Exo Info

Regulatory Intelligence

28
Total Companies
6
Compliant
9
FDA Warnings
44
Avg Score
5
Gold Rated
13
cGMP Verified
Filters

Section

Manufacturing

FDA Status

COA

DMF/IND

Gold Standard, 351(a) Registered, cGMP Compliant
DynaCord

DynaCord

A+

Mesenchymal Exosomes from Wharton's Jelly Stem Cells, manufactured as a drug under FDA Center for Biologics Evaluation and Research (CBER)

100
dyna-cord.com
351(a)cGMPCOAInsured9 PatentsDMF3rd Party Lab
Direct Biologics

Direct Biologics

B

Bone Marrow MSCs

70
directbiologics.com
351(a) (Investigational)cGMPCOAInsuredDMF
Organicell

Organicell

B

Amniotic Fluid (LOW CLINICAL VALUE - PLACENTAL CONTAMINATION)

70
organicell.com
351(a) (Investigational)cGMPCOAInsuredDMF
Exoqure

Exoqure

F

Wharton's Jelly MSCs from Umbilical Cord

40
exoqure.com
361 HCT/P (Cosmetic)GMPCOAInsuredDMF
Regenexx

Regenexx

D

Bone Marrow Concentrate (Autologous MSCs)

55
regenexx.com
Autologous (Practice of Medicine)GMPCOAInsured
Benev

Benev

F

Adipose-derived (Fat Tissue) Exosomes

40
benev.com
361 HCT/P (Cosmetic)GMPCOAInsured
ExoCoBio

ExoCoBio

F

Stem Cell Derived

42
exocobio.com
361 HCT/P (Cosmetic)GMPCOAInsured
Kimera Labs

Kimera Labs

FFDA

Placental/Amniotic (LOW CLINICAL VALUE)/Umbilical

30
kimeralabs.com
361 HCT/P (FDA Disputes)cGMPCOA
Vitti Labs

Vitti Labs

FFDA

Umbilical Cord/Wharton's Jelly

30
vittilabs.com
361 HCT/P (FDA Disputes)cGMP
Platinum Biologics

Platinum Biologics

FFDA

Umbilical Cord

20
platinumbiologics.com
361 HCT/P (FDA Disputes)GMP
C

Chara Biologics

FFDA

Umbilical Cord

20
charabiologics.com
361 HCT/P (FDA Disputes)GMP
New Life Medical Services

New Life Medical Services

FFDA

Umbilical Cord/Wharton's Jelly

15
newlifemedical.com
361 HCT/P (FDA Disputes)GMP
Plated Skin Science

Plated Skin Science

F

Platelet-Derived Exosomes

42
platedskinscience.com
361 HCT/P (Cosmetic)cGMPCOAInsured2 Patents
BioStem Life Sciences

BioStem Life Sciences

FFDA

Umbilical Cord/Placental Tissue

15
biostemlifesciences.com
361 HCT/P (FDA Disputes)GMP
R

RION

B

Platelet-derived exosomes (PEP - Purified Exosome Product)

70
riontx.com
351(a) (Investigational)cGMPCOA
A

Aruna Bio

C

Neural stem cell-derived exosomes (AB126)

68
arunabio.com
351(a) (Investigational)cGMPCOA
C

Capricor Therapeutics

B

Cardiosphere-derived cells (CDCs) secreting exosomes; StealthX engineered exosome platform

72
capricor.com
351(a) (Investigational)cGMPCOAInsuredDMF
A

Aegle Therapeutics

B

Allogeneic bone marrow-derived MSC extracellular vesicles (AGLE-102, AGLE-103)

70
aegletherapeutics.com
351(a) (Investigational)cGMPCOADMF
E

Elevai Labs

F

Human umbilical cord MSC-derived exosomes (PREx platform)

35
elevailabs.com
361 HCT/P (Cosmetic)GMPCOA
P

Predictive Biotech

FFDA

Umbilical cord tissue / amniotic membrane (CoreCyte, Predicyte-EB)

18
predictivebiotech.com
361 HCT/P (FDA Disputes)GMPCOA
E

Evolutionary Biologics

FFDA

Umbilical cord tissue, placental tissue, amniotic membrane (EXO RNA, EVO JEL, EVO HYBRID)

12
evolutionarybiologics.com
361 HCT/P (FDA Disputes)GMP
L

Liveyon / Genetech

FFDA

Umbilical cord blood (ReGen Series)

5
liveyon.com
361 HCT/P (FDA Disputes)GMP
U

United Therapeutics

C

Mesenchymal stem cell-derived EVs for bronchopulmonary dysplasia (BPD)

68
unither.com
351(a) (Investigational)cGMPCOAInsuredDMF
A

Aethlon Medical

D

N/A - Hemopurifier device captures tumor-derived exosomes and viruses (not a biologic for infusion)

55
aethlonmedical.com
351(a) (Investigational)cGMPCOA
A

AnteAGE / Cellese Regenerative Therapeutics

F

Bone marrow MSC conditioned media (growth factors, cytokines, exosomes)

35
ante-age.com
361 HCT/P (Cosmetic)GMPCOA
C

Creative Medical Technology Holdings

F

Amniotic fluid-derived cells; exosome secretion (AmnioStem, StemSpine, ImmCelz)

38
creativemedicaltechnology.com
361 HCT/P (Tissue Bank)GMPCOA
B

Bio-Techne / Exosome Diagnostics

D

Patient urine exosome RNA extraction (ExoDx Prostate IntelliScore diagnostic)

55
bio-techne.com
361 HCT/P (Tissue Bank)cGMPCOAInsured
I

Invitrx / ReLuma

F

MSC-derived conditioned media (ReLuma Serum, Eye Cream, Body)

32
invitrx.com
361 HCT/P (Cosmetic)GMPCOA