enVVeno Medical Corp

Previous wording

enVVeno Medical Corporation is a late clinical-stage medical device company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of venous disease. Chronic Venous Disease (CVD) is the world’s most prevalent chronic disease, impacting approximately 71% of the adult population of the U.S. Chronic Venous Insufficiency (CVI), is a large subset of CVD, which most often occurs when valves inside of the veins of the leg become damaged, resulting in the backwards flow of blood (reflux), blood pooling in the lower leg, increased pressure in the veins of the leg (venous hypertension) and in severe cases, venous ulcers that are difficult to heal. The Company is developing surgical and non-surgical replacement venous valves for patients suffering from severe CVI of the deep venous system of the leg.

Current wording

enVVeno Medical Corporation is a late clinical-stage medical device company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of venous disease. Chronic Venous Disease (CVD) is the world’s most prevalent chronic disease, impacting approximately 70% of the adult population of the U.S. Chronic Venous Insufficiency (CVI), is a large subset of CVD, which most often occurs when valves inside of the veins of the leg become damaged, resulting in the backwards flow of blood (reflux), blood pooling in the lower leg, increased pressure in the veins of the leg (venous hypertension) and in severe cases, venous ulcers that are difficult to heal. The Company is developing surgical and non-surgical replacement venous valves for patients suffering from severe CVI of the deep venous system of the leg.

Previous wording

The VenoValve and enVVe are being developed first for approval by the U.S. Food and Drug Administration (FDA). We expect the VenoValve to be eligible for FDA approval first, followed two to three years later by enVVe. If approved, we expect the VenoValve and enVVe to co-exist, with the VenoValve as a surgical replacement venous valve option and enVVe as a non-surgical replacement venous valve option, although we cannot provide any assurance that either the VenoValve or enVVe will receive approval from the FDA (see the section entitled “Risk Factors” in our Annual Report on Form 10-K). There are currently no devices approved as surgical or non-surgical replacement venous valves, and there are currently no effective treatments for deep venous CVI caused by incompetent valves.

Current wording

The VenoValve and enVVe are being developed first for approval by the U.S. Food and Drug Administration (FDA). We expect the VenoValve to be eligible for FDA approval first, followed two to three years later by enVVe. If approved, we expect the VenoValve and enVVe to co-exist, with the VenoValve as a surgical replacement venous valve option and enVVe as a non-surgical replacement venous valve option, although we cannot provide any assurance that either the VenoValve or enVVe will receive approval from the FDA (see the section entitled “Risk Factors” in this Annual Report on Form 10-K). There are currently no devices approved as surgical or non-surgical replacement venous valves, and there are currently no effective treatments for deep venous CVI caused by incompetent valves.

Previous wording

Our team of officers and directors has been affiliated with numerous medical devices that have received FDA approval or CE marking and that have been commercially successful. We develop and manufacture our products in a 14,507 sq. ft. leased manufacturing facility in Irvine, California, which has been ISO 13485-2016 certified for the design, development and manufacturing of tissue based implantable medical devices.

Current wording

Our team of officers and directors has been affiliated with numerous medical devices that have received FDA approval or CE marking and that have been commercially successful. We develop and manufacture our products in connection with our clinical trials in a 14,507 sq. ft. leased manufacturing facility in Irvine, California, which has been ISO 13485-2016 certified for the design, development and manufacturing of tissue based implantable medical devices.

Previous wording

As a late-stage clinical medical device Company, we are not currently generating revenue and our future revenue, if any, is dependent on our ability to commercialize our product candidates. We do not expect to begin generating revenue with respect to any of our product candidates in the near term. We hope to eventually achieve revenues by commercializing and selling our products or licensing our technologies to companies that have the resources and infrastructure in place to manufacture, market and sell our products. The commercialization and/or licensing of any of our products may take several years, if it is to occur at all, and depends on our ability to obtain regulatory approval.

Current wording

As a late-stage clinical medical device Company, we are not currently generating revenue and our future revenue, if any, is dependent on our ability to commercialize our product candidates. We will not begin generating revenue with respect to any of our product candidates until after we obtain FDA approval, if at all. We hope to eventually achieve revenues by commercializing and selling our products or licensing our technologies to companies that have the resources and infrastructure in place to manufacture, market and sell our products. The commercialization and/or licensing of any of our products may take several years, if it is to occur at all, and depends on our ability to obtain regulatory approval.

Previous wording

We reported net losses of $23.5 million and $24.7 million for the years ended December 31, 2023 and 2022, respectively, representing a decrease in net loss of $1.2 million or 5%, resulting from, as described in further detail below, an increase in operating expenses of $0.3 million, and an increase in other income of $1.5 million.

Current wording

We reported net losses of $21.8 million and $23.5 million for the years ended December 31, 2024 and 2023, respectively, representing a decrease in net loss of $1.7 million or 7%, resulting from, as described in further detail below, a decrease in operating expenses of $1.5 million, and an increase in other income of $0.2 million.

