Financial Report Articles: EnVVeno Medical Corporation - Form 10-Q for the Quarterly Period Ended March 31, 2024
Financial Report Articles: EnVVeno Medical Corporation - Form 10-Q for the Quarterly Period Ended March 31, 2024
The financial report highlights key events and developments, such as changes in common stock, retained earnings, and additional paid-in capital. It also mentions software development expenses, leasehold improvements, furniture, and fixtures. The report also discusses selling, general, and administrative expenses, as well as employee stock options and warrants. The report is filed with the Securities and Exchange Commission and covers the quarterly period ended March 31, 2024.
Overview
enVVeno Medical Corporation is a late-stage medical device company developing solutions to treat chronic venous disease (CVD). CVD impacts 70% of U.S. adults and can cause leg pain, swelling, skin changes, and leg ulcers.
The company is developing two products - the VenoValve and enVVe - to act as replacement venous valves to help blood flow properly in the veins. The VenoValve is a surgically implanted valve and the enVVe is a non-surgical, catheter-delivered valve.
The VenoValve is currently in a pivotal U.S. trial called the SAVVE study. The company achieved full enrollment of 75 patients in September 2023. Preliminary safety data indicates a device-related adverse event rate of 8%, mainly due to blood clots and bleeding. Preliminary efficacy data at 6 months indicates 97% of patients showed improvement in disease severity, with 74% showing a clinically meaningful benefit.
The company is also developing enVVe and plans to start the pivotal trial in 2025. Initial testing of enVVe has been successful.
The company ended 2023 with approximately $46 million in cash and investments. Cash burn is approximately $4-5 million per quarter as clinical trials progress. The company will need to raise additional financing in the future.
CVI Background
- CVD impacts 70% of U.S. adults
- 20 million U.S. adults have severe deep venous CVI
- 3.5 million new cases per year
- Treatment costs exceed $3 billion per year
- Severe CVI reduces quality of life and mobility
CVI occurs when valves inside leg veins fail, causing backward blood flow, leg swelling, pain, and sometimes leg ulcers.
VenoValve
- Surgically implanted valve for severe CVI
- Granted Breakthrough Device designation by FDA
- 75 patient pivotal SAVVE study fully enrolled in Sept. 2023
| Safety Results | # Patients | Description |
|---|---|---|
| Deaths | 0 | |
| Blood clots | 6 moderate 4 mild |
Occurred within 30 days of surgery |
| Bleeding | n/a | Outside of vein after surgery |
| Wound infections | n/a | At surgery incision site |
| Efficacy Results | Description |
|---|---|
| Improved disease severity | 97% of patients at 6 months |
| Clinically meaningful benefit | 74% improved by ≥3 points on disease severity scale |
- Average improvement of 8 points on disease severity scale
- Company plans to file for FDA approval in Q4 2024
enVVe
- Non-surgical, catheter-delivered valve
- Successfully completed initial bench and animal testing
- Six month animal study beginning Q3 2024
- Plan to start pivotal trial in 2025
- Estimated 3.5 million U.S. patients eligible
Financial Results
| Q1 2024 | Q1 2023 | Change |
|---|---|---|
| Net loss | $5 million | $6.4 million |
| Cash burn | ~$4-5 million per quarter |
n/a |
- Cash and investments of $46 million at end of 2023
- Cash and investments of $42.9 million at March 31, 2024
- Will need to raise additional financing in future