Evaluating and choosing a PRP system is no easy task - not all systems are created equal. That’s why at APEX Biologix, we are committed to providing you, our customers and potential customers, with transparency in what our devices create. With new studies rolling out on our PRP and Protein Concentrate systems, you will continue to see we offer only best in class devices. Recently, an EmCyte distributor pursued a campaign that leveraged a targeted marketing angle utilizing a biased selection of data. Let’s address the main points.
Literature has emphasized the role platelet dose plays in clinical outcomes. From the well-known study by Bansal, et al., emphasizing the role 10 billion platelets plays in Knee OA, to the review by Berrigan, et al., showing a higher platelet dose may correlate to better outcomes, one thing is apparent; higher platelet concentrations equates to greater bioactive factor release, suggesting that total platelet dose plays a crucial role in outcomes(2)(3)(5). Everts, et al., argued the importance of platelet dose and bioformulation and their effect on initiating angiogenic pathways; platelet dose directly correlates to the availability of angiogenetic platelet factors. He continues that it has been demonstrated that cellular processes respond in a dose-dependent manner(7).
To demonstrate platelet dose and recovery with the XCELL PRP 60 mL kit, an analysis was conducted on 70 consecutive patients at two separate outpatient orthopedic and physiatry clinical sites. The average age of patients was 53.8 years, 35 patients were male, 35 female. These patients were not hand-picked, this was not data collected in a controlled laboratory setting, this is truly real world. All baseline whole blood and PRP samples were evaluated using the Horiba Micros 60 to quantify platelets, white blood cells, red blood cells, and hematocrit. The average platelet dose produced by the 60 mL kit, in a 6.3 mL sample, was 10.8 billion platelets, exhibiting an average platelet recovery of 83% at both sites, and a concentration factor of 7.9x baseline. This exceeds the 9.37 billion platelet dose in the 69 data points demonstrated in real world data provided in the competitor's post, which as they mentioned, equated to a 66.34% platelet recovery. As discussed in the Nota bene, it is very important to consider real-world clinical data to provide a more accurate picture of expected platelet yield and reproducibility, it doesn’t get any more real world than the data collected in clinical practice to demonstrate the efficiency and reproducibility of the XCELL PRP system.
|
APEX Biologix XCELL PRP n=70 |
Average Volume (mL) |
Average Platelets (per μL x 103) |
Average Platelet Dose (per mL x 106) |
Average Platelet Recovery (%) |
Average Platelet Concentration Factor |
|
Whole Blood (with 6mL ACD-A) |
60 |
218.86 |
13131.43 |
N/A |
N/A |
|
Platelet Rich Plasma (PRP) |
6.30 |
1718.59 |
10752.86 |
83% |
7.9x |
As disclosed in their own white paper, there are multiple aseptic entries when processing using the PurePRP II kits, which is the case with most systems, including XCELL PRP. Specifically, a table is provided in said paper noting 6 aseptic entries, where the XCELL system has only 3(8). Open systems cited in literature are typically referring to manual, open processing methods that utilize standard laboratory equipment, such as sterile tubes and pipettes, much different than the 510k cleared XCELL PRP kit. What we learned from a systematic review by Alazzeh, et al., is that across 91 randomized controlled trials and 5,914 intra-articular PRP injections, including studies that reported infection rates, 30 studies implementing closed techniques, 45 implementing open, the infection rate for both techniques was 0 per 1000 injections(1). Only 12 studies disclosed using laminar flow during processing. There has never been a reported complaint of infection with the XCELL PRP system since its launch in 2019.
With the XCELL PRP system being utilized in both operative and non-operative environments, the following statement “The XCELL PRP Platelet Concentrating System may be contraindicated when used in a non-sterile environment.” provides language to support our customers utilizing the XCELL PRP system in an operative environment where sterility is of the utmost importance.
The XCELL PRP system is exceptional at creating a super concentrate. Users have the ability to titrate and control volumes using our precision lighted Benchtop Processing Station, tailored to clinical needs, without compromising platelet dose. From research on each 1mL stack from 12 centrifuged samples, an average of 80% of platelets are directly recovered from the buffy coat. Whether you need 2 mLs or 10 mLs, you can adjust volume and formulation to anatomic area and pathology.
Leukocyte inclusion is an area of ongoing debate. The duality between leukocyte rich and leukocyte poor PRP in literature emphasizes the need to have the ability to customize the final bioformulation. There is evidence supporting their use, attributing their benefit to the release of beneficial cytokines, while other evidence suggests they may impair the overall effects of PRP(6). Results from two large randomized controlled trials comparing LP- and LR-PRP in knee OA revealed similar outcomes; both significantly improved pain and function from baseline, with no significant difference in safety and efficacy between the two groups(6)(9). Based on the 1 mL data, we know where neutrophils lie in the stack, making it possible to customize the output, based on provider preference and anatomic area of injection.
The effect of the presence of red blood cells is poorly studied. Red blood cells do not contribute to tissue regeneration, unlike platelets and leukocytes(5). Within our most recent data set, hematocrit was consistently reduced to 1.99%, without sacrificing platelet recovery.
The upfront cost of PRP kits can be deceptive. There are over 50 commercial platelet rich plasma systems, with variations in initial blood draw, as well as centrifugation and processing protocols. As Don Buford, MD, explained in his article relaying his 15 data points to better evaluate these systems, there is no universal comparison to evaluate them, and the best possible metric is cost per billion platelets(5). When considering cost, based on real-world Horiba data, the average platelet dose produced from the XCELL 60 mL PRP kit is 10.8 billion platelets, equating to $22.68/ billion platelets.
Integrating PRP processing into your clinic workflow is critical. With a simplified single spin, the user sets the centrifuge once and returns upon completion. The lighted benchtop processing station is utilized to create your customizable bioformulation, minimizing errors and enhancing reproducibility. As discussed in their white paper, typical processing with the PurePRP II system takes 19 minutes(8). The simplified process with the XCELL PRP system equates to less time and less room for error, for your team and your patients.
Choosing a PRP system should never be about noise, marketing spin, or selective data. It should be grounded in transparent performance, reproducibility, safety, and real-world results. APEX Biologix remains committed to these standards. The evidence speaks for itself: our XCELL PRP technology consistently delivers clinically relevant platelet doses, strong recovery rates, customizable bioformulations, and streamlined workflow efficiency, not in theory, but in real-world patient care settings.
Our focus remains clear: empowering providers, advancing science, and improving patient outcomes. We invite clinicians to evaluate the data, experience the performance firsthand, and continue advancing the field alongside us.
APEX Biologix — Elevating biologics. Empowering providers. Advancing patient care.
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