Manufacture Information Flashcards
Learn Company's History and Background (33 cards)
When was Stability Biologics founded?
2010
What year was the tissue bank established?
2014
Where is the corporate headquarters of Stability Biologics located?
Nashville, TN
What is the primary focus of Stability Biologics?
Full-scale manufacturer of human biologics
What types of products did Stability Biologics initially focus on?
Surgical bone products
What has Stability Biologics expanded to include in its product line?
Wound care
What classification do the clean rooms at Stability Biologics fall under?
ISO Class 5-8
ISO: International Organization for Standardization
How often are the clean rooms at Stability Biologics sterilized?
Daily, twice a day. With extreme sensitivity to airborne contaminants.
What accreditation does Stability Biologics hold?
AATB-accredited
AATB: American Association of Tissue Bank
Who runs Stability Biologics tightly with zero FDA observations?
Dr. Terry Hill
FDA: Food and Drug Administration
What is the names of the flagship wound care products?
AmnioCore Dual Layer
Amnio Tri-Cor
Amnio Quad-Cor
AmnioCore Pro
AmnioCore Pro+
What are the composition of the Pro and Pro+ products?
Amnion + chorion
Amnion + chorion + amnion (sandwich)
What is Physio (bone product) based on?
DBM-based moldable graft
DBM: Demineralized Bone Matrix
What does the amnion layer boost?
Granulation, epithelialization
Scaffold for healing
What does the chorion layer support?
Connective tissue regrowth
What are some properties of the amniotic tissue?
- Reduces inflammation
- Antibacterial
- Non-immunogenic
- Scaffold for cell migration
Who are the target customers for Stability Biologics?
- Podiatrists
- Vascular surgeons
- General and plastic surgeons
- Wound care specialists
- NPs/PCPs doing in-office wound care
- SNFs
- Outpatient surgical centers
What is the significance of Medicare Part B for Stability Biologics?
It requires no prior authorization
What does ASP stand for?
Average Sales Price
What must wounds be to qualify for treatment?
- Chronic (>30 days, failed conservative care)
- Granular (75%+)
- Free of necrosis, infection, exposed bone/tendon
What is the maximum number of billing units per patient per application?
180 units
What does the IVR Form include?
Wound details and insurance info
How long is the invoice period offered by Stability?
60 days
What does the Limited Warranty Program protect physicians against?
Billing denials
