enVVeno Medical Reports Fourth Quarter and Year-End 2021 Financial Results and Provides Corporate Update

  • Ended the Year With $55 Million in Cash Expected To Fund Operations Through the End of 2024 Including Release of Topline Pivotal Trial Data
  • Nine (9) VenoValve Surgeries Successfully Completed and 16 Clinical Sites Currently Active in Ongoing SAVVE U.S Pivotal Trial
  • Continued Advancement in Development of Second Device for the Treatment of Venous Disease Expected To Be Unveiled in Mid-2022

IRVINE, CA / ACCESSWIRE / March 28, 2022 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today provided a corporate update and reported financial results for the fourth quarter and year-end of 2021.

Recent Highlights

  • Successfully completed 9 VenoValve surgeries and 16 sites currently activated in the Company's SAVVE U.S. pivotal trial for the VenoValve;
  • Presented positive long-term VenoValve first-in-human data at the 34th Annual Meeting of the American Venous Forum;
  • Announced publication of one-year VenoValve data in the peer-reviewed journal, Vascular and Endovascular Surgery; and
  • Announced ISO 13485 Quality Management System certification, representing an important step towards commercialization.

The Company ended 2021 with approximately $55 million of cash and cash equivalents having raised in excess of $62 million of capital in 2021. The Company also had its Investigational Device Exemption (IDE) approved by the U.S. Food and Drug Administration (FDA) and began the U.S. pivotal trial for the VenoValve, the Company's lead product, which also received Breakthrough Device Designation from the FDA in 2021. As a late-stage clinical company, the Company's focus has begun to shift towards commercialization, and the requirements necessary to manufacture and distribute the VenoValve. In early 2022, the Company announced that it had received ISO 13485 certification for its Irvine facility covering the design, development, and manufacture of tissue based implantable medical devices. Progress has continued on a second product for the treatment of venous disease which the Company expects to announce in mid-2022.

"This past year was marked by execution in all critical areas of our business including financial, clinical, regulatory and operations. More recently, we worked through the challenges brought on by the COVID resurgence and are now seeing increased activity in our U.S. pivotal trial in both site activations and patient enrollment, with our 10th VenoValve surgery scheduled to take place before the end of the month," commented enVVeno Medical CEO, Robert Berman. "Importantly, our strong cash position enables us to focus on executing the clinical trial with the thoughtfulness and attention to detail necessary to achieve the highest quality clinical study result. That is how we can best use our capital to build long-term shareholder value and bring relief to the millions of CVI sufferers with no current effective treatment options."

Clinical Program Update

The SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) U.S. pivotal trial is a prospective, non-blinded, single arm, multi-center trial designed to evaluate the safety and efficacy of the VenoValve to improve lower leg blood flow, alleviate symptoms and improve quality of life for patients suffering from CVI caused by dysfunctional valves in the deep veins of the lower leg. The Company expects to enroll 75 patients in the SAVVE U.S. pivotal trial at up to 20 centers across the U.S. Enrollment is expected to be completed in the first quarter of 2023, with primary safety and efficacy data expected in the second half of 2023.

CVI occurs when the natural valves inside of the veins fail, causing blood to flow in the wrong direction (reflux), and creating increased pressure inside of the veins of the leg (venous hypertension). CVI can cause the leg to swell, and blood vessels to break, resulting in discoloration, pain, and the breakdown of the skin leading to venous ulcers (open sores) which are difficult to treat. The Company estimates that approximately 2.4 million people in the U.S. have the type of CVI for which the VenoValve is being evaluated. There are currently no effective treatments for patients with deep venous CVI resulting from malfunctioning valves.

Patients suffering from lower leg swelling, pain, non-healing leg sores, enlarged veins, and/or brownish or blueish skin discoloration - who may also have leg pain when standing or walking - may be candidates for the SAVVE trial. Interested patients can learn more about the SAVVE trial and fill out a pre-qualification questionnaire by visiting www.VenoValve.com.

In addition to the VenoValve, the Company is making progress on the development of a second device for the treatment of venous disease, which it expects to unveil in mid-2022.

Summary of Financial Results for the Full Year 2021

  • The Company ended the year with $55 million in cash and cash equivalents. Based on management's current expectations, the Company believes it has sufficient cash to sustain operations at least through the end of 2024.
  • The Company reported net losses of $16.5 million and $9.1 million for the year ended December 31, 2021 and 2020, respectively, representing an increase in net loss of $7.4 million or 81%, due to an increase in operating expenses of $7.8 million, and a net increase in other income and expense of $0.4 million.
  • For the year ended December 31, 2021, selling, general and administrative expenses increased by $6.3 million or 129%, to $11.2 million from $4.9 million for the year ended December 31, 2020. The net increase reflects increases in compensation due to higher share-based compensation in 2021 and increases in personnel and corporate expenses. These increases were partially offset by lower legal expenses due to the resolution of a number of legal matters during 2020.
  • For the year ended December 31, 2021, research and development expenses increased by $1.4 million or 35%, to $5.7 million from $4.3 million for the year ended December 31, 2020. The increase is primarily due to an increase of $1.1 million in compensation and related costs due to a larger team in 2021, $0.5 million in higher lab costs and supplies, also to support the SAVVE trial and product development, an increase of $0.4 million for lab quality testing to prepare for regulatory audits and the SAVVE trial, partially offset by a $0.6 million decrease in trial related consulting as the Columbian first in human trial wrapped up in 2020 and the SAVVE trial was not launched until late in 2021.

About enVVeno Medical Corporation

enVVeno Medical (NASDAQ:NVNO) is an Irvine, California-based, late clinical-stage medical device company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve the standard of care in the treatment of venous disease. The Company's lead product, the VenoValveĀ®, is a first-in-class implant being developed for the treatment of deep venous Chronic Venous Insufficiency (CVI). In healthy patients, valves inside the veins of the leg assist in propelling blood up the leg, and back to the heart and lungs. Affecting approximately 2.4 million people in the United States, CVI 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 and become chronic. Implanted into the femoral vein, the VenoValve is designed to act as a one-way valve, to help restore proper blood flow in the leg. The VenoValve is currently being evaluated in the SAVVE pivotal study with data expected in late 2022.

Cautionary Note on Forward-Looking Statements

This press release and any statements of stockholders, directors, employees, representatives and partners of enVVeno Medical Corporation (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 may include, without limitation, statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results (including, without limitation, with respect to our name change, our progress with the VenoValve and the expected timeline related to the SAAVE U.S. pivotal trial, including the timing of beginning patient enrollment, the VenoValve's ability to fill the unmet medical needs of CVI sufferers and our development of a second device for the treatment of venous disease) may differ significantly from those set forth or implied in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required by applicable law.

Jenene Thomas, JTC Team, LLC
(833) 475-8247

SOURCE: enVVeno Medical Corporation


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