The Company is in search of an opportunity to sell to an organization that has the ability to acquire and to continue to fully commercialize its unique and patented nerve saving device for prostate surgery. The Company’s device has received two FDA 510K Class II clearances and has four US Patents.
The Company is focused on the development and commercialization of proven, standard of care nerve monitoring technology used in conjunction with laparoscopic and robotic assisted procedures. The Company’s device is the first & only FDA-cleared real-time nerve monitoring system for laparoscopic & robotic assisted surgery. The company’s FDA-cleared product has completed over 6,000 commercial Prostate cases. This system enables surgeons to identify critical non-visible nerves at risk during surgery, allowing the surgeon to spare these nerves.
The Unmet Need – Preserve the nerves during laparoscopic and robotic assisted surgical procedures. Surgeons generally rely on anatomic landmarks to identify which tissue to preserve in order to try to protect nerves. Anatomically nerves are highly variable within the human anatomy. Published literature confirm the path of various nerves through the body varies dramatically from patient to patient; Hence, the reasoning why Nerve Monitoring is Standard of Care in many other Surgical procedures.
Solution For Patients - Surgeons using the Company’s device have additional real-time information available during the operation that may help them reduce inadvertent damage to critical nerves, significantly reducing common side effects & recovery time of laparoscopic and robotic assisted procedures.
NDA is required to secure comprehensive Confidential Information Memorandum (CIM) crafted by ProNova Partners.
