White Plains, Dec. 10, 2024 (GLOBE NEWSWIRE) -- White Plains, NY – December 10, 2024 – Iantrek, Inc., a venture-backed, medical technology company pioneering next-generation bio- and micro-interventional approaches for the treatment of ophthalmic diseases, announced one-year results for the first 100 eyes enrolled in the CREST Registry, a real-world, prospective, observational study evaluating the outcomes of bio-interventional procedures in patients with open angle glaucoma (OAG). The study, titled "One-Year Safety and Effectiveness of Bio-Interventional Cyclodialysis and Scleral Reinforcement in Open-Angle Glaucoma Patients," was recently published in Clinical Ophthalmology, and reported on the safety and effectiveness outcomes of micro-invasive cyclodialysis cleft formation with the CycloPen™ System, followed by scleral reinforcement with AlloFlo™ Bio-Tissue implantation.
The CREST Registry study is the largest of its kind to report long-term results of this breakthrough approach using surgical micro-instrumentation and allogeneic bio-tissue to increase aqueous outflow for the lowering of intraocular pressure. The bio-interventional technique is designed to enhance uveoscleral outflow (one of the two natural outflow pathways in the eye) by creating an internal cyclodialysis channel, which is bio-reinforced for maintenance of long-term patency. This technique offers a promising new approach for patients with OAG, a condition that affects over 80 million people worldwide.
Key Findings:
- IOP Reduction: In patients with a baseline IOP > 21 mmHg, 12-month mean IOP was reduced by 39.7%.
- Medication Reduction: At 12-months postoperatively, the average number of IOP-lowering medications decreased from 1.4 ± 1.3 to 0.8 ± 0.9, with 81.9% of patients achieving an IOP of ≤18 mmHg without the need for additional medications.
- Safety: The procedure demonstrated a favorable safety profile, with a low rate of postoperative complications. Notably, there were no vision-threatening adverse events, and only 3.2% of patients required secondary glaucoma surgery within the 12-month follow-up period to achieve target IOP.
Innovative Approach: The study highlights the use of homologous, minimally modified allogeneic scleral tissue as a bio-scaffold to reinforce the cyclodialysis cleft, enhancing cleft durability and effectiveness. Unlike implantable medical-grade metal stents or shunts, the scleral allograft bio-tissue is natural, homologous and made of 100% biologic acellular collagen matrix specifically prepared and packaged for bio-scaffolding and internal structural reinforcement.
Clinical Implications: The CycloPenTM System with AlloFloTM Bio-Tissue represents a significant advancement in glaucoma surgery. By enhancing uveoscleral outflow, the procedure provides a promising alternative for patients in need of IOP reduction. With its strong safety profile and promising results, this approach could become a vital tool in managing OAG, one of the leading causes of blindness worldwide.
About the Authors: The study was published by a multidisciplinary team of experts from top institutions:
- Tsontcho Ianchulev, MD – New York Eye and Ear of Mount Sinai, New York, NY and Founder of Iantrek, Inc.
- Robert N. Weinreb, MD – Shiley Eye Institute, University of California San Diego, La Jolla, CA
- Ernesto A. Calvo, MD – Clínica de Ojos Orillac-Calvo, Panama City, Panama
- James Lewis, MD – Cataract Philadelphia, Elkins Park, PA
- Gautam Kamthan, MD – New York Eye and Ear of Mount Sinai, New York, NY
- Arsham Sheybani, MD – Washington University School of Medicine, St. Louis, MO
- Douglas J. Rhee, MD – University Hospitals, Case Western Reserve University, Cleveland, OH
- Iqbal K. Ahmed, MD – John Moran Eye Center, University of Utah, Salt Lake City, UT
About Iantrek
Iantrek, Inc. (www.iantrekmed.com) is a medical technology company founded by ophthalmic innovator Dr. Tsontcho Ianchulev, which is focused on micro- and bio-interventional solutions to advance the surgical treatment of chronic eye diseases. The company has developed a comprehensive late-stage portfolio for ophthalmic interventions and is advancing next-generation micro-surgical instrumentation and biologic tissue solutions for surgeons and patients.
Media contact:
Mike Haydin
