Financial Performance - The company reported net losses of $4.5 million for Q1 2025, a decrease of 10% from $5.0 million in Q1 2024[56]. - Other income decreased by $0.1 million or 25% to $0.4 million for the three months ended March 31, 2025, compared to $0.5 million for the same period in 2024[60]. - The company incurred losses from operations of $5.0 million and used $4.0 million in operating activities for the three months ended March 31, 2025, an increase of $0.4 million from $3.6 million in the same quarter of 2024[61]. - The increase in cash usage is primarily due to product research and development activities, including clinical studies for VenoValve and enVVe[62]. - The company does not currently generate revenue and does not expect significant revenue until successful commercialization of product candidates after FDA approval[63]. Research and Development - Research and development expenses decreased by $0.5 million or 19% to $2.6 million in Q1 2025, primarily due to lower costs related to the VenoValve pivotal study[58]. - The VenoValve pivotal study reached full enrollment on September 1, 2023, and is currently in the post-enrollment follow-up period[47]. - The company expects to file for IDE approval for the enVVe pivotal study in Q3 2025[54]. - The VenoValve has shown an 85% clinical meaningful benefit at one year, with an average improvement of 7.91 points in the revised Venous Clinical Severity Score (rVCSS)[50]. - The VenoValve is estimated to be eligible for FDA approval in the second half of 2025[51]. - The increase in cash usage is primarily due to product research and development activities, including clinical studies for VenoValve and enVVe[62]. Financial Position and Capital Requirements - The company finished 2024 with approximately $43.2 million in cash and investments, with an expected increase in cash burn rate to $4 million to $5 million per quarter[55]. - Future capital requirements will depend on the success of clinical studies and product development costs, with an anticipated cash burn rate increasing to $5 million per quarter[65]. - The company has sufficient capital resources to meet obligations for at least one year after March 31, 2025, based on current cash and working capital[66]. - The company expects a modest increase in property and equipment purchases as it continues clinical studies and plans for commercialization of VenoValve[64]. Market Context - The total direct medical costs from venous ulcer sufferers in the U.S. exceed $3 billion annually[45]. - Approximately 20 million people in the U.S. are estimated to suffer from severe deep venous CVI (C4 to C6 disease) with reflux[45].

Financial Performance - The company reported net losses of $21.8 million for the year ended December 31, 2024, a decrease of 7% from the $23.5 million loss in 2023[173]. - The company incurred losses from operations of $23.8 million and used $16.8 million in cash for operating activities in 2024, a decrease from $18.9 million in 2023[179]. - The cash balance as of December 31, 2024, was $1.8 million, with total cash and investments amounting to $43.2 million[179]. - The company anticipates an increase in cash burn rate to $5 million to $6 million per quarter in 2025, while having sufficient cash to fund operations through mid-2026[183]. Expenses - Research and development expenses decreased by 10% to $12.2 million in 2024 from $13.6 million in 2023, primarily due to reduced costs for the SAVVE trial[174]. - Selling, general and administrative expenses decreased by 1% to $11.6 million in 2024, driven by a $1.1 million reduction in share-based compensation[176]. Income and Investments - Other income increased to $2.0 million in 2024 from $1.7 million in 2023, reflecting realized gains and interest from investments in U.S. Treasury securities[178]. - The company has no current revenue and relies on future commercialization of its products for potential income[172]. Future Plans - The company aims to receive FDA approval for the VenoValve in 2026 and has begun limited activities toward commercial launch[181]. - The company expects a modest increase in capital expenditures related to ongoing clinical trials and commercialization efforts[182].

