Presentations will address 24-month treatment outcomes, systemic antibiotic exposure, and new treatment strategies for recalcitrant periprosthetic joint infection
DALLAS, Nov. 05, 2026 (GLOBE NEWSWIRE) — Osteal Therapeutics, Inc. (“Osteal”), a clinical-stage biopharmaceutical company developing innovative combination drug/device therapies for orthopedic infections, today announced that three scientific presentations evaluating treatment of periprosthetic joint infections with cyclic local antibiotic irrigation treatment will be featured at the 2026 American Association of Hip and Knee Surgeons (AAHKS) Annual Meeting, November 5–8, in Grapevine, Texas. The presentations will include 24-month treatment outcomes from the APEX clinical trial program.
The presentations address important clinical considerations in the management of periprosthetic joint infection (“PJI”) of the hip and knee, including long-term treatment outcomes, systemic antibiotic exposure, and innovative treatment strategies for patients with recalcitrant infections.
The scientific presentations include:
24-Month Treatment Outcomes: Nicolas S. Piuzzi, MD, of Cleveland Clinic, will present 24-month treatment outcomes from the APEX and APEX-2 randomized clinical trials evaluating cyclic local antibiotic irrigation with investigational NEXCHANGE™ KIT compared with conventional two-stage exchange arthroplasty.
Systemic Antibiotic Exposure: Investigators will present an analysis comparing systemic antibiotic exposure among patients treated with conventional two-stage exchange arthroplasty versus investigational NEXCHANGE KIT treatment in the APEX clinical trial program. The research addresses an important consideration in PJI management: balancing effective infection control with responsible antimicrobial stewardship.
Recalcitrant PJI: A separate scientific presentation will examine cyclic local antibiotic irrigation compared with repeat two-stage exchange arthroplasty in patients with recalcitrant PJI, a particularly challenging patient population with persistent or recurrent infection.
“Periprosthetic joint infection remains one of the most devastating complications of joint replacement surgery, placing an enormous burden on patients, surgeons, and healthcare systems,” said David Thompson, President and Chief Executive Officer of Osteal Therapeutics. “We are pleased to see multiple scientific presentations addressing important questions in PJI treatment at this year’s AAHKS Annual Meeting. These investigations reflect our commitment to advancing the science of orthopedic infection and supporting the development of new treatment approaches for patients who urgently need better options.”
The APEX clinical trial program includes two prospective, multicenter, randomized controlled trials evaluating the safety and efficacy of NEXCHANGE KIT, an investigational drug/device combination product designed to deliver cyclic local antibiotic irrigation during an exchange arthroplasty procedure. The studies enrolled 152 patients with chronic PJI of the hip or knee across 23 U.S. clinical centers.
About Periprosthetic Joint Infection (PJI)
Affecting over 50,000 people in the U.S. annually, PJI is a rare and potentially devastating complication of joint replacement surgery in which pathogenic bacteria colonize the joint prosthesis, forming difficult-to-remove structures called biofilms. Biofilm infections are challenging to resolve, requiring long, invasive and expensive treatments that are often unsuccessful, resulting in high rates of permanent disability and early death. The current gold standard for treatment of PJI, two-stage exchange arthroplasty, takes an average of 16 weeks and has a success rate under 50% after 12 months, highlighting the unmet need for faster and more efficacious treatment options.
About NEXCHANGE™ KIT (formerly known as VT-X7 KIT)
NEXCHANGE KIT (vancomycin hydrochloride and tobramycin sulfate for irrigation/irrigation system) is an investigational drug/device combination product designed to deliver therapeutic concentrations of vancomycin and tobramycin, well-established, broad-spectrum antibiotics, directly to the joint space and surrounding tissue to treat PJI. NEXCHANGE treatment is a seven-day therapy designed to address the unmet clinical need for rapid, reliable treatment for these challenging infections. The US Food and Drug Administration has granted NEXCHANGE KIT Breakthrough Therapy, Orphan Drug, Fast Track and Qualified Infectious Disease Product designations. This initial application of NEXCHANGE KIT represents a first-of-its-kind opportunity to dramatically improve outcomes for a serious unmet medical need.
About Osteal Therapeutics, Inc.
Osteal Therapeutics is a privately held, clinical-stage biopharmaceutical company developing novel musculoskeletal therapeutics to treat orthopedic infections and their consequences. The company is leveraging the ability of concentrated, locally delivered antimicrobials to treat the bacterial biofilms typically responsible for musculoskeletal infections while minimizing off-target tissue exposure and associated adverse effects. Osteal employs an efficient, risk-reducing development strategy by using approved drugs with long histories of safety and efficacy as candidates for new routes of local delivery. The company’s lead candidate, NEXCHANGE KIT, is in late-stage clinical development to treat periprosthetic joint infections, a serious complication of joint replacement surgery. For more information, please visit: http://www.ostealtx.com
CONTACT: Corporate Contact: Todd Saunders Vice President of Marketing Osteal Therapeutics, Inc. Email: info@ostealtx.com
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