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,contributingtototaldirectmedicalcostsexceeding3 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 6.4millionforthethreemonthsendedMarch31,2023,anincreaseof215.3 million in the same period of 2022[61]. - Research and development expenses increased by 125% to 3.6millionforthethreemonthsendedMarch31,2023,primarilyduetocostsrelatedtotheSAVVEstudy[64].−Selling,generalandadministrativeexpensesdecreasedby163.2 million for the three months ended March 31, 2023, down from 3.8millionin2022[63].−Thecompanyhadapproximately39.1 million in cash and investments at the end of 2022, which decreased to approximately 34.2millionbyMarch31,2023[58].−Thecompanyexpectstohavesufficientcashtofundoperationsthroughtheendof2024andinto2025atthecurrentcashburnrateofapproximately4 - 5 million per quarter[71]. - Other income for the three months ended March 31, 2023, was 0.4million,reflectinginterestandgainsfrominvestmentsinUSTreasurybills[65].−Thecompanyincurredlossesfromoperationsof6.8 million and used 5.1millionincashforoperatingactivitiesduringthethreemonthsendedMarch31,2023[66].FuturePlans−Thecompanyplanstocontinueinvestinginproductdevelopmentandclinicaltrials,particularlyfortheVenoValveandenVVe[67].−AsofApril26,2023,thecompanyhadcashandinvestmentbalancesof2.8 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].
