Commercializing CivaSheet for Pancreatic Cancer Patients

Abstract public domain (NIH RePORTER)

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.

Public health relevance public domain (NIH RePORTER)

With NIH/NCI SBIR support, CivaTech Oncology developed CivaSheet®, the only directional intraoperative radiation device to deliver a curable radiation dose to microinvasive disease at the surgical margin while protecting healthy tissues. Phase I/II clinical trials for pancreatic cancer demonstrate no device related toxicity and 0% local recurrence. Controlling localized pancreatic cancer is the first step to providing better outcomes for these difficult to treat patients. To enable patients the best possible outcomes, we request funds to expand patient access to CivaSheet by evaluating cost outcomes, applying for reimbursement coverage, and engineering support to scale manufacturing.