Previous wording

For the year ended December 31, 2023, research and development expenses increased by $3.7 million or 37%, to $13.6 million from $9.9 million for the year ended December 31, 2022. The increase is due to an increase of $2.7 million in costs for the SAVVE trial from $3.5 million in 2022 to $6.2 million in 2023, and $1.1 million in compensation from the increases in staffing also to support the SAVVE trial, partially offset by a decrease of $0.1 million in other lab costs for development and other preparation for the enVVe trials.

Current wording

For the year ended December 31, 2024, research and development expenses decreased by $1.4 million or 10%, to $12.2 million from $13.6 million for the year ended December 31, 2023. The decrease is due to a decrease of $2.2 million in costs for the SAVVE trial, and a $0.3 million decrease in other lab costs, partially offset by an increase of $0.9 million in employee compensation from the increases in staffing, and an increase of $0.2 million in costs related to the GLP study for the enVVe. Costs related to SAVVE decreased in 2024 because, after full enrollment in 2023, activity shifted to ongoing monitoring, data collection, and preparation and filing of the PMA. The increase in compensation cost is due to the hiring of additional personnel supporting ongoing VenoValve testing and trial activity in addition to the preparation for the enVVe GLP study.

Previous wording

For the year ended December 31, 2023, the Company incurred losses from operations of $25.2 million and used $18.9 million cash in operating activities. The net cash used in operating activities during 2023 increased by $3.3 million from $15.6 million for the year ended December 31, 2022, primarily due to the increase in research and development expenses from 2022 to 2023. Our cash balance as of December 31, 2023, is $3.6 million. In addition, we have $42.8 million in investments, for total cash and investments of $46.4 million.

Current wording

For the year ended December 31, 2024, the Company incurred losses from operations of $23.8 million and used $16.8 million cash in operating activities. The net cash used in operating activities during 2024 decreased by $2.1 million from $18.9 million for the year ended December 31, 2023, primarily due to the decrease in research and development expenses from 2023 to 2024. Our cash balance as of December 31, 2024, is $1.8 million. In addition, we have $41.4 million in investments, for total cash and investments of $43.2 million.

Previous wording

The operating losses and the uses of cash are primarily due to the Company’s product research and development and administrative activities. Administrative functions relate to costs to support the Company’s public reporting and investor relations activities as well as internal administrative functions. Research and development activities are for continued product development and clinical trials for the VenoValve and for the enVVe. The Company will continue to incur these costs to complete its clinical trials, enhance products, develop new products, and operate as a public company for the foreseeable future as we seek to obtain regulatory approval for our studies and product candidates. We are not currently generating revenue.

Current wording

The operating losses and the uses of cash are primarily due to the Company’s product research and development and administrative activities. Administrative functions relate to costs to support the Company’s public reporting and investor relations activities as well as internal administrative functions. Research and development activities are for continued product development and clinical trials for VenoValve and for enVVe. The Company will continue to incur these costs to complete its clinical trials, enhance products, develop new products, and operate as a public company for the foreseeable future as we seek to obtain regulatory approval for our studies and product candidates.

Previous wording

We do not currently have material commitments for capital expenditures or other expenditures with the exception of our facility lease commitment of $0.3 million per year. We expect a modest increase in purchases of property and equipment as we continue SAVVE, commence TAVVE, and plan for commercialization of the VenoValve.

Current wording

We do not currently have material commitments for capital expenditures or other expenditures with the exception of our facility lease commitment of $0.3 million per year. We expect a modest increase in purchases of property and equipment and in facility lease costs as we continue SAVVE, commence TAVVE, and plan for commercialization of the VenoValve.

Previous wording

Our future capital requirements will remain dependent upon a variety of factors, especially including the success of our clinical trials and related product development costs and our ability to successfully bring products to market. We anticipate that our cash burn rate will increase from current levels of approximately $4 million to $5 million per quarter to $5 million to $6 million per quarter in 2025. Even after considering this increase, we should have sufficient cash to fund operations through late 2025.

Current wording

Our future capital requirements will remain dependent upon a variety of factors, especially including the success of our clinical trials and related product development costs and our ability to successfully bring products to market. We anticipate that our cash burn rate will increase from current levels of approximately $4 million to $5 million per quarter to $5 million to $6 million per quarter in 2025. Even after considering this increase, we should have sufficient cash to fund operations through mid-2026.

Previous wording

We have historically funded our operations through financing activities such as the capital raise completed in 2023 and will need to raise additional capital in the future. Any inability to raise additional financing would have a material adverse effect on us.

Current wording

We have historically funded our operations through financing activities such as the capital raises completed in 2024 and 2023. We will need to raise additional capital in the future. Any inability to raise additional financing would have a material adverse effect on us.