Existing dialyzer reprocessing methods should be re-examined by including additional requirements to ensure effective recovery of middle solute clearance for every dialysis treatment. Thus, cardinal modifications of dialyzer reprocessing technology are urgently needed to satisfy effective clearance of various uremic retention solutes other than urea. The NovaTron technology developed by Novaflux Technologies (Novaflux) has been validated to satisfy these recent demands, namely: the recovery of dialyzer membrane functions to like-new conditions, including clearance of middle solutes over many reuses. This technology will be significant since >70% of dialysis patients in the U.S. receive treatment with reprocessed dialyzers. Novaflux has received SBIR Phase I (R43-DK55419) and Phase II (R44-DK55419) grants to develop a novel dialyzer reprocessing technology that solves the fundamental limitations of current reprocessing methods. The Company has demonstrated that the NovaTron technology accomplishes the following results: i) full replacement of manual cleaning at the sink; ii) full recovery of TCV; iii) demonstrated in vitro and clinical capability to recover clearance of middle solutes (?2-microglobulin); iv) increase in reuse number to >40 without adverse effects; v) decrease in consumption of chemicals and RO water and in dialyzer disposal cost; and vi) deliverance of performance equivalent to that of single-use dialyzers during every reuse. The objectives of the proposed Competing Continuation Phase II study are to: i) build and validate a Beta-prototype device to satisfy FDA requirements; ii) assess the device with respect to performance standards related to the FDA approval process; iii) evaluate safety and effectiveness of the device; and iv) complete clinical studies in support of the FDA approval process for devices and to support new claims. Novaflux will be responsible for planning, directing, and executing the proposed study.
The Specific Aims of this study are:
Aim 1 : Finalize and define the design requirements, performance specifications and standards of the NovaTron device (hardware and software) according to the FDA process;
Aim 2 : Validate, assess and refine (VAR) the Beta NovaTron device and processing chemistries following the GMP process according to FDA requirements for preclinical and clinical trials;
Aim 3 : Perform system validation, preclinical studies, in vitro assessment and field simulation of the Beta NovaTron device;
Aim 4 : Prepare, submit and receive approval for FDA-IDE and IRB needed for the clinical evaluation;
Aim 5 : Perform two clinical trials using Polyflux(r) and Optiflux(r) dialyzers to evaluate the safety, performance and efficacy of the NovaTron technology and to meet the requirements of the FDA submission;
Aim 6 : Conduct post-clinical final validation and assessment, and refine the final NovaTron device;
Aim 7 : Perform final audit for FDA approval process;
Aim 8 : Prepare interim and final reports and publications;
Aim 9 : Hold periodic meetings with FDA regarding requirements and process for submitting an application. P 7. Project Narrative: Relevance: This study proposes to develop a new improved technology for reprocessing hemodialyzers, referred to as the NovaTron. The NovaTron technology recovers the entire dialyzer function to near-new state for every reuse. Since >70% of dialysis patients in the U.S. reuse their dialyzers, the NovaTron will improve the treatment of dialysis patients, as well as their quality of life. ? ? ?
|Dukhin, Stanislav S; Tabani, Yacoob; Lai, Richard et al. (2014) Outside-In Hemofiltration for Prolonged Operation without Clogging. J Memb Sci 464:173-178|