Describe your device and how it will benefit healthcare.
We are developing a scanner capable to provide instantaneous 3D imaging during surgery, allowing surgeries to be safer, faster and consistently accurate. We are targeting spine surgery for our beachhead market because of the high rate of revisions due to misplaced screws.
UVision360 Inc. ("UVision") is focused on the simplification of hysteroscopic systems, especially for the office setting. The system includes a reusable slim-line hysteroscope and our unique disposable 360° cannula. UVision360 offers an all-in-one office system with a patented rotatable cannula providing a 360°, 30-mm depth of view, high-definition optics, integrated fluid management, and an operating channel. This allows gynecologists to perform global hysteroscopic procedures with superior visualization due to our high-definition optics and integrated flow system. The operative channel enables therapeutic procedures that can be done in the office. The system works with off-the-shelf monitors and computer systems. UVision's hysteroscopy system enables office-based gynecological procedures such as diagnostic hysteroscopy, directed biopsy, fallopian tubal occlusion for permanent sterilization using currently marketed devices, and other outpatient surgical procedures that are currently performed in the ASC or hospital setting. Female cystoscopy will also be able to be performed with the current scope system.
How does your product differ from the competition?
This is the only x-ray scanner capable to do intra-operative 3D imaging with real-time performance, allowing surgeons to use it for intra-operative imaging and image guidance.
Tower systems that cost $30,000 plus licensing and servicing contracts are currently available but financially prohibitive. EndoSee Medical, now a part of Cooper Surgical, is the only other targeted, office-based product. The EndoSee device is useful for only diagnostic procedures (no therapeutic capabilities) and no outflow fluid management, with less visualization due to the small screen. Our product is geared to the in-office hysteroscopist with an all-in-one system for under $6000
Do you have customers yet?
We are performing cadaver lab testing of our device.
Product is currently in validation testing and expected to launch in 4Q17
How much money have you raised?
$1.8M in federal & state grant, with seed money from two angel investors.
$1.9MM in Series A
$250,000 Small Business Loan from the North Carolina Biotechnology Center
Who are your investors?
Turner Ventures and an angel investor
Angel funds and angel investors
What is the next milestone for your device?
Clinical validation followed by a 510(k) submission.
FDA submission and approval