enVVeno Medical reports Q3 EPS (23c) vs. (35c) last year

The Company ended the quarter with $31M in cash and investments. With the VenoValve commercializations costs and enVVe IDE expenses currently on hold pending resolution with the FDA, this capital has the potential to fund the Company through the second quarter of 2027. The Company expects its cash burn rate to increase from current levels in the event the Company proceeds to commercialization of the VenoValve and the IDE study with enVVe. “We are well capitalized and should have sufficient capital to cover the period of our ongoing discussions with the FDA seeking a potential commercial path forward for the VenoValve and clarity for the enVVe IDE study,” commented Robert Berman. “Our recent in-person appeal meeting with the FDA provided a focused setting to address the concerns outlined in the not-approvable letter, including safety concerns raised by the FDA, proposed mitigations, the VenoValve’s effectiveness, and also provided the opportunity for the Agency to hear directly from one of our primary investigators and a patient from the VenoValve study. We look forward to our continued interactions with the FDA and remain committed to the 2.5 million patients suffering from severe deep chronic venous insufficiency.”