Product Development and Regulatory Approval - The VenoValve® is currently being evaluated in a U.S. pivotal study, with an estimated 2.5 million people in the U.S. being candidates for this surgical replacement venous valve[18][28]. - The first-in-human study for the VenoValve showed an average improvement of 6 points in rVCSS scores, a 54% improvement in popliteal reflux time, and a 76% improvement in VAS pain scores after one year[30]. - The FDA granted Breakthrough Device Designation status to the VenoValve on August 3, 2020, to expedite its development and review process[33]. - The SAVVE pivotal study has achieved full enrollment of 75 subjects, approximately four months earlier than expected due to increased demand for the VenoValve[37]. - Preliminary device-related Material Adverse Event (MAE) data from the SAVVE study indicated an 8% MAE rate, with no deaths or pulmonary embolisms reported among the fully enrolled cohort[38]. - The company expects to release initial topline rVCSS efficacy data from the SAVVE study on March 6, 2024, and plans to file for pre-market approval in Q4 of 2024[39]. - The enVVe® is a non-surgical transcatheter-based replacement venous valve, with an estimated U.S. market of approximately 3.5 million patients[42]. - The company plans to expedite the development of enVVe, starting a six-month Good Laboratory Practice animal study in Q1 2024 and aiming to file for IDE approval by the end of 2024[41]. - The company received regulatory approval from the Colombian FDA for its first-in-human study for the VenoValve in December 2018[51]. - The FDA requires extensive clinical trials to support PMA submissions, which must demonstrate the safety and effectiveness of the devices[47]. - The company is subject to rigorous regulation by the FDA and comparable agencies in other jurisdictions, which can delay or deny product approvals[63]. - The company must comply with extensive post-market regulations, including medical device reporting and post-market surveillance activities[50]. - The FDA approval process for the company's product candidates is complex and can take years, with no guarantee of success[102]. - Legislative changes in the U.S. and EU may increase costs and complicate regulatory approvals for product candidates[108]. - The transition from EU Medical Device Directives (MDD) to Medical Device Regulation (MDR) introduces stricter clinical requirements and a centralized database for public transparency[110]. - The FDA may require additional testing and impose costs for corrective actions related to product deficiencies, potentially delaying market re-entry[112]. Financial Performance and Projections - The company incurred net losses of $23.5 million and $24.7 million for the years ended December 31, 2023 and 2022, respectively[59]. - The company has not generated revenue from operations and expects to incur losses for the foreseeable future as it seeks regulatory approval[59]. - The company has recorded a full valuation allowance related to its NOLs and deferred tax assets due to uncertainty in realizing future tax benefits[95]. - The company may face limitations on utilizing its NOLs due to ownership changes, which could affect its future taxable income[94][95]. - The company has federal research and development tax credit carryforwards of approximately $0.2 million, expiring in 2027[96]. - The company has sufficient capital resources to meet obligations for at least one year after the date of the Annual Report[187]. - The cash balance as of December 31, 2023, is $3.6 million, with total cash and investments amounting to $46.4 million[183]. - Future cash burn rate is expected to increase from approximately $4 million to $5 million per quarter to $5 million to $6 million per quarter by 2025[186]. - The company does not currently generate revenue and will continue to incur costs for product development and clinical trials[184]. - Other income in 2023 was $1.7 million, consisting of $1.2 million in interest income and realized gains, and $0.5 million of unrealized gains[182]. - The company has no material commitments for capital expenditures, except for a facility lease commitment of $0.3 million per year[185]. - The company reported net losses of $23.5 million for the year ended December 31, 2023, a decrease of 5% from the $24.7 million loss in 2022[178]. - Selling, general and administrative expenses decreased by $3.3 million or 22%, from $15.0 million in 2022 to $11.7 million in 2023, primarily due to lower share-based compensation[179]. Operational Risks and Challenges - The company currently lacks a sales and marketing infrastructure, which may hinder the commercialization of approved product candidates[87]. - The medical device industry is highly competitive, and the company must continue to innovate to avoid obsolescence[79]. - Regulatory approval processes for product candidates can be lengthy and costly, impacting time to market[78]. - The company faces risks related to supply chain disruptions and price fluctuations due to reliance on third-party suppliers[73]. - The company relies on a limited number of suppliers for porcine tissue, and any loss of these suppliers could adversely impact operations[71]. - The manufacturing facility in Irvine, California is critical for production, and any disruption could significantly impair the ability to produce product candidates[84]. - The company has experienced negative operating cash flows since inception and primarily funded operations through capital stock sales and note issuances[66]. - Future capital requirements are significant, and the inability to raise adequate funds may lead to asset liquidation or program delays[67]. - Insufficient funds may require the company to delay product development or commercialization, potentially harming operating results[68]. - The company may need to cease manufacturing and distribution of affected products if malfunctions occur, which could harm its business and financial condition[107]. - The company may face civil liability and litigation if it experiences a data breach, which could negatively impact its business[126]. - The company has limited ability to ensure third-party manufacturers comply with applicable regulations, which could cause delays in