DENVER, CO — November 4, 2025 — Leads & Copy — ForCast Orthopedics announced that the FDA has granted Qualified Infectious Disease Product (QIDP) Designation for FC002, its second pipeline program, which will treat periprosthetic joint infection (PJI). FC002 combines ForCast’s Wearable Intra-Articular Infusion System (WIIS) delivery platform with tobramycin for targeted treatment of gram-negative PJI cases.
The QIDP designation for FC002 builds on the Company’s success with its lead program, FC001, which pairs the WIIS platform with vancomycin to target PJI cases with gram-positive bacteria and has also received QIDP designation from the FDA.
Peter Noymer, PhD, Executive Chairman and CEO of ForCast Orthopedics, said the FDA’s second QIDP designation is an important regulatory milestone for ForCast and validates their aim to address the full spectrum of PJI cases. He said this underscores the potential of their WIIS platform to improve infection treatment strategies and deliver better outcomes for all PJI patients.
PJI is a rare but serious complication of joint replacement procedures that can threaten the function of the joint, the preservation of the limb, and even the patient’s life. PJI is challenging to treat because the infecting bacteria adhere to the prothesis and form a protective biofilm resistant to standard systemic antibiotics.
Jared Foran, MD, Chief Scientific Officer and co-founder of ForCast Orthopedics, added that coverage for both gram-positive and gram-negative pathogens is critical to being able to effectively treat all PJI patients, and they are pleased the FDA recognizes the positive impact they can have with their WIIS platform.
QIDP designation, provided under the Generating Antibiotic Incentives Now Act (GAIN Act), offers certain incentives for developing new antifungal and antibacterial drugs that treat serious or life-threatening infections. These incentives include Fast Track designation, priority review, and additional market exclusivity if the product is approved by the FDA.
ForCast is a development-stage company focused on pioneering the treatment of periprosthetic joint infection (PJI) with targeted antibiotic therapies. The Company’s mission is to modernize the standard of care for PJI and to provide better treatments and improved outcomes for the growing population of joint replacement patients.
Contact Information: Peter Noymer, Executive Chairman and CEO, pnoymer@forcastortho.com
Source: ForCast Orthopedics
