What's Happening?
Diality Inc. has announced the first patient treatment in its PRESCRIBE Diality Home Hemodialysis Clinical Trial, conducted in partnership with aQua Research Institute and aQua Dialysis in Houston, Texas. The trial aims to evaluate the Moda-flx Hemodialysis System for home use under an Investigational Device Exemption (IDE). The system, which received FDA clearance for professional care settings in August 2024, features an integrated reverse osmosis system and variable flow rates. Diality's CEO, Dr. Osman Khawar, highlighted the system's potential to bridge gaps between conventional in-center dialysis and current home hemodialysis technologies.
Why It's Important?
The clinical trial represents a significant step forward in expanding home hemodialysis options for patients with kidney disease. By offering a more flexible and user-friendly system, Diality aims to improve the quality of life for patients and reduce the burden on healthcare facilities. The trial's success could lead to broader adoption of home hemodialysis, providing patients with greater autonomy and potentially lowering healthcare costs. This development is particularly relevant as the healthcare industry seeks innovative solutions to meet the growing demand for personalized and accessible medical care.
What's Next?
As the trial progresses, Diality will gather data on the system's efficacy and safety in a home setting. Positive results could lead to FDA approval for home use, expanding the availability of the Moda-flx Hemodialysis System to a wider patient population. The company may also explore partnerships with healthcare providers to integrate the system into existing care models. Stakeholders, including patients, clinicians, and healthcare organizations, will be closely monitoring the trial's outcomes to assess the system's impact on dialysis care.
