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 Companys 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.
Public Health Relevance Statement: PROJECT NARRATIVE Pancreatic necrosis is a complex and challenging complication of severe acute pancreatitis occurring in about 20% of patients with acute severe pancreatitis. Development of more sophisticated debridement devices are necessary in order to further improve technical success of direct endoscopic necrosectomy. This will result in reduced instrument-related adverse events, a reduction in length of hospital stays, and improved quality of life for impacted patients.
Project Terms: acute pancreatitis; Fatty Tissue; adipose; white adipose tissue; yellow adipose tissue; Adipose tissue; Affect; Animals; Autopsy; necropsy; postmortem; Blood Vessels; vascular; Capital Financing; Capital Funding; Complication; Debridement; Dedications; Forcep; Goals; Hair; Hospitalization; Hospital Admission; Infection; instrumentation; Length of Stay; Number of Days in Hospital; hospital days; hospital length of stay; hospital stay; Manuals; Marketing; Massachusetts; Medical Device; Methods; Morbidity - disease rate; Morbidity; mortality; Multiple Organ Failure; MOF syndrome; Multiple Organ Dysfunction Syndrome; multiorgan failure; multiple organ system failure; Necrosis; Necrotic; Orthopedics; Orthopedic; Orthopedic Surgical Profession; Pancreas; Pancreatic; Pancreatitis; Patients; pressure; Quality of life; QOL; Research Design; Study Type; study design; Running; Safety; Saline; Saline Solution; medical specialties; Specialty; Stents; Stomach; gastric; Suction; Mechanical Aspiration; Suction Drainage; Family suidae; Pigs; Suidae; Swine; porcine; suid; Systems Analysis; Systems Analyses; Technology; Testing; Thinness; Leanness; Time; Tissues; Body Tissues; Water; Hydrogen Oxide; Work; Health Costs; Healthcare Costs; Health Care Costs; Catheters; Treatment Cost; Gastroscopes; Label; improved; Procedures; Site; Acute; Solid; Clinical; Specified; Specific qualifier value; Phase; Histologically; Histologic; Training; Gastroenterologist; pancreatitis necrotizing; Acute Necrotizing Pancreatitis; Therapeutic; fluid; liquid; Liquid substance; instrument; Nature; Specimen; Research Specimen; Knowledge; Mechanics; mechanic; mechanical; Complex; Stream; Techniques; System; gastrointestinal; Operative Surgical Procedures; Operative Procedures; Surgical; Surgical Interventions; Surgical Procedure; surgery; Visit; success; care delivery; cell injury; Cellular injury; cell damage; cellular damage; damage to cells; injury to cells; Sterility; sterile; Structure; novel; Devices; Excision; Abscission; Extirpation; Removal; Surgical Removal; resection; Positioning Attribute; Position; Modeling; Sampling; Adverse event; Adverse Experience; Intervention; Intervention Strategies; interventional strategy; Effectiveness; preventing; prevent; Length; Harvest; Preclinical Testing; pre-clinical testing; Protein Structure Initiative; PSI; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Tissue Model; transmission process; Transmission; Characteristics; Resected; follow-up; Active Follow-up; active followup; follow up; followed up; followup; Development; developmental; Pathway interactions; pathway; cost; designing; design; blood infection; bloodstream infection; Sepsis; prospective; innovate; innovative; innovation; commercial application; prototype; commercialization; minimally invasive; patient population; product development; pre-clinical efficacy; preclinical efficacy; pre-clinical safety; preclinical safety; flexible; flexibility; arm; improved outcome; experiment; experimental research; experiments; experimental study; surgical outcome; surgery outcome; off-label application; off-label prescribing; off-label use; wound assessment; wound monitoring; wound care; tissue necrosis; necrotic tissue; pig model; piglet model; swine model; porcine model; Prognosis; Diameter; technology platform; technology system
