Technology

Patient Focused Product Platform To Support Natural Healing

Our multi-product platform brings amnion derived hydrogel, powder and aerosol product candidates to market. Using a unique proprietary and patented technology sourced from porcine amnion membrane. The products are easy to produce, store and apply to wounds as a covering to support natural healing.

Patient Population:

• 37.3M Americans have diabetes
• 11.2M diabetics will develop a diabetic foot ulcer in their lifetime
• 8.2M Medicare patients are affected by hard-to-heal wounds each year
• 5.2M adults are estimated to suffer from chronic wound annually, 60% of these are hard to heal
• There are 1M severe burns & abrasions in the US per year

Costs To Treat Chronic Wounds Annually:

• Chronic wound care costs an estimated 28B
• Direct costs of materials (such as wound dressings) are estimated to be 15-20% of total care costs
• Costs can vary per patient from $1,890 to $33,900 per treatment episode
• There are an estimated 500,000 burns treated in the United States each year and medical costs for burn treatments approaches $2 billion per year

Patients who suffer from chronic wounds and severe burns can benefit from wound coverings that support the natural healing process.

BIOHEAL THERAPEUTICS BioHeal® Hydrogel - XG100 Product Candidate Processed With The Proprietary & Patented BioHeal Matrix™ Technology  

BIOHEAL THERAPEUTICS Proprietary & Patented BioHeal Matrix™ Technology (BMT)

BIOHEAL THERAPEUTICS signed an exclusive worldwide licensing agreement to develop, manufacture and distribute mammalian derived amniotic membrane technologies invented at the Wake Forest Institute of Regenerative Medicine (WFIRM). Amniotic membrane patches have been implemented as dressings for skin wounds for many years. However, application of freeze-dried or cryopreserved patches (amnion-based or artificial grafts) is not optimal for wounds that are irregularly-shaped and/ or of variable depth.

To address this problem, a process was developed for formulating superior amniotic membrane preparations, which can be used independently, or combined with a number of materials for wound coverings, the BioHeal Matrix Technology (BMT).

The key difference from other tissue processing technologies that decellularize the tissue, is BMT solubilizes the amnion membrane,  resulting in non-immunogenic amnion membrane that maintains the extra cellular matrix (ECM) in a moisture retaining hydrogel barrier.

BIOHEAL THERAPEUTICS BioHeal® Hydrogel - XG100 Product Candidate

Research studies have demonstrated the potential benefit of XCell Biologix BioHeal Hydrogel - XG100 product candidate to function as a wound covering for natural wound healing.

The BioHeal® Hydrogel - XG100 product candidate is manufactured with a proprietary and patented technology using BIOHEAL THERAPEUTICS BioHeal Matrix™ technology combined with the carrier hyaluronic acid (HA) hydrogel, resulting in a off-the-shelf wound covering product that is easy to produce, store and apply to wounds.

HA is a natural physiological constituent of connective tissue. Made up mostly of collagen, it is one of the major components of the human body. Collagen serves as a matrix and scaffold to support angiogenesis and cell proliferation for wound healing and provides a protective barrier.

Committed to Delivering Innovative Technologies 

BIOHEAL THERAPEUTICS has 12 patents issued or pending globally for its Solubilized Amnion Membrane (SAM) product portfolio in the US, Canada, Europe, Australia, Japan and South Korea. The technology was initially funded by a $1,240,000 grant from the U.S. Department of Defense to WFIRM to develop a technology to treat US soldiers suffering from severe burns and wounds inflicted on the battlefield.

Published Research Articles

There have been 14 published research articles and numerous podium presentations at scientific meetings focused on BIOHEAL THERAPEUTICS amnion technology or hyaluronic acid technology platforms by the inventors and their team from WFIRM.

Bibliography:

1)“Exploiting maleimide-functionalized hyaluronan hydrogels to test cellular responses to physical and biochemical stimuli”, Andrea Mazzocchi et al 2022 Biomed. Mater. 17 025001.

2)“A Rapid Crosslinkable Maleimide-Modified Hyaluronic Acid and Gelatin Hydrogel Delivery System for Regenerative Applications” Kyung Min Yoo et al 2021 Gels Vol 7, Issue 1.

3)“Engineering a thixotropic and biochemically tunable hyaluronan and collagen bioink for biofabrication of multiple tissue construct types”, Julio Aleman et al bioRxiv 2021.09.01.458584.

4)“Tunable Hydrogel Systems for Delivery and Release of Cell-Secreted and Synthetic Therapeutic Products”, Kylie G. Nairon et al Controlled Drug Delivery Systems 2020, 1st Ed, CRC Press.

5)“Amnion membrane hydrogel and amnion membrane powder accelerate wound healing in a full thickness porcine skin wound model”, Sean V. Murphy et al Stem Cells Translational Medicine, Volume 9, Issue 1, January 2020.

6)“Hyaluranan chemistries for three-dimensional matrix applications” Monica A. Serban et al 2019 Matrix Biology, Vol 78-79.

7)“A mechanically robust thixotropic collagen and hyaluronic acid bioink supplemented with gelatin nanoparticles” Casey C. Clark et al 2019 BioPrinting, vol 16.

8)“In Situ Bioprinting of Autologous Skin Cells Accelerates Wound Healing of Extensive Excisional Full-Thickness Wounds” Mohammed Albanna et al Scientific Reports volume 9, Article number: 1856 (2019)

9)“HyStem®: A Unique Clinical Grade Hydrogel For Present and Future Medical Applications” Thomas I. Zerembinski et al 2019 Hydrogels: Smart Materials for Biomedical Applications, ch.5.

10)“Optimization of collagen type I-hyaluronan hybrid bioink for 3D bioprinted liver microenvironments” Andrea Mazzocchi et al 2019 Biofabrication 11 015003.

11)“Evaluation of hydrogels for bio-printing applications” Sean V. Murphy et al 2013 J Biomed Mater Res Part A:101A:272-284.

12)“Bioprinted Amniotic Fluid-Derived Stem Cells Accelerate Healing of Large Skin Wounds” Aleksander Skardal et al Stem Cells Translational Medicine, 2012Volume 1, Issue 11.

13)“Solubilized Amnion Membrane Hyaluronic Acid Hydrogel Accelerates Full-Thickness Wound Healing” Sean V. Murphy et al 2017 Stem Cells Translational Medicine, Volume 6, Issue 11.

14)“Photocrosslinkable Hyaluranan-Gelatin Hydrogels for Two-Step Bioprinting” Aleksander Skardal et al 2010 Tissue Engineering Part A, vol 16, no 8.