What changed in this filing

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Item 1. Financial Statements

2026-07-30 compared with 2026-05-06 · 113 added, 99 removed, 164 unchanged (56% of the section changed)

21 unchanged sentences

Preferred stock, par value $ 0.00001 , 10,000 shares authorized, no shares issued or outstanding

Common stock, par value $ 0.00001 , 250,000 shares authorized, 656 shares issued and outstanding as of March 31, 2026 and December 31, 2025

Common stock, par value $ 0.00001 , 250,000 shares authorized, 673 and 656 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively

Additional paid-in capital

7 unchanged sentences

For the Three Months Ended

(In thousands, except per share data)

For the Six Months Ended

Operating expenses:

3 unchanged sentences

Other income:

Realized gain from sales of trading securities

Realized gains from sales of trading securities

Unrealized loss from trading securities

2 unchanged sentences

Total other income

Net loss per basic and diluted common share:

Weighted average number of common shares outstanding:

Net loss per basic and diluted

common share:

Weighted average number of

common shares outstanding:

Basic and Diluted

3 unchanged sentences

thousands, unless otherwise indicated)

Three Months Ended March 31, 2026

Three Months Ended June 30, 2026

Stockholders’

Balance, April 1, 2026

$ ( 175,176 )

Issuance of common stock from At-the-Market offering (ATM), net of fees

Stock-based compensation

Balance, June 30, 2026

$ ( 178,776 )

Three Months Ended June 30, 2025

Stockholders’

Balance, April 1, 2025

$ ( 156,358 )

Exercise of common stock warrants

Stock-based compensation

Balance, June 30, 2025

$ ( 163,052 )

Six Months Ended June 30, 2026

Stockholders’

Balance, January 1, 2026

$ ( 171,327 )

Issuance of common stock from At-the-Market offering (ATM), net of fees

Effect of reverse stock split

Stock-based compensation

Balance, March 31, 2026

Balance, June 30, 2026

$ ( 178,776 )

Three Months Ended March 31, 2025

Six Months Ended June 30, 2025

Stockholders’

3 unchanged sentences

Stock-based compensation

Balance, March 31, 2025

Common stock issued for exercise of pre-funded warrants

Balance, June 30, 2025

$ ( 163,052 )

4 unchanged sentences

thousands, unless otherwise indicated)

For the Three Months Ended

For the Six Months Ended

Cash Flows from Operating Activities

13 unchanged sentences

Purchases of investments

Purchases of property and equipment

Net cash provided by investing activities

Cash Flows from Financing Activities

Proceeds from sale of common stock in At-the-Market offering, net of fees

Net cash provided by financing activities

Net (decrease) increase in cash and cash equivalents

5 unchanged sentences

1 – Business Organization and Nature of Operations

Medical Corporation (the “Company”) 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.

The Company is developing a replacement venous valve for

patients suffering from severe Chronic Venous Insufficiency (“CVI”) of the deep venous system of the leg.

Company first developed the VenoValve®, which was a potential first-in-class surgical replacement venous valve (the Company received

a not-approvable letter from the U.S.

Food and Drug Administration (“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.

The Company’s Investigational

Device Exemption (“IDE”) application was approved by the FDA 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 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 220th patient is enrolled in the second stage

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

Medical Corporation (the “Company”) is a late-stage 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.

The Company is

developing a replacement venous valve for patients suffering from severe Chronic Venous Insufficiency (“CVI”) of the

deep venous system of the leg.

Company is focused on its next-generation, non-surgical replacement venous valve, 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.

enVVe Valve is a first-in-class transcatheter based replacement venous valve being developed for the treatment of severe, deep venous

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.

April 2026, the U.S.

Food and Drug Administration (“FDA”) awarded the Company an Investigational Device Exemption (“IDE”) approval to proceed with

pivotal study of the enVVe System.

The Transcatheter Venous Valve Endoprosthesis (“TAVVE”) pivotal study will evaluate

the Company’s minimally invasive enVVe System for patients with severe CVI.

IDE approval positions the Company to advance what could become the first effective treatment option for the approximately 3 million

patients who suffer from the debilitating impact of severe CVI due to malfunctioning valves in the deep veins of the leg.

first stage of the TAVVE® study, which is expected to commence in the second half of 2026, 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.

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

FDA post-marketing approval.

Reverse Stock Split

9 unchanged sentences

2 – Management’s Liquidity Plan

of March 31, 2026, the Company had a cash and investment balance of $ 24.9 million and working capital of $ 23.3 million.

Company expects to continue incurring losses for the foreseeable future and may need to raise additional capital to sustain its operations,

of June 30, 2026, the Company had a cash and investment balance of $ 21.5 million and working capital of $ 20.2 million.

Although the Company

expects to continue incurring losses for the foreseeable future and will need to raise additional capital to sustain its operations,

pursue its product development initiatives and penetrate markets for the sale of its products, management believes that the Company’s

9 unchanged sentences

recurring items) which are considered necessary for a fair presentation of the Company’s unaudited condensed financial statements

of the Company as of and for the three months ended March 31, 2026 and 2025, and as of December 31, 2025.

results of operations for the three months ended March 31, 2026 are not necessarily indicative of the operating results for the full

These unaudited condensed financial statements should be read in conjunction with the financial statements and notes thereto for

the year ended December 31, 2025 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 26, 2026.

accompanying condensed balance sheet as of December 31, 2025 has been derived from the Company’s audited financial statements.

of the Company as of and for the three and six months ended June 30, 2026 and 2025, and as of December 31, 2025.

results of operations for the three and six months ended June 30, 2026 are not necessarily indicative of the operating results for the

These unaudited condensed financial statements should be read in conjunction with the financial statements and notes thereto

for the year ended December 31, 2025 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 26, 2026.

