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 ...

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, 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 33-09361 ...

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, 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 Hancock Jaffe Laboratories, Inc. (Exact name of registrant as specified in its charter) | 33-0936180 | | ...

HANCOCK JAFFE L A B O R A T O R I E S Nasdaq: HJLI May 2021 Setting New Standards for Venous Care Ladenburg Thalmann 2021 Healthcare Conference July 13, 2021 Robert Berman, Chief Executive Officer Legal Disclaimers This presentation contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward looking statements are not statements of historical facts, but rather reflect HJLI's curre ...