Our Lead Product
F14
A First-in-Class intra-articular celecoxib formulation designed to reduce post-operative pain and inflammation resulting in accelerated functional recovery after total knee replacement. Currently in Phase 3.
The Problem
Post-Surgical Inflammation
Limits Recovery
Total knee replacement (TKR) is one of the most commonly performed orthopedic procedures, with more than one million surgeries performed annually in North America. Although surgical outcomes are generally excellent, many patients experience persistent inflammation, pain, swelling, and limited range of motion that can delay rehabilitation and impair functional recovery for weeks to months after surgery.
Current post-operative standard-of-care analgesia is designed primarily to control pain (e.g., opioids). And while oral NSAIDs can help reduce inflammation, their local effect within the joint is limited and their use may be constrained by systemic side effects. As a result, there remains a significant unmet need for a localized, sustained anti-inflammatory therapy that can improve both pain and functional recovery following TKR.
The Formulation
F14: Sustained Release Celecoxib
F14 uses the BEPO® technology from Medincell — a viscous non-aqueous PLA-PEG copolymer mixture combined with the NSAID celecoxib (previously marketed as Celebrex®). F14 is administered as a single intraoperative dose injected directly into the knee joint at the conclusion of TKR surgery — requiring no mixing, compounding, or specialized training.
By combining BEPO® with celecoxib — a well-characterized, FDA-approved COX-2 inhibitor — AIC has created a product where the innovation lies entirely in the delivery system, not an unproven new chemical entity. This significantly de-risks the regulatory pathway.
Single intraoperative administration integrates seamlessly into existing surgical workflow
Localized delivery achieves high intra-articular celecoxib concentrations while minimizing systemic exposure
FDA-authorized 505(b)(2) development pathway leveraging the established safety and efficacy data of Celebrex® as the reference drug
Designed to both improve pain control and accelerate functional recovery following TKR
BEPO® manufacturing is scalable and commercially validated
Mechanism of Action
Patented, Targeted, Dual-Phase Drug Delivery
The intra-articular space presents a unique opportunity for sustained-release therapy. The knee joint is a contained environment with limited systemic clearance, making it ideal for a depot-forming technology like BEPO®. However, once in the joint, the F14 depot undergoes a mechanical disruption resulting in a novel mechanism of action for delivering celecoxib to the source of inflammation itself, the synovial tissue.
Clinical Validation of Mechanism of Action
Pharmacokinetic (PK) data from AIC's Phase 2 clinical trial of F14 demonstrated measurable plasma concentrations of celecoxib for up to 6 weeks following a single intra-articular administration of F14 in TKR patients, consistent with sustained release of celecoxib within the knee.
Data on file. F14 is an investigational product and has not been approved by the FDA.
Human Data
Clinical Evidence Supporting F14
F14 has been evaluated in a randomized Phase 2 and a Phase 3 registration trial in patients undergoing total knee replacement, demonstrating consistent improvements across pain, function, opioid use, and long-term safety.
Favorable Safety Profile — Well tolerated, with no treatment-related safety concerns through 12 months of follow-up.
Sustained Pain Relief — Reduced post-operative pain during the weeks following surgery.
Accelerated Functional Recovery — Improved performance on range of motion, Timed Up and Go (TUG), and Knee Society Score (KSS-2011).
Reduced Opioid Use — Lower opioid consumption during post-operative recovery.
Increased Patient Satisfaction — Improvements in SF-12 and EQ-5D domain scores, with faster return to work.
Durable Benefit — Improvements observed across the acute, subacute, and longer-term phases of recovery.
Concordant findings across multiple independent clinical endpoints provide compelling support for F14 as a differentiated therapy designed to improve both pain control and functional recovery following total knee replacement.
Where We Are
Development Status
F14
Post-TKR Pain and Functional Recovery
Status
Phase 3 ActiveInterested in Partnering or Investing?
We welcome conversations with investors, strategic partners, and healthcare professionals.