Long Bridge Medical Receives Clearance from FDA to Initiate U.S. Pivotal Clinical Study for LensOne Prosthetic Capsular Bag

By: Long Bridge Medical, Inc. via Business Wire

March 26, 2026 at 21:24 PM EDT

FDA Approves Initiation of GOLDEN GATE Pivotal Trial Following FDA Breakthrough Device Designation

Long Bridge Medical, Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared initiation of its Investigational Device Exemption (IDE) study for LensOne™, the company's prosthetic capsular bag designed to enable reliable secondary intraocular lens (IOL) fixation in patients with absent or compromised lens capsule support in eyes that are poor candidates for anterior chamber intraocular lenses (ACIOL).

The approval of the IDE application enables initiation of the GOLDEN GATE pivotal trial, a prospective, multicenter study evaluating the safety and effectiveness of LensOne in patients with IOL dislocation who are poor candidates for ACIOL. The clearance builds on Long Bridge Medical’s previously granted FDA Breakthrough Device Designation, which recognized the device's potential to address a significant unmet need in a patient population with no FDA-approved surgical options.

Tens of thousands of patients in the United States suffer from conditions requiring secondary IOL placement, including post-surgical aphakia, trauma, and spontaneous IOL dislocation. Current surgical alternatives — including scleral suture fixation and the Yamane technique — are technically demanding, associated with significant complication rates, and lack a standardized, reproducible solution.

"This IDE approval is a pivotal moment for Long Bridge Medical and, more importantly, for the patients who need better options," said Frank Brodie, MD, Co-Founder of Long Bridge Medical. "We have seen firsthand how challenging these cases are for surgeons and how the off-label options currently used lead to inferior patient outcomes. LensOne was designed to change that — with the potential to give surgeons a reliable, reproducible tool and patients better outcomes in these complex cases. We look forward to evaluating LensOne in the GOLDEN GATE trial and building the clinical evidence needed to support a new standard of care for these patients."

Long Bridge Medical previously reported 12-month first-in-human data in 15 patients, demonstrating a favorable safety and performance profile justifying further evaluation in a U.S.-based pivotal study. Results from that study were featured in a presentation by J Michael Jumper, MD, President of the American Society of Retina Specialists (ASRS) at the annual meeting in 2025.

More information on Long Bridge Medical and the LensOne device is available at www.longbridgemedical.com.

About LensOne

LensOne is an investigational, prosthetic capsular bag designed to restore the anatomic foundation needed for standard IOL implantation in eyes lacking capsule support who are poor candidates for ACIOL. Designed to support a variety of IOL types, LensOne enables surgeons to use familiar techniques in complex cases previously requiring high-risk surgical alternatives. CAUTION—Investigational device. Limited by United States law to investigational use.

About Long Bridge Medical

Long Bridge Medical is a South San Francisco-based ophthalmic device company developing solutions for complex IOL fixation. The company is backed by leading ophthalmic surgeons and life science investors committed to advancing vision care.