Pure Human Amniotic Fluid

Pure Human Amniotic Fluid

 

100% PURE HUMAN AMNIOTIC FLUID

It can be difficult to watch dedicated athletes be slowed down by constant wear and tear to their bodies.

They want to be back on their feet as soon as possible, and you want that, too.

Offer a cutting-edge — and non-invasive — treatment option with 100% Pure Human Amniotic Fluid (HAF).

Containing more than 200 growth factors and other naturally occurring nutrients,

Human Amniotic Fluid is a versatile liquid allograft that encourages the regeneration and reconstruction of cells and soft tissue.

This safe, drug-free injection is the first sterile, processed amniotic fluid product that retains its bioactivity.

Offering an alternative to cortisone injections and PRP injections, our 100% Pure Human Amniotic Fluid

is a strong addition to any practice looking to expand their treatment options for patients

who struggle with sport tissue injuries, arthritis or intra-articular injury.

See what’s possible when modern-day medicine takes a natural approach.

Benefits of 100% Pure Human Amniotic Fluid:

  • Anti-inflammatory & Anti-microbial
  • Contains over 200 Different Growth Factors
  • All Natural and Drug-free
  • Reduced Recovery Time
  • Safe, Non-steroidal Alternative to Surgery

 

Potential Clinical Applications:

• Orthopedics – augment tendon, fasciae, ligament and capsule repair
• Neurosurgery – chronic neuritis and pain
• Spinal Surgery – facet inflammation
• General Surgery – augment tissue repair 

 

Recommended Preparation Instructions:

•  For single patient one time use, amniotic fluid is packaged frozen with a locked cap and

stored at -80°C ± 15°C with a 2 year shelf life.

It is intended for use as an additive for surgical applications associated with soft tissue procedures.
• Remove product from cold storage and open outer packaging, thaw vial in hand
• Using aseptic technique, draw allograft out of vial with a ~ 30 gauge or larger needle.
• The HCT/P is ready to use (may or may not be used with a dilutent).

FDA Regulatory:
• Qualifies as a 361 tissue
• Minimally manipulated
• FDA considers the use of amnion to be for homologous use

 

PDA-HAFTM

PDA-HAFTM is a next generation, acellular, 100% pure amniotic fluid product that retains

over 200 bioactive growth factors, is sterilized without irradiation, and is 361 compliant.

PDA-HAFTM is 100% pure amniotic fluid, it has the added benefit of being able to be injected

through as small as a 30 gauge needle, without being compromised, for minimal to no patient discomfort.

The combination of these characteristics is what makes PDA-HAFTM a premium and unique offering in the regenerative product space.

Product summary and a comparative explanation broken into key categories.

  • 100% pure amniotic fluid (no ground up membrane or dead tissue)
  • Maximized naturally occurring hyaluronic acid
  • Acellular
  • Membrane and chorion free
  • Sterilized without irradiation
  • Cryopreserved without chemical protectant
  • Over 200 growth factors, cytokines, and peptides proven present including GDF-11 (the youth hormone)
  • Minimal to no patient discomfort
  • 361 compliant

 

Composition

PDA-HAFTM  is acellular, unadulterated, 100% pure amniotic fluid.

In comparison, most of the competitors provide a dehydrated or morselized product

containing ground up membranes that are approximately 7-12% amnion product by weight.  

Providing PDA-HAFTM as an acellular, membrane free, and chorion free injection ensures

there are no dead cells or debris being injected into patients,thus limiting the likelihood of an immune response or post injection inflammation.

FDA 361 Compliance

As PDA-HAFTMis unadulterated, pure amniotic fluid, we have ensured our

injection complies with the minimal manipulation guidelines set forth by the FDA.  

Many companies with morselizing processes are being looked at by the FDA and some have already been pulled from the market.

Sterility and Cryopreservation

PDA-HAF™ is sterilized through a proprietary process (AmnioCleanse™)

which does not use irradiation and allows us to retain the bioactivity of the growth factors.

Other amnion products are provided aseptically (without sterilization)

or are terminally sterilized which significantly impacts the bio availability of the growth factors.

Our cryopreservation process (CryoActiv™) is also proprietary and allows us to preserve the PDA-HAF™

without using a chemical protectant which maintains the integrity of the amniotic fluid and its properties.

 

Bioactivity

PDA-HAFTM  is proven to contain over 200 growth factors including GDF-11 (the youth hormone) in the final product.

The majority of amniotic products are not tested post preparation and those that have been have lower bioactivity and fewer growth factors.

Ease of Use and Comfort

PDA-HAFTM is provided in a vial for ease of use.

There is minimal patient discomfort compared to other products since the fluid can be injected through as small as a 30g needle.

Additionally, we see less post injection discomfort and inflammation than other amniotic products

because there are no dead cells, membrane, or chorion components in PDA-HAFTM.

Ordering information:

  • (small, 0.25ml)
  • (medium, 0.50ml)
  • (large, 1.00ml)
  • (x large, 2.00ml)