Manual drug compounding of chemotherapy medications permits deadly dosing errors and toxic drug exposure and therefore poses unnecessary risks to patients and healthcare professionals. Some robotic compounding devices have been developed in response;however, poor drug containment safety capabilities and prohibitive cost and size have limited widespread adoption of existing compounding devices. Corvida Medical has developed a novel disposable closed system drug transfer device (CSTD) to protect health care workers from toxic exposure to hazardous drugs used in cancer treatments. During Phase II, the Corvida R&D team has completed further validation studies to show the Corvida CSTD meets the NIOSH and USP definition of a CSTD, and validated our device against ISO standards and most FDA requirements. Corvida has also developed an innovative compounding device that overcomes the safety, cost, and size limitations of existing compounding devices. At a fraction of the size and cost of current products, our technology will ensure reliable, accurate compounding to prevent patient medication errors, enhancing patient care, and will reduce exposure to toxic drugs by interfacing with disposable Corvida CSTD, optimizing both worker and patient safety. Phase IIB activities will focus on expanded testing requirements necessary to secure FDA 510(k) clearance of the disposable Corvida CSTD product, benchmarking studies against a commercial competitor, and on productizing the new compounding device through development of beta prototype that meets preliminary specifications, functions with the Corvida CSTD, and completing validation testing for process reliability, accuracy, containment, sterility, and system throughput.
We aim to show a minimum 95% reliability, 95% accuracy, containment and sterility that meet USP standards, and system throughput in line with market expectations. Successful completion of these studies will help catalyze commercialization through clearing regulatory hurdles and by validating our novel compounding device that integrates the advantages of existing technology with the containment capabilities of the Corvida CSTD. Our device is more efficient and cost-effective, has a small footprint, provides accurate and reliable compounding and minimizes risks to both health professionals and patients. Once commercialized, these innovative products will help solve the significant problems of patient and healthcare worker safety though advancements in compounding equipment and disposable CSTDs as well as integration of these technologies into a complete and effective system.
Millions of healthcare workers are at risk of exposure to hazardous drugs, such as chemotherapeutics used to treat cancer patients, during drug preparation and administration. Patients are also at risk of medication errors that occur during manual preparation of chemotherapy treatments. To improve safety for healthcare workers as well as to reduce medication errors and improve treatment outcomes for patients, this Phase IIB Bridge project will expand testing for FDA approval for a patented closed system transfer device (CSTD) and will continue development of an improved compounding system for safer and more efficient preparation of hazardous drugs.