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LevaSOLTM Human Amniotic Fluid Allograft

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Material of Choice for Regenerative Healing and Repair in Wounds, Burns, Bone, Eye, Muscle, Cartilage, Tendon, and Nerves

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Photo: 0.5 cc vial of LevaSOLTM

[/vc_column_text][/vc_column][vc_column width=”2/6″][vc_column_text]LevaSOLTM is a decellularized human amniotic fluid allograft that has been bioengineered utilizing a cutting-edge sterile filtration technology that delicately extracts dead tissue and debris from the fluid. LevaSOLTM has been cryopreserved to ensure maximum patient safety while preserving high concentrations of the beneficial proteins, extracellular matrix components and hyaluronic acid. Components of LevaSOLTM interact with Multiple Tissue Types to enhance the body’s own healing process and stimulate normal regeneration to provide strength in healing.Data on file[/vc_column_text][/vc_column][vc_column width=”1/6″][/vc_column][/vc_row][vc_row][vc_column width=”1/6″][/vc_column][vc_column width=”2/3″][vc_tta_accordion active_section=”0″ collapsible_all=”true”][vc_tta_section title=”Functionality & Regenerative Properties” tab_id=”1507470055522-6a0fb6c5-d02d”][vc_column_text]

  • Anti-microbial
  • Anti-inflammatory
  • Promotes homeostasis
  • Enhances angiogenesis
  • Reduces pain
  • Promotes re-epithelialization
  • Promotes stem cell proliferation and migration
  • Accelerates tissue and muscle regeneration
  • Secretes collagen and fibronectin
  • Reduces scar tissue formation
  • Lubricates and increases mobility
  • Osteo-promotive
  • Non-tumorigenic
  • Low or negligible immunogenicity
    (1-12)

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  • Carbohydrates, proteins, lipids, lactate, pyruvate, electrolytes, enzymes, and hormones
  • Hyaluronic acid
  • Growth Factors
  • Epidermal Growth Factor (EGF)-angiogenic
  • Transforming growth factors (TGFa & TGFb)
  • Insulin-like growth factor (IGF)
    (1-12)

[/vc_column_text][/vc_tta_section][vc_tta_section title=”Uses & Applications” tab_id=”1507470788520-9ac731e8-649f”][vc_column_text]LevaSOLTM manufacturer has supplied 1,000+ units of LevaSOLTM for the stated applications with no known or reported adverse reactions. This list is not inclusive of all potential applications. Not all uses and applications listed have successfully completed IRB approvals. Some of these applications are currently undergoing clinical trials. It is up to the clinician to determine its usefulness or effectiveness.

  • Dry Eye Syndrome
  • Wounds & burns
  • Contractures
  • Urethroplasty
  • Bowel fistula
  • Hypertrophic scars
  • COPD (Aerosolized)
  • Penile adhesions
  • TMJ discomfort
  • Erectile Dysfunction
  • Joint arthritis
  • Urinary Incontinence
  • Carpal Tunnel
  • Esophageal fistula
  • Torn Rotator Cuff
  • Esophageal strictures
  • Plantar Fasciitis
  • Finger Strictures
  • Peyronie’s Disease

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  • LevaSOLTM 100% pure amniotic fluid- free of additives or cryoprotectants
  • Cutting-edge sterile filtration technology- ensures maximum safety while preserving high quantities of the beneficial “native” properties
  • Some applications may qualify for insurance reimbursement
  • 400+ cytokines, chemokines and growth factors verified post-preservation
  • Non-invasive, safe and can be performed in an out-patient setting
  • Can be sprayed, aerosolized, injected. Levana Biologics offers LevaSOLTM in vials or eye dropper formats
  • Safe for subcutaneous or intramuscular injection into joints, tendons and connective tissues (Not safe for intravenous injection)
  • Levana Biologics provides practitioners with a free consultation with our Chief Scientific Officer
  • Human Amniotic Fluid has been utilized in over 10,000 applications with no known or reported adverse reactions
  • Must be stored at -20ºC or colder (Can be thawed and ready to use in 10 minutes)
  • Levana Biologics will coordinate delivery of LevaSOLTM to arrive on dry ice the day of procedure, preventing the need for storage.
  • Aseptically packaged in a single-use, sterile cryovial and ready for use upon thawing

