Placentas are disinfected with a validated method to achieve a 6-7 log reduction, desiccated and then cut into shapes/sizes from 16mm disc up to 9 cm x 20 cm 

The goal of regenerative therapies is to modulate the stages of healing—such as inflammation, cell migration and proliferation, and tissue remodeling—to enhance the body’s natural repair processes.

Amniotic tissue serves as a unique bioactive wound covering, offering a protective barrier that fosters an antimicrobial, growth factor-rich healing environment.

Amniotic membrane contains a significant number of cytokines and essential growth factors that contributes to:

• Reduced pain when applied to a wound
• Increases and enhances the wound healing process
• Has antibacterial properties 
• In non-immunogenic
• Provides a biologic barrier
• Provides naturally occurring extracellular matrix for migration and proliferation of cells
• Reduces inflammation 
• Reduces scare tissue

Amnioc membrane has been used clinically for over 100 years with  more than 100 publications to date.1 The first applications were in wound care,  followed by a large variety of other applications, including the use in musculoskeletal conditions. Amniotic membrane is the innermost layer of the placenta consisting of  epithelium, a thick basement membrane and an avascular stromal matrix. Amniotic  membrane provides an extracellular matrix of structural matrix protein fibers and  glycosaminoglycans, it promotes cellular migration and proliferation by providing a 3D  scaffold which acts as a physical support structure while regulating cellular activity. 

Publications report that dehydrated human amniotic membrane has been found to  have a number of characteristics that make it uniquely suited to act as natural, biologic  covering to provide protection of wounds from the surrounding environment. Amniotic  membrane’s unique properties include an-adhesive effects and bacteriostatic wound protection.These biological processes are further regulated by extracellular signaling pathways involving cytokines, growth factors and membrane receptors.6 

AmnioCore: AmnioCore is a dual-layer amniotic tissue allograft, which provides a safe,  natural, biologic barrier. AmnioCore delivers essential growth factors on a structural  protein matrix, with superior handling properties. Stability Biologics utilizes a robust,  proprietary processing method in the production of AmnioCore to fully disinfect and  decellularized the amniotic tissue while retaining the beneficial growth factors, yielding  the largest grafts, maintaining sufficient supply and ensuring the highest quality, safe  and effective grafts.  

AmnioCore is stored at room temperature eliminating the need for cryopreservation on, resulting in easier shipping and storage. Their repositionable design reverts to its  original shape when placed in water or saline. AmnioCore provides a reliable and  versatile biologic covering option within a multitude of procedures including Spine &  Orthopedics, Extremity, Vascular, Urological and General Surgery. 

The Patient Reassurance Program provides statement credit for the patient when a patient claim is denied after receiving a positive
coverage response from the Stability Biologics Reimbursement Hotline. The intention of this program is to provide assistance to
patients such that they will not be charged for grafts that have gone through the Stability Biologics Hotline Reassurance program
but are subsequently denied payment through CMS or their insurance. This reimbursement will only be for the value of the
implanted graft and may be provided to cover a patients bill for that graft or on behalf of the patient in the form of a credit to the
Physician Clinic/Hospital Outpatient Clinic.
The patient will be eligible for the Hotline Reassurance Program when the following criteria are met:
1. The Physician Clinic / Hospital Outpatient Clinic contacts the Stability Hotline with proper documents allowing the hotline
to verify the benefits for the patient.
2. Coverage details and authorization requirements as outlined in the summary of patient benefits (provided by the
Reimbursement Hotline) must have been followed by the Physician Clinic / Hospital Outpatient Clinic.
3. The claim was submitted with proper billing and coding requirements.
4. Product was used for the diagnosis provided on the insurance verification intake form and it was used in line with the
product directions for use.
5. Atleast one level of appeal has been completed. The Physician Clinic / Hospital Outpatient Clinic must follow the appeal
instructions and provide all necessary information and documentation to the insurer and/or Stability Biologics
Reimbursement Hotline.
Physician Clinic/Hospital Outpatient Clinic agrees that any replacement product or credit for product implanted on the patient
received under the Hotline Reassurance Program shall be full and accurately reported as discounts in accordance with the
federal anti-kickback statute (42 U.S.C. § 1320a-7b(b)) and its discount safe harbor regulation (42 C.F.R. § 1001.952(h)) and
to provide information about such discounts to Medicare and Medicaid officials upon request.

Medicare Covers The Following:

• Office: A site where a health professional regularly provides outpatient health exams, diagnoses, and treatments, excluding hospitals, SNFs, military facilities, community health centers, public health clinics, and ICFs.
• Home: A location outside of a hospital or facility where the patient receives care in their private residence.
• Nursing Facility: A facility that primarily offers skilled nursing care and related services for the rehabilitation of injured, disabled, or ill individuals, as well as health-related care services beyond custodial care for those who do not have intellectual disabilities.
• Inpatient Hospital: A facility, excluding psychiatric ones, that offers diagnostic, therapeutic surgical and nonsurgical, and rehabilitation services under physician supervision for various medical conditions.
• Out Patient:A hospital campus section providing diagnostic, therapeutic, and rehabilitation services to individuals not needing hospitalization.