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Organogenesis Holdings Inc

Organogenesis Holdings Inc. is a regenerative medicine company that develops, manufactures, and commercializes products for the advanced wound care, surgical, and sports medicine markets in the United States. Its advanced wound care portfolio includes placental allografts such as Affinity, Novachor, NuShield, CYGNUS Dual, VIA Matrix, and SimpliMax; bioengineered skin and dermal substitutes including Apligraf, Dermagraft, and TransCyte; antimicrobial barriers PuraPly AM and PuraPly SX; PuraPly MZ, a micronized version of PuraPly; PuraForce, a porcine collagen surgical matrix; and FortiShield, a biosynthetic wound matrix. The company is also developing ReNu, a cryopreserved suspension in Phase 3 trials for symptoms associated with knee osteoarthritis, along with placental products. It serves hospitals, wound care centers, government facilities, ambulatory service centers, and physician offices through direct sales representatives and independent agencies, and is headquartered in Canton, Massachusetts.

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United States
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Organogenesis Holdings reports second quarter 2026 net loss of $96.3 million

Organogenesis Holdings reported a net loss of $96.3 million for the second quarter of 2026, compared to a net loss of $9.4 million in the same period last year. Net revenue fell 58% to $42.8 million, driven by a 61% decline in Advanced Wound Care product revenue to $36.1 million, while Surgical & Sports Medicine revenue decreased 18% to $6.7 million. The company also lowered its full-year 2026 revenue guidance to between $179 million and $215 million, representing a decline of 62% to 68% from 2025. Adjusted EBITDA loss widened to $34.4 million from $3.6 million a year earlier. Cash and equivalents stood at $46.8 million with no outstanding debt as of June 30, 2026.
ORGO · Capital · Negative Reports large net loss, revenue decline, and lowered guidance.
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Biotech & Genomic Medicine▲

Organogenesis' ReNu knee OA therapy accepted for FDA review

Organogenesis Holdings announced that the U.S. FDA has accepted its Biologics License Application for ReNu, a cryopreserved amniotic suspension allograft for managing pain in symptomatic knee osteoarthritis. The FDA set a PDUFA action date of April 24, 2027. ReNu combines amniotic fluid cells and micronized amniotic membrane and has been studied in three large randomized controlled trials involving over 1,300 patients. The therapy previously received FDA RMAT designation in 2021. The FDA also conditionally accepted Amnuvx as the proprietary name for ReNu, pending final review and approval.
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Biotech & Genomic Medicine › Regenerative Medicine & Tissue Engineering ▲Regulation
ORGO · Regulation · Positive FDA accepted BLA for ReNu, a key regulatory milestone toward approval
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Biotech & Genomic Medicine▼

Regenerative Medicine Market Projected to Surpass $100 Billion Within a Decade

The regenerative medicine market is projected to surpass US$100 billion within roughly a decade, driven by a shift from tissue replacement to regeneration using biomaterials, cell therapies, and 3D bioprinting. Independent estimates place the broad market in the tens of billions of dollars in 2026, with compound annual growth rates frequently estimated in the high teens to mid-20s percent. Key drivers include aging populations, the diabetes epidemic, rising surgical volumes, and growing demand in aesthetics, partly fueled by GLP-1 weight-loss medications. The sector spans profitable commercial leaders like Integra LifeSciences and Vericel to early-stage platform companies such as Conexeu Sciences, which began trading on Nasdaq in May 2026 with its collagen-based extracellular-matrix platform. Reimbursement policy and regulatory pathways remain critical risks, as illustrated by recent upheaval in the U.S. skin-substitute market affecting companies like Organogenesis and MiMedx.
About megatrends
Biotech & Genomic Medicine › Regenerative Medicine & Tissue Engineering ▲Demand
Aging Population › Medical Devices for the Aging Body ▲Technology
Aging Population › Chronic-Disease Pharma Franchises Competition
MDXG · Regulation · Negative Recent upheaval in the U.S. skin-substitute market due to reimbursement and regulatory risks negatively affects MiMedx.
ORGO · Regulation · Negative Recent upheaval in the U.S. skin-substitute market due to reimbursement and regulatory risks negatively affects Organogenesis.
IART · Demand · Positive Mentioned as a profitable commercial leader benefiting from market growth driven by aging populations and rising surgical volumes.
VCEL · Demand · Positive Mentioned as a profitable commercial leader benefiting from market growth driven by aging populations and rising surgical volumes.
CNXU · Technology · Positive Early-stage platform company with collagen-based ECM platform, benefiting from sector growth and 3D bioprinting trends.
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