Summary

KEY INSIGHTS
ReNu is a cryopreserved amniotic suspension allograft (ASA) containing micronized amniotic membrane and amniotic fluid cells. The amniotic membrane serves a protective function, surrounding the fetus and acting as a barrier between mother and baby. Amniotic tissue has been used in medical treatments for over a century due to its healing properties. ReNu is rich in anti-inflammatory cytokines, regenerative growth factors, amniotic fluid cells, extracellular matrix (ECM) proteins, and hyaluronic acid, a natural lubricant found in adult joints.
Moreover, it has demonstrated potential in promoting the healing of soft tissues, especially in degenerative conditions like osteoarthritis and joint and tendon injuries such as tendinosis and fasciitis. ReNu initially focused on managing knee osteoarthritis symptoms. However, in May 2021, its commercial distribution was halted after the US Food and Drug Administration (FDA) ended the enforcement grace period for certain products previously classified as 361 HCT/Ps.
Despite this, the drug developing company continues clinical studies to secure Biologics License Application (BLA) approval for treating osteoarthritis patients with knee OA symptoms and is planning additional studies to explore its use for advanced osteoarthritis of the hip. Further, ReNu could be explored for other osteoarthritis treatments and tissue regeneration applications, pending further clinical evaluation and approval.
ReNu is developed by Organogenesis, a regenerative medicine company specializing in the production and commercialization of products for the surgical, sports medicine, and advanced wound care markets. Founded in 1985 as a spin-off from regenerative technology developed at the Massachusetts Institute of Technology (MIT), Organogenesis is headquartered in Canton, Massachusetts, United States.
MARKET POTENTIAL AND POSITIONING
The market outlook for ReNu looks exceptionally promising, especially following the positive top-line results from its Phase III clinical trial. In May 2024, Organogenesis announced that the trial met its primary endpoint, highlighting both the safety and efficacy of ReNu in treating knee osteoarthritis (OA).
This achievement positions ReNu as a potentially groundbreaking option in the osteoarthritis treatment landscape. Its distinctive formulation, which includes amniotic fluid cells, micronized amniotic membrane, and various cellular, growth factor, and extracellular matrix components, sets it apart from existing therapies. By harnessing the regenerative properties of amniotic tissue, ReNu offers an innovative approach to managing OA symptoms.
REGIONAL ANALYSIS
Inkwood Research offers an analysis of seven key markets:
• United States
• Germany
• France
• United Kingdom
• Italy
• Spain
o A large segment of Spain’s population is impacted by osteoarthritis (OA), with knee and hip OA being the most prevalent forms. Contributing to the increasing number of OA cases are factors such as an aging population, rising obesity rates, and more sedentary lifestyles. These trends are putting significant pressure on Spain’s healthcare system, as osteoarthritis, being a chronic condition, requires ongoing care and treatment. Industry reports suggest that around 10-15% of adults in Spain suffer from OA, many of whom experience moderate to severe symptoms that interfere with daily life.
o With the rising demand for effective treatments, there is an urgent need for therapies that not only relieve symptoms but also improve the quality of life for individuals with osteoarthritis. The healthcare system is placing greater emphasis on developing and implementing treatments that provide long-term relief and potentially slow OA progression, addressing the needs of a population expected to face even higher rates of the disease in the future.
• Japan

ページTOPに戻る

Table of Contents

TABLE OF CONTENTS
1. INTRODUCTION TO THE REPORT
2. RENU OVERVIEW
2.1. PRODUCT DETAIL
2.2. CLINICAL DEVELOPMENT
2.2.1. CLINICAL STUDIES
2.2.2. CLINICAL TRIALS INFORMATION
2.2.3. SAFETY AND EFFICACY
2.3. OTHER DEVELOPMENTAL ACTIVITIES
2.4. PRODUCT PROFILE
3. COMPETITIVE LANDSCAPE
3.1. MARKETED THERAPIES
3.2. LATE-STAGE EMERGING THERAPIES
4. RENU MARKET ASSESSMENT
4.1. MARKET OUTLOOK OF RENU IN OSTEOARTHRITIS
5. 7 MAJOR MARKET’S ANALYSIS
5.1. MARKET SIZE OF RENU IN THE 7 MAJOR MARKETS FOR OSTEOARTHRITIS
5.2. 7 COUNTRY ANALYSIS
5.2.1. MARKET SIZE OF RENU IN UNITED STATES FOR OSTEOARTHRITIS
5.2.2. MARKET SIZE OF RENU IN GERMANY FOR OSTEOARTHRITIS
5.2.3. MARKET SIZE OF RENU IN FRANCE FOR OSTEOARTHRITIS
5.2.4. MARKET SIZE OF RENU IN ITALY FOR OSTEOARTHRITIS
5.2.5. MARKET SIZE OF RENU IN SPAIN FOR OSTEOARTHRITIS
5.2.6. MARKET SIZE OF RENU IN UNITED KINGDOM FOR OSTEOARTHRITIS
5.2.7. MARKET SIZE OF RENU IN JAPAN FOR OSTEOARTHRITIS
6. SWOT ANALYSIS
7. ANALYST PERSPECTIVE