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Development of a tele-mentoring system integrated into an ultra-portable surgical microscope to treat cataract in underserved populations

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43EY034066-01A1
Agency Tracking Number: R43EY034066
Amount: $293,470.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NEI
Solicitation Number: PA21-259
Timeline
Solicitation Year: 2021
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-09-30
Award End Date (Contract End Date): 2024-09-29
Small Business Information
3815 WEST CHESTER PIKE
Newtown Square, PA 19073-2304
United States
DUNS: 080982848
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: Yes
Principal Investigator
 MATTHEW MALTESE
 (484) 418-8037
 maltese@x-biomedical.com
Business Contact
 MATTHEW MALTESE
Phone: (484) 418-8037
Email: maltese@x-biomedical.com
Research Institution
N/A
Abstract

Currently, in austere environments like the rural regions of Africa, there are millions of people who go blind
each year due to cataract. This is an easily preventable condition if they receive the correct treatment in a
timely manner. Unfortunately, there is a growing shortage of ophthalmologists and other surgeons throughout
the world, and in many African countries unsupervised non-physicians perform cataract surgery, resulting in
“borderline” or “poor” outcomes for patients. Called the X-Scope, our novel, patented, ultra-portable all-digital
surgical microscope, compared to the heavy, fragile, and expensive traditional microscopes, offers an
inexpensive and lightweight solution. Our business model is to disrupt the $2B+ surgical visualization market in
high-income countries with our revolutionary, patented X-Scope to support dissemination globally, all at an
affordable price.In this application we propose to develop telementoring and telestration capabilities integrated into the
X-Scope utilizing civilian cellular radio networks. Tele-mentoring in our system would allow ophthalmologists to
remotely train physicians in ophthalmic surgery techniques over very large geographic distances, and when
applied to other branches of surgery, has the potential to benefit people everywhere. Furthermore, we will
demonstrate feasibility of telementoring and telestration as a training modality for physicians via a multi-arm
randomized feasibility trial. Study subjects will be randomized to receive either mentoring at the bedside or
telementoring as they perform small incision cataract surgery on artificial eyes. Performance will be objectively
compared between the groups using an established ophthalmology scoring rubric and statistical analyses of
results. Additionally, usability of X-scope will be determined by administration of a USE questionnaire to
mentees and mentor to assess ease of use and functionality of X-Scope. Successful completion of this Phase I
research will lay groundwork for Phase II, which includes scale up of X-Scope for commercial distribution and a
510k submission to FDA. Ultimately, the system developed herein has potential for broad use in all branches of
surgery in the developed and un-developed world, and can be extended to mass casualty events, refugee
encampments, and other surgical environments in austere settings.

* Information listed above is at the time of submission. *

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