What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-05-06 compared with 2025-10-30 · 192 added, 289 removed, 75 unchanged (87% of the section changed)

26 unchanged sentences

or the “Company” are to enVVeno Medical Corporation

Medical Corporation is a late clinical-stage medical device company focused on the advancement of innovative bioprosthetic (tissue-based)

solutions to improve the standard of care for the treatment of deep venous disease.

Chronic Venous Disease (CVD) is the world’s

most prevalent chronic disease, impacting approximately 70% of the adult population of the U.S.

Medical Corporation is a medical device company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve

the standard of care for the treatment of venous disease.

Chronic Venous Disease (“CVD”) is the world’s most prevalent

chronic disease, impacting approximately 70% of the adult population of the U.S.

Chronic Venous Insufficiency (“CVI”), is

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cases, venous ulcers that are difficult to heal.

The Company is developing surgical and non-surgical replacement venous valves for patients

suffering from severe CVI of the deep venous system of the leg.

Company’s lead product is the VenoValve ® , a potential first of its kind surgical replacement venous valve currently

in post-enrollment follow-up of its U.S.

pivotal study.

The Company is also developing a second product called enVVe ® ,

a potential next-generation, non-surgical, transcatheter based replacement venous valve.

The Company is currently conducting pre-clinical

testing on enVVe.

Both the VenoValve and enVVe are designed to act as one-way valves, to help assist in propelling blood up the veins

of the leg, and back to the heart and lungs.

VenoValve and enVVe are being developed first for approval by the U.S.

Food and Drug Administration (FDA).

We expect the VenoValve to

be eligible for FDA approval first, followed approximately three years later by enVVe.

If approved, we expect the VenoValve and enVVe

to co-exist, with the VenoValve as a surgical replacement venous valve option and enVVe as a non-surgical replacement venous valve option,

although we cannot provide any assurance that either the VenoValve or enVVe will receive approval from the FDA (see the section entitled

“Risk Factors” in our Annual Report on Form 10-K/A, filed with the SEC on February 28, 2025).

There are currently no devices

FDA approved as surgical or non-surgical replacement venous valves, and there are currently no effective treatments for deep venous CVI

caused by incompetent valves.

team of officers and directors has been affiliated with numerous medical devices that have received FDA approval or CE marking and that

have been commercially successful.

We develop and manufacture our products in connection with our clinical trials in a 14,507 sq.

leased manufacturing facility in Irvine, California, which has been ISO 13485-2016 certified for the design, development and manufacturing

of tissue based implantable medical devices.

The Company is developing a replacement venous valve for patients suffering from severe

CVI of the deep venous system of the leg.

Company first developed the VenoValve®, which was a first-in-class surgical replacement venous valve (the Company received a not-approvable

letter from the FDA in response to its PMA application for the VenoValve in August 2025).

The Company is now focused on its next-generation,

non-surgical venous valve product, called the enVVe® System.

The enVVe System consists of the enVVe Valve, enVVe Delivery System,

enVVe Nose Cone, the enVVe Delivery System Accessories, and the enVVe Crimping System.

The enVVe Valve is a first-in-class, non-surgical,

transcatheter based replacement venous valve being developed for the treatment of severe CVI.

The enVVe Valve is designed to act as a

one-way valve, to help assist in propelling blood up the veins of the leg, and back to the heart and lungs.

The Company has completed

pre-clinical testing on the enVVe System.

29, 2026, the Company announced that the FDA had approved the Company’s Investigational Device Exemption (“IDE”) application,

authorizing the Company to commence a study of a non-surgical replacement venous valve.

The Transcatheter Venous Valve Endoprosthesis

(“TAVVE ® ”) pivotal study will evaluate the Company’s minimally invasive enVVe System for patients with severe

The first stage of the TAVVE study, which is expected to commence later this year, will consist of 10 patients, whose 30-day

safety results will be submitted to the FDA for review.

This group of 10 patients will continue to be followed as a separate cohort throughout

the study, and their safety and efficacy data will be reported publicly from time to time.

The second stage of the study, which will begin

immediately after the 30-day safety results for the first group are reported to the FDA, will enroll 220 patients, with 165 patients receiving

the enVVe valve, and 55 patients randomized into a control arm who will receive standard of care treatment.

