Our Products

Cellular Amniotic Products

  • Cryopreserved as a sterile, frozen liquid shipped overnight in an easy-to-open vial.
  • Melts into a viscous liquid simple to inject where desired.
  • Easy to draw and administer with a syringe and 20-gauge or larger hypodermic needle.
  • May be applied directly to skin layers or tissue.
  • May be used according to physician discretion.
  • is a natural biologic alternative to synthetic products
  • is derived from live, healthy, prescreened donors after live child birth
  • Donor Screening: Our tissue is recovered from living donors that are tested and qualified after a full-term pregnancy and during a scheduled C-section. Our processor is thorough in their screening and testing process to ensure patient safety.
  • Donor selection and amniotic tissue recovery and processing procedures meet or exceed all applicable medical industry standards
  • products undergo independent sterility testing
  • products are free of MHC class II antigens that are normally associated with the immune response
  • Down-regulating TGF-B receptor expression by fibroblasts.
  • Contains important growth factors and proteins including PGE2, WNT4, GDF-11, PDGF, VEGF, EGF, FGF and TGF-B
  • Composed of collagens and structural proteins that may support angiogenesis, tissue growth, and collagen production during tissue regeneration and repair.
  • High concentrations of PGE2. Prostaglandin E2 (PGE2) is secreted by mesenchymal stem cells in response to injury.  This molecule modulates immunity by converting macrophages to the phenotype that secretes IL-10.
  • High concentrations of WNT4.  The WNT4 protein is implicated in cell proliferation.
  • Contains GDF-11, a growth factor specific to amniotic tissues.
  • Available and Shipped frozen. Product recommended storage -80 C.
  • Human allograft under FDA regulation 21 CFR Part 1271 and section 361 of the PHS
  • Immune privileged with anti-inflammatory and anti-bacterial properties
  • A rich source of growth factors, proteins, cytokines, hyaluronic acid, and collagen scaffolds
  • Contains extracellular matrix components for cellular attachment and proliferation
  • Cryopreserved for an extended shelf life

AmnioGlo is derived from the Amniotic Fluid which is rich in carbohydrates, proteins, lipids, electrolytes, growth factors, and hyaluronic acid. The natural properties of the Amniotic Fluid help to protect and re-develop the injured site. Amnio Glo is also aseptically processed and cryopreserved to deliver all native properties of the Amniotic Fluid to the tissue. The Amniotic Fluid is packaged in a cryogenic storage tube and is released by Final Sterility Results with and SAL 10-3.

Amnio Plus a cryopreserved liquid allograft derived from the placental components of the amniotic membrane and amniotic fluid.  It provides structural support and is good for clinical research or further manufacturing purposes to advance soft tissue repair, replacement, and reconstruction.

Amnio Flo is a morselized, flowable tissue allograft derived from human placental amnion which functions as a biologic structural matrix to facilitate and enhance tissue healing and repair.  This product provides an optimized environment to evaluate clinical research or further manufacturing purposes for tissue growth and repair.

Acellular Amniotic Products

Amniotic fluid is a versatile, powerful tissue which supports the development of the fetus in utero. The properties of amniotic fluid which benefit the fetus also make it an ideal material for covering wounds(1-3,7), while at the same time contributing to an environment conducive to the regeneration of healthy tissue.(4-7)
Allogenic human birth tissues, including amniotic fluid, can be used in a variety of surgical and clinical settings. Published literature shows that amniotic fluid contains important growth factors(1,2,6), extracellular matrix(2,5,6) molecules, hyaluronic acid(1,4-6), fibronectin(2), laminin(4), prostaglandins(3), and cells(7). Some of the different growth factors present in liquid amnion are: FGFs, TGFs, ILs, BMPs, TIMPs

Tissue Safety

  • Placental donors go through a rigorous prescreening qualification and are tested according to FDA guidelines for infectious disease.
  • Collection of the donor tissue is performed during planned Cesarean section delivery by appropriately licensed personnel.
  • Tissue is processed in accordance with the standards and guidelines established by the American Association of Tissue Banks (AATB).
  • Recommended for clinical research or further manufacturing purposes only.

Handling & Storage Guidelines: AmnioTempTM

  • Store at ambient temperature (59-86°F/15-30°C) until ready for use.
  • Provided as a sterile, ready to use, flowable graft with no thawing or preparation required.
  • Apply directly to the wound or area of inflammation.
  • See instructions for use for more details.