Disclaimer: LevaSOLTM contains an impressive multi-dimensional array of regenerative properties. There are no live stem cells, dead tissue, or debris in this product. Per FDA regulations, bioengineered human birth tissue products are not permitted to contain any live stem cells, dead tissue or debris at this time. The product is intended to support your body’s ability to repair itself by stimulating the body’s own cells to heal, repair and regenerate.[/vc_column_text][/vc_tta_section][vc_tta_section title=”Manufacturer” tab_id=”1507488225117-fb017d3c-f54f”][vc_column_text]LevaSOL and LevaGRAF Manufacturer Preparing Crosslinking MechanismLevana Biologics is partnered with a world-renowned Cell Therapy and Regenerative Medicine Academic Institution and University to manufacture LevaGRAFTM, LevaSOLTM and other biomaterials.  These products qualify as a human tissue allograft (HCT/P) as outlined in 21 CFR 1271 under Section 361 of the Public Health Service Act. LevaSOLTM is free of additives or cryoprotectants and each lot has been obtained from a pre-screened, healthy and qualified volunteer donor during full-term Cesarean birth. LevaSOLTM is bioengineered utilizing a cutting-edge sterile filtration technology, to delicately extract dead tissue and debris to ensure maximum patient safety while preserving high quantities of the beneficial “native” properties.  Collection, processing, preservation and storage are performed utilizing a proprietary process (patent pending) by an FDA registered, AATB, FACT, CAP accredited, CLIA certified laboratory. Data on file.

Photo: LevaSOLTM Amniotic Fluid during manufacturing process[/vc_column_text][/vc_tta_section][vc_tta_section title=”Methods & Administration” tab_id=”1507470055450-94dd5f8c-0801″][vc_column_text]

The sterile amniotic fluid formulation is aseptically packaged and can be administered in concentrated form, diluted with sterile water or buffer, formulated as a gel, ointment or lotion, solution, suspension or aerosol. It can include additional therapeutic, prophylactic or diagnostic agent, either in the solution, gel, ointment or suspension, or as particles (nanoparticles, liposomes, microparticles) or implants. Injections can be administered subcutaneously (“SC”), intramuscularly (“IM”), or into a joint. This product is not safe for intravenous injective (IV). For additional information regarding recommended dosages, methods and formulations for specific applications fill out form below.

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Disclosure: The efficacy is determined by Physician evaluations, patient self-evaluations, imaging studies and Quality of Life evaluations. Dosage and dosing regimens are dependent on the intended use of the formulation. It is up to the healthcare provider to determine dosages, formulation, and methods that are most suitable for the patient. Levana Biologics can only provide scientific resources and a scientific expert consultation so you are better equipped to make an informed decision.[/vc_column_text][/vc_tta_section][/vc_tta_accordion][/vc_column][vc_column width=”1/6″][/vc_column][/vc_row][vc_row][vc_column width=”1/6″][/vc_column][vc_column width=”2/3″][vc_column_text]

LevaSOLTM Composition of Cytokine/Growth Factor Arrays (Post-Sterilization)

[/vc_column_text][vc_single_image image=”758″ img_size=”full” alignment=”center” onclick=”link_image”][vc_column_text]Figure 1: Protein arrays of post-sterilized LevaSOLTM revealed that of 400, 285 or 59% of proteins tested were present in LevaSOLTM. Classification of the proteins indicated that they were involved in various functional activities that include cell adhesion, proliferation embryonic development, angiogenesis and host defense.  Proteins assigned to the miscellaneous category included proteins involved in Ca++ regulation, apoptosis, cell migration lysosomal sorting and ectodermal organ morphogenesis.  Figure 2: Upon sub-categorized of the host defense proteins a number of proteins were found to be associated with the inflammatory response, innate immunity or as an anti-microbial. (1)

(LevaSOLTM viscosity rating: 0.9+/-0.1 cP)

For a Complete List of Defense Proteins found in LevaSOLTM see below in dropdown.[/vc_column_text][vc_tta_accordion active_section=”0″ collapsible_all=”true”][vc_tta_section title=”Complete List of Defense Proteins found in LevaSOL” tab_id=”1507744066041-42cacaca-b359″][vc_single_image image=”489″ img_size=”full” alignment=”center”][/vc_tta_section][/vc_tta_accordion][vc_column_text]

LevaSOLTM Sizes and Ordering Information

LevaSOLTM is offered in a variety of sizes in both a vial and eye dropper format.

LS-0025   –  0.25 cc
LS-0050   –  0.50 cc
LS-1000   –   1.0 cc
LS-1500   –   1.5 cc
LS-2000   –   2.0 cc
LS-3000   –   3.0 cc

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