enVVeno Medical (US:NVNO)2025-07-31 20:25Financial Performance - The company reported a net loss of $6.7 million for the three months ended June 30, 2025, compared to a net loss of $5.0 million for the same period in 2024, representing a 35% increase in net loss [55]. - Net losses for the six months ended June 30, 2025, were $11.2 million, an increase of $1.2 million or 13% compared to $10.0 million for the same period in 2024 [60]. - The company incurred losses from operations of $12.0 million and used $7.7 million in cash for operating activities for the six months ended June 30, 2025 [65]. - Other income for the six months ended June 30, 2025, decreased by $0.2 million to $0.8 million from $1.0 million for the same period in 2024 [64]. - Selling, general and administrative expenses for the three months ended June 30, 2025, increased by $1.6 million or 58%, to $4.2 million from $2.6 million for the same period in 2024 [58]. - Selling, general and administrative expenses for the six months ended June 30, 2025, increased by $1.5 million or 29%, to $6.6 million from $5.1 million for the same period in 2024 [63]. - Research and development expenses for the three months ended June 30, 2025, increased by $0.1 million or 2%, to $2.9 million from $2.8 million for the same period in 2024 [57]. - Research and development expenses for the six months ended June 30, 2025, decreased by $0.5 million or 7%, to $5.4 million from $5.9 million for the same period in 2024 [62]. - The anticipated cash burn rate is expected to increase to between $5 million and $7 million per quarter as the company conducts clinical studies and works toward product commercialization [69]. - The company expects to file for IDE approval for the enVVe pivotal study in the third quarter of 2025, following successful completion of pre-clinical testing [53]. - The company has sufficient capital resources to meet obligations for at least one year after June 30, 2025 [70]. - The company does not expect to generate significant revenue until successful commercialization of its product candidates after receiving FDA approval [61]. Product Development - The VenoValve is currently in the post-enrollment follow-up period of its U.S. pivotal study, which reached full enrollment of 75 patients on September 1, 2023 [46]. - At one year follow-up, 85% of patients in the VenoValve trial experienced a clinically meaningful benefit, with an average improvement of 7.91 points in the revised Venous Clinical Severity Score (rVCSS) [48]. - The median reduction in pain for patients in the VenoValve study was 75%, and for CEAP C6 patients, ulcer area was reduced by a median of 87% [48]. - The VenoValve has been granted Breakthrough Device designation by the FDA, which may expedite its PMA review process [45][50]. - The company is developing the enVVe as a next-generation, non-surgical replacement venous valve, currently undergoing pre-clinical testing [37][52]. Market Context - Approximately 20 million people in the U.S. are estimated to suffer from severe deep venous CVI (C4 to C6 disease), with 3.5 million new cases diagnosed annually [44]. - The average annual cost for a patient seeking treatment for a venous ulcer is estimated to be $30,000, with total direct medical costs exceeding $3 billion annually in the U.S. [44].