Stedical Scientific
Stedical Scientific is a healthcare technology company dedicated to bringing disruptive innovation to healthcare. It focuses on acquiring, nurturing, and growing organizations with life-changing products that impact large markets globally. The company aims to expand extensively in the China market, in addition to marketing products in the U.S. and Europe, with a mission to improve patient and clinician experiences while delivering economic value to investors and shareholders. Stedical is involved in tissue engineering technology and develops proprietary innovative medical solutions, including the FDA-cleared PermeaDerm platform for wound management.
Industries
Products
Biosynthetic wound matrix (variable-porosity primary dressing)
A multilayer biosynthetic primary dressing designed as a temporary skin substitute for management of partial-thickness burns, donor sites, coverage of meshed autograft, chronic and acute wounds; incorporates a gas-/exudate-diffusing membrane, adjustable porosity, a 3D micro-scaffold and hydrophilic bio-coating.
Biosynthetic wound matrix (variable-porosity primary dressing)
A multilayer biosynthetic primary dressing designed as a temporary skin substitute for management of partial-thickness burns, donor sites, coverage of meshed autograft, chronic and acute wounds; incorporates a gas-/exudate-diffusing membrane, adjustable porosity, a 3D micro-scaffold and hydrophilic bio-coating.
Services
Global commercialization and distribution
Market development, distributor partnerships and international market expansion for medical device products in wound care and burns.
Clinical trial support and investigator engagement
Design and operational support for multi-center clinical studies, investigator symposia, site selection and enrollment management.
R&D and product development in tissue engineering
Research, iterative product development and platform advancement for biosynthetic wound matrices and related medical devices.
Regulatory and quality support
Support for regulatory submissions, quality management system implementation (ISO 13485) and product verification activities.
Global commercialization and distribution
Market development, distributor partnerships and international market expansion for medical device products in wound care and burns.
Clinical trial support and investigator engagement
Design and operational support for multi-center clinical studies, investigator symposia, site selection and enrollment management.
R&D and product development in tissue engineering
Research, iterative product development and platform advancement for biosynthetic wound matrices and related medical devices.
Regulatory and quality support
Support for regulatory submissions, quality management system implementation (ISO 13485) and product verification activities.
Expertise Areas
- Tissue engineering and biosynthetic skin substitutes
- Wound care and burn management
- Clinical trial management and investigator engagement
- Regulatory compliance and 510(k) submissions
Key Technologies
- Biosynthetic skin-substitute technology
- Variable-porosity primary dressing design
- Silicone membrane diffusion layers for gas and exudate control
- 3D biomimetic micro-scaffold materials