– Quarter marked by corporate rebranding and strategic prioritization of development programs
– Company executing on SAVVE U.S pivotal trial evaluating lead product, the VenoValve®, as a potential treatment for severe deep venous Chronic Venous Insufficiency (CVI)
– Bolstered cash position with recently completed $20 million registered direct offering with leading life sciences investment firm
IRVINE, CA / November 11, 2021 / enVVeno Medical Corporation (NASDAQ:NVNO) (“enVVeno” or the “Company”), a company setting new standards of care for the treatment of venous disease, today reported its financial results for the quarter ended September 30, 2021.
The Company also provided an update on its lead product, the VenoValve®, a first-in-class implant being developed for the treatment of deep venous Chronic Venous Insufficiency (CVI).
- Successfully completed the first VenoValve surgery in the SAVVE U.S. pivotal trial;
- Closed a $20 million registered direct offering priced at-the-market under NASDAQ rules with a fund managed by Perceptive Advisors, a leading life sciences investment firm;
- Presented positive two-year post-VenoValve implantation data at the Society for Vascular Surgery® (SVS) Annual Meeting in San Diego, CA; and
- Received Breakthrough Device Designation status from the U.S. Food and Drug Administration (FDA) for the VenoValve.
“We have made significant progress on all strategic fronts over the past quarter. The launch of the SAVVE pivotal trial was a monumental achievement for the Company which represents the last study needed before we are able to submit for premarket approval of the VenoValve with the FDA,” commented enVVeno Medical CEO Robert Berman. “On the financial front, we have never been stronger. Having secured an additional $20 million in financing from a leading healthcare institutional investor, we now have sufficient capital to fund operations through what we hope will be regulatory approval of the VenoValve. Lastly, we realigned our corporate identity and now have a brand that reflects our overall mission and goals to establish enVVeno as a global leader for venous care.”
Clinical Program Update
The VenoValve, the Company’s lead product is currently being evaluated in the SAVVE pivotal trial and is intended to restore proper directional blood flow for patients with CVI of the deep veins of the leg. 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 studied. There are currently no effective treatments for patients with deep venous CVI resulting from malfunctioning valves.
The SAVVE ( S urgical A nti-reflux V enous V alve E ndoprosthesis) 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 first in-human VenoValve surgery in the U.S. was recently completed at Albany Medical College. The Company expects to enroll 75 patients at up to 20 centers throughout the U.S. and hopes to have topline safety and/or efficacy data from the SAVVE study by the end of 2022.
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 find a study center near them by visiting www.venovalve.com.
Additionally, the Company has begun development of a second device for the treatment of venous disease which the Company is calling enVVe. The Company expects to unveil enVVe in mid-2022.
Summary of Financial Results for the Third Quarter 2021
- The Company reported net losses of $2.4 million and $2.0 million for the three months ended September 30, 2021 and 2020, respectively, representing an increase in net loss of $0.4 million or 21%, due to an increase in operating expenses of $0.8 million, and a net increase in other income and expense of $0.4 million.
- For the three months ended September 30, 2021, selling, general and administrative expenses increased by $0.3 million or 27%, to $1.5 million from $1.2 million for the three months ended September 30, 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 three months ended September 30, 2021, research and development expenses increased by $0.5 million or 62%, to $1.2 million from $0.8 million for the three months ended September 30, 2020. The increase is primarily due to increases of $0.3 million in compensation and related costs due to a larger team in 2021, and $0.1 million in higher consulting costs and $0.1 million in lab testing, both related to preparations for the SAVVE study.
- On September 9, 2021, the Company entered a securities purchase agreement pursuant to which it completed a registered direct offering for aggregate net proceeds of approximately $18.3 million.
- The Company ended the quarter with $57.9 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 Q3 2022.
About enVVeno Medical Corporation
enVVeno Medical (Nasdaq: NVNO) is an Irvine, California-based medical device company focused on the development of innovative bioprosthetic (tissue-based) solutions to improve the standard of care in the treatment of venous disease. The Company’s lead product, the VenoValve®, 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
Michelle McAdam, Chronic Communications, Inc.
SOURCE: enVVeno Medical Corporation
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