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Organogenesis Holdings Inc. (ORGO)

Organogenesis Holdings Inc. is a U.S.-based regenerative medicine firm that specializes in creating, producing, and marketing innovative therapies for advanced wound management, as well as surgical and sports medicine applications. Within its advanced wound care portfolio, Organogenesis offers several distinct products. These include Affinity and Novachor, both amniotic membrane dressings designed to preserve vital cells, growth factors, and ECM proteins found in natural tissue. Apligraf is a bioengineered living cell therapy that releases a range of healing cytokines and growth factors, while Dermagraft is another bioengineered solution that generates human collagen, ECM, proteins, and cytokines. NuShield provides a wound covering incorporating both amnion and chorion membranes to maintain a spongy intermediate layer. PuraPly acts as an antimicrobial barrier, allowing for flexibility and effective fluid drainage. For the surgical and sports medicine sectors, the company provides products such as NuCel, a dehydrated placental tissue designed for surgical application to promote natural tissue regeneration. ReNu is a cryopreserved suspension aimed at aiding soft tissue recovery. Additionally, FiberOS and OCMP serve as bone void fillers, primarily utilized in orthopedic and neurosurgical procedures. Looking ahead, Organogenesis's product pipeline features PuraPly XT and PuraPly MZ, which are being developed for treating chronic, acute, and open wounds. PuraForce is a bioengineered porcine collagen surgical matrix intended for soft tissue reinforcement. TransCyte, another bioengineered tissue, is in development for addressing partial thickness burns. Organogenesis distributes its offerings to a diverse client base, including hospitals, specialized wound care centers, government institutions, ambulatory surgical centers, and physician offices, leveraging both its direct sales team and independent agencies. Established in 1985, the company maintains its headquarters in Canton, Massachusetts.

Sector: Pharmaceutical Preparations

Industry: Drug Manufacturers - Specialty & Generic

Organogenesis Holdings Inc. logo

Organogenesis Holdings Inc.

NASDAQ:ORGOHealthcare
-6.20%$0.7681
AH$0.7681+0.00%vs close
Mkt Cap$98.83M
Float71.77M
O/S128.67M
Vol
$ Vol
RVOL
Inst Own51.3%
SI21.7%
Earnings
Dilution
Organogenesis Holdings Inc. logoNASDAQ:ORGO$0.7681-6.20%
Upcoming Catalysts
  • ReNuPDUFA
    symptomatic knee osteoarthritis
    Apr 24, 2027in 173 days8-K
Phase Distribution
27 lead-sponsored trials·2 active·14 completed
Phase 1/23
Phase 38
Phase 43
Not applicable13
(11 more as collaborator)

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Sponsor role
Status
Phase
  • Phase 4
    Withdrawn

    A Post-Marketing Clinical Study of Apligraf for Venous Leg Ulcers

    Apligraf

    Varicose Ulcer

    Enrollment
    0
    Start
    Jul 2008
    Primary Completion
    Mar 2010est.
    Completion
    Mar 2010est.
    NCT00648674
  • Phase 4
    Completed

    A Post Marketing Study of Apligraf in Non-healing Wounds of Subjects With Venous Leg Ulcers

    Apligraf, Standard of Care Dressing Group

    Venous Ulcer

    Enrollment
    30
    Start
    Mar 2011
    Primary Completion
    Nov 2013
    Completion
    Dec 2013
    NCT01327937
  • Phase 4
    Unknown status

    A Study Of Pain And Quality Of Life Outcomes In Subjects With a Single Painful Venous Leg Ulcer Treated With Apligraf®

    Apligraf

    Venous Leg Ulcers

    Enrollment
    100
    Start
    Nov 2013
    Primary Completion
    Jan 2014est.
    Completion
    Jan 2014est.
    NCT02011724
  • Phase 3
    Terminated

    Apligraf Versus Standard Therapy in the Treatment of Diabetic Foot Ulcers

    Bi-layered cell therapy (Apligraf)

    Diabetic Foot

    Enrollment
    82
    Start
    Oct 2000
    Primary Completion
    -
    Completion
    Sep 2002
    NCT00512538
  • Phase 3
    Terminated

    Safety and Efficacy of Apligraf in Nonhealing Wounds of Subjects With Junctional or Dystrophic Epidermolysis Bullosa (EB)

    Apligraf, Standard dressing regimen

    Epidermolysis Bullosa, Junctional, Epidermolysis Bullosa Dystrophica

    Enrollment
    1
    Start
    Dec 2007
    Primary Completion
    Dec 2008
    Completion
    Dec 2008
    NCT00587223
  • Phase 3
    Completed

    Safety and Efficacy of Gintuit(TM)for Oral Soft Tissue Regeneration

    Gintuit, Autologous palatal tissue

    Gingival Recession

    Enrollment
    96
    Start
    Oct 2007
    Primary Completion
    Dec 2008
    Completion
    Dec 2008
    NCT00587834
  • Phase 3
    Completed

    Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers

    Dermagraft(R), Profore

    Venous Leg Ulcer

    Enrollment
    537
    Start
    Jun 2009
    Primary Completion
    May 2011
    Completion
    Aug 2011
    NCT00909870
  • Phase 3
    Completed

    Dermagraft(R) for the Treatment of Patients With Diabetic Foot Ulcers

    Dermagraft(R), Conventional care

    Diabetic Foot Ulcer

    Enrollment
    281
    Start
    Sep 1994
    Primary Completion
    Jan 1997
    Completion
    Jan 1997
    NCT01181440
  • Phase 3
    Completed