The accompanying condensed balance sheet as of December 31, 2025 has been derived from the Company’s audited financial statements.

4 – Investments

1 unchanged sentence

Schedule of Components of Investments

March 31, 2026

June 30, 2026

December 31, 2025

2 unchanged sentences

Government Securities

Total debt investments

losses of $ 43,000 and $ 0.2 million for the three months ended March 31, 2026 and 2025, respectively, from fixed-income securities and

are primarily attributable to changes in interest rates.

Insured Money Market Account

Total investments

losses of $ 22,000 and $ 0.1 million for the three months ended June 30, 2026 and 2025, respectively, and $ 0.1 million and $ 0.3 million

for the six months ended June 30, 2026 and 2025, respectively, are from fixed-income securities and are primarily attributable to changes

in interest rates.

5 – Concentrations

3 unchanged sentences

There were aggregate uninsured cash balances of

$ 1.6 million and $ 1.1 million as of March 31, 2026 and December 31, 2025, respectively.

$ 1.8 million and $ 1.1 million as of June 30, 2026 and December 31, 2025, respectively.

6 – Accounts Payable Accrued Expenses and Other Current Liabilities

15 unchanged sentences

compensation expense is reflected in selling, general and administrative expenses in the accompanying condensed statements of operations

and was $ 0.5 million and $ 0.7 million during the three months ended March 31, 2026 and 2025, respectively.

As of March 31, 2026, there

was $ 2.2 million of unrecognized stock-based compensation expense related to outstanding stock options that will be recognized over the

weighted average remaining vesting period of 1.51 years.

were no options granted or exercised during the three months ended March 31, 2026 and 2025.

were 4,476 option grants forfeited during the three months ended March 31, 2026 and no option grants were forfeited during the three

months ended March 31, 2025.

were no warrants issued or exercised during the three months ended March 31, 2026 and 2025.

were 85,219 and 262 warrants that expired during the three months ended March 31, 2026 and 2025, respectively.

and was $ 0.4 million and $ 1.4 million during the three months ended June 30, 2026 and 2025, respectively, and $ 0.9 million and $ 2.1 million

during the six months ended June 30, 2026 and 2025, respectively.

As of June 30, 2026, there was $ 1.7 million of unrecognized stock-based

compensation expense related to outstanding stock options that will be recognized over the weighted average remaining vesting period

of 1.36 years.

were no options granted during the three and six months ended June 30, 2026.

There were 17,142 options granted during the three and

six months ended June 30, 2025 in connection with entering into certain employment and consulting agreements.

were no options exercised during the three and six months ended June 30, 2026 and 2025.

were 7,850 and 12,316 option grants forfeited during the three and six months ended June 30, 2026, respectively.

15,110 option grants forfeited during the three and six months ended June 30, 2025.

were no warrants issued or exercised during the three and six months ended June 30, 2026.

Pre-funded warrants issued in 2023 and 2021

were exercised for 48,890 shares of common stock during the three and six months ended June 30, 2025 at an exercise price of $ 0.0001

per pre-funded warrant.

were no warrants that expired during the three months ended June 30, 2026.

There were warrants exercisable for 11,128 shares of common

stock that expired during the three months ended June 30, 2025.

There were warrants exercisable for 85,219 and 11,390 shares of common

stock that expired during the six months ended June 30, 2026 and 2025, respectively.

were approximately 17,000 shares of common stock issued during the three and six months ended June 30, 2026 under our at-the-market equity

program resulting in proceeds of $ 0.1 million, net of transaction fees.

9 – Net Loss per Share

7 unchanged sentences

10 – Segment Reporting

Company has determined that it currently operates in a 1 single

segment, Medical Device development, located in a single geographic location, the United States.

The accounting policies of the segment

are the same as those described in the summary of significant accounting policies set forth in the Company’s Form 10-K, filed with

the SEC on March 26, 2026.

Since the Company operates in a single segment, the measure of segment total assets and loss from operations

is the same as that reported on the accompanying balance sheets as total assets, and the accompanying statement of operations as loss

from operations, respectively.

Company has determined that it currently operates in a 1 single segment, Medical Device development, located in a single geographic location,

the United States.

The accounting policies of the segment are the same as those described in the summary of significant accounting policies

set forth in the Company’s Form 10-K, filed with the SEC on March 26, 2026.

Since the Company operates in a single segment, the

measure of segment total assets and loss from operations is the same as that reported on the accompanying balance sheets as total assets,

and the accompanying statement of operations as loss from operations, respectively.

Company’s chief operating decision maker (“CODM”) is the chief executive officer.

3 unchanged sentences

of Segment Expenses

(In thousands)

For the Three Months Ended

For the Six Months Ended

(In thousands)

5 unchanged sentences

Professional fees

Reserve for uncollectible prepaid clinical costs

Total selling, general and administrative expense

4 unchanged sentences

Treasury securities.

11 – Subsequent Events

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.

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

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

FDA post-marketing approval.

During April 2026, we raised approximately $ 0.1 million, net of expenses,

through an at-the-market equity offering of 12,148 shares of common stock.

Under our at-the-market equity program, which is currently

effective and may remain available for us to use in the future, as of the date hereof, we may sell approximately an additional $ 48.8 million

of common stock.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1. Financial Statements