Core Insights - enVVeno Medical's submission of the final module for VenoValve's Premarket Approval (PMA) application to the FDA is a significant milestone in addressing the treatment of Chronic Venous Insufficiency (CVI) [1][4] - The device targets a market of approximately 2.5 million candidates annually in the U.S., positioning enVVeno to potentially transform the standard of care for venous disease [2] - Despite a recent 5.5% drop in share price to $3.41, the latest development is expected to positively influence market sentiment towards NVNO stock [3][4] Company Developments - The latest submission is the fifth and final module of the FDA application, containing favorable clinical data, following the approval of the previous four modules [4] - NVNO's market capitalization stands at $59.8 million, with an estimated earnings growth of 31.9% projected for 2024 [5] - VenoValve's PMA approval could significantly expand enVVeno's portfolio of bioprosthetic solutions, aligning with the company's mission to develop innovative treatments for venous disease [6][8] Market Potential - The global venous disease treatment market was valued at $6.17 billion in 2023 and is projected to reach $10.85 billion by 2031, growing at a CAGR of 7.30% [9] - The market expansion is driven by the rising prevalence of diabetes and advancements in technology, indicating a favorable environment for enVVeno's growth [9] Competitive Position - VenoValve's pending approval is expected to catalyze enVVeno's growth in the medical device market, fostering new revenue streams and enhancing its competitive position [7] - The planned pivotal trial for the enVVe valve in mid-2025 further emphasizes enVVeno's focus on innovation and market expansion [7]

Clinical Trials and Device Development - The VenoValve is currently being evaluated in the SAVVE trial, with definitive one-year data expected in Q4 2024[33]. - The SAVVE trial achieved full enrollment of 75 subjects on September 1, 2023, across 21 U.S. sites[46]. - Preliminary data from the SAVVE study indicated an 8% rate of device-related material adverse events (MAEs) among the 75 subjects, with no deaths reported[48]. - At six months, 97% of patients showed clinical improvement as measured by the revised Venous Clinical Severity Score (rVCSS), with 74% achieving a clinically meaningful benefit[49]. - The average improvement in rVCSS among the clinically meaningful benefit cohort was 8 points, significantly exceeding the required improvement[50]. - For venous ulcer patients in the SAVVE study, 91% showed healing or improvement at one year, with 100% of ulcers lasting one year or less fully healed[51]. - The company expects to file the final module of its premarket approval (PMA) application for the VenoValve in Q4 2024, having already filed four of the five required modules[52]. - The enVVe valve is being developed for non-surgical treatment of CVI, targeting an estimated market of 3.5 million patients in the U.S.[53]. - The company is conducting pre-clinical testing on enVVe, with plans to file for IDE approval for its pivotal trial in mid-2025[34]. - The company plans to file for IDE approval for the enVVe pivotal study in mid-2025, following the completion of a six-month pre-clinical GLP study[54]. Financial Performance - The company reported a net loss of $5.6 million for the three months ended September 30, 2024, an increase of 12% compared to a net loss of $5.0 million for the same period in 2023[59]. - Research and development expenses for the three months ended September 30, 2024, increased by 2% to $2.9 million from $2.8 million in the prior year[60]. - Selling, general and administrative expenses rose by 27% to $3.3 million for the three months ended September 30, 2024, compared to $2.6 million in the same period in 2023[60]. - The company closed a public offering on September 30, 2024, raising approximately $13.6 million in net cash proceeds, which is expected to fund operations through significant milestones[57]. - As of September 30, 2024, the company had approximately $48.4 million in cash and investments, up from $46.4 million at the end of 2023[55]. - The anticipated cash burn rate is expected to increase to $4 million to $5 million per quarter as clinical trials progress[56]. - For the nine months ended September 30, 2024, the company reported a net loss of $15.6 million, a decrease of 13% from a net loss of $17.9 million for the same period in 2023[61]. - Other income increased by 52% to $0.5 million for the three months ended September 30, 2024, compared to $0.3 million in the prior year[61]. - The company incurred $11.7 million in cash used in operating activities for the nine months ended September 30, 2024, a decrease of $2.2 million from $13.9 million in the same period in 2023[67].

