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Commercializing CivaSheet for Pancreatic Cancer Patients

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44CA210770-04A1
Agency Tracking Number: R44CA210770
Amount: $1,864,846.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NCI
Solicitation Number: CA22-025
Timeline
Solicitation Year: 2022
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-07-08
Award End Date (Contract End Date): 2026-06-30
Small Business Information
627 Davis Dr. Tech 7/Suite 200
Morrisville, NC 27560-7116
United States
DUNS: 801431862
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 KRISTY PEREZ
 (470) 217-8694
 kperez@civatechoncology.com
Business Contact
 SUZANNE BABCOCK
Phone: (919) 314-5515
Email: sbabcock@civatechoncology.com
Research Institution
N/A
Abstract

CivaTech Oncology’s mission is to provide improved radiation therapy directly to diseased tissues while
sparing healthy tissues. With NIH/NCI SBIR support, the Company has eliminated local recurrence of disease
in pancreatic cancer patients – a huge success. Pancreatic cancer is predicted to soon become the most
commonly diagnosed cancer in the US and there are no significant, impactful therapies making a difference.
However, CivaTech has developed a novel, polymer-encapsulated, membrane-like radiation source that emits
radiation on only one side of the device – CivaSheet®. This directional source is compatible with open and
minimally invasive surgical techniques and has FDA clearance to be used as primary or combined cancer
therapy. CivaSheet is a bio-absorbable, implantable planar device that can be applied at the time of the initial
surgery. CivaSheet decreases the time between surgery and radiation therapy, which is a benefit to the
outcomes for many indications, in particular, for pancreatic cancer. Additionally, CivaSheet can shield healthy
tissues while irradiating the diseased tissue or tumor margin. This shielding enables CivaSheet to be implanted
close to radiosensitive structures without overdosing them – a huge advantage for cancers in the abdomen.
In clinical trials, patients are recovering from their surgical procedures without negative effects from the device.
CivaTech Oncology has confirmed no radiation related adverse events, no device-related toxicity. CivaSheet
delivers substantially less radiation to adjacent duodenum, stomach, liver, and kidneys compared to other
forms of radiation delivery and has targeted dosimetry for pancreatic cancer. CivaSheet greatly benefits these
patients by delivering localized radiation therapy at the time of initial surgery to protect against local
recurrence. Pancreatic cancer is an aggressive disease that progresses quickly and has about 30% local
recurrence rates. Over the course of the SBIR Fast Track Grant, CivaTech has collected clinical evidence that
the CivaSheet is highly effective and has a 100% local control rate for pancreatic cancer patients.
These data will be compiled and compared to hospital-based outcomes for SOC patients to complete a
healthcare economic analysis. Preventing local recurrence while maintaining quality of life is highly impactful
for patients and for the healthcare system.
This Phase IIB proposal requests funds for the healthcare economic analysis and compiling a dossier that will
be presented to hospitals’ value analysis committees, private payors, and CMS. Additionally, this proposal
aims to provide engineering support to increase manufacturability and improve our ability to supply products to
meet the projected demand following the publication of our clinical trial data. CivaSheet is a truly unique
brachytherapy device that has the potential to become the first line of defense for localized cancer and has
data to demonstrate it can substantially reduce recurrence rates after a surgical tumor removal. CivaTech
Oncology is committed to making CivaSheet available to improve outcomes of pancreatic cancer patients.

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

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