Summary
Organogenesis: High-Tech Skin Substitute Company On Sale
Organogenesis receives a Buy rating, driven by Q3/2025 beats, raised guidance, and favorable CMS payment reform for skin substitute products. AWC revenues grew 31% year-over-year; 2025 guidance calls for AWC net revenues of $500–$525M (4–9% growth) and Surgical & Sports Medicine up 6–23%. ReNu's BLA submission is delayed by about two months, with a critical FDA pre-BLA meeting scheduled for 12/12/2025, impacting the late 2026–early 2027 approval timeline.
Organogenesis Holdings Inc. (ORGO) Q2 2025 Earnings Call Transcript
Organogenesis Holdings Inc. (NASDAQ:ORGO ) Q2 2025 Earnings Conference Call August 7, 2025 5:00 PM ET Company Participants David C. Francisco - Chief Financial Officer Gary S.
Organogenesis Holdings: ReNu And New LCD Offer A Rebound Scenario
ORGO's main drivers are its advanced wound-care and surgical biologics that leverage its evidence-rich portfolio. They have a Phase 3 trial on ReNu knee-osteoarthritis with data anticipated by September 2025. Its potential BLA filing could eventually unlock the injectable OA market. CMS skin-substitute LCD was postponed to January 2026. This regulatory standard will require more robust evidence for insurance reimbursements.
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Organogenesis Holdings Inc. Profile
| Specialty Retail Industry | Consumer Discretionary Sector | Gary S. Gillheeney CEO | NASDAQ (CM) Exchange | 68621F102 CUSIP |
| US Country | 869 Employees | - Last Dividend | - Last Split | 5 Jan 2017 IPO Date |
Overview
Organogenesis Holdings Inc. is a pioneering regenerative medicine company dedicated to developing, manufacturing, and commercializing innovative solutions primarily for the advanced wound care, and surgical and sports medicine markets within the United States. With its foundation dating back to 1985, Organogenesis Holdings Inc. has established its headquarters in Canton, Massachusetts. The company is renowned for its commitment to enhancing patient care by providing cutting-edge regenerative medicine products and therapies. Through its direct sales representatives and independent agencies, Organogenesis serves a diverse clientele, including hospitals, wound care centers, government facilities, ambulatory service centers, and physician offices.
Products and Services
Affinity: An amniotic membrane product preserving viable cells, growth factors/cytokines, and extracellular matrix (ECM) proteins from the native tissue, offering advanced wound care solutions.
Novachor: Similar to Affinity, Novachor is a chorion membrane product that retains viable cells, growth factors/cytokines, and ECM proteins, aimed at enhancing wound healing processes.
Apligraf: A pioneering bioengineered living cell therapy that produces a broad spectrum of cytokines and growth factors, designed for the treatment of wounds.
Dermagraft: A bioengineered product known for producing human collagen, ECM proteins, cytokines, and growth factors, contributing to effective wound repair.
NuShield: A dehydrated placental tissue product covering both amnion and chorion membranes to keep the spongy/intermediate layer intact, designed for wound care management.
PuraPly AM: This antimicrobial barrier is known for its conformability and fluid drainage capabilities, offering a solution in the management of wound infections.
FortiShield: A biosynthetic wound matrix developed for use as a temporary protective covering for wounds, part of the advanced wound care line-up.
PuraPly MZ: A micronized particulate version of PuraPly, designed specifically for the management of open wounds in a surgical setting.
CYGNUS Dual: A dehydrated placental tissue product, preserved meticulously to retain the ECM scaffold, offering support in wound care.
ReNu: A pipeline product, ReNu is a cryopreserved suspension aimed to support the healing of soft tissues, showcasing the company's ongoing innovation.
PuraForce: Another bioengineered product in the pipeline, PuraForce is a porcine collagen surgical matrix intended for soft tissue reinforcement applications.
TransCyte: A bioengineered tissue designed for the treatment of partial thickness burns, reflecting the company's commitment to addressing a broad range of medical challenges.
Contact Information
