AmbioDry2™ Processed Human Amniotic Membrane - IOP Inc

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Processed Human Amniotic Membrane
Historical Sackground and Surgical Use
Historical Background
The successful surgical use of
dehydrated, substra{e-iree hunan
amniotic mernbrane - ior the
surgical treatment of the ocular
surface * was first reporled by
both Lavery and Sorsby in 1946.
ln the 1980s, Dr. Juan F. Batlle
re-pioneered the surgical use of
preserved amnrotic membrane for the
treatment of plerygium and other ocular
conditions. Dr. Batlle's research noted
the importance of utilizi,rg preserved
amniotic mernbrane conta ning
devitalized, inlact cellular c0mponents.
hTAD?, the Ap[ e!1y' Amniotic
Membrane technology was introduced
lo the ophthalmic surgical community.
This "generation 1" AmbioDry
technology featured a dehydrated,
decellularized configuration for the
surgical managemenl of ocular wounds.
Today, with c0ntinued direction and
input from industry leaders like Dr. Juan
Satlle, a second gene ration AmbioDry
technology is available. AmbioDry2.
Surgical Application
AmbioDry2 may be used for the
surgical management of :
O Pterygium
O Persislent lpilhelial Defects
I Dermoids
I Fornix HeconstructionlSymblepharon
C Corneal U lcerations/Perforalions
O Bullous Keralopathy
"The surgical use of preserved
amn i atic membra ne tra n spl a ntation
(AMT)has been repo{ted for
decades as a vtable and advantageaus
substitute for conjunctival
a utog rafts. S i g n ifi cantly less
surgical tine is reqaired and
hast canjunctiva is preserved."
Juan F. Ballle, M.D.
Pioneer AMT
President & Foundet
Centro Microcirugia 0cular
Laser {Santo Domingo, DR)

Mio@#e-W
Advancement$, Advantages and Benefits
Continued Innovation for 0ptimal Surgical Utility
Optimized Storage &
Surgical Utility
AmbioDry2' is a processed, dehydrated, substrale-
{ree amnintic membrane tissue graf1. [ach unil is
sterilized and packaged wlth proprietary, device-like
methods, designed to optimize st0rage and utility.
AmbioDryZ can be stored on the shelf for 5 years.
No freezrng or ref rigeration is required,
This unique membrane can be trimme d in its dry
state. applied to the surgical sile, activaled withrn
minute s and the n fixated into place.
lmproved Visual
0rientation ldentification
AmbioDry2 features a unique, proprielary
"watermark" impression on the graft surface-for
the simple, error-f ree rdentification of the basement
rnembrane and stronal surfaces. The basement
rnembrane can be easily identified by noting the
prOper vertical orientation 0f the "10P" watermark.
IAP "waterna*" i(lentifies the baserilent nenbrane
More Biostructurally Intact
AmbioDry2 tissue techn0lcgy combines minimallymanrpulative
tissue processing methods with
validaied sterrlization processes to produce a
unique, high-quality amniotic membrane techn0logy.
The generation 1 AmbioDry tissue process produced
a decellularized collagen membrane, void of
epilhelial cells and fibroblasts.
6eneration 1 AnbiaDry: Phalanicrcgraph n7tes ll I the absence ol
epithelial ce!ls an the surface af the nenbrane with (2) aa intact
basenefrl nenbrane.
The new generation AmbioDryZ provides a more
intact, nalive amniotic membrane graft. While the
unique tissue process destroys poten{ial bioburden
and virulency, the membrane's devitalized cellular
comp0nents - along with its dense connective
malrix - ale preserved.
1eneration ? AnbioDry2: Phatani*ograph shavr's {1) an intact epilhelial
cell structurc cn tlle nenbrane.'s surfarc; 12) an iuiad dense basenent
rnetnbranc and l3) lhe presetlce 0f a l00se Nllagen laye! with librcblasts
lloninal thickness: 35 nicrcns.
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Mio&
Human Amniotic Membrane Allografts
Procured, processed and configured with our focus on the surgoon and the patient.
Tissue Safety Danor Selectian, Screening & Testing
All tissue recovered meets stringent specifications during donor
screening and laboratory testing to reduce the risk of transmitting
rnfectious disease. AmbroDry2 allografts are procured and
processed according to standards established by the American
Association ol Tissue Eanks {AATB} and the United States Food
& Drug Administration {FDA). All tissues are re covered under {ull
iniormed 00nsent 0f the donors {represented by the mr:lhers of {he
newborn children). The donors have consented to transfer oflhe
allografts to third parties. A thorough medical and social history
of the donor is also obtained, including detailed family history. The
donor is screened for.
Blood Type & Rh Factor HTLV{ Antibody f-lepatitis Cr:re Antibody
HIV{ Antibody HTLV-2 Antibody Hepatitis Surface Antigen
HIV-2 Antibody Syphrlis Screening l-lepatitis C Antibody
HIV NAT
CMV
All tests results are reviewed prior to the release of the tissue.
0nly tissue from donors that have a normal CBC, test negative for
serology and test negative or non-reactive for infectious dtseases
and conlamination are released.
-..'lOP tn.,
Reimbursement Information
CPT Code 65780
Amniotic Membrane Tralsplantation, 0cular Surface Rec0nslf ucti0n
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Ordering Information
AmbioDry2 Confi gutations
- - ;"*,_11--11?g , no-ilso-' il;440 _[3 rtji
r;;'-AD-irzo lr...Aoa*so-' il;440 At-ai$.'.1
tl:" ;::l{rr l5x2cm _._?r3rt 4x4cnr 15mmd
lt&,!r lrqir -Js''g.p l
Slorage flssm femp: 0o to 30" C {32" to 1 B0' F}
I{ominal Thickness 35 nicrons
3184-B Airway Avenue
Costa Mesa, CA 92626 USA
Tel (714) 549-1185
Fax {714i 549-0557
email: ambiodry@iopinc.com
Amblorfv ard Ambi0l]ryT are lraCemark; sl 0K | 0 0phth0. €)2108 l0P. lic
Customer Service
1-800-535-3545
www.iopinc.com
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