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Custom Sensor Manufacturing and Regulatory Preparation Assistance for Novel Intraoperative Ureter Detection Device

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2SB1HD089769-04
Agency Tracking Number: SB1HD089769
Amount: $497,923.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NICHD
Solicitation Number: PAR20-129
Timeline
Solicitation Year: 2020
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-09-19
Award End Date (Contract End Date): 2026-08-31
Small Business Information
4660 N RAVENSWOOD AVE
Chicago, IL 60640-4510
United States
DUNS: 078742429
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 SHETHA SHUKAIR
 (708) 227-0058
 s.a.shukair@briteseed.com
Business Contact
 JONATHAN GUNN
Phone: (206) 384-0311
Email: j.w.gunn@briteseed.com
Research Institution
N/A
Abstract

PROJECT SUMMARY/ABSTRACT
The goal of this small business innovation research grant is to commercialize a cost-effective and contrast-free
intraoperative ureter detection system, which integrates into a laparoscopic vessel sealing device to identify
ureters in real-time and prevent iatrogenic injuries. 70% of iatrogenic ureteral injuries are detected
postoperatively, up to 30 days after hospital discharge. These injuries can cause ureteral obstruction, fistula(e)
and eventually renal failure when not repaired immediately, and cost hospitals an average of $30,000 per
patient with an added hospitalization time of 4 days. Additionally, for women with pelvic inflammatory conditions
or endometriosis, gynecologic surgery is further complicated due to lack of critical structure visualization.
Currently, the only available technologies that assist in ureter injury detection, including cystoscopy and lighted
stents, are costly and/or time-consuming and have led to additional complications such as reflux anuria and
urinary tract infections. The Briteseed system would be the first unobtrusive, easy to use and cost-effective
alternative with the potential to decrease the incidence of ureteral complications during pelvic surgery. In this
CRP project, Briteseed will finalize steps to prepare its hyperspectral imaging based rapid ureter detection
(HSI-RUD) laparoscopic vessel sealer for commercialization. The HSI-RUD uses transmission based optics to
non-invasively detect the ureters in real-time without any contrast agent. Preventing ureteral injury through
real-time detection will lead to better outcomes for patients and lessen the financial burden on the healthcare
system. In Phase I of the SBIR, the technology was optimized and validated to provide: (a) real-time,
automated ureter detection and (b) the ability to differentiate between the ureter and surrounding tissues. In
Phase II, the RUD system was integrated into a laparoscopic grasper and used in pre-clinical studies to
receive clinician feedback on the user interface. Since the end of Phase II, the company has successfully,
independently integrated an optical subsystem into a vessel sealer, which has created significant interest from
strategics to integrate our technology into their tools through co-development. Additionally, the company has
engaged with the FDA to understand the regulatory pathway of the HSI-RUD device. The technology must
undergo late stage activities to prepare for a de novo FDA submission and a high-cost manufacturing step
before it can be commercialized by either a strategic partner or Briteseed independently and made available in
operating rooms for gynecological procedures, where the ureter is at risk with no proven detection method
currently available to prevent injury.

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

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