Osteal Therapeutics
Osteal Therapeutics is a privately-held, clinical-stage pharmaceutical company dedicated to developing novel musculoskeletal therapeutics to treat orthopedic infections and their consequences. Their lead product, VT-X7, is a drug-device combination designed to deliver antibiotics directly to infected joint prostheses, aiming to improve outcomes and lower healthcare costs. The company employs a low-risk development strategy by utilizing approved drugs with long safety and efficacy histories, supported by a team of experienced orthopedic industry veterans.
Industries
Nr. of Employees
small (1-50)
Osteal Therapeutics
4835 Lyndon B. Johnson Freeway Suite 635 Dallas, TX 75244
Patents
System and method for treatment and prevention of periprosthetic joint infections
US-12239538-B2
View DetailsAntibiotic delivery system and method for treating an infected synovial joint during re-implantation of an orthopedic prosthesis
US-RE50051-E1
View DetailsAntibiotic delivery system and method for treating an infected synovial joint during re-implantation of an orthopedic prosthesis
US-RE49239-E1
View DetailsPost-operative surgical site wound treatment and method for device removal
US-11400203-B2
View Details
System and method for treatment and prevention of periprosthetic joint infections
US-12239538-B2
View DetailsAntibiotic delivery system and method for treating an infected synovial joint during re-implantation of an orthopedic prosthesis
US-RE50051-E1
View DetailsAntibiotic delivery system and method for treating an infected synovial joint during re-implantation of an orthopedic prosthesis
US-RE49239-E1
View DetailsPost-operative surgical site wound treatment and method for device removal
US-11400203-B2
View DetailsProducts
VT-X7 KIT (investigational drug-device combination for local antibiotic irrigation)
An investigational combination product consisting of an implanted spacer and irrigation system designed to deliver vancomycin and tobramycin directly to the joint space over a seven-day treatment period for periprosthetic joint infection.
VT-X7 KIT (investigational drug-device combination for local antibiotic irrigation)
An investigational combination product consisting of an implanted spacer and irrigation system designed to deliver vancomycin and tobramycin directly to the joint space over a seven-day treatment period for periprosthetic joint infection.
Services
Sponsorship and operational management of multicenter randomized clinical trials for investigational combination drug/device therapies in orthopedic infection.
Pursuit and management of regulatory designations and preparation of data packages to support New Drug Application or equivalent regulatory filings.
Engineering support for product verification and validation, documentation control, and new product introduction activities for drug delivery device components.
Sponsorship and operational management of multicenter randomized clinical trials for investigational combination drug/device therapies in orthopedic infection.
Pursuit and management of regulatory designations and preparation of data packages to support New Drug Application or equivalent regulatory filings.
Engineering support for product verification and validation, documentation control, and new product introduction activities for drug delivery device components.
Expertise Areas
- Clinical trial management for drug-device combination therapies
- Periprosthetic joint infection (PJI) therapeutics
- Local antimicrobial delivery and biofilm-targeted therapy
- Medical device and combination product R&D
Key Technologies
- Drug-device combination for local antibiotic delivery
- Intra-articular antibiotic irrigation systems
- Implanted spacer engineering
- Biofilm-targeted local antimicrobial delivery
News & Updates
Outcomes at 12 months demonstrate a statistically significant net treatment effect of 19% compared to the standard of care two-stage exchange arthroplasty and highlight a 71% reduction in PJI burden.
Results from the APEX clinical trial program showing positive outcomes for VT-X7 in treating joint infections.
Osteal was recognized as a 2023 Rising Star by BioNTX, highlighting its innovative approach and progress in the field of orthopedic infection treatment.
Outcomes at 12 months demonstrate a statistically significant net treatment effect of 19% compared to the standard of care two-stage exchange arthroplasty and highlight a 71% reduction in PJI burden.
Results from the APEX clinical trial program showing positive outcomes for VT-X7 in treating joint infections.
Osteal was recognized as a 2023 Rising Star by BioNTX, highlighting its innovative approach and progress in the field of orthopedic infection treatment.