product delivery[127]. - The trading price of the company's securities is likely to be volatile and subject to wide fluctuations due to various factors[142]. - Future sales or issuances of substantial amounts of the company's common stock could result in significant dilution[146]. Management and Governance - The company has 31 full-time employees and maintains good relations with its workforce[54]. - Matthew M. Jenusaitis has over 30 years of healthcare experience, focusing on building and selling medical device companies for vascular diseases[206]. - Robert C. Gray helped increase Highmark's revenues from $6.9 billion to $12.3 billion, generating an operating gain of $375 million from an operating loss of $91 million[207]. - Craig Glynn has over 39 years of financial services experience, including roles as Chief Financial Officer for various companies[209]. - The board of directors currently consists of five members, with staggered three-year terms for each class of directors[215]. - The company has no formal policy regarding board diversity, focusing instead on professional accomplishments and contributions to the board's collaborative culture[214]. - The company does not have a formal policy on whether the roles of Chief Executive Officer and Chairman should be separate[213]. - The board of directors meets regularly to provide oversight and strategic guidance to management[213]. - The company prioritizes the identification of board members who can further stockholder interests through their professional accomplishments[214]. - All required Section 16(a) reports were filed on a timely basis during fiscal year 2023[212]. Compliance and Legal Risks - The company is subject to various governmental regulations related to manufacturing, which could incur significant expenses and delays in product commercialization[127]. - The company must comply with extensive regulatory requirements in the U.S. and foreign jurisdictions, which could impact its operations and financial condition[98][100]. - Non-compliance with healthcare laws, such as the Anti-Kickback Statute, could result in civil penalties up to $25,000 and criminal fines[113]. - Medicare payment reductions of up to 2% per fiscal year are in effect through 2024 due to the Budget Control Act of 2011[118]. - Future healthcare reforms may limit government payments for healthcare products, impacting demand for product candidates[119]. - Relationships with physician consultants are subject to scrutiny, and violations could lead to administrative and civil penalties[121]. - HIPAA and HITECH Act compliance is mandatory, with penalties for violations potentially reaching up to $1.5 million per year[123]. - The HITECH Act expands penalties for HIPAA violations and allows state attorneys general to enforce federal laws, increasing compliance risks[124]. - The company faces risks related to product liability claims, which could lead to significant litigation costs and decreased demand for its product candidates[89][91].

Product Development and Clinical Studies - The VenoValve® is currently being evaluated in a U.S. pivotal study, with expectations for FDA approval in Q4 of 2024[46][65]. - The first-in-human study for the VenoValve showed a 54% improvement in reflux time, a 56% improvement in Venous Clinical Severity Scores (VCSS), and a 76% improvement in visual analog scale (VAS) pain scores after one year[57]. - The VenoValve has received Breakthrough Device Designation from the FDA, facilitating priority review for its approval[60]. - The SAVVE pivotal study has achieved full enrollment of 75 subjects, four months ahead of schedule, with initial safety data expected in Q4 of 2023[65]. - The company plans to expedite the development of enVVe, with a six-month GLP animal study expected to begin in Q1 of 2024[67]. - The VenoValve is estimated to be suitable for approximately 2.5 million patients with severe deep venous CVI in the U.S.[54]. - The enVVe® non-surgical transcatheter valve is expected to target approximately 3.5 million patients in the U.S. market[68]. Financial Performance - The company reported net losses of $5.0 million for the three months ended September 30, 2023, a decrease of 18% from a net loss of $6.1 million in the same period of 2022[71]. - The company incurred a net loss of $17.9 million for the nine months ended September 30, 2023, a decrease of 3% from a net loss of $18.5 million in the same period of 2022[76]. - Selling, general and administrative expenses decreased by $1.1 million or 30% to $2.6 million for the three months ended September 30, 2023, compared to $3.7 million in the prior year[73]. - Selling, general and administrative expenses decreased by $3.0 million or 26% to $8.4 million for the nine months ended September 30, 2023, compared to $11.4 million in the prior year[79]. - Research and development expenses increased by $0.3 million or 12% to $2.8 million for the three months ended September 30, 2023, primarily due to increased personnel and lab costs for the SAVVE study[74]. - Research and development expenses increased by $3.5 million or 49% to $10.6 million for the nine months ended September 30, 2023, primarily due to costs related to the SAVVE study[81]. - The company used $13.9 million in cash for operating activities for the nine months ended September 30, 2023, an increase of $2.1 million from $11.8 million in the same period of 2022[83]. - The company raised approximately $25.7 million in net cash proceeds from a financing offering closed on October 11, 2023, which is expected to fund operations through significant milestones[87]. - As of October 23, 2023, the company had cash and investment balances of $1.9 million and $48.6 million, respectively[88]. - The company does not currently generate revenue and does not expect significant revenue until successful commercialization of its product candidates[76]. Market Context - Approximately 20 million people in the U.S. are estimated to suffer from severe deep venous Chronic Venous Insufficiency (CVI), with 3.5 million new cases diagnosed annually[53]. - The average annual treatment cost for a patient with a venous ulcer is estimated at $30,000, contributing to total direct medical costs exceeding $3 billion annually in the U.S.[53].

