Human Medical Solutions

ACell, Inc. offers the next generation of regenerative medicine through the development, manufacture and marketing of unique extracellular matrix (ECM) products. ACell’s patented ECM products are covered by multiple 510(k) clearances and address important unmet clinical needs, providing safe, effective and  therapeutic outcomes. Derived from porcine urinary bladders and referred to as UBM ( urinary bladder matrix), ACell’s extracellular matrix is a naturally occurring, non-crosslinked, completely resorbable acellular biomaterial. A similar "first generation" ECM technology called SIS (derived from porcine small intestine) has been used to treat over 500,000  patients with remarkable effect. ACell’s UBM is the next generation of ECM technology due to its  unique characteristics  featuring a basement membrane surface which is ideal for epithelial cell growth in many applications.  

Naturally derived, non-crosslinked ECMs, like UBM, are unique among scaffold technologies which fundamentally change healing by triggering abundant new blood vessel formation and recruitment of numerous cell types to the wound site. These cells, including progenitor cells, have the potential to differentiate into numerous types of site specific tissues. During the healing process, the scaffold is rapidly degraded and completely resorbed leaving new tissue where scar tissue would normally be expected.   ACell technology is not limited to one market segment (e.g., wound care), but instead can serve as a core technology for treatments across a broad range of human medical conditions.

Highlights

Core technology for regenerative medicine. ACell technology is strongly centered on the scaffold based approach to regenerative medicine.  UBM is a graft material that can be implanted at the site of an injury or damaged has the ability to attract tissue in order to stimulate a unique healing response. UBM the body’s own progenitor cells to the site of the injury and serve as a scaffold for these cells.  The progenitor cells attracted to the UBM scaffold have the ability to differentiate into site specific tissues such as muscle, skin, tendon or bone.  Consequently, instead of the body’s default healing mechanism of scar tissue formation, the body heals by remodeling with new tissue that resembles the original tissue in both structure and function.  ACell core technology can be developed into a broad range medical applications such as gastroenterology, orthopaedics, cardiovascular and neurological surgery in addition to our current focus in the areas of wound care, reconstructive surgery, urogynecology and general surgery.

Five FDA 510(k) Clearances for Multiple Clinical Applications. ACell has five 510(k) premarket notifications for multiple product configurations (sheet, multi-laminate and powder) in   wound care and general surgical applications. These clearances enable ACell or a strategic partner to begin immediate commercialization.

Substantial Preclinical Evidence in Multiple Fields of Use. ACell has a substantial portfolio of preclinical evidence supporting the safety and effectiveness of UBM in a broad range of clinical applications. Based on these preclinical studies, ACell plans to pursue additional 510(k) clearances and develop clinical marketing studies to substantiate the results.