions. In research studies, HemoStyp® not only adhered to calcium ions, but because its surface area initially increases as it dissolves, it also expanded contact surfaces with blood coagulation factors needing calcium, thus increasing its overall effectiveness.

HemoStyp® helps stabilize new clots by accelerating the formation of fibrin cross-linkages.
HemoStyp® increases whole blood viscosity significantly in a wound, thus promoting the aggregation of red blood cells. At the same time, it helps restrict the loss of red blood cells and platelets to accelerate hemostasis. Unlike other materials used for hemostasis, HemoStyp® increases blood viscosity even in patients with coagulation defects.”

We believe that the above novel materials, exhibiting pharmaceutical activity with regard to the coagulation factors, should not be submitted through 510K regulatory path, but should follow the more stringent NDA path.

Best regards,

Adam Gefvert, CFA

Head of Research, White Diamond Research, LLC

agefvert@whitediamondresearch.com