U.S. Food and Drug Administration Clears UVision360, Inc. Novel LUMINELLE® 360° Bx (Biopsy) Sheath

First and only integrated directed biopsy device when combined with the LUMINELLE DTx System

RALEIGH, N.C., July 7, 2021 /PRNewswire/ -- UVision360, Inc., an innovative medical device company, announces today that the U.S. Food and Drug Administration (FDA) has approved the patented LUMINELLE 360° Bx (Biopsy) Sheath which expands the capability of the LUMINELLE® DTx System. The LUMINELLE 360° Bx sheath, combined with the LUMINELLE DTx System, is the first and only integrated directed biopsy device not requiring the use of additional instruments, and indicated for uterine and bladder biopsies. The LUMINELLE DTx System is an endoscopic platform assisting both male/female procedures, bringing operating room capabilities affordably to physician offices so bladder and uterine tissue samples can be obtained easily with visualization.

The first and only integrated directed biopsy device not requiring the use of additional instruments

"The FDA approval of our LUMINELLE Bx Sheath not only marks a major milestone for UVision360 but is also a game changer when it comes to the standard of care for tissue biopsy procedures," said UVision360 CEO Allison London Brown. "The affordability, reusability, and adaptability of the LUMINELLE DTx System enhances the patient experience and gives doctors the flexibility to perform needed procedures when and where they see fit."

"Prior to the LUMINELLE Bx Sheath, doctors could not visualize and sample abnormal tissue without the use of additional biopsy tools," said Dr. David Robinson, UVision360's Chief Medical Officer. "Now, doctors will be able to easily visualize areas of concern, while sampling occurs. In addition, the clear biopsy sampling tube allows the physician to see how much actual tissue they are acquiring, ensuring they have an adequate sample. Taking directed tissue samples helps doctors and patients and arrange for follow up treatment sooner rather than later. A patient can have increased confidence in their diagnosis while the simplicity of the equipment makes the procedure more convenient and less challenging for the physician. The new biopsy sheath and improved reimbursement codes ensure doctors can provide superior medical coverage and help fill a critical unmet need."

The LUMINELLE DTx System is FDA cleared for both diagnostic and operative hysteroscopy and cystoscopy. Health professionals can perform office procedures for uterine, bladder health, without a prohibitive investment in equipment and provides convenience to office staff and patients, cost savings and addresses limitations with current disposable devices on the market.

UVision360 will bring the new LUMINELLE Bx Sheath to market with a limited launch in Q3 of 2021, for use with the LUMINELLE DTx System and plans a broader distribution shortly thereafter.

About UVision360

UVision360, Inc. is dedicated to advancing access to care for men and women by transitioning procedures from the operating room to their physician's office. The company has created the LUMINELLE DTx System, a simplified, compact, and modular endoscopic system employing the latest in high–tech optics and interchangeable accessories to meet the needs of physicians and patients. More information about the LUMINELLE DTx System can be found by contacting info@UVision360.com or visiting www.luminelle360.com.

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SOURCE UVision360, Inc

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