Reviticell

Reviticell: A Therapeutic Treatment for Radiation Fibrosis

Radiation Induced Fibrosis (RIF) is a serious problem that impacts women and men. RIF is caused by radiation treatments and is characterized by significant swelling, intense pain, and extreme limitation of movement. Currently, no treatment modality exists that can reverse the impact of the soft tissue fibrosis that occurs. Existing medications, ointments and therapies only help alleviate symptoms—they do not address the underlying problem.

Breast cancer survivors represent the greatest increase in the number of radiation-treated patients. Approximately half of the 4 million women alive today in the US with breast cancer have been treated with radiation. More than 1 million of these women have been afflicted with RIF. This number is projected to exceed 2 million by 2030. Without an effective treatment, women and men with RIF will continue to suffer from pain, a loss of productivity, and a reduced quality of life.

Bioregenerative treatments prepared from adipose tissue can regenerate tissue damaged by radiation. Further, recent studies indicate that these treatments can influence tissue regeneration by altering biological and molecular cues which drive angiogenesis, while suppressing local inflammatory responses. The reason is that adipose tissue contains an easily accessible source of multipotent adipose stromal cells (ASCs) that are like mesenchymal stem cells found in bone marrow. Comparatively, these adult stem cells are more easily accessible, vastly more plentiful, and have a higher differentiation capacity, proliferation rate, and regenerative potential.

Unfortunately, current methods of adipose tissue preparation are divergent and cause a wide spectrum of inconsistent outcomes. For this reason, the FDA imposes a standard of Minimal Manipulation. This limitation precludes manipulation of adipose tissue for therapeutic purposes, except for simple cleaning prior to homologous transplantation. However, to unlock the healing power within adipose tissue, “more than minimal manipulation” is necessary to concentrate the stromal vascular fraction (SVF) and its constituent subpopulation of ASCs. The Minimal Manipulation limitation is, therefore, a roadblock to developing a bioregenerative treatment for RIF. In fact, the FDA has not approved any treatments that require SVF concentration or any related devices. Thus, there is an urgent need for a standardized medical device and protocols that physicians can use to prepare adipose tissue with safe, robust, and consistent outcomes.

Reviticell is aggressively pursuing commercialization of the Reviticell System^TM to meet this urgent need. This single-use, point-of-care, medical device would make it possible for any physician in any operating environment to efficiently prepare adipose tissue for an RIF treatment with safe, robust, and consistent outcomes. The patented modular platform of the Reviticell System^TM is comprised of a sequence of cartridges, and a systematic organization of components and materials within each cartridge, that correlate with a proprietary protocol developed for each type of bioregenerative treatment to be prepared. This user-friendly device would make it easy for operators to understand each protocol in terms of what is provided, as well as to visualize the steps required and where they are in the process of conducting the protocol.