REFERENCES:

  • Nyman E, Huss F, Nyman T, Junker J, Kratz G. (2013 Apr) Hyaluronic acid, an important factor in the wound healing properties of amniotic fluid: in vitro studies of re-epithelialisation in human skin wounds. J Plast Surg Hand Surg. 47(2):89-92
  • Adzick NS, Lorenz HP. (1994 Jul) Cells, matrix, growth factors, and the surgeon. The biology of scarless fetal wound repair. Annals of Surgery.;220(1):10-18.
  • Gao X, Devoe LD, Given KS. (1994 Aug) Effects of amniotic fluid on proteases:
  • Bolat E, Kocamaz E, Kulahcilar Z, Yilmaz A, Topcu A, Ozdemir M, Coskun ME. (2013 Dec) Investigation of efficacy of mitomycin-C, sodium hyaluronate and human amniotic fluid in preventing epidural fibrosis and adhesion using a rat laminectomy model. Asian Spine J. 7(4):253-9.
  • Cobanglu U, Kutlu N, Karacal N, Kosucu P. (2005 Dec) Effect of human amniotic fluid on bone healing. J Surg Res.129(2):283-7.
  • Ozgenel GY, Filiz G, Ozcan M. (2004 Jul) Effects of human amniotic fluid on cartilage regeneration from free perichondrial grafts in rabbits. Br J Plast Surg. 57(5):423-8.
  • Rosner M, Hipany K, Shanmugasundaram B, Lubec G, Hengstschläger M (2012 Jun) Amniotic Fluid Stem Cells: Future Perspectives. Stem Cells Int. 2012: 741810.

AmnioDry is an acellular product that is derived from a chorion free, morselized amniotic membrane in powder form.  The amniotic membrane is rich in collagen, fibronectin, cytokines, laminins, and growth factors.  The natural properties of the Amniotic Membrane in clinical research may  reduces scar formation, provide anti-microbial and anti-inflammatory responses at the injured site. This product is terminally sterilized in its final configuration with and SAL 10-6 which allows for an each application to the injured site.  Amnio Dry is comes as a  20 mg powder stable at room temperature.

AmnioTemp is a flowable tissue allograft derived from human amniotic fluid. AmnioTemp is an acellular, ambient temperature, amnion allograft that is ready to use in a liquid state. AmnioTemp is provided in an easy to apply flowable form for precise delivery to the intended site. It is ideal for clinical research or further manufacturing purposes only.

Glide Serums

Amnio Glide is a sterile, lower dilution acellular amnion extract liquid used only idea for clinical research in topical applications.  This product can be used with variety of skin treatments.

HPL Glide is a topical product composed of GMP grade pooled human platelet lysate prepared by single application ideal for clinical research or further manufacturing purposes.

*Our serums are available in 5 mL vials. They are shipped frozen and can be stored in a conventional freezer for 5-7 days.

Centrifuge

Genius PRP990 Cyclone Centrifuge System:  The Genius Cyclone Centrifuge System is one of the fastest and most comprehensive systems for concentrating platelets.  It can process a sample in 60 to 90 seconds.  When time is money, this system will keep your clinic flow going.  This product is 510K approved by the US FDA.

In order to concentrate platelets, they first must be captured. Higher capture rate may allow more platelets to be available in the final output.

Capturing a high percentage of total platelets translates into higher increase over baseline, and 3.5% coefficient of variance produces consistently high results.

GeniusPRP uses a unique vertical centrifuge system that requires only 90 seconds of spin time.

Indications for use: The Genius PRP System is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient's point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics.

Tissue Storage Freezers

So-Low Mini Ultra-Low Freezer:  Model C85-2

Product Summary:  2 Cubic Ft. (56 liters) 
Mini Ultra Low Chest Freezer 
Temperature Range: -40°C to -85°C
Exterior w x d x h (inches): 25" x 26" x 38.5"
Exterior w x d x h (cm): 63 x 66 x 97

Stirling Ultracold: The Shuttle

Model: Portable Shuttle

Product Summary: Stirling Ultracold has introduced the Shuttle™, a portable, shippable -86°C ultra-low freezer developed for personal and space or power constrained applications. The Shuttle™ offers compact reliable, energy-efficient storage for cold-chain management, short-term or long-term ultra-low storage and transport of biological specimens.

The Shuttle™ is ideal for use within biorepositories, pathology laboratories, tissue banks, regenerative medicine, and in other applications associated with clinical or diagnostic medicine, and pharmaceutical distribution.

  • Stable Operation from -20°C to -86°C
  • Plugs into Any Outlet, Worldwide
  • Easily Transportable, Runs on 12V, DC Power
  • Lightweight, Low Shipping Costs
  • Small Footprint, Efficient 0.9 cu.ft. (25 liter) Interior
  • Lowest Energy Consumption, <2.8 kWh/day @ -80°C
  • 100% Natural refrigerants