At a glance
- Company
- Regentis Biomaterials Ltd.
- Ticker
- NYSE American: RGNT
- Announcement
- Product
Key figures
- Estimated U.S. market
- $3 billion
- Annual U.S. knee cartilage repair cases
- roughly 470,000
- Procedure duration
- approximately 10-minute
- Pain improvement versus microfracture
- approximately 100% greater
- Pivotal U.S. Phase III enrollment
- more than 50%
Products and programs
Regentis Biomaterials Ltd. (NYSE American: RGNT) is advancing GelrinC®, a cell-free hydrogel implant designed to simplify knee cartilage repair through a single-step, approximately 10-minute procedure that may offer an alternative to traditional microfracture and complex cell-based therapies. The company is targeting an estimated $3 billion U.S. market encompassing roughly 470,000 annual knee cartilage repair cases, where no approved off-the-shelf regenerative solution currently exists. Clinical data have shown approximately 100% greater pain improvement versus microfracture, alongside MRI-confirmed regeneration of near-native cartilage and durable multi-year outcomes. GelrinC® has already secured CE Mark approval in Europe and is currently progressing through a pivotal U.S. Phase III trial that is more than 50% enrolled, positioning Regentis for several upcoming catalysts, including potential European commercialization, completion of the pivotal study, and eventual FDA submission.
To view a full corporate profile, visit https://ibn.fm/bpPp6
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.
NOTE TO INVESTORS: IBN is a multifaceted financial news, content creation and publishing company utilized by both public and private companies to optimize investor awareness and recognition. For more information, please visit https://www.InvestorBrandNetwork.com
Please see full terms of use and disclaimers on the InvestorBrandNetwork website applicable to all content provided by IBN, wherever published or re-published: http://IBN.fm/Disclaimer
The latest news and updates relating to RGNT are available in the company’s newsroom at https://ibn.fm/RGNT
Corporate Communications
IBN
Austin, Texas
www.InvestorBrandNetwork.com
512.354.7000 Office
[email protected]
In brief
Regentis Biomaterials says it is moving GelrinC, a cell-free hydrogel implant for knee cartilage repair, through a pivotal U.S. Phase III study that is more than 50% enrolled. The company describes the procedure as a single-step treatment taking approximately 10 minutes and says it may provide an alternative to microfracture and cell-based therapies. Regentis cites clinical data showing greater pain improvement than microfracture, along with MRI evidence of cartilage regeneration and multi-year outcomes. GelrinC has CE Mark approval in Europe. The company is targeting a U.S. market it estimates at $3 billion, covering about 470,000 annual knee cartilage repair cases. Potential milestones include European commercialization, finishing the pivotal study and a future FDA submission.
Key takeaways
- GelrinC is a cell-free hydrogel implant for knee cartilage repair, according to Regentis.
- The pivotal U.S. Phase III trial is more than 50% enrolled.
- The company cites CE Mark approval in Europe and potential European commercialization.
- Regentis estimates the U.S. market at $3 billion and about 470,000 annual cases.
