Market:
There are no approved drug-based therapies for improvement in scar appearance, wound tensile strength and wound healing that are both safe and effective. Our primary target market includes patients undergoing surgery as elective surgery and as a result of trauma. For elective surgery alone, our target market in the U.S. includes aesthetic plastic surgery procedures plus surgical procedures in appearance sensitive populations such as cesarean section. The combined population of patients in these two segments represents $1.2 billion annually based on a very conservative estimate with majority paid out of pocket.Meanwhile, chronic wounds, which include conditions like diabetic ulcers, pressure sores, and venous leg ulcers, affect approximately 6.5 million people in the U.S. alone. These wounds are particularly prevalent among the elderly and individuals with underlying health issues such as diabetes and obesity, leading to significant healthcare expenses and reduced quality of life. Unfortunately, conventional treatments, such as dressings and antibiotics, often fail to address the underlying causes of non-healing wounds, while advanced therapies, like hyperbaric oxygen treatment and growth factor therapy, can be costly and inaccessible to many patients. These limitations highlight the need for more effective, accessible, and comprehensive treatment options for chronic wound patients. The global chronic wound care market was valued at approximately USD 13.29 billion in 2023 and is projected to grow to USD 24.03 billion by 2032, with a compound annual growth rate of 6.8% during the forecast period and rising demand for advanced wound care products and therapies.
Technology:
Scarless Laboratories has developed a therapeutically innovative, first-in-class product that reproducibly modulates wound healing events to recreate a microenvironment for rapid regenerative repair with less scar and more wound strength. Scarless Laboratories' platform technology can be used as a drug for intradermal and topical application, and as a Drug/Device combination product coated on a suture or in a gel.
Advantages:
- Minimizes scar formation
- Increases wound tensile strength
- Promotes wound healing
- Excellent preclinical safety profile
- Safety demonstrated in Phase 1/2a Human Clinical Studies
- Preliminary efficacy compared to placebo
- Inexpensively synthesized chemically
Development Stage:
- Clinical
Patents Issued:
- Fibromodulin Peptide; 9,409,963 (US); 2435468 (UK, France); 60 2010 055 26.1 (Germany); 2,763,466 (Canada)
- Method And Composition For Inducing Human Pluripotent Stem Cells; 9,549,954 (US); 9885,014 (US); 10,190,097 (US); ZL 201180023880.9 (China); ZL 201610788218.7 (China); 2569420 (UK, France); 60 2011 051 813.5 (Germany)
- Methods And Compositions For Modulating Myofibroblast Activities; 9,744,214 (US); 10, 279,010 (US); 10,279, 010 (US); 12,144,843 (US)
- Methods And Compositions Using Compounds From Fetal Cells And Tissues To Improve Condition Of Skin; 9,782,337 (US); 2,509,666 (Canada); I356707 (Taiwan); ZL 200380109582.7 (China); ZL 20110048128.1 (China); 10-1166579 (Korea)
- Re-conditioned Serum-free Culture Medium Composition Obtained By Culturing Mammalian Cells In Fibromodulin; 9,885,014 (US)
- Fibromodulin formulation for reducing corneal scarring; 10,016,452 (US)
- Methods Of Promoting Angiogenesis In Tissue With Fibromodulin; 11,033,605 (US)
- Novel wound-healing-enhancing devices; 3229855 (UK, Germany, France)
Select Publications:
- The identification of novel wound-healing genes through differential display | Plastic and Reconstructive Surgery
- Confocal Microscopic Analysis of Scarless Repair in the Fetal Rat: Defining the Transition | Plastic and Reconstructive Surgery
- Decreased expression of fibroblast and keratinocyte growth factor isoforms and receptors during scarless repair | Plastic and Reconstructive Surgery
- Delayed wound closure in fibromodulin-deficient mice is associated with increased TGF-ß3 signaling | Journal of Investigative Dermatology [DOI: 10.1016/j.ajpath.2010.10.019]
- Fibromodulin promoted in vitro and in vivo angiogenesis | Biochemical and Biophysical Research Communications [DOI: 10.1016/j.bbrc.2013.06.005]
- Fibromodulin-deficiency alters temporospatial expression patterns of transforming growth factor-β ligands and receptors during adult mouse skin wound healing | PLoS ONE 2014 [DOI: 10.1371/journal.pone.0090817]
- Fibromodulin enhances angiogenesis during cutaneous wound healing | Plastic and Reconstructive Surgery-Global Open [DOI: 10.1097/GOX.0000000000000243]
- Fibromodulin is essential for fetal-type scarless cutaneous wound healing | American Journal of Pathology [DOI: 10.1016/j.ajpath.2016.07.023]
- Fibromodulin reduces scar formation in adult cutaneous wounds by eliciting a fetal-like phenotype | Signal Transduction and Targeted Therapy [DOI: 10.1038/sigtrans.2017.50]
- Fibromodulin reduces scar formation in adult cutaneous wounds by eliciting a fetal-like phenotype | Journal of Cellular and Molecular Medicine [DOI: 10.1111/jcmm.13516]
- A novel injectable fibromodulin-releasing granular hydrogel for tendon healing and functional recovery | Bioengineering & Translational Medicine [DOI: 10.1002/btm2.10355]
Contact:
Email: info@scarlesslabs.comPhone: 323-496-6649
Website: www.scarlesslabs.com
Graduated in 2023
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