Standards that matter.

Predictive Biotech is committed to truth, trust, and transparency. We set high standards and hold ourselves to them by being honest with our clients, being meticulous with our processing and ensuring the optimal viability of every product. It's a better way to treat people—and it starts here.

Why Predictive Topics - Click on section to jump to the topic or scroll for the full story

Mission & Vision
Wharton's Jelly
Factors
Viability
Processing and Safety
Our Lab

Science and standards to live by.

Predictive's vision is simple: convert cutting-edge research in human biology to products that can replenish the healing environment in everybody. The promise of regenerative medicine is revealing itself every day as research and application grow, but navigating new companies in the market can be hard, especially if they have not kept up with the science or shown a commitment to setting or meeting standards. To fulfill our vision and more importantly to connect it with patients and clinicians, Predictive Biotech follows an all-encompassing ethos of truth, trust, and transparency. This means that we hold ourselves to the highest standards of product development, product communication, regulatory compliance, and safety. Period.

A mission that can serve everybody.

Our mission is to make a healthy difference in people’s lives through safe, effective and affordable non-surgical alternatives. This is represented by Predictive Biotech’s industry-leading products and our push to champion regenerative medicine in academic, scientific and practical arenas. Whether it’s sponsoring international perinatal stem cell research or sharing Predictive’s story with a local clinician, we are actively establishing regenerative medicine as a ground-breaking and viable part of today’s care continuum.

Working with the medical Community.

Patients and doctors are surely aligned; nobody wants unnecessary pain or surgery. That’s precisely why we cooperate with the medical community to provide options; when a steroid shot or ibuprofen isn’t enough but surgery feels like a leap...there’s the option of regenerative medicine. And even when surgery is necessary, Predictive Biotech is there with products to help support tissue repair and recovery. It’s a full-circle view that’s patient-focused and bound to a higher standard. Refreshing, right?

Working with your body.

Science that benefits everybody starts with understanding the power of regenerative medicine. That is, its cooperative nature. As your body loses its ability to heal and repair, Predictive Biotech’s products cooperate with your body's natural functions to help supplement, cushion, protect and provide support right where it’s needed. Whether you’re 18 or 68, it’s about maintaining your ideal healing environment in the least invasive and disruptive way possible.

Better begins here: tissue with great potential.

Aiding the optimal healing environment within the body is the essence of regenerative medicine. And the notion of supplementing what already exists within the body is what makes birthing tissue the idea source for regenerative products. Specifically, the Wharton’s Jelly layer of the umbilical cord as well as placental tissue. So committed to the potential of these sources, Predictive has invested millions in perfecting the processing techniques necessary to maximize the promise of their regenerative factors. By combining scientific knowledge with proprietary processing we are able to fulfill demand for consistent, potent human cell and tissue products (HCT/P), and establish higher standards for the field.

The untapped potential of Wharton’s Jelly.

Researchers have long known that the Wharton's Jelly layer of the umbilical cord is an incredibly rich source for the growth factors needed to regenerate tissue. While the Wharton’s jelly layer of the umbilical cord can be easily procured, it is extremely difficult to process effectively. That’s where Predictive prides itself most; we use a proprietary method that minimally processes the tissue in order to preserve maximum integrity of the tissue. In fact, we’re the first and only company in the world to develop a suite of products derived from Wharton’s Jelly, thus leading the field.

The only thing more important than facts: sharing them.

When considering regenerative medicine, it’s crucial to know what factors are (and aren’t) in the products you choose. Consult the grid to see how our product analysis considers over 440 cytokines, proteins, growth and scaffolding factors, hyaluronic acid and cells present in our structural allografts. To our knowledge, we are the only company that freely shares this detailed information with physicians, all for the purpose of better understanding the ideal regenerative environment.

Click here for Cytokine Grid

What makes our products valuable? Viability.