Product Development and Clinical Trials - enVVeno Medical Corporation is focused on developing innovative bioprosthetic solutions for Chronic Venous Disease (CVD), which affects approximately 71% of the adult population in the U.S.[45] - The lead product, VenoValve®, is currently in a pivotal study and has shown an average improvement of 54% in reflux, 56% in Venous Clinical Severity Scores (VCSS), and 76% in pain scores (VAS) after one year in a first-in-human study[56] - The VenoValve is expected to be eligible for FDA approval first, followed by the enVVe® valve two to three years later, with an estimated 2.5 million candidates for VenoValve in the U.S.[47][54] - The enVVe® valve is a non-surgical option currently awaiting approval for an early feasibility study, targeting an estimated market of approximately 3.5 million patients in the U.S.[63][64] - The company has enrolled 57 subjects in the SAVVE trial and expects to achieve full enrollment of 75 subjects by the end of 2023[62] - The VenoValve received Breakthrough Device Designation from the FDA, which aims to expedite the development and review of devices for life-threatening conditions[58] - The first-in-human study for VenoValve included 11 patients, with significant improvements in clinical outcomes and no reported safety issues from one year to three years post-surgery[60][61] - Severe CVI patients miss approximately 40% more workdays than average workers, highlighting the significant impact of the disease on quality of life[52] - The company hired 4 Clinical Technologists to assist in training site personnel for the SAVVE study, addressing staffing shortages in hospitals[85] Financial Performance - The company reported net losses of $6.5 million for the three months ended June 30, 2023, a decrease of 8% compared to a net loss of $7.1 million for the same period in 2022[67] - Selling, general and administrative expenses decreased by $1.3 million or 33% to $2.6 million for the three months ended June 30, 2023, primarily due to a decrease in share-based compensation[69] - Research and development expenses increased by $1.1 million or 35% to $4.2 million for the three months ended June 30, 2023, mainly due to costs related to the SAVVE study[71] - The company incurred a net loss of $12.9 million for the six months ended June 30, 2023, an increase of 4% compared to a net loss of $12.4 million for the same period in 2022[73] - Cash and investments as of June 30, 2023, were approximately $39.1 million, with a cash burn rate of approximately $4 - 5 million per quarter, expected to fund operations through the end of 2024 and into 2025[82] - The company purchased $15.1 million of treasury bills during the six months ended June 30, 2023, and generated $0.3 million in realized gains and interest income from matured treasury bills[80] - Other income increased to $0.3 million for the three months ended June 30, 2023, compared to a net expense of $0.1 million for the same period in 2022, reflecting higher yields from investments in US Treasuries[72] - Research and development expenses for the six months ended June 30, 2023, increased by $3.1 million or 66% to $7.8 million, primarily due to costs related to the SAVVE study[76] - The company has sufficient capital resources to meet obligations for at least one year after the date of the report[83] Operational Overview - The company operates in a 14,507 sq. ft. ISO 13485-2016 certified facility in Irvine, California, dedicated to the design and manufacturing of tissue-based implantable medical devices[48]

Chronic Venous Disease and Treatment - Chronic Venous Disease (CVD) affects approximately 71% of the adult population in the U.S., with severe Chronic Venous Insufficiency (CVI) impacting around 20 million people[38][46]. - The average annual treatment cost for a patient with a venous ulcer is estimated at $30,000, contributing to total direct medical costs exceeding $3 billion annually in the U.S.[46]. - The enVVe™, a non-surgical transcatheter replacement venous valve, is expected to target approximately 3.5 million patients in the U.S. market[56][57]. VenoValve Development and Trials - The VenoValve, a first-in-class surgical replacement venous valve, is currently being evaluated in a pivotal study, with an estimated 2.5 million candidates in the U.S.[39][47]. - Results from a first-in-human study of the VenoValve showed an average improvement of 54% in reflux, 56% in Venous Clinical Severity Scores (VCSS), and 76% in pain scores (VAS) at one year post-surgery[49]. - The FDA granted Breakthrough Device Designation status to the VenoValve, aimed at expediting its development and review process[51]. - The VenoValve's pivotal trial, known as SAVVE, has expanded to include up to 30 clinical sites across the U.S.