Omega Ophthalmics LLC Raises $7 Million in a Series A Financing and Schedules FDA Pre-Submission Meeting to Advance Gemini Refractive Capsule Toward U.S. Approval

Omega Ophthalmics LLC Raises $7 Million in a Series A Financing and Schedules FDA Pre-Submission Meeting to Advance Gemini Refractive Capsule Toward U.S. Approval

Strategic financing and regulatory milestones position the company to accelerate development of its novel intraocular lens platform designed to transform cataract surgery

Omega Ophthalmics LLC, a medical technology company developing next-generation implant technology for cataract surgery, today announced the successful close of a $7million Series A financing led by a group of strategically aligned ultra-high net worth investors. The company also announced that it has scheduled its FDA pre-submission meeting, marking another important milestone as Omega advances its proprietary Gemini™ Refractive Capsule toward U.S. regulatory approval.

The financing will support continued product development, intellectual property, regulatory activities, manufacturing scale-up, and clinical planning as the company prepares for future FDA studies and commercialization.

"We are grateful for the support and confidence of our investors who recognize the potential of the Gemini Refractive Capsule to fundamentally improve cataract surgery," said Rick Ifland, Chief Executive Officer, Omega Ophthalmics. "This financing, together with our upcoming FDA pre-submission meeting, represents a significant step forward as we execute our regulatory strategy and prepare for the next phase of clinical development. These resources will enable us to continue advancing the Gemini platform toward FDA approval with the goal of delivering cataract surgeons and their patients a new level of flexibility, precision, and long-term refractive outcomes."

The Gemini Refractive Capsule is designed to provide a stable, biologically integrated platform for intraocular lens (IOL) implantation while preserving the capsular bag. By creating a new approach to lens implantation, the technology has the potential to improve long-term refractive stability while enabling future lens exchange and accommodating next-generation ophthalmic technologies.

"Omega's approach represents one of the most innovative advances we've seen in cataract surgery," said John Berdahl, MD, Vance Thompson Vision. "The Gemini Refractive Capsule has the potential to address longstanding challenges associated with conventional IOL implantation by providing surgeons with greater flexibility while creating opportunities to improve long-term patient outcomes. If successful, this technology could significantly expand what's possible in refractive cataract surgery."

The company's recent momentum was highlighted at the Octane Ophthalmology Tech Forum, where John Sheets, Jr., Ph.D., Chief Operating Officer of Omega Ophthalmics, presented the company's vision and clinical development strategy to investors, industry leaders, and strategic partners. The presentation underscored the growing interest in technologies that can redefine cataract surgery and enhance refractive outcomes for millions of patients worldwide.

The upcoming FDA pre-submission meeting will be an early interaction where Omega can align its proposed regulatory pathway and clinical development plans with feedback from the FDA review team. Omega intends to remain in close communication with the Agency as the company advances toward initiating U.S. clinical studies.

About Omega Ophthalmics

Omega Ophthalmics LLC is developing breakthrough technologies designed to transform cataract surgery and the future of intraocular lens implantation. Its proprietary Gemini™ Refractive Capsule is intended to create a biologically inert, integrated platform that supports enhanced refractive outcomes while enabling future ophthalmic innovations. The company's mission is to expand what's possible in cataract surgery by providing surgeons with greater flexibility and patients with improved long-term visual outcomes.

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