Research Project
8833380
DESCRIPTION (provided by applicant): The surgeon's choice of method for closing incisions is becoming increasingly problematic. Metal surgical staples are unacceptable for Minimally Invasive Surgery (MIS) procedures (currently 25 percent of surgeries in the US) and are out of favor in traditional procedures due to complications and the cost of staple removal. Due to the time required for manually applied sutures, many surgeons are trying skin adhesives, but with mixed results as these should be used only in limited applications. Other devices attempting to address these problems have not been accepted for a variety of reasons. The founders of Opus KSD have developed a bioabsorbable fastener and a disposable, hand-held stapler able to insert the preloaded fasteners subcutaneously to close surgical incisions. This novel surgical device provides the speed and convenience of a metal stapler and the improved healing of a bioabsorbable suture, resulting in improved outcomes for patients and savings to the healthcare system. The technological innovation which allows the plastic SubQ It! fastener, weighing only 0.006 grams, to replace a metal staple that is significantly heavier and stronger, is the unique hybrid design that compliments the plastic with the strength and sharpness of surgical needles only during insertion. After insertion, the needles are retracted within the stapler, leaving in siu only the bioabsorbable plastic. Barbs on the fastener engage the tissue and the excellent tensile strength of plastic holds the two sides of the incision in the desired everted shape for optimal healing. The successful Phase I study demonstrated excellent performance in a porcine wound healing model with superior performance discovered for traditional, longer incisions, which were requested by FDA. The Specific Aims for Phase II are to extend the capability of the stapler device outside the MIS market to address these longer, traditional incisions. The Long Term Goal is to replace metal staples and hand-applied sutures with bioabsorbable fasteners in the majority of the skin closure procedures world-wide. In the US, there are 3 million MIS procedures and an estimated 4.5 million other procedures that could be closed if the product from this Phase II effort is successful. At an end-user price of $40-45 each, this represents a Commercial opportunity of $300 million in the US alone.
