about
cassderma Rx is the developer of an innovative prescription topical gel that supports the rapid regeneration of tissue for atrophic recalcitrant wounds. The gel is based on a patented formulation that uses a serum-free, nutrient-rich medium supplemented with a non-steroidal anabolic hormone to stimulate and support the growth of connective tissue originating from a wound bed and its peripheral walls.
about
cassderma Rx is the developer of an innovative prescription topical gel that supports the rapid regeneration of tissue for atrophic recalcitrant wounds. The gel is based on a patented formulation that uses a serum-free, nutrient-rich medium supplemented with a non-steroidal anabolic hormone to stimulate and support the growth of connective tissue originating from a wound bed and its peripheral walls.
background
cassderma Rx was founded in 2020 to begin the process of bringing to market an innovative discovery in a curative wound healing topical product that has resulted from the decade-long work of Dr. Daniel Rastein. As an educator and noted industry leader in healthcare and biomedical research, Dr. Rastein has been involved in designing the regulatory standards of numerous drugs and biomedical devices for cutting-edge manufacturing, research, medical, aerospace, and agriculture companies.
In 2010, Dr. Rastein became aware of an abandoned patent for a unique wound-care formulary. Because of his background in Bioresearch, Dr. Rastein immediately saw how important the product that was described would be in presenting a game-changing shift for the treatment of chronic wound-care patients. During the next ten years, Dr. Rastein worked with a key group of formulary researchers, patent lawyers, and pharmaceutical marketing experts to take the concepts from the abandoned patent in order to secure the rights and revive the patent in order to bring this work from vision to reality. Because of the dedication of Dr. Rastein and his team, a new patent was able to be granted providing four unique allowances, two for formulary and two for application methods, and so cassderma Rx was created to begin the next steps for regulatory approval.
The result of this effort is the cassderma Rx Wound Healing Hydrogel which is a first-of-its-kind topical agent that delivers vital nutrients directly to a wound site while also providing a naturally occurring hormone that stimulates the growth of healthy cells to promote the regeneration of connective tissues vital to the restoration of new skin and deep tissue to heal a variety of wound types including those from pressure wounds, diabetic ulcers, burn, and surgical wounds, which are some of the most difficult to cure. cassderma Rx is now focused on moving the invention through the necessary formulation and non-clinical toxicity trials to gain an FDA Investigational New Drug authorization that would allow it to begin human clinical trials.
vision
cassderma Rx’s vision for its unique wound healing hydrogel comes from the extensive research and clinical work of founder and CEO Dr. Daniel Rastein, MD, MPH. Dr. Rastein is an educator and noted industry leader in healthcare and biomedical research who served as Chief Compliance Officer at RadCore Labs LLC, Compliagent Inc., and Beacon Behavioral Solutions/Evolve Treatment Centers. He also worked for 11 years as the Corporate and Research Compliance Officer for Cedars-Sinai Medical Center. Dr. Rastein’s experience includes licensing, accreditation, and regulatory projects in opening new replacement hospitals for Stanford Medical Center and Stanford Lucile Packard Children’s Hospital, in addition to Children’s Hospital Los Angeles and the Public Health Institute/Children’s Oncology Group.
Dr. Rastein is active in the Healthcare Compliance Association, Society of Quality Assurance, American Biological Safety Association, and the British Association of Research Quality Assurance. He is an industry expert in the field of governmental regulations, from CMS to OIG to FDA to USDA. Dr. Rastein has been integrally involved in designing regulatory standards in the development of numerous drugs and biomedical devices for cutting-edge manufacturing, research, medical, aerospace, and agriculture companies.
innovation
The cassderma Rx Wound Healing Hydrogel represents a novel disruptive solution in the topical wound care market sector. The product’s patented formulation is the first to bring active nutrients in a cell culture medium along with a naturally occurring cell growth hormone that together is designed to not just protect a wound site while healing occurs but to promote and accelerate healthy cell and connective tissue repair in order for the cure to occur.
cassdermaRx Wound Healing Hydrogel
OVERVIEW
cassderma Rx Wound Healing Hydrogel is a serum-free cell culture nutrient medium supplemented with a non-steroidal anabolic hormone to successfully treat atrophic recalcitrant wounds. The formulation is a first-of-its-kind product in that no other topical wound care product’s active agent actually promotes the new cell regeneration that is important to the healing of any wound and is critical for wounds that have become persistent and chronic.
By bringing both nutrient-rich cell culture and a cell-growth promoter in the form of a naturally occurring anabolic hormone, the cassderma Rx Wound Healing Hydrogel when applied directly into a wound site creates an environment that becomes enriched with the nutrients required for cells proliferation and the growth of the granulation tissue into the wound space. The formulation stimulates and supports the growth of connective tissue components originating from the wound bed and its peripheral walls and the granulation tissue filling the wound space creates the substratum required for re-epithelialization and wound closure.
FEATURES
The cassderma Rx Wound Healing Hydrogel is a unique product formulary that has the following features:
- A proprietary Cell-Culture Medium (CCM) that provides a biologically stable source of nutrients targeted to promote cell growth.
- A stable non-steroidal anabolic hormone that creates an ability to accelerate health cell replication and proliferation.
- Together these features accelerate the growth of fibroblast and epithelial cells.
- The product has a proprietary “delivery polymer” embodiment that allows the formulation to be incorporated into a topical hydrogel.
- The product has efficacy on all types of wounds but is being researched and studied for the chronic wound disease market. An FDA acceptance at this level creates a simple path forward for acceptance of use in lesser wound-care models.
cassderma Rx and PFD
PFD Management has identified cassderma Rx as one of the five Medical Technology companies to include in the PFDMOF3001 Opportunity Fund, LLC. PFD Management believes that cassderma Rx is on track to meet a significant commercialization event within the fund’s time frame. To learn more about the specifics of this component of the fund, register for access at our Membership Portal.