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Administrative Supplement for the Evaluation of the novel, uni-directional, Pd-103 CivaSheet for Lung Cancer

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 4R44CA217587-02
Agency Tracking Number: R44CA217587
Amount: $2,188,488.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NCI
Solicitation Number: PA20-272
Solicitation Year: 2017
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-09-01
Award End Date (Contract End Date): 2021-08-31
Small Business Information
Durham, NC 27713-2234
United States
DUNS: 801431862
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (678) 954-5744
Business Contact
Phone: (919) 314-5515
Research Institution

Parent Award: R44CA217587 Clinical Evaluation of the novel, Uni-directional Pd-103 CivaSheet for Lung Cancers
CivaTech Oncology’s mission is to provide improved radiation therapy directly to localized tumors. The Company 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 implant 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 patient. 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 near the heart and mediastinum.
CivaTech Oncology has confirmed in case studies, that CivaSheet does not move after implantation and that a
substantial and beneficial dose can be delivered for lung cancer patients. CivaSheet greatly benefits these patients by
delivering localized radiation therapy at the time of initial surgery to protect against local recurrence, a significant
concern for lung cancer patients. Over the course of the SBIR Fast Track Parent Grant, the safety of CivaSheet in lung
cancer patients was demonstrated and general surgical recommendations for its use were defined.
Additionally, the SBIR Fast Track Parent Grant (R44CA217587) supports a clinical trial to implant CivaSheet during
sublobar resection of lung cancer patients. The rate of local recurrence in patients implanted with CivaSheet is being
evaluated and compared to the historical rate of 20%. The acute radiation toxicity is also monitored as part of the study.
CivaSheet delivers substantially less radiation to adjacent mediastinum and heart muscle compared to other forms of
radiation delivery and no device related toxicity has been reported.
This Administrative Supplement is requested to provide budget for the production and supply of CivaSheets for clinical
trial use. The SBIR Fast Track Parent Grant budget assumed CivaSheet would be reimbursed through CMS and private
payors. CivaSheet is not reimbursed and it is greatly impacting the ability to complete this proposed work and provide
access to patients. With this Administrative Supplement, CivaTech Oncology will be able to more quickly complete the
clinical trials. CivaSheet is a truly unique brachytherapy device that has the potential to become the first line of defense
for localized cancer. CivaTech Oncology is committed to making CivaSheet available to cancer patients in multiple
indications.CivaTech Oncology has developed a membrane-like brachytherapy device – CivaSheet®
– that is truly customizable to a specific patient’s condition and offers a novel
unidirectional option to shield healthy tissue. CivaSheet brachytherapy has been shown
to minimize exposure of healthy tissue to radiation, thus reducing treatment-induced side
effects while potentially delivering a higher dose of radiation to the target tissues
compared to external beam or other forms of radiation treatment. CivaSheet has not
gained reimbursement pathways as anticipated during the Parent Grant’s budget. In this
Administrative Supplement, we request additional funds to support the use of CivaSheet
for lung cancer patients.

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

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