Who is your customer?
Our direct customer is the thoracic surgeon as they have the ultimate authority in deciding what type of procedures should be implemented in the clinic when repairing a damaged esophagus. Our indirect customer is CMS (Medicaid) as they cover the reimbursement costs to implement our regenerative esophageal device in the clinic.
What problem does this idea/product solve or what market need does it serve?
Our product is an absorbable device that can functionally regenerate a damaged esophagus. The standard of care for a severely impaired esophagus is a last resort gastric pull up surgery, which involves a thoracic surgeon excising the damaged portion of the esophagus and then pulling up the stomach to the missing tissue. The stomach is not a great substitute for an esophagus, and thus this gruesome surgery causes a very low quality of life as patients often have to rely on feeding tubes for survival, and the 5-year survival rate is less than 20%. However, our device spares the stomach tissue while functionally regenerating one's own esophagus ultimately reducing surgery time for the surgeon, decreasing operative complications, and dramatically increasing the survival and quality of life of the patients. We aim to treat those that suffer from advanced Barrett's Esophagus (chronic regurgitation of stomach acid), esophageal cancer, birth defects of the esophagus (i.e. atresia - gaps in the esophagus), and in pediatrics where caustic ingestion of poisons are fatal.
What attributes will make this idea/product successful? Why do you believe that those features will create success?
The product is an implantable, bioresorbable medical device that can functionally regenerate one’s damaged esophagus. It is developed by utilizing our partner’s (WibiWorks Therapeutics) proven anti-inflammatory “off-the-shelf” human stem cells grown on an FDA approved bioresorbable tubular material provided by our other partner, Nanofiber Solutions. The stem cells are grown on the tube in a specialized bioreactor for 1 week. Subsequently, the cells are washed away through a key process called “decellularization” leaving only the secreted therapeutic factors that promote esophageal tissue regeneration within the body. This deems the technology as a medical device that can be sterilely packaged and delivered “off-the-shelf” in the clinic, in which the thoracic surgeon can open up the package and transplant/suture the device (either endoscopically or through surgery) into the missing or excised damaged portion of the esophagus in the patient, sparing surgical reconstruction with the stomach and functionally regenerating the damaged esophageal tissue. The material exhibits similar biomechanics to the esophagus allowing proper growth of one’s damaged esophageal tissue while the material dissolves. Furthermore, the device harnesses ant-inflammatory therapeutics that no other competitor can directly address. Overall the device is anti-inflammatory, biocompatible/non-immunogenic, bioresorbable, easily packaged (a minimum one year shelf life), and readily available “off the shelf” to be used in the clinic by the thoracic surgeon.
Explain how you (your team) will execute to make this idea/product successful? What gives you (your team) an advantage over others already in the market or new to this market?
Our team comprises of stem cell biologists, materials science engineers, bioengineers, thoracic surgeons, gastroenterology experts, and regenerative medicine marketing strategists. The founders of D&P Bioinnovations have a combined experience of over 16 years of stem cell tissue engineering research practice. Moreover, our regenerative medicine partners (WibiWorks Therapeutics – stem cell supplier) and Nanofiber Solutions (biomaterials supplier) are instrumental in translating the regenerative esophageal device to the market. With the support from our partners we can enter the market as the only device to directly address inflammatory wound healing of the esophagus.
In order to get our product approved to the U.S. market for the patients we aim to treat, we realize our technology will have to go through FDA device regulations such as a 510(k) or PMA through the CDRH branch. Nevertheless, we also realize that there is an ideal market opportunity in the veterinary space with horses that suffer from an esophageal condition called “Megaesophagus.” Thus, before approaching the FDA we plan to utilize our regenerative esophageal device in horses, allowing us to collect effective pre-clinical animal data from an animal that exhibits similar esophageal characteristics to that of a human. Initially we will begin to accrue revenue in the veterinary market space, and then have enough pre-clinical data to enter for a 510(k) or PMA regulation with the FDA. Moreover, our product can be regulated as an FDA humanitarian use device (HUD) for the pediatric population we will treat, thus allowing our technology to undergo very limited human clinical trials in the FDA for market approval.
Currently, we have distribution agreements with MediVet and Nanofiber Solutions for horse trials in the veterinary space. We will publish our results in both animals and humans, encouraging our technology to be adopted in the thoracic surgery community.