At a glance
- Company
- Regentis Biomaterials
- Ticker
- NYSE American: RGNT
- Announcement
- Partnership
- Location
- Israel
Key figures
- Exclusive distribution agreement term
- four-year
- Expected start of initial revenue contributions
- 2027
- U.S. annual cartilage knee repair cases described
- approximately 470,000
Products and programs
Regentis Biomaterials (NYSE American: RGNT), a regenerative medicine company focused on tissue repair solutions, announced a four-year exclusive distribution agreement with AMI Medical Technologies Ltd. for the commercialization of GelrinC (R), its proprietary implant for repairing damaged knee cartilage, in Israel. GelrinC has received regulatory approval from Israel’s Ministry of Health for the same indication approved in Europe and being pursued in the United States. Under the agreement, AMI will leverage its established relationships with orthopedic surgeons, hospitals and clinics to support the product’s commercial introduction. The agreement includes minimum purchase requirements, with Regentis expecting initial revenue contributions beginning in 2027.
The companies will also collaborate to establish reimbursement coverage for GelrinC with Israel’s leading health maintenance organizations and promote adoption among orthopedic surgeons treating patients with focal cartilage defects. Until reimbursement coverage is established, patients may be able to access the implant through private health insurance. The agreement supports Regentis’ broader commercialization efforts in Europe and Israel as the company continues advancing its pivotal Phase 3 clinical program in the United States.
To view the full press release, visit https://ibn.fm/gk9yG
About Regentis Biomaterials
Regentis Biomaterials Ltd is a regenerative medicine company dedicated to developing innovative tissue repair solutions that restore health and enhance quality of life. With an initial focus on orthopedic treatments, Regentis’ Gelrin platform technology, based on synchronized, degradable hydrogel implants, regenerates damaged or diseased tissue including inflamed cartilage and bone. Regentis’ lead product GelrinC(R), is a cell-free, off-the-shelf hydrogel that is eroded and resorbed in the knee, allowing the surrounding cells to regenerate the cartilage in a controlled and synchronous process. GelrinC(R) aims to address a market of approximately 470,000 cases for cartilage knee repair annually in the U.S. where no off-the-shelf treatment is available.
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In brief
Regentis Biomaterials says it has signed a four-year exclusive distribution agreement with AMI Medical Technologies Ltd. for GelrinC in Israel. The company describes GelrinC as an implant for damaged knee cartilage and says the product has received approval from Israel’s Ministry of Health for the stated indication. AMI will use its connections with orthopedic surgeons, hospitals and clinics to support the commercial introduction. The agreement has minimum purchase requirements, and Regentis expects revenue contributions to start in 2027. The companies also plan to work on reimbursement coverage through Israel’s health maintenance organizations and encourage use among orthopedic surgeons. Before coverage is established, private health insurance may offer patients access. Regentis says the arrangement supports its commercialization activity in Europe and Israel while its U.S. Phase 3 program advances.
Key takeaways
- Regentis signed a four-year exclusive Israeli distribution agreement with AMI Medical Technologies for GelrinC.
- The company says Israel’s Ministry of Health has approved GelrinC for the stated knee cartilage indication.
- Regentis expects initial revenue contributions from the agreement beginning in 2027.
- The companies plan to pursue reimbursement coverage and promote adoption among orthopedic surgeons.
SEC filings
Earlier from Regentis Biomaterials
- Regentis Biomaterials (NYSE American: RGNT) Advances GelrinC as a Potential New Approach to Knee Cartilage Repair
- Regenerative Hydrogel Is Redefining Cartilage Repair as Regentis Advances GelrinC
- Regentis Biomaterials (NYSE American: RGNT) Moves GelrinC Along Parallel US Clinical and European Commercial Tracks
- Regentis Biomaterials (NYSE American: RGNT) Builds a Manufacturing and Intellectual Property Powerhouse for the Global Cartilage Repair Market
- Regentis Biomaterials (NYSE American: RGNT) Targets $3B Cartilage Repair Market with Cell-Free Gelrin C