The results from the patients

who receive the enVVe valve will be compared to the results from the patients in the control arm of the study.

The TAVVE study will enroll

patients at up to 40 U.S.

clinical sites and will include vascular surgeons, interventional radiologists and interventional cardiologists.

One year after the 220 th patient is enrolled in the second stage of the study, the Company would be eligible to file for FDA

post-marketing approval.

cannot provide any assurance that the enVVe System will receive pre-market approval from the FDA to be marketed and sold in the U.S.

(see the section entitled “Risk Factors” in our Annual Report on Form 10-K filed with the SEC on March 26, 2026).

are currently no devices approved as surgical or non-surgical replacement venous valves, and there are currently no effective

treatments for deep venous CVI caused by incompetent valves.

develop and manufacture our products in a 14,507 sq.

leased manufacturing facility in Irvine, California, which has been ISO 13485-2016

certified for the design, development and manufacturing of tissue based implantable medical devices.

venous disease (“CVD”) is the world’s most prevalent chronic disease.

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at night, prevents them from getting adequate sleep.

Severe CVI sufferers with venous leg ulcers (VLU) are known to miss approximately

40% more workdays than the average worker without the condition.

A high percentage of venous ulcer patients also experience severe itching,

leg swelling, and an odorous discharge.

Wound dressing changes, which occur several times a week, can be extremely painful.

Venous ulcers

from deep venous CVI are very difficult to heal, and a significant percentage of venous ulcers remain unhealed for more than a year.

Even if healed, recurrence rates for venous ulcers are known to be high (20% to 40%) within the first year and as high as 60% after five

Patients with severe CVI often become housebound and experience social isolation due to difficulty with ambulation.

studies have shown that patients with active venous ulcers experience higher rates of anxiety and depression, with reported rates of

anxiety of up to 30% and depression up to 40%.

Rates of depression caused by venous ulcers among the elderly are even higher, with 48%

of elderly venous ulcer patients having severe depressive symptoms.

estimate that there are approximately 2.5 million to 3.5 million patients with severe deep venous CVI in the U.S.

including approximately

1.5 million patients that develop venous leg ulcers (C6 patients).

The average patient seeking treatment of a venous ulcer spends as

much as $30,000 a year on wound care, and the total direct medical costs from venous ulcer sufferers in the U.S.

has been estimated to

exceed $20 billion a year.

VenoValve is a surgically implanted replacement venous valve developed by enVVeno Medical, designed for use in the deep veins of the

leg to treat severe CVI caused by valvular incompetence.

By lowering pressure (venous hypertension) within the deep venous system of

the leg, the VenoValve has the potential to reduce or eliminate the symptoms of severe deep venous CVI, including the potential to heal

recurring venous leg ulcers.

The VenoValve is implanted into the femoral vein of the patient in an open surgical procedure via a 5-to-6-inch

incision in the upper thigh.

The surgical approach for implanting the VenoValve is referred to as the SAVVE ® procedure,

which enables physicians to implant the VenoValve to restore valve function in the deep veins of the leg.

As our planned initial entrant

to the replacement venous valve market, we estimate that approximately 2.5 million people with severe deep venous CVI in the U.S.

be candidates for the VenoValve, including approximately 1.5 million people with active venous ulcers.

The VenoValve has been granted

Breakthrough Device designation by the FDA.

Clinical Status

March of 2021 we received IDE approval from the FDA to begin the VenoValve pivotal study.

An investigational device exemption or IDE

from the FDA is required before a medical device company can proceed with a pivotal trial for a Class III medical device.

This approval

allowed us to proceed with our U.S.

pivotal study for the VenoValve, a prospective, non-blinded, single arm, multi-center clinical study.

The seventy-five patient U.S.

pivotal study reached full enrollment on September 1, 2023 and is now in the post-enrollment follow-up

VenoValve is implanted using the SAVVE ® procedure, an open surgical approach that enables precise placement of the device

within the femoral vein to restore valve function.

Efficacy endpoints for the U.S.

pivotal study include rVCSS scores, which are used

to provide evidence of clinically meaningful benefit, as well as reflux time measurements, VAS pain scores, quality of life measurements,

ulcer healing (for CEAP class C6 patients), and intra-operative and one-year vein patency and valve functionality.

