enVVeno Medical Corp
For the period ended Sep 30, 2025. Filed Oct 30, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Oct 30, 2025
NVNO$6.73-3.4%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-07-31.
0001493152-25-011521
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-10-30.
0001493152-25-020215
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 65 previous paragraphs and 75 current paragraphs.
48 unchanged; 16 reworded; 11 added; 0 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 0 previous and 0 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (11)
Current report
On August 19, 2025, the Company announced that it received a not-approvable letter from the FDA in response to its PMA application for the VenoValve. 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.
Current report
On 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. Internal 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 2025.
Current report
In 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. pivotal 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.
Current report
The 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.
Current report
Although 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.
Current report
Nasdaq Deficiency Letter
Current report
On 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.
Current report
Nasdaq’s notice has no immediate effect on the listing of the Company’s common stock on the Nasdaq Capital Market.
Current report
In 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.
Current report
In 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.
Current report
Comparison of the nine months ended September 30, 2025 and 2024
Reworded paragraphs (16)
Previous wording
Prevalence is generally defined as the portion of the population that has a given condition. Estimates indicate that the prevalence of people in the U.S. with severe, deep venous CVI (C4 to C6 disease) with reflux to be approximately 20 million. Incidence is generally defined as the number of new cases of an ailment that develop in a given time period. We estimate that approximately 3.5 million new patients with severe deep venous CVI are diagnosed each year 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 $3 billion a year.
Current wording
We 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.
Previous wording
The 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 each year with severe deep venous CVI in the U.S. would 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.
Current wording
The 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. would 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.
Previous wording
In November 2024, one year efficacy and safety data from the U.S. pivotal study was presented at the 51th Annual VEITH Symposium. The data 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.
Current wording
In November 2024, one year efficacy and safety data from the U.S. pivotal study was presented at the 51st Annual VEITH Symposium. The data 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.
Previous wording
On November 19, 2024, the Company submitted the final module of its PMA application for review by the FDA. The VenoValve is designated as a breakthrough product and, as a result, its PMA application is subject to priority review. This may serve to shorten the PMA review process. Regardless, it is difficult to predict precisely how long the PMA process will take, and the Company’s best estimate is to expect an FDA decision during the second half of 2025.
Current wording
On November 19, 2024, the Company submitted the final module of its PMA application for review by the FDA.
Previous wording
On December 16, 2024, we announced the successful completion of the final wave of implants for the six-month pre-clinical GLP study for enVVe. 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 enVVe U.S. pivotal study. The Company expects to file for IDE approval for the enVVe pivotal study in the third quarter of 2025.
Current wording
On December 16, 2024, we announced the successful completion of the final wave of implants for the six-month pre-clinical GLP study for enVVe. 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 enVVe U.S. 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.
Previous wording
We finished 2024 with approximately $43.2 million of cash and investments and had approximately $35.1 million of cash and investments as of June 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.
Current wording
We 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.
Previous wording
We reported net losses of $11.2 million and $10.0 million for the six months ended June 30, 2025 and 2024, respectively, representing an increase in net loss of $1.2 million or 13%, due to an increase in operating expenses of $1.0 million and a decrease in other income of $0.2 million, as described in further detail below.
Current wording
We 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 in other income of $0.2 million, as described in further detail below.
Previous wording
For the three months ended June 30, 2025, research and development expenses increased by $0.1 million or 2%, to $2.9 million from $2.8 million for the three months ended June 30, 2024. This increase primarily resulted from $0.2 million in higher compensation costs from additional personnel, as well as higher professional fees, partially offset by $0.1 million in lower costs related the VenoValve pivotal study as the amount of follow-up for each participant decreases over time.
Current wording
For 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.
Previous wording
For the six months ended June 30, 2025, selling, general and administrative expenses increased $1.5 million or 29%, to $6.6 million from $5.1 million for the six months ended June 30, 2024. Of this increase, $0.3 million was due to a non-recurring severance expense recorded in 2025 and $0.4 million related to higher compensation costs from additional personnel. This increase was also due to a non-recurring $0.6 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 $0.2 million increase related to various other expenses.
Current wording
For 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.
Previous wording
For the three months ended June 30, 2025, other income decreased $0.1 million or 29% to $0.4 million from $0.5 million for the three months ended June 30, 2024. Other income in both periods reflects realized gains, interest, and unrealized gains from our program to invest excess cash in US Treasury bills.
Current wording
For 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.
Previous wording
We reported net losses of $6.7 million and $5.0 million for the three months ended June 30, 2025 and 2024, respectively, representing an increase in net loss of $1.7 million, or 35%, due to an increase in operating expenses of $1.6 million and a decrease in other income of $0.1 million, as described in further detail below.
Current wording
We 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.
Previous wording
For the six months ended June 30, 2025, research and development expenses decreased by $0.5 million or 7%, to $5.4 million from $5.9 million for the six months ended June 30, 2024. This decrease primarily resulted from $0.9 million in lower costs related to the VenoValve study as the amount of follow-up for each participant decreases over time, partially offset by $0.4 million in higher compensation costs from additional personnel, as well as higher professional fees.
Current wording
For 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.
Previous wording
For the three months ended June 30, 2025, selling, general and administrative expenses increased by $1.6 million or 58%, to $4.2 million from $2.6 million for the three months ended June 30, 2024. Of this increase, $0.4 million was due to compensation costs from the net effect of higher stock-based compensation from the issuance of additional option grants, a non-recurring severance expense of $0.3 million recorded in 2025, and $0.2 million related to higher compensation costs from additional personnel. This increase was also due to a non-recurring $0.6 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 $0.1 million increase related to various other expenses.
Current wording
For 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.
Previous wording
For the six months ended June 30, 2025, other income decreased $0.2 million to $0.8 million from $1.0 million for the six months ended June 30, 2024. Other income in both periods reflects realized gains, interest, and unrealized gains from our program to invest excess cash in U.S. bills.
Current wording
For 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.
Previous wording
For the six months ended June 30, 2025, the Company incurred losses from operations of $12.0 million and used $7.7 million cash in operating activities. The net cash used in operating activities during the 2025 period increased by $0.2 million from $7.5 million for the period ended June 30, 2024.
Current wording
For 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.
Previous wording
Our future capital requirements will remain dependent upon a variety of factors, especially including the success of our clinical studies 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 to between $5 million and $7 million per quarter as we conduct our clinical studies and work toward bringing our product candidates to market.
Current wording
Our future capital requirements will remain dependent upon a variety of factors, especially including the success of our clinical studies 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.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
Comparison of the six months ended June 30, 2025 and 2024