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Item 1. Business

2026-03-26 compared with 2025-02-28 · 126 added, 154 removed, 141 unchanged (67% of the section changed)

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 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 a large

subset of CVD, which most often occurs when valves inside of the veins of the leg become damaged, resulting in the backwards flow of

blood (reflux), blood pooling in the lower leg, increased pressure in the veins of the leg (venous hypertension) and in severe 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®, which is a first-in-class surgical replacement venous valve that is currently being

evaluated in a U.S.

pivotal study.

The Company is also developing a second product called enVVe®, which is a first-in-class, 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 this Annual Report on Form 10-K).

There 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.

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.

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

a large subset of CVD, which most often occurs when valves inside of the veins of the leg become damaged, resulting in the backwards

flow of blood (reflux), blood pooling in the lower leg, increased pressure in the veins of the leg (venous hypertension) and in severe

cases, venous ulcers that are difficult to heal.

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 and has begun discussions with the U.S.

Food and Drug Administration (“FDA”) regarding

the enVVe pivotal trial.

is being developed for approval by the FDA.

We cannot provide any assurance that enVVe will receive approval from the FDA (see the section entitled “Risk Factors”

in this Annual Report on Form 10-K).

There 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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depressive symptoms.

is generally defined as the portion of the population that has a given condition.

Estimates indicate that the prevalence of people in

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 patients that develop venous leg ulcers (C6 patients).

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.

VenoValve is a replacement venous valve developed at enVVeno Medical to be surgically implanted in the deep venous system 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.

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.

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.

approval allowed us to proceed with our U.S.

pivotal study for the VenoValve which is called the SAVVE® (Surgical Anti-reflux

Venous Valve Endoprosthesis) a prospective, non-blinded, single arm, multi-center clinical study.

The seventy-five patient SAVVE study reached full enrollment on September 1, 2023.

endpoints for the SAVVE 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.

In November 2024, one year preliminary

efficacy and safety data from the SAVVE was presented at the 51th Annual VEITH Symposium, the largest vascular conference in the world.

The data indicated that eighty-five percent (85%) of the patients enrolled in SAVVE 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

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

Patients in the SAVVE 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.

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.

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

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, and the final wave for the shorter-term subjects was completed in December.

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 mid-2025.

estimate that there are approximately 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

enVVe System is designed to treat severe deep chronic venous insufficiency (“CVI”) through a minimally invasive, catheter-based

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 directly addresses prior FDA concerns related to venous valves implanted via open surgical procedures.

In addition 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 has begun discussions with the FDA regarding the enVVe pivotal trial,

which it expects to begin in 2026.

March 2021, the Company received FDA investigational device exemption (“IDE”) approval to initiate the SAVVE® (Surgical

Anti-reflux Venous Valve Endoprosthesis) 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 of 2024.

In August of 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 enVVe 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 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 enVVe pivotal study.

product candidates and our operations are subject to extensive regulation by the FDA, and other federal and state authorities in the

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Approval Pathway

III devices such as the VenoValve and enVVe generally require pre-market approval (PMA) before they can be marketed in the U.S.

PMA review and approval process is more demanding than the 510(k) premarket notification process.

In a PMA, the manufacturer must

demonstrate that the device is safe and effective, and the PMA must be supported by extensive data, including data from preclinical

studies and human clinical trials.

The PMA also must contain a full description of the device and its components, a full description

of the methods, facilities and controls used for manufacturing, and proposed labeling.

Following receipt of a PMA, the FDA

determines whether the application is sufficiently complete to permit a substantive review.

If the FDA accepts the application for

review, it has 180 days under the FDCA to complete its review of a PMA, although in practice, the FDA’s review often takes

significantly longer, and can take several years.

With the recent reduction in workforce that has taken place within the federal

government, including at the FDA, we may experience longer review periods from the FDA for any applicable regulatory approvals.

advisory panel of experts from outside the FDA may be convened to review and evaluate the application and provide recommendations to

the FDA as to the approvability of the device.

The FDA may or may not accept the panel’s recommendation.

In addition, the FDA

generally will conduct a pre-approval inspection of the applicant or its third-party manufacturers’ manufacturing facility or

facilities to ensure compliance with the QSR.

The FDA will generally approve the new device for commercial distribution if it

determines that the data and information in the PMA constitute valid scientific evidence and that there is reasonable assurance that

the device is safe and effective for its intended use(s).

III devices such as enVVe generally require pre-market approval (“PMA”) before they can be marketed in the U.S.

The PMA review

and approval process is more demanding than the 510(k) premarket notification process.

The PMA application consists of multiple parts,

sometimes referred to as “modules”.

Modules typically include testing such as sterilization, packaging and shelf-life testing,

biocompatibility, manufacturing, and clinical data.

All modules are reviewed by the FDA to ensure that the device is safe and effective.

In certain instances, the sponsor may elect a modular PMA, where certain sections are submitted for approval by the FDA in advance of

the clinical data.

Following receipt of a PMA, the FDA determines whether the application is sufficiently complete to permit a substantive

If the FDA accepts the application for review, it has 180 days under the FDCA to complete its review of a PMA.

With the recent

reduction in workforce that has taken place within the federal government, including at the FDA, we may experience longer review periods

from the FDA for any applicable regulatory approvals.

An advisory panel of experts from outside the FDA may be convened to review and

evaluate the application and provide recommendations to the FDA as to the approvability of the device.

The FDA may or may not accept

the panel’s recommendation.

In addition, the FDA generally will conduct a pre-approval inspection of the applicant or its third-party

manufacturers’ manufacturing facility or facilities to ensure compliance with the QSR.

The FDA will generally approve the new device

for commercial distribution if