BIOxHEAL
351 Biologic Advanced Wound Care Product
351 Biologic Advanced Wound Care Product
BIOxHEAL
Investigational Biologic Therapy for Chronic Wounds
BIOxHEAL is an investigational biologic therapy being developed under the FDA Biologics License Application (BLA) pathway for the treatment of chronic wounds. Manufactured through a controlled, pharmaceutical-grade process, BIOxHEAL is designed to provide consistent biologic activity while meeting the rigorous quality, safety, and manufacturing standards required for licensed biologic products.
Unlike products intended primarily to provide physical wound coverage, BIOxHEAL is being developed as a biologic therapy designed to provide controlled biologic exposure to the wound environment through weekly administration as part of a short-course treatment strategy.
Clinical Development
BIOxHEAL is currently in clinical development for the treatment of chronic wounds. The investigational program is focused on evaluating the safety and efficacy of BIOxHEAL in patients with chronic wounds that remain difficult to heal despite established standards of care.
Potential clinical indications under investigation include:
- Diabetic Foot Ulcers (DFU)
- Venous Leg Ulcers (VLU)
- Pressure Injuries
These chronic wound types represent significant unmet medical needs and account for substantial healthcare utilization worldwide.
Short-Course Biologic Therapy
BIOxHEAL is being developed as a short-course biologic therapy administered weekly according to the clinical protocol. Each administration is intended to provide biologic exposure to the wound environment while clinicians continue to manage the wound using established standards of care.
The number of administrations is determined by clinical response and continued presence of an unhealed target ulcer, consistent with the investigational protocol.
Manufacturing & Quality
BIOxHEAL is manufactured using a controlled process designed to maintain product consistency across manufacturing lots. The development program incorporates pharmaceutical-grade quality systems, defined release specifications, and analytical characterization intended to support product identity, purity, potency, and manufacturing consistency throughout clinical development and future commercial production.
Regulatory Pathway
BIOxHEAL is being developed through the FDA Biologics License Application (BLA) pathway. This regulatory pathway is intended for biologic products and includes comprehensive evaluation of manufacturing, quality, clinical safety, and clinical efficacy before potential licensure.
Applied Biologics is committed to developing BIOxHEAL in accordance with the scientific and regulatory standards applicable to licensed biologic therapies.
Our Vision
Applied Biologics is committed to advancing the treatment of chronic wounds through biologic innovation. Our goal is to develop therapies that improve outcomes for patients with chronic, non-healing wounds while maintaining the highest standards of scientific rigor, manufacturing quality, and regulatory compliance.
BIOxHEAL represents the next-generation approach to tissue repair and regenerative healing, working at the cellular and molecular levels to stimulate tissue regeneration, improve vascularization, and enhance the body’s natural healing response.