Development of a Dedicated Fluidjet Technology for Single-session Debridement of Necrotizing Pancreatitis

Acute pancreatitis results in over 275,000 U.S. hospital admissions and more than $2.5 billion in healthcare cost annually. Pancreatic necrosis occurs in about 20% of patients who have severe acute pancreatitis. One in three of these patients will develop infected pancreatic necrosis, which is associated with mortality rates of 11 -39%.

Treatment of infected acute necrotizing pancreatitis is crucial to prevent ongoing infection and sepsis-related multiorgan failure. Minimally invasive direct endoscopic techniques have become the preferred method of enabling surgical debridement of pancreatic necrosis. A significant limitation of these procedures is the lack of

instruments capable of safely and effectively removing necrotic tissue. Advanced therapeutic endoscopists, trained on stent-enabled access to the pancreas through the stomach wall, are currently using manual instruments and accessories designed for other indications. As a result, removal of necrotic tissue requires

multiple instrument passes and an average of 4 separate debridement sessions. The ineffectiveness of off-label instrument use directly contributes to overall procedure-related adverse events of between 21% - 36% and lengthy hospital stays for an already challenged patient population. HydroCision has developed a proprietary

method of controlling a hair-thin, supersonic stream of sterile saline while simultaneously enabling an in-line Venturi suction system to cut and remove tissue of various densities from a surgical site in a minimally invasive manner. It has commercialized rigid forms of the technology in the fields of wound care and orthopedics. To

meet the unmet need in the gastrointestinal space, the Company is developing G.I.Jet, a dedicated instrument designed to debride necrotic tissue from the pancreas in a single-session without negatively impacting healthy tissue. Adaptation of its technology for direct endoscopic necrosectomy will require the system be made flexible,

smaller in diameter, and capable of safely transmitting high-pressure sterile saline over longer operative distances. It will also require adjusting saline-flow rates and instrument configuration parameters such that the system is capable of discernably resecting necrotic pancreatic tissue without disrupting healthy adjacent issue

and structures. The long-term goal of the project is to develop an effective dedicated application capable of single-session debridement of pancreatic necrosis, thereby reducing procedure-related complications and associated length of hospital stays among a patient population of high morbidity and mortality. The company will

demonstrate feasibility through bench-top studies designed to test a flexible, endoscopically compatible prototype on surrogate tissue models followed by an animal study designed to assess and determine fluidjet velocity, suction forces and instrument configuration required for discernable resection. The Company’s

technology platform is uniquely positioned to become the technology of choice for gastroenterologists trained on direct endoscopic methods. There are approximately 27,000 patients per year in the US who will benefit from improved treatment with G.I.Jet at an approximate annual market value of $120 million.