enVVeno Medical Reports Third Quarter 2021 Financial Results and Provides Corporate Update - Seite 2

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