Bio-Validation Program

Progenitor stem cell and platelet biologics, stemming from whole blood, bone marrow and adipose tissue, are rapidly becoming a therapeutic standard of care for various conditions. It has become more evident that patient outcomes vary based on the product or technique used to prepare these cellular biologics.

The Bio-Validation Program is a research tool developed for physicians and other clinical providers, and is dedicated to the independent review and validation of products and processes used to prepare stem cell and platelet biologics. The Bio-Validation Program has allocated bioassays that are relevant to clinical outcomes and consist of CBC with WBC differentiation, mesenchymal progenitor stem cell marker CFU-F, hematopoetic progenitor stem cell marker CD34+, and total nucleated cells TNC.

Clinicians can submit product samples, utilizing the Bioassay Kit, and track the results online through their private login. Performance results are automatically calculated and running averages are automatically maintained. These provide clinicians with qualified research data concerning the quality of their products and/or processes used to prepare their biologics. Performance reports are automatically generated outlining the overall performance of the practice. This report will provide patients with the assurance they need when making a decision on a regenerative biologic provider.

Sign up today and give your patients the confidence of quality. 


 DEMO LOGIN

Username: testuser

Password: test0000

Login to try it out


 

The Bio-Validation Program is comprehensive

samplere 
    

Keep a running tab of your

PRP, BMA & Lipoaspirate

sample results

 

 samplers


 

 

 Review individual sample

results including

Concentration and

Yield calculations

 sampleav  

 Track the overall performance 

of your facility with automatically

calculated Running Averages for

all sample types

 


How does the Bio-Validation Program work

The following steps will take you through the process.

  1. Configure your Bioassay kit and include "Get Results Online" in your selection.
  2. Prepare and ship your sample to BSR.
  3. Login to track your results online.

IMPORTANT REMINDERS:

  1. Bioassay samples MUST be shipped from Monday to Thursday.  No samples can be shipped on Friday.

 

certexs

BSR Certificate Program

The BSR Certificate represents a high standard of care in regenerative biologics.  To attain this certificate, your practice must pass the biologics performance criteria.  This certificate is the first step towards standardization of care in biologics and a representation of defined treatment in biologics.  If you believe your practice can pass the performance criteria, then enroll for the evaluation. ENROLL HERE

 

BSR PRP CERTIFICATE

Criteria requires that ten (10) consecutive samples of the same approximate volume.  Each sample result requirement:

  1. Platelet yield ≥ 75%
  2. Platelet concentration ≥ 5 times baseline
  3. Deliverable platelets ≥ 1 billion per mL

 

BSR BMA CERTIFICATE

Criteria requires that five (5) consecutive samples of the same approximate volume. Sample result requirement:

  1. CFU-F yield ≥ 70%
  2. CFU-F concentration ≥ 4 times baseline
  3. CD34+ yield ≥ 70%
  4. CD34+ concentration ≥ 4 times baseline
  5. TNC yield ≥ 70%
  6. TNC concentration ≥ 4 times baseline

 

IMPORTANT REMINDERS:

  1. Certificates are valid for two (2) years.
  2. A complete report is provided at the end of the evaluation. 
  3. A certificate will be provided ONLY for successful evaluations.
  4. Evaluations are NOT refundable.