– Ended the quarter with $51.3 million in cash – expected to fund operations through the end of 2024 including release of topline pivotal trial data
– Ongoing advancement of SAVVE U.S pivotal trial with 20 sites available to enroll patients
– Progress on development of second device for the treatment of venous disease expected to be unveiled in mid-2022
IRVINE, CA / May 2, 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 first quarter ended March 31, 2022.
“We made significant progress over the past four weeks and now have 20 clinical trial sites that are available to enroll patients in the SAVVE pivotal study. Our cash burn for the quarter was approximately $3.4 million, leaving us with over $51 million of capital at the end of the quarter. Even with moderate increases in cash burn that we expect as we progress deeper into the study, based on our current forecasts we believe we have sufficient cash to take us well beyond primary safety and efficacy data from the trial, which should be a major inflection point for our company,” commented enVVeno Medical CEO, Robert Berman.
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 First Quarter 2022
- The Company ended the quarter with $51.3 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 $5.3 million and $2.8 million for the three months ended March 31, 2022 and 2021, respectively, representing an increase in net loss of $2.5 million, or 89%, resulting from an increase in operating expenses.
- For the three months ended March 31, 2022, selling, general and administrative expenses increased by $2.6 million or 222%, to $3.8 million from $1.2 million for the three months ended March 31, 2021. Of this increase, $2.1 million was due to share based compensation from grants made during 2021, which increased share-based compensation cost to $2.2 million in 2022 from $0.1 million in 2021.
- For the three months ended March 31, 2022, research and development expenses decreased by $0.1 million or 5%, to $1.5 million from $1.6 million for the three months ended March 31, 2021. This decrease primarily results $0.3 million in costs related the Coreograft product development in 2021, which we did not incur in 2022 due the change in our strategic direction and decision to focus on development of the VenoValve, partially offset by a $0.2 million increase in lab and personnel costs to support the VenoValve pivotal trial and continued development.
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 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 U.S. pivotal trial 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
SOURCE: enVVeno Medical Corporation
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