Safety endpoints include

device related events and procedure related events including mortality, pulmonary embolism, ipsilateral deep vein thrombosis, infection

and bleeding.

November 2024, one year efficacy and safety data from the U.S.

pivotal study was presented at the 51st Annual VEITH Symposium.

indicated that eighty-five percent (85%) of the patients enrolled in the trial experienced a clinical meaningful benefit from the VenoValve,

defined as a three (3) or more point improvement in revised Venous Clinical Severity Score (rVCSS), at one year, compared to baseline.

The average rVCSS improvement in the clinically meaningful responder cohort was 7.91 points.

Patients in the study also experienced a

seventy-five percent (75%) median reduction in pain and improvements in quality-of-life indicators.

For patients with venous ulcers (CEAP

C6 patients), ulcer area was reduced a median average of eighty-seven percent (87%).

Over the course of the one (1) year period, there

was one (1) death (unrelated to the VenoValve), zero (0) pulmonary embolisms, twelve (12) target vein thromboses, ten (10) surgical pocket

hematomas, four (4) other bleeds, and seven (7) deep wound infections.

Ninety-four percent (94%) of the patients that experienced a material

safety event also went on to experience a clinically meaningful benefit from the VenoValve.

Also, the reported target vein patency rates

at thirty (30) days and one (1) year were ninety one percent (91%) and ninety seven percent (97%), respectively.

November 19, 2024, the Company submitted the final module of its PMA application for review by the FDA.

June 2025, the Company announced that interim two-year follow-up data on forty-two (42) subjects from the seventy-five (75) patient VenoValve

pivotal trial at the Society for Vascular Surgery 2025 Vascular Annual Meeting.

The data indicated that eighty-three percent (83.3%)

of patients enrolled in the trial (n=35/42) maintained a clinically meaningful benefit from the VenoValve, defined as an improvement

of 3 or more points in the revised Venous Clinical Severity Score (rVCSS), at year two, compared to baseline.

The average rVCSS improvement

in the clinically meaningful responder cohort was 9.1 points.

Patients in the study also experienced a seventy-four percent (74%) median

reduction in leg pain, as measured by the Visual Analog Scale (VAS).

For patients with venous ulcers, wound healing outcomes in seventeen

(17) patients with twenty-five (25) ulcers showed that 60% of ulcers healed completely, 24% decreased in size, and 16% increased in size.

Patient-reported outcomes also demonstrated sustained improvements across all venous specific QoL indicators (VEINES-QoL/Sym).

the patients (n=30), a 100% valve patency rate was observed at the two-year follow up.

All values were calculated comparing each patient’s

baseline levels to the reported values at the patient’s 24-month visit.

The Revised Venous Clinical Severity Score (rVCSS) is a

clinically validated scoring system used to track the progression or regression of venous diseases.

August 19, 2025, the Company announced that it received a not-approvable letter from the FDA in response to its PMA application for the

The letter indicated that the FDA completed its review of the VenoValve PMA application and determined that it is unable to

approve the PMA for the VenoValve in its current form.

In particular, the FDA indicated that the favorable rVCSS data generated by the

study to show clinical improvement, together with the improvements in pain scores and venous specific quality of life indicators was

not sufficient on its own to determine favorability of the benefit risk profile for the VenoValve.

Without a specific hemodynamic measurement

that correlates with patient improvement, the FDA raised concerns about bias and the possibility that clinical improvement occurred as

a result of the patients being enrolled in a study.

The FDA also focused on safety concerns which were attributed to the VenoValve open

surgical procedure, and that required re-hospitalizations.

The Company would not expect to see similar safety events with a non-surgical

replacement valve.

September 18, 2025, the Company filed a request for supervisory appeal of the not-approvable letter from the Center for Devices and Radiological

Health (CDRH) of the FDA received on August 19, 2025, in response to its PMA application for the VenoValve.

The FDA provides several

internal informal and formal mechanisms to challenge staff decisions, including scientific controversies.

One mechanism is a request

for supervisory review in which an appeal is made to the next line of supervision.

