MedPath

Orthocell Ltd

Ownership
-
Employees
327
Market Cap
-
Website
Introduction

Optical Cable Corp. engages in the business of manufacturing fiber optic and copper data communication cabling and connectivity solutions primarily for the enterprise market and various harsh environment, specialty markets, and the wireless carrier market offering integrated suites of high-quality products which operate as a system solution or seamlessly integrate with other components. Its products include fiber optic and copper cabling, hybrid cabling, fiber optic and copper connectors, specialty fiber optic, copper and hybrid connectors, fiber optic and copper patch cords, pre-terminated fiber optic and copper cable assemblies, racks, cabinets, datacom enclosures, patch panels, face plates, multimedia boxes, fiber optic reels, and other cable and connectivity management accessories. The company was founded on June 10, 1983 and is headquartered in Roanoke, VA.

Orthocell's Remplir Shows Positive Results in Nerve Repair Study, Eyes FDA Clearance

• Orthocell's Remplir nerve repair study met all required endpoints, demonstrating safety and effectiveness in repairing peripheral nerves. • The study showed return of motor and sensory function with no adverse tissue reactions, supporting Remplir's biocompatibility. • Orthocell plans to submit its 510(k) application to the FDA this month, anticipating potential U.S. market clearance in early 2025. • With approximately $33 million in cash and no debt, Orthocell is well-positioned for Remplir's launch in key markets, including the U.S.

Orthocell's Remplir™ Achieves Milestone in FDA Regulatory Study for Nerve Repair

• Orthocell has successfully completed a pivotal FDA regulatory study for Remplir™, validating its safety and efficacy in peripheral nerve repair. • The study demonstrated that Remplir™ facilitated effective nerve regeneration, restoring motor and sensory functions comparable to an FDA-cleared control device. • Orthocell plans to submit its marketing application this month, with FDA clearance anticipated in the first quarter of the New Year, targeting the $1.6 billion US nerve repair market. • Clinical data showed that 85% of nerve repairs using Remplir™ achieved functional recovery, supporting its adoption in Australia, New Zealand, and Singapore.
© Copyright 2025. All Rights Reserved by MedPath