“A severely impaired esophagus requires a largely invasive standard of care surgery known as an esophagectomy, whereby the surgeon removes the affected tissue of the esophagus and splices the stomach or intestine on to the remaining tissue,” noted Dr. Derek Dashti, CEO & Founder of D&P Bioinnovations (D&P), continuing, “This can result in high morbidity and mortality rates and a low quality of life.”
D&P is a regenerative medicine startup focused on repairing damaged organs with engineered biomaterials and stem cells.
“We are developing an implantable, bioresorbable "off-the-shelf" medical device to regenerate a damaged esophagus,” he continued, “This device will address a $1.3 billion U.S. annual market to treat advanced Barrett's Esophagus, esophageal cancer, birth defects of the esophagus, and fatal cases of caustic ingestion.”
Founded three years ago, D&P is headquartered in San Diego, as a spin off from J-Labs, Tulane University, and Commence Bio. The company now has four full-time personnel and a prestigious list of Advisors.
“Our solution for esophageal resection, is to develop a decellularized synthetic electrospun tubular scaffold from absorbable polymers loaded with established therapeutic factors from anti-inflammatory allogeneic bone marrow derived human mesenchymal stem cells as an off-the shelf implantable device that can robustly regenerate a damaged portion of an esophagus,” explained Dashti.
The company is based on Derek’s’ Tulane Bioinnnovation PhD work in stem cell tissue engineering, where he developed a Regenerative Medicine platform for many indicators for treating severe esophageal malignancies; but also one which can translate to other diseases to regenerate tissue of the intestine as well as nerve, muscle, and blood vessels. As a Tulane University doctoral NSF fellow his education has focused on bio-innovation/tissue engineering and regenerative medicine.
“Our product improves the standard of care by avoiding surgical reconstruction from the stomach (gastric pull up) and saves over $240,000 per treatment as compared to the standard, Dashti said.
Dashti has also worked at regulatory agencies such as the FDA and has a solid understanding of the regulations involved in bringing innovative biologics and medical devices to market approval.
“We very much wanted to collaborate with others to produce novel technology and bolster the industry and give back to RM,” said Dashti adding, “We are happy that so many members of ARMI are also focused on the manufacturing aspects, you don’t get that anywhere else. We are an RM company focused on the next generation of R&D so we are able to discuss our framework and the hurdles we have overcome to build the platform with other ARMI members,” he offered.
The company, focused on repairing damaged organs with unique biomaterials and stem cells, has developed a platform immunomodulatory medical device to regenerate damaged organs in which the technology development has been tested in six different diseased animal models. The device can also serve as a platform technology for other areas such as regenerating damaged blood vessels, nerves, muscle, tendons/ligaments, and gastrointestinal ulcers.
“Our ‘off-the-shelf device’ uses immune modulating factors contributed by primed stem cells in which we harness these secreted immunomodulatory factors onto dissolvable anti-inflammatory biomaterials to create a potent implant for esophageal repair. The device is non-immunogenic and can be implanted/sutured by a thoracic surgeon or gastroenterologist (direct user) into a damaged area,” he said.
The platform has five elements in the process including: Electrospinning; Cell Culture of MSCs on PCL; Freeze/thaw Decellularization; Scanning Electron Microscopy (SEM) and finally DAPI Staining. The process initiates a path in developing a synthetic construct to be used by a thoracic surgeon as a one-time use device implant to robustly regenerate an impaired esophagus.
“We are now well positioned within the prominent New England regenerative medicine community in Nashua, NH to progress our regenerative technology platform,” said Dashti, noting the companies new lab and office space resources, won through the prestigious 2017 Flatley Challenge in New England.
D&P predicts pre-clinical trials, within three years for many implantable devices and in 5-10 years or sooner, Dashti sees off-the-shelf implants will become a reality in RM.
“These are really tangible predictions for medical advances with a wide variety of wound issues from the battlefield to use by NASA in the Space Station.”