Supervisory appeals are required to be filed within

30 days of the decision being appealed, which was on or before September 18, 2025.

These appeals involve a formal substantive request,

an in-person meeting, and a decision.

It also often includes multiple interactions even after an initial appeal decision is made.

Agency reviews are based on information already in the administrative file.

Due to the variety of both physician reported and patient

reported data generated by the VenoValve pivotal study and which is already a part of the file, the Company is confident that explaining

this data to supervisory management in a focused appeal setting may lead to a positive outcome, with a decision expected by the end of

October 2025, the Company completed an in-person meeting with the FDA.

In addition to representatives from an outside firm specializing

in FDA matters and appeals and representatives from the Company, the meeting also included a patient advocate from VenoValve U.S.

study as well as one of the Company’s primary investigators from the trial.

Several employees from the FDA attended the meeting

including the Director of the Center for Devices and Radiological Health, who elected to hear the appeal and who will be issuing the

appeal decision.

The FDA meeting provided the Company with the opportunity to put the major adverse events—those tied to the SAVVE

study’s safety endpoints—into the proper context.

It also allowed the Company to re-emphasize the multiple physician-and

patient-reported clinical benefits that comprise the totality of the evidence from the study, supported by firsthand perspectives shared

by both the SAVVE study patient and investigator in attendance.

Because there are no established industry or regulatory standards to

determine the effectiveness for a replacement venous valve, it is necessary for the Company and the Agency to establish a new regulatory

pathway for VenoValve effectiveness.

Company worked collaboratively with the FDA over the past several years to help ensure that the Company was collecting the necessary

data to support effectiveness of the VenoValve and that dialogue with respect to effectiveness is continuing as part of this appeal.

There are often multiple ways to satisfactorily address a given regulatory issue, and at the meeting, the Company proposed an alternative

effectiveness pathway for the VenoValve, supported by data already collected in SAVVE.

The Company expects to hear from the FDA about

this stage of the appeal process by the end of 2025.

the subject of the FDA appeal and the FDA meeting is specific to the VenoValve, the appeal does also have implications for enVVe, our

next generation transcatheter replacement venous valve, and as a result, the Company is waiting for clarity from the FDA prior to filing

the enVVe IDE application.

September 21, 2022, we announced the development of a non-surgical transcatheter based replacement venous valve called enVVe ® ,

for the treatment of CVI of the deep veins of the leg.

Initial preliminary bench testing and pre-clinical testing for enVVe have been

successfully completed.

December 16, 2024, we announced the successful completion of the final wave of implants for the six-month pre-clinical GLP study for

The first wave of implants, for the long-term subjects, was successfully completed in October 2024, and the final wave for the

shorter-term subjects was completed in December 2024.

The GLP study is a prerequisite to seeking IDE approval from the FDA to begin the

pivotal study.

The Company is waiting until certain regulatory issues with respect to the VenoValve are resolved with the

FDA before filing the IDE for enVVe, which the Company expects to file in the first quarter of 2026.

finished 2024 with approximately $43.2 million of cash and investments and had approximately $31.0 million of cash and investments as

of September 30, 2025.

Our future capital requirements will remain dependent upon a variety of factors, especially including the success

of our clinical trials, related product development costs, and our ability to successfully bring products to market.

We anticipate that

our cash burn rate will increase from current levels of approximately $4 million per quarter to between $5 million and $7 million per

quarter as we conduct our clinical trials and work toward bringing our product candidates to market.

Deficiency Letter

October 7, 2025, the Company received notification from Nasdaq notifying the Company that, because the closing bid price for the Company’s

common stock has fallen below $1.00 per share for 30 consecutive business days, the Company no longer complies with the minimum bid price

requirement for continued listing on the Nasdaq Capital Market under Rule 5550(a)(2) of Nasdaq Listing Rules.

notice has no immediate effect on the listing of the Company’s common stock on the Nasdaq Capital Market.

accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has a period of 180 calendar days from the date of notification, or until

April 6, 2026, to regain compliance with the minimum bid price requirement.

