Namsa announced a strategic partnership with Lexitas Pharma Services to deliver comprehensive product development support to ophthalmic medical device sponsors. According to a company press release, Lexitas brings to the partnership over 15 years of ophthalmic expertise and operational delivery, an extensive investigator site network, and an integrated reading center. By pairing these strengths with Namsa's medical device experience and global CRO capabilities, the collaboration creates a comprehensive platform for sponsors. Together, Namsa and Lexitas will provide device innovators with a single, accountable partner for the entire development lifecycle, ensuring seamless support and coordination throughout every phase, Namsa said in the press release.
As part of the partnership, Namsa and Lexitas will operate as a unified team. Lexitas clinical experts—including medical monitoring, ophthalmic imaging specialists, and site strategy leads—are integrated directly into Namsa's project and study management structure, operating under a shared technology and process platform and a unified quality management system.
According to the press release, ophthalmic device sponsors will have access to end-to-end product lifecycle support from preclinical and biocompatibility through IDE, pivotal trial, regulatory submission, and commercialization. They will also have access to specialized ophthalmic clinical execution through Lexitas’s network of 700+ investigator sites, integrated reading center, BCVA certification program, and dedicated medical monitoring team. Device-native clinical research expertise will also be available, including FDA medical device endpoint fluency, IDE strategy, and device-specific trial design.
Other benefits that ophthalmic device sponsors will also have access to include deep therapeutic-area coverage across anterior-segment and posterior-segment ophthalmic indications, including cell and gene therapy, rare disease and advanced modalities; global reach across the United States, Europe, and Asia-Pacific; and a single, accountable team under a single contract that reduces vendor management burden and coordination risk for sponsors.