TCPO2 Testing Overview and Procedures C E LLI ANT 888.721.1545 c 949.697.7795 f 888.721.1546 1112 Montana Ave.«#13m Santa Monica, CA 90403

HOLOGENIX TCPO2 Testing Overview and Procedures Dr. Michael Coyle Reports Latest TCPO2 Findings…….

Re: Testing overview and procedures To Whom It May Concern: At Hologenix, LLC we understand and appreciate the skepticism surrounding our technology and resulting claims. Accordingly, we have dedicated a significant amount of resources to develop, test and validate our science. Celliant’s mineral matrix provides a wide range of benefits. To substantiate our claims and provide assurances to their validity, all Celliant products undergo extensive and methodical testing. This is performed in addition to independent clinical trials and studies. We have also established a Research and Development...

Please direct any and all further questions regarding our testing procedure to our Testing Director, Trenton Horinek at [email protected], or by phone at +1 888721-1545. Thank you for your interest in our technology Best regards, Seth Casden Seth Casden CEO Hologenix, LLC

Re: Updated TCPO2 Findings To Whom It May Concern:: My name is Michael Coyle and I am the Chief Science Officer for Hologenix, the maker of Celliant®. As you may know, our technology is composed of finely ground, optically responsive minerals that are added to yarn to make garments. The minerals absorb infrared light emitted from the body and reflect it back into the skin and tissue, which results in the vasodilation of capillaries to improve circulation and tissue perfusion and oxygenation. I would like to take this opportunity to share the findings of our latest tcPO2 validation study in hopes...

Transcutaneous Partial Pressure of Oxygen (tcPO2) as a Primary Endpoint to Assess the Efficacy of Celliant® as a Vasoactive Material

INTRODUCTION Celliant® technology is a patented process for adding micron sized optically active quartz, silicon oxide and titanium oxide particles to polymer fibers. The resulting Celliant® yarns have unique effects on the electromagnetic energy environment of the skin in the visible and near infrared portion of the spectrum leading to increased blood flow and oxygen levels in the tissue. This report is a summary of data collected under the auspices of Ian Gordon, M.D., Ph.D., Associate Clinical Professor of Surgery at the University of California- Irvine Medical School. Fifty-one (51) healthy...

used in numerous clinical trials and is a well-accepted clinical measure for tissue perfusion and oxygenation (Burgess, Matsen, Wyss, & Simmons, 1982; Dooley, Schirmer, Slade, & Folden, 1996; Franzeck, Talke, Bernstein, Golbranson, & Fronek, 1982; Hanna et al., 1997; Jaszczak, 1988; Le Devehat & Khodabandehlou, 1990; Le Devehat, Khodabandehlou, & Vimeux, 2001; Matsen, Bach, Wyss, & Simmons, 1980; Matsen et al., 1980; Matsi, Manninen, Suhonen, Pirinen, & Soimakallio, 1993; Shoemaker & Vidyasagar, 1981; White et al., 1982) with well established norms for intra-subject variability (Coleman, Dowd,...

30-min and 90-min during BL and with CL. All measurements of transcutaneous oxygen tension were recorded using a PeriFlux System 5000 (Perimed, Inc., Kings Park, NY, USA) and modified Clarke Electrodes (Radiometer America, Inc., Ohio, USA). Data were sampled using Perisoft Version 2.10 (Perimed America, Inc., North Royalton, Ohio, USA). All subjects received the same treatment in the same order: Baseline (BL) followed by Celliant® (CL). Transcutaneous oxygen tension (tcPO2) does not vary significantly over time, therefore, establishing a baseline prior to measuring a treatment effect was warranted....

Next, a two-way Repeated Measures ANOVA was employed to evaluate the influence of treatment at the different time points. The interaction between Condition (BL & CL) and Time was not significant ((F(1, 45) = 0.012, p. = 0.914). However, there was a significant within subject contrast for Time (F(1, 45) = 7.423), p. = 0.009). Pairwise comparisons were conducted using dependent sample t-tests to evaluate the differences between the means to identify statistical differences between specific time points. At all time points, the Celliant® condition was statistically greater than the Baseline as assessed...

corresponded to a mean change from the Baseline condition of seven percent (7%). See Table 1 for a summary of these data. Table 1. Summary of Two-tailed Paired t-tests vs. Time To be certain that mean tcPO2 did not significantly increase over time during the Baseline, as well as to show that the Baseline did not influence the Celliant® condition, a two-tailed paired t-test was executed in the Baseline condition between t=10-min (76.2 mmHg (SD 14.2)) and t=90-min (77.8 mmHg (SD 14.1), t(49) = -1.18, p. = 0.242. Figure 2 shows the difference in treatment means graphically.

* At all time points, Celliant was statistically greater than Baseline. See Table 1 for p values.

A boxplot of the treatment means (Figure 3) is helpful to identify skewed data. The median is the line in the middle of the box; the upper edge of the box is the 75th percentile and the lower edge is the 25th percentile. The ends of the vertical bars or “whiskers” indicate the minimum and maximum data values. A datum outside the whiskers is an outlier, in this case there were none (McGill, Tukey, & Larsen, 1978). This graphic suggests that these data show good symmetry and are not skewed. Baseline Celliant

SUMMARY Fifty-one subjects underwent separate ninety (90) minute testing periods where transcutaneous partial pressure of oxygen (tcPO2), a well-accepted clinical measurement for tissue perfusion and oxygenation, was used as the primary endpoint. First, a Baseline was established. Then, a shirt made with Celliant® material was worn during a subsequent session. All measurements were taken at the bicep. Transcutaneous oxygen tension proved to be a sensitive measure of efficacy, which resulted in the rejection of the null hypothesis. Thus, mean tcPO2 values for the Celliant® garment were statistically...