To regain compliance, the closing bid price of the Company’s

common stock must close at or above $1.00 per share for a minimum of 10 consecutive trading days (which period may be extended to greater

than 10 consecutive trading days at the sole discretion of Nasdaq) prior to April 6, 2026.

the event the Company does not regain compliance by April 6, 2026, the Company may be eligible for an additional 180 calendar day compliance

period to demonstrate compliance with the bid price requirement.

To qualify for the additional 180-day period, the Company will be required

to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq

Capital Market, with the exception of the bid price requirement, and will need to provide written notice to Nasdaq of its intention to

cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary.

If the Nasdaq staff determines

that the Company will not be able to cure the deficiency, or if the Company is otherwise not eligible for such additional compliance

period, Nasdaq will provide notice that the Company’s common stock will be subject to delisting.

The Company would have the right

to appeal a determination to delist its common stock, and the common stock would remain listed on the Nasdaq Capital Market until the

completion of the appeal process.

Severe CVI sufferers are known to miss approximately 40% more workdays than the

average worker.

A high percentage of venous ulcer patients also experience severe itching, leg swelling, and an odorous discharge.

dressing changes, which occur several times a week, can be extremely painful.

Venous ulcers from deep venous CVI are very difficult to

heal, and a significant percentage of venous ulcers remain unhealed for more than a year.

Even if healed, recurrence rates for venous

ulcers are known to be high (20% to 40%) within the first year and as high as 60% after five years.

Patients with severe CVI often become

housebound and experience social isolation due to difficulty with ambulation.

As a result, studies have shown that patients with active

venous ulcers experience higher rates of anxiety and depression, with reported rates of anxiety of up to 30% and depression up to 40%.

Rates of depression caused by venous ulcers among the elderly are even higher, with 48% of elderly venous ulcer patients having severe

depressive symptoms.

estimate that there are approximately 3 million patients with severe deep venous CVI in the U.S.

including approximately 1.5 million

patients that develop venous leg ulcers (C6 patients).

The average patient seeking treatment of a venous ulcer spends as much as $30,000

a year on wound care, and the total direct medical costs from venous ulcer sufferers in the U.S.

has been estimated to exceed $20 billion

enVVe System is designed to treat severe deep CVI through a minimally invasive, catheter-based approach.

The procedure is performed without

the need for open surgery or an overnight hospital stay.

Built on the clinical foundation of the VenoValve program, the enVVe Valve incorporates

design enhancements intended to improve performance, strength and long-term durability.

The enVVe System seeks to address prior FDA concerns

discerned in the clinical trial process for the VenoValve related to venous valves implanted via open surgical procedures.

to eliminating open surgical complications, its transcatheter approach is expected to broaden adoption by appealing to a wider range

of implanting physicians including vascular surgeons, interventional radiologists, and interventional cardiologists.

Company has completed pre-clinical testing on the enVVe System and, on April 29, 2026, the Company announced that the FDA had approved the Company’s IDE application, authorizing

the Company to commence a study of a non-surgical replacement venous valve.

The TAVVE pivotal study will evaluate the Company’s

minimally invasive enVVe System for patients with severe deep CVI.

The first stage of the TAVVE study, which is expected to commence later

this year, will consist of 10 patients, whose 30-day safety results will be submitted to the FDA for review.

This group of 10 patients

will continue to be followed as a separate cohort throughout the study, and their safety and efficacy data will be reported publicly from

time to time.

The second stage of the study, which will begin immediately after the 30-day safety results for the first group are reported

to the FDA, will enroll 220 patients, with 165 patients receiving the enVVe valve, and 55 patients randomized into a control arm who will

receive standard of care treatment.

The results from the patients who receive the enVVe valve will be compared to the results from the

patients in the control arm of the study.

The TAVVE study will enroll patients at up to 40 U.S.

clinical sites and will include vascular

surgeons, interventional radiologists and interventional cardiologists.

One year after the 220 th patient is enrolled in the

second stage of the study, the Company would be eligible to file for FDA post-marketing approval.