By maintaining the integrity and quality of the tissue as it is harvested and transferred to the patient, we can better insure product viability. Our single-minded focus on minimizing tissue degradation shows in our careful procurement and minimal processing in our own FDA-registered lab. And it continues all the way to the doctor’s office where we provide custom cryotanks for maintaining product viability at a strict -196 degrees.

Setting standards: from donor to doctor to patient.

From donation to administration, Predictive Biotech is unwavering in its commitment to perfecting each and every step. All of our allograft products are prepared utilizing a proprietary mechanical process; two small samples are obtained from each lot with one sent to a third party laboratory for sterility testing and the second used in our flow cytometer to verify viability and quantify cell populations. After the tissue has been screened for bacterial or viral contamination, processed and aliquoted into the vials, the samples are then cryogenically preserved and placed into quarantine. Once the sterility testing has been completed and all of the paperwork has been reviewed and approved by our Chief Medical Officer, then--and only then--are our products ready to market.

  • process_icon/Mother-Blue Created with Sketch. Mother
    • Donors (mother and father) are screened for any history of communicable diseases and behavioral risk
    • Blood tests are required within 7 days before or after birth
  • process_icon/Birth Created with Sketch. Birth
    • All donated tissues are procured and collected after full-term, live births
    • Collection of the tissue is performed by a licensed professional
  • process_icon/Collection Created with Sketch. Collection
    • Donated tissues are collected and shipped overnight for processing at our laboratory
    • Any birth tissue received later than 48 hours after birth is rejected
  • process_icon/Clean Created with Sketch. Clean
    • Tissue is sanitized and cleaned prior to processing
    • All tissue samples are handled utilizing aseptic protocols to minimize contamination
  • process_icon/Processing Created with Sketch. Processing
    • Each tissue is recorded and separated into controlled lots
    • Those lots are then processed into one of our four products
  • process_icon/Cryo Created with Sketch. Cryo Storage
    • Once the tissue has been processed cryopreservation of CoreCyte begins through a slow freeze process
    • CoreCyte is stored in a cryotank at -196°C all other products can be stored at -80°C
  • process_icon/Quarantine Created with Sketch. Quarantine
    • A sample of each lot is sent to a third-party lab for sterility testing
    • All products from each lot are placed into quarantine for a minimum of 3 weeks
  • process_icon/Release Created with Sketch. Release
    • All sterility and secondary donor tests for each lot must be completed and authorized by our medical director
    • Once authorized, lot is released into inventory
  • process_icon/Ship Created with Sketch. Ship
    • All products are shipped overnight on dry ice
    • Once the clinic has received the product, it must be used within 48 hours or immediately placed into liquid nitrogen storage
  • process_icon/Patient Created with Sketch. Patient
    • Physician will thaw the product according to instructions
    • Product will then be used as determined by a licensed healthcare proffesional (according to homologous use guidelines)

Home base for better science: our lab.

Predictive Biotech’s staff of researchers and technicians control and oversee every aspect of tissue processing through our own FDA-registered laboratory. Our lab is outfitted with the best-in-practice aseptic laboratory and analytical equipment. This equips our team with the tools needed to not only better ensure safety and viability but also to discover new breakthroughs in the field. New breakthroughs that can aid healing for everybody.

Critical for maintaining maximum viability.

To truly help everybody we need to do all we can to optimize tissue functionality, and that hinges on our best-in-practice cryopreservation system. Not only do we promptly cryogenically freeze our samples after processing, but we even go the extra step to develop and implement a cryopreservation protocol for each of our medical partners.

Viability to the finish.

Predictive’s cryotank program provides physicians with storage capabilities that help to ensure the viability and preservation of all of our products. The liquid nitrogen storage tanks that we service and supply, provide the optimal storage environment of -196 degrees. Our team helps to monitor the liquid nitrogen levels and provides each clinic with the assistance needed to help maintain the integrity of the products. It’s not just a nice-to-have perk; we consider it a must-have practice.