ReNerve Limited has gained marketing approval for its NervAlign® Nerve Cuff™ in Bahrain, marking its first regulatory success in the Middle East and opening access to a rapidly expanding regional market.
- Marketing approval obtained in Bahrain for NervAlign® Nerve Cuff™
- Partnership with Union MediScience B.S.C enables regional commercialisation
- Middle East and North Africa market valued at over USD 80 million annually
- Global nerve repair biomaterials market projected to grow to USD 6.19 billion by 2031
- ReNerve reported 38% revenue growth in FY24, driven by innovative nerve repair solutions
Breaking Ground in the Middle East
ReNerve Limited (ASX:RNV), a medical device innovator focused on peripheral nerve repair, has achieved a significant milestone by securing marketing approval for its flagship product, the NervAlign® Nerve Cuff™, in Bahrain. This marks the company’s first regulatory success in the Middle East, a region poised for rapid growth in nerve repair technologies.
The approval was facilitated through ReNerve’s exclusive partnership with Union MediScience B.S.C, a well-established medical supplier in the region. Union MediScience’s extensive network across Bahrain, Saudi Arabia, Kuwait, the UAE, and Qatar positions ReNerve to accelerate commercialisation efforts and expand its footprint across key Middle Eastern markets.
Tapping into a Growing Market
The Middle East and North Africa (MENA) market for nerve repair biomaterials is currently valued at over USD 80 million annually and is growing at an impressive rate exceeding 35% per year. This growth is underpinned by increasing awareness and demand for advanced nerve repair solutions, coupled with relatively limited competition compared to larger markets like the US.
Globally, the nerve repair biomaterials market was valued at USD 1.96 billion in 2024 and is forecasted to expand at a compound annual growth rate of 17.8%, reaching USD 6.19 billion by 2031. ReNerve’s innovative, bioabsorbable NervAlign® Nerve Cuff™ is well positioned to capture a meaningful share of this expanding market, especially given its proven clinical benefits.
Clinical Impact and Commercial Momentum
ReNerve’s device has demonstrated remarkable clinical outcomes, notably reducing post-surgical pain scores significantly compared to traditional treatments. These results have driven strong adoption in the US since the product’s 2022 launch, contributing to a 38% revenue increase in FY24, with sales reaching $177,000.
Dr Julian Chick, ReNerve’s Director, praised the collaborative efforts with Union MediScience and expressed optimism about expanding sales and marketing activities in the Middle East. The partnership leverages Union MediScience’s regional expertise to navigate regulatory landscapes and customer needs efficiently.
Looking Ahead
With Bahrain’s approval secured, ReNerve and Union MediScience plan to use early commercial data to support further regulatory approvals across the Middle East. This step is critical to unlocking the full potential of the region’s nerve repair market and establishing ReNerve as a leading player in this high-growth sector.
As ReNerve continues to innovate with its comprehensive portfolio, including the NervAlign® Nerve Graft and the next-generation NervAlign® Bionic Nerve, the company is setting the stage for sustained growth and improved patient outcomes worldwide.
Bottom Line?
Bahrain approval is just the first step in ReNerve’s ambitious Middle East expansion, with broader regional growth on the horizon.
Questions in the middle?
- How quickly will ReNerve secure approvals in other key Middle Eastern countries?
- What sales targets has ReNerve set for the Middle East market in the coming years?
- How will competition in the MENA region evolve as nerve repair technologies gain traction?