Key features of the enVVe System

invasive procedure requiring no general anesthesia or overnight hospital stay;

Self-expanding

frame made from a specially formulated biocompatible nickel and titanium alloy;

geometry that accommodates the natural dilation and contraction of the vein;

enVVe valve sizes to ensure a proper fit across a broad range of vein sizes;

mono-cusp leaflet design that is laser cut from porcine pericardium tissue;

profile of only 13 Fr (4.3 mm) when crimped, giving it the smallest profile of any replacement valve currently in use for the cardiovascular

via an over-the-wire, coaxial, single-stage pull system for ease of use.

In March 2021, the Company received IDE approval from the FDA to initiate

the Surgical Anti-reflux Venous Valve Endoprosthesis (“SAVVE®”) U.S.

pivotal clinical study evaluating the VenoValve.

The prospective, multi-center, single-arm study enrolled 75 patients with severe CVI.

An application seeking pre-market approval for the

VenoValve was filed in November 2024.

In August 2025, the Company received a non-approvable letter from the FDA for the VenoValve and

a subsequent appeal was unsuccessful.

medical devices start out as surgical iterations and transition to less invasive, trans-catheter delivered versions over time.

The Company’s

strategy was to first develop the VenoValve, and then to transition to enVVe.

That strategy remains intact.

The enVVe System could not

have been developed without the experience gained from the VenoValve.

Because the VenoValve was not approved by the FDA, the Company

has elected to forego any potential approval and commercialization efforts outside of the U.S.

for the VenoValve and to instead focus

its resources on bringing the enVVe System to market.

from the SAVVE pivotal study has been presented at vascular conferences throughout the world and has been very well received.

recognize the need for a replacement venous valve for patients suffering from deep venous CVI and we believe that both the short-term

and long-term VenoValve efficacy data has been extremely promising for this difficult to treat patient population.

Although interest

in a surgical replacement venous valve has been strong, clinicians recognize that long-term the large potential market is best served

via a trans-catheter delivered iteration of the device.

There continues to be significant interest from clinicians wanting to participate

in the TAVVE pivotal study.

finished 2025 with approximately $28.2 million of cash and investments and had approximately $24.9 million of cash and investments

as of March 31, 2026.

Our future capital requirements will remain dependent upon a variety of factors, especially including the

success of our clinical trials, related product development costs, and our ability to successfully bring products to market.

anticipate that our cash burn rate may increase from current levels of approximately $3 million to $4 million per quarter to between

$4 million and $5 million per quarter in 2026.

Even after considering this increase, we should have sufficient cash and investments

to fund operations into the third quarter of 2027.

have historically funded our operations through financing activities such as the capital raises.

We will need to raise additional capital

in the future.

Any inability to raise additional financing would have a material adverse effect on us.

upon our cash and working capital as of March 31, 2026, we have sufficient capital resources to meet our obligations as they become due

within at least one year after the date of this Quarterly Report and sustain operations.

of Operations

of the three months ended September 30, 2025 and 2024

reported net losses of $4.5 million and $5.6 million for the three months ended September 30, 2025 and 2024, respectively, representing

a decrease in net loss of $1.1 million, or 20%, due to a decrease in operating expenses of $1.3 million, partially offset by a decrease

of the three months ended March 31, 2026 and 2025

reported net losses of $3.8 million and $4.5 million for the three months ended March 31, 2026 and 2025, respectively, representing a

decrease in net loss of $0.7 million, or 15%, due to a decrease in operating expenses of $0.9 million, partially offset by a decrease

in other income of $0.2 million, as described in further detail below.

3 unchanged sentences

and Development Expenses

the three months ended September 30, 2025, research and development expenses decreased by $0.3 million or 10%, to $2.6 million from $2.9

million for the three months ended September 30, 2024.

This decrease primarily resulted from $0.4 million in lower costs related the

VenoValve pivotal study as the amount of follow-up for each participant decreases over time, partially offset by $0.1 million in higher

compensation costs from additional personnel.

General and Administrative Expenses

the three months ended September 30, 2025, selling, general and administrative expenses decreased by $1.0 million or 31%, to $2.3 million

from $3.3 million for the three months ended September 30, 2024.

Of this decrease, $0.7 million was due to non-recurring legal costs

incurred during the three months ended September 30, 2024 and $0.3 million was due to the net effect of lower stock-based compensation

cost incurred as option grants are issued and vest.

