Intuitive Surgical
This article was originally published in The Gray Sheet
Executive Summary
Initial public offering of up to $50 mil. in common stock is outlined in a preliminary prospectus filed with the Securities and Exchange Commission. Founded in November 1995, the Mountain View, California company is developing a tele-robotic instrumentation system for minimally invasive surgery. The device's three components include a surgeon's control console with 3D visual display, patient-side cart that holds electromechanical instrument manipulators, and surgical instruments designed for use through small (1 cm) incisions. Although Intuitive, which plans initially to pursue cardiac surgery indications, has already gained 510(k) clearance for the console, patient-side cart and "certain blunt resposable instruments," regulatory clearance for certain other instruments is necessary prior to commercialization, the firm explains. A clinical trial is slated to begin in July under a March investigational device exemption in order to obtain data requested by FDA for use of the instruments in certain thoracoscopic and laparoscopic surgical procedures. Net proceeds from the IPO are tabbed for continued R&D, clinical trials, manufacturing scale-up, expansion of marketing and sales capabilities, and other corporate purposes. Morgan Stanley Dean Witter, Bear Stearns and BT Alex. Brown are underwriters for the offering