    Pivotal Trial of Dermagraft(R) to Treat Diabetic Foot Ulcers

    Dermagraft, Comparator

    Diabetic Foot Ulcer

    Enrollment
    314
    Start
    Dec 1998
    Primary Completion
    Mar 2000
    Completion
    Mar 2000
    NCT01181453
  • Phase 3
    Completed

    Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee

    Amniotic Suspension Allograft, Placebo

    Knee Osteoarthritis

    Enrollment
    516
    Start
    Dec 2020
    Primary Completion
    Jul 2023
    Completion
    Aug 2025
    NCT04636229
  • Phase 3
    Completed

    A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee

    Amniotic Suspension Allograft, Placebo

    Knee Osteoarthritis

    Enrollment
    594
    Start
    Sep 2023
    Primary Completion
    Aug 2025
    Completion
    Nov 2025
    NCT06000410
  • Phase 1/2
    Completed

    A Pilot Study of Apligraf for the Treatment and Prevention of Recurrence of Excised Keloids

    Apligraf, Standard dressing regimen

    Keloid

    Enrollment
    30
    Start
    Dec 2007
    Primary Completion
    Mar 2010
    Completion
    Mar 2010
    NCT00587587
  • Phase 1/2
    Terminated

    A Pilot Study of CelTx(TM) (Apligraf®) in the Treatment of Gingival Recession Requiring Root Coverage

    CelTx, Autologous sub-epithelial connective tissue graft

    Gingival Recession

    Enrollment
    15
    Start
    May 2008
    Primary Completion
    Sep 2010
    Completion
    Sep 2010
    NCT00679081
  • Phase 1/2
    Terminated

    Safety Study of Gintuit™ in Subjects Requiring Socket Grafting

    Gintuit

    Edentulous Alveolar Ridge

    Enrollment
    5
    Start
    Jul 2013
    Primary Completion
    Mar 2015
    Completion
    Mar 2015
    NCT01929954
  • Not applicable
    Terminated

    Safety Study of VCT-01™ in Split-Thickness Skin Graft Donor Site Wounds

    VCT-01

    Wounds

    Enrollment
    3
    Start
    Jun 2011
    Primary Completion
    Sep 2012
    Completion
    Sep 2012
    NCT01292122
  • Not applicable
    Completed

    A Pilot Clinical Trial of Gintuit (TM)in Establishing a Functional Zone of Attached Gingiva

    Gintuit, autologous Free Gingival Graft (FGG)

    Gingival Recession

    Enrollment
    25
    Start
    Sep 2005
    Primary Completion
    May 2006
    Completion
    May 2006
    NCT01547962
  • Not applicable
    Unknown status

    Study of Nucel for One and Two Level Lumbar Interbody Fusion

    One or two level lumbar interbody fusion surgery, Nucel

    Degenerative Disc Disease, Spondylolisthesis +1

    Enrollment
    200
    Start
    Dec 2015
    Primary Completion
    Dec 2022est.
    Completion
    Dec 2022est.
    NCT02808234
  • Not applicable
    Completed

    Effect of Fresh Amniotic Membrane in the Treatment of Diabetic Foot Ulcers

    Affinity Allograft, Standard of care

    Diabetic Foot Ulcers

    Enrollment
    89
    Start
    Aug 2016
    Primary Completion
    Apr 2019
    Completion
    Apr 2019
    NCT02880592
  • Observational
    Completed

    Prospective PuraPly™ AM Case Series Study

    PuraPly™ Antimicrobial Wound Matrix

    Pressure Ulcers, Venous Ulcers +3

    Enrollment
    43
    Start
    Nov 2016
    Primary Completion
    Apr 2017
    Completion
    May 2017
    NCT03070925
  • Observational
    Completed

    PuraPly™ Antimicrobial Wound Matrix and Wound Management

    PuraPly™ Antimicrobial Wound Matrix

    Pressure Ulcer, Venous Ulcer +3

    Enrollment
    100
    Start
    Nov 2016
    Primary Completion
    Sep 2017
    Completion
    Oct 2017
    NCT03070938
  • Not applicable
    Completed

    Affinity Prospective Diabetic Foot Trial Crossover Group

    Affinity human amniotic membrane

    Diabetic Foot Ulcer

    Enrollment
    20
    Start
    May 2017
    Primary Completion
    Jun 2019
    Completion
    Aug 2019
    NCT03205436
  • Observational
    Completed

    The RESPOND Registry

    PuraPly™ Antimicrobial Wound Matrix

    Partial Thickness Wound, Pressure Ulcer +6

    Enrollment
    310
    Start
    Feb 2017
    Primary Completion
    Jul 2018
    Completion
    Jan 2019
    NCT03286452
  • Not applicable
    Terminated

    PuraPly® AM Plus the Standard of Care to Standard of Care Alone for the Management of Stage II-IV Pressure Ulcers.

    PuraPly® Antimicrobial Wound Matrix, SOC for Pressure Ulcers

    Chronic Pressure Ulcers

    Enrollment
    40
    Start
    May 2018
    Primary Completion
    Sep 2021
    Completion
    Sep 2021
    NCT03502824
  • Not applicable
    Unknown status

    Randomized Clinical Study Assessing NuShield Versus Standard of Care in Diabetic Foot Ulcers

    NuShield

    Diabetic Foot Ulcer

    Enrollment
    200
    Start
    Feb 2019
    Primary Completion
    Nov 2021est.
    Completion
    Dec 2021est.
    NCT03855514
  • Not applicable
    Unknown status

    Clinical Study Of Affinity Versus SOC In The Management Of VLUs

    Affinity

    Venous Leg Ulcer

    Enrollment
    200
    Start
    Jun 2021
    Primary Completion
    Mar 2023est.
    Completion
    Jun 2023est.
    NCT04901013

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