This decrease was also due to a $0.3 million partial recovery of a non-recurring

$0.6 million reserve recorded during the six months ended June 30, 2025 for potentially uncollectible prepaid clinical costs resulting

from payments made to a vendor that were not passed through from the vendor to clinical sites, as contractually required.

These decreases

were partially offset by a net $0.3 million increase related to various other expenses.

the three months ended September 30, 2025, other income decreased $0.2 million or 35% to $0.3 million from $0.5 million for the three

months ended September 30, 2024.

Other income in both periods reflects realized gains, interest, and unrealized gains or losses from

our program to invest excess cash in US Treasury securities.

of the nine months ended September 30, 2025 and 2024

reported net losses of $15.7 million and $15.6 million for the nine months ended September 30, 2025 and 2024, respectively, representing

an increase in net loss of $0.1 million or 1%, due to a decrease in other income of $0.3 million, partially offset by a decrease in operating

expenses of $0.2 million, as described in further detail below.

a developmental stage Company, our revenue, if any, is expected to be diminutive and dependent on our ability to commercialize our product

We are not currently generating revenue and do not expect significant revenue until we successfully commercialize our lead

product candidate after receiving FDA approval, if ever.

and Development Expenses

the nine months ended September 30, 2025, research and development expenses decreased by $0.7 million or 8%, to $8.0 million from $8.7

million for the nine months ended September 30, 2024.

This decrease primarily resulted from $1.3 million in lower costs related to the

VenoValve study as the amount of follow-up for each participant decreases over time, partially offset by $0.6 million in higher compensation

costs from additional personnel, as well as higher professional fees.

the three months ended March 31, 2026, research and development expenses decreased by $0.5 million or 17%, to $2.1 million from $2.6

million for the three months ended March 31, 2025.

This decrease primarily resulted from $0.7 million in lower costs related the VenoValve

pivotal study as the amount of follow-up for each participant decreases over time and our focus has shifted to the development of the

enVVe System, as well as a net decrease of $0.2 million in various other expenses.

These decreases were partially offset by an increase

of $0.4 million in product development, testing and other expenses related to the enVVe System being developed for approval by the FDA.

General and Administrative Expenses

the nine months ended September 30, 2025, selling, general and administrative expenses increased $0.5 million or 6%, to $8.9 million

from $8.4 million for the nine months ended September 30, 2024.

Of this increase, $0.3 million was due to a non-recurring severance expense

recorded in 2025 and $0.6 million related to higher compensation costs from additional personnel.

This increase was also due to a non-recurring

$0.3 million reserve for potentially uncollectible prepaid clinical costs resulting from payments made to a vendor that were not passed

through from the vendor to clinical sites, as contractually required, and a net $0.5 million increase related to various other expenses.

These increases were partially offset by $0.9 million in non-recurring legal costs incurred during the nine months ended September 30,

2024 and $0.3 million from the net effect of lower stock-based compensation cost incurred as option grants are issued and vest.

(Income) Expense

the nine months ended September 30, 2025, other income decreased $0.3 million to $1.2 million from $1.5 million for the nine months ended

September 30, 2024.

Other income in both periods reflects realized gains, interest, and unrealized gains or losses from our program to

invest excess cash in US Treasury securities.

the three months ended March 31, 2026, selling, general and administrative expenses decreased by $0.4 million or 19%, to $2.0 million

from $2.4 million for the three months ended March 31, 2025.

The decrease was due to the net effect of lower stock-based compensation

cost incurred as option grants are issued and vest, as well as a net decrease in various other expenses.

the three months ended March 31, 2026, other income decreased $0.3 million or 53% to $0.2 million from $0.5 million for the three months

ended March 31, 2025.

Other income in both periods reflects realized gains, interest, and unrealized gains or losses from our program

to invest excess cash in U.S.

Treasury securities.

and Capital Resources

the nine months ended September 30, 2025, the Company incurred losses from operations of $15.7 million and used $12.1 million cash in

operating activities.

The net cash used in operating activities during the 2025 period increased by $0.4 million from $11.7 million for

the period ended September 30, 2024.

losses and the uses of cash are primarily due to our product research and development activities, including clinical studies, and administrative

Research and development activities are for continued product development and clinical studies for our product candidates,

currently the VenoValve and enVVe.

