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)
Products
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
Clinical trial sponsorship and management
Sponsorship and operational management of multicenter randomized clinical trials for investigational combination drug/device therapies in orthopedic infection.
Regulatory strategy and designation support
Pursuit and management of regulatory designations and preparation of data packages to support New Drug Application or equivalent regulatory filings.
Product development engineering and V&V support
Engineering support for product verification and validation, documentation control, and new product introduction activities for drug delivery device components.
Clinical trial sponsorship and management
Sponsorship and operational management of multicenter randomized clinical trials for investigational combination drug/device therapies in orthopedic infection.
Regulatory strategy and designation support
Pursuit and management of regulatory designations and preparation of data packages to support New Drug Application or equivalent regulatory filings.
Product development engineering and V&V support
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