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. Purchase a Bio-Validation Membership Plan.
  2. Purchase the Bioassays you would like to perform.
  3. Ship the samples to BSR.
  4. Login to track your results and review the automatic calculations.

IMPORTANT REMINDERS:

  1. You must be an active member in order to utilize the Bio-Validation service.
  2. Bio-Validation members are provided login access to review the bioassay results and calculations.
  3. If you terminate, or allow your membership to expire, the online data results you have accumulated will be permanently removed.
  4. Bioassay samples MUST be shipped from Monday to Thursday.  No samples can be shipped on Friday.

 

certexs

BSR Certificate of Quality Program

The BSR Certificate of Quality represents the highest standard of care to your patients. This certificate represents Excellence in Quality of Regenerative Biologics. To attain this certificate, your practice must meet the stringent Quality Performance Criteria developed by BSR. This certificate is the first step towards standardization of care in biologics and a representation of defined treatment in biologics.  If you believe your overall practice is strong enough to meet the standard required to attain the BSR Certificate of Quality, then enroll for the evaluation through the online store.

 

BSR CERTIFICATE OF QUALITY - PLATELET RICH PLASMA

Criteria requires that fifteen (15) consecutive samples of the same approximate volume, meet the following standard:

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

 

BSR CERTIFICATE OF QUAITY - PLATELET RICH PLASMA RBC & NEUTROPHIL POOR

Criteria requires that fifteen (15) consecutive samples of the same approximate volume, meet the following standard:

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

 

CERTIFICATE OF QUALITY - BONE MARROW CONCENTRATE

Criteria requires that five (5) consecutive samples of the same approximate volume, meet the following criteria:

  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 one (1) year for platelet rich plasma and two (2) years for bone marrow concentrate.
  2. Bioassays processed for certification are separate from the BQE program and are not posted online.
  3. A complete report is provided at the end of the evaluation. If the evaluation successfully passes the BSR performance criteria requirement, a Certificate will also be granted.
  4. Users that fail to qualify for the Certificate are NOT entitled to a refund.

 

SEE SAMPLE CERTIFICATE