Administrative functions relate to costs to support our public reporting and investor relations activities,

internal administrative functions and, starting in 2024, costs to prepare for commercialization of the VenoValve.

The Company will continue

to incur these costs, and we anticipate these costs will increase, as we work to complete our clinical studies, enhance products, develop

new products, bring those products to market, and operate as a public company.

are not currently generating revenue and do not expect significant revenue until we successfully commercialize one or more of our product

candidates after receiving FDA approval, if ever.

do not currently have material commitments for capital expenditures or other expenditures except for our facility lease commitment of

$0.4 million per year.

However, we expect a modest increase in purchases of property and equipment as we continue clinical studies, plan

for commercialization of the VenoValve and continue development of enVVe.

future capital requirements will remain dependent upon a variety of factors, especially including the success of our clinical studies

the three months ended March 31, 2026, the Company incurred losses from operations of $4.1 million and used $3.2 million cash in operating

The net cash used in operating activities during the 2026 period decreased by $0.8 million from $4.0 million for the three

months ended March 31, 2025 primarily due to the decrease in research and development expenses from 2025 to 2026.

Our cash balance as

of March 31, 2026, is $2.6 million.

In addition, we have $22.3 million in investments, for total cash and investments of $24.9 million.

operating losses and the uses of cash are primarily due to the Company’s product research and development and administrative activities.

Administrative functions relate to costs to support the Company’s public reporting and investor relations activities as well as

internal administrative functions.

Research and development activities were for product development and clinical trials for the VenoValve

and for the enVVe System.

The Company will continue to incur these costs to complete its clinical trials for the VenoValve and the enVVe

System, enhance products, develop new products, and operate as a public company for the foreseeable future as we seek to obtain regulatory

approval for our studies and product candidates.

do not currently have material commitments for capital expenditures or other expenditures with the exception of our facility lease commitment

of $0.4 million per year.

We expect a nominal increase in purchases of property and equipment and in facility lease costs as we commence

the enVVe System pivotal study.

future capital requirements will remain dependent upon a variety of factors, especially including the success of our clinical trials

and related product development costs and our ability to successfully bring products to market.

We anticipate that our cash burn rate

will increase from current levels of approximately $4 million per quarter to between $5 million and $7 million per quarter as we conduct

our clinical studies and work toward bringing our product candidates to market.

have historically funded our operations through financing activities, such as the capital raise completed in 2024, and will need to raise

additional capital in the future.

We anticipate that our cash burn

rate may increase from current levels of approximately $3 million to $4 million per quarter to between $4 million and $5 million per

quarter in 2026.

Even after considering this increase, we should have sufficient cash and investments to fund operations into the

third quarter of 2027.

have historically funded our operations through financing activities such as the capital raises.

We will need to raise additional capital

in the future.

Any inability to raise additional financing would have a material adverse effect on us.

on our cash and working capital as of September 30, 2025, we have sufficient capital resources to meet our obligations as they become

due for at least one year after the date of this Quarterly Report and sustain operations.

upon our cash and working capital as of March 31, 2026, we have sufficient capital resources to meet our obligations as they become due

within at least one year after the date of this Quarterly Report and sustain operations.

Accounting Estimates

preparation of our consolidated financial statements requires management to make judgments, estimates and assumptions that affect the

reported amounts of expenses, assets and liabilities, and the accompanying disclosures, and the disclosure of contingent liabilities,

Critical accounting estimates are those for which uncertainty about the assumptions and estimates could result in outcomes that

require a material adjustment to the carrying amount of assets or liabilities in future periods if the actual outcomes differ from estimates.

preparation of our condensed financial statements requires management to make judgments, estimates and assumptions that affect the reported

amounts of expenses, assets and liabilities, and the accompanying disclosures, and the disclosure of contingent liabilities, if any.

Critical accounting estimates are those for which uncertainty about the assumptions and estimates could result in outcomes that require

a material adjustment to the carrying amount of assets or liabilities in future periods if the actual outcomes differ from estimates.

do not have any matters that have a significant risk of causing a material adjustment to the carrying amounts of assets and liabilities

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What changed 10-Q

Item 2. Management’s Discussion and Analysis