The preclinical animal studies are currently underway at Palamor Biosciences in Hyderabad, utilizing a calf model. These studies aim to meet the Good Laboratory Practice (GLP) standards mandated by the US FDA. The objective is to complete trials involving six surviving calves over a two-month observation period. The studies are progressing as planned, with completion expected in the coming months. The preclinical animal studies are currently underway at Palamor Biosciences in Hyderabad, utilizing a calf model. These studies aim to meet the Good Laboratory Practice (GLP) standards mandated by the US FDA. The objective is to complete trials involving six surviving calves over a two-month observation period. The studies are progressing as planned, with completion expected in the coming months.

The first-in-human implant is anticipated by the end of the first quarter of 2025, marking a significant milestone in the clinical translation of the device. Following this, a pilot clinical trial involving 10 patients will be conducted across India and Australia to assess initial safety and efficacy. Based on the outcomes of the pilot trial, an expanded clinical trial with 50 patients is planned. This larger trial will provide comprehensive data for formal evaluation, paving the way for regulatory approvals and market entry.

The development team has successfully completed the LVAD (Left Ventricular Assist Device), Dual VAD Control System, and the Hospital Monitor System. Currently in progress is the RVAD (Right Ventricular Assist Device), which has been designed and is undergoing development. In the interim, two LVADs can be configured to function as a BiVAD using the existing controller, enabling full biventricular support.