[52]. - Preliminary safety data from the SAVVE trial indicated one mild device-related and two moderate procedure-related adverse events among the first twenty patients[54]. - The VenoValve has shown no recurrences of severe CVI or venous ulcers in a three-year follow-up of study participants[53]. - The company has filed numerous patent applications for the VenoValve, with 19 patents granted globally, including 5 from the USPTO[59]. Financial Performance - The company reported net losses of $6.4 million for the three months ended March 31, 2023, an increase of 21% from a net loss of $5.3 million in the same period of 2022[61]. - Research and development expenses increased by 125% to $3.6 million for the three months ended March 31, 2023, primarily due to costs related to the SAVVE study[64]. - Selling, general and administrative expenses decreased by 16% to $3.2 million for the three months ended March 31, 2023, down from $3.8 million in 2022[63]. - The company had approximately $39.1 million in cash and investments at the end of 2022, which decreased to approximately $34.2 million by March 31, 2023[58]. - The company expects to have sufficient cash to fund operations through the end of 2024 and into 2025 at the current cash burn rate of approximately $4 - 5 million per quarter[71]. - Other income for the three months ended March 31, 2023, was $0.4 million, reflecting interest and gains from investments in US Treasury bills[65]. - The company incurred losses from operations of $6.8 million and used $5.1 million in cash for operating activities during the three months ended March 31, 2023[66]. Future Plans - The company plans to continue investing in product development and clinical trials, particularly for the VenoValve and enVVe[67]. - As of April 26, 2023, the company had cash and investment balances of $2.8 million and $31.0 million, respectively[73]. - The company has hired 4 Clinical Technologists to assist with training and support for the SAVVE study amid staffing shortages in hospitals[55].

Financial Performance - The company reported a net loss of $24.7 million for the year ended December 31, 2022, compared to a net loss of $16.5 million in 2021, representing an increase of 50% or $8.2 million [183]. - Selling, general and administrative expenses rose by 34% to $15.0 million in 2022 from $11.2 million in 2021, with share-based compensation costs increasing to $9.0 million from $6.0 million [184]. - The company has not generated any revenue and does not expect to do so in the near term, as future revenue depends on the commercialization of product candidates [182]. Research and Development - Research and development expenses increased by 74% to $9.9 million in 2022 from $5.7 million in 2021, primarily due to costs associated with the SAVVE trial and preparation for the enVVe first-in-human trial [187]. Cash and Investments - The company has a cash balance of $4.6 million and $34.5 million in investments, totaling $39.1 million in cash and investments as of December 31, 2022 [194]. - The company expects to have sufficient cash to fund operations through the end of 2024 and into 2025, with a cash burn rate of approximately $4 million to $5 million per quarter [195]. - The company plans to continue investing in U.S. Treasury bills, having purchased $48.1 million in 2022, generating $0.2 million in realized gains and interest income [192]. Product Development - The lead product, VenoValve®, is currently being evaluated in a U.S. pivotal study, with expectations for FDA approval ahead of the enVVe product [179]. - The company anticipates that the VenoValve and enVVe will co-exist post-approval, addressing a significant unmet need in the treatment of deep venous chronic venous insufficiency [180]. Operations - The company operates from a 14,507 sq. ft. ISO 13485-2020 certified facility in Irvine, California, focused on the design and manufacturing of tissue-based implantable medical devices [181].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________ to ___________________ Commission file number: 001-38325 enVVeno Medical Corporation (Exact name of registrant as specified in its charter) Delaware 33-09361 ...

| --- | --- | --- | --- | |-------|-------|-------|-------| | | | | | | | | | | Legal Disclaimers This presentation and any statements of stockholders, directors, employees, representatives and partners of enVVeno Medical, Inc. (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements m ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to ___________________ Commission file number: 001-38325 enVVeno Medical Corporation (Exact name of registrant as specified in its charter) (State or other jurisdiction of inco ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-38325 enVVeno Medical Corporation (Exact name of registrant as specified in its charter) Delaware 33-0936180 (State or other jurisdiction of incorporation or organization) Identification No.) For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANG ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________ to ___________________ Commission file number: 001-38325 enVVeno Medical Corporation (Exact name of registrant as specified in its charter) Delaware 33-0936180 (State ...