Clinical Trials and Product Development - The VenoValve is currently being evaluated in the SAVVE trial, with patients reporting reduced pain and enhanced quality of life[26] - The company expects to file for FDA approval of the VenoValve in Q4 2024, followed by the enVVe in 2026[27] - The SAVVE trial achieved full enrollment of 75 subjects on September 1, 2023, four months earlier than expected due to increased demand[38] - Preliminary data from the SAVVE study indicated an 8% rate of device-related material adverse events within 30 days of enrollment[40] - At the six-month mark, 97% of patients showed clinical improvement as measured by rVCSS, with an average improvement of 8 points[41] - The VenoValve has been granted Breakthrough Device designation by the FDA, indicating its potential significance in treating severe CVI[34] - The company is also developing the enVVe, a non-surgical replacement venous valve system, with IDE approval expected in Q2 2025[26] - The average improvement in the Clinical Meaningful Benefit cohort was 8.46 points, with 94% of patients showing clinical improvement at a follow-up of 11.04 months[42] - In the SAVVE study, 91% of venous ulcer patients evaluated at one year either had fully healed ulcers or ulcers that had improved, with 100% of ulcers lasting one year or less fully healed[43] - The company expects to file the PMA application for the VenoValve in Q4 of 2024, pending one-year data for all 75 patients[44] - The enVVe system targets approximately 3.5 million patients in the U.S. market for the treatment of chronic venous insufficiency (CVI)[44] Financial Performance - Research and development expenses decreased by 33.3% to $2.8 million for the three months ended June 30, 2024, compared to $4.2 million for the same period in 2023[48] - The company reported net losses of $5.0 million for the three months ended June 30, 2024, a decrease of 23.1% from $6.5 million in the same period in 2023[46] - Selling, general and administrative expenses remained flat at $2.6 million for the three months ended June 30, 2024, compared to the same period in 2023[48] - The company incurred a net loss of $10.0 million for the six months ended June 30, 2024, a decrease of 22.5% from $12.9 million in the same period in 2023[51] - Cash burn rate is expected to increase from approximately $4 million to $5 million per quarter as clinical trials progress[55] - The company had approximately $39.1 million in cash and investments as of June 30, 2024[46] Market Impact and Patient Statistics - Approximately 20 million people in the U.S. suffer from severe deep venous CVI (C4 to C6 disease) with reflux[32] - The average annual treatment cost for a patient with a venous ulcer is estimated at $30,000, with total direct medical costs exceeding $3 billion annually in the U.S.[32] - Severe CVI patients miss approximately 40% more workdays than the average worker, highlighting the condition's impact on quality of life[31]

Clinical Trials and Device Development - The VenoValve is currently being evaluated in the SAVVE trial, with patients reporting reduced pain and enhanced quality of life[41] - The SAVVE trial achieved full enrollment of 75 subjects on September 1, 2023, four months earlier than expected due to increased demand[59] - Preliminary device-related adverse event data from the SAVVE study indicated an 8% rate of material adverse events within 30 days of enrollment[60] - At the six-month mark, 97% of patients in the SAVVE study showed clinical improvement as measured by rVCSS, with an average improvement of 8 points[61] - The VenoValve has been granted Breakthrough Device designation by the FDA, indicating its potential significance in treating severe CVI[51] - The VenoValve showed a clinical improvement in 94% of study patients, with an average improvement of 8.46 points in rVCSS[62] - The company expects to file the PMA application for the VenoValve in Q4 2024, pending one-year data for all 75 patients[63] - The company expects to file for IDE approval for the enVVe pivotal trial in Q2 of 2025[42] - The company plans to start a six-month chronic GLP study for the enVVe valve in Q3 2024, with IDE approval expected to be filed in Q2 2025[65] Market and Financial Overview - Approximately 20 million people in the U.S. are estimated to suffer from severe deep venous CVI (C4 to C6 disease) with reflux[50] - The average annual treatment cost for a patient with a venous ulcer is estimated at $30,000, with total direct medical costs exceeding $3 billion annually in the U.S.[50] - The enVVe system targets an estimated U.S. market of approximately 3.5 million patients with less severe CVI[64] - The company reported net losses of $5.0 million for Q1 2024, a decrease of 22% from $6.4 million in Q1 2023[67] - Research and development expenses decreased by 14% to $3.1 million in Q1 2024, down from $3.6 million in Q1 2023[69] - Selling, general and administrative expenses decreased by 22% to $2.5 million in Q1 2024, compared to $3.2 million in Q1 2023[70] - Other income increased by 25% to $0.5 million in Q1 2024, up from $0.4 million in Q1 2023[71] - The company finished 2023 with approximately $46.4 million in cash and investments, and had approximately $42.9 million as of March 31, 2024[66] - The company anticipates a cash burn rate increase from approximately $4 million to $5 million per quarter as clinical trials progress[75] Regulatory and Approval Timeline - The VenoValve is projected to be eligible for FDA approval in Q4 of 2024, with enVVe expected to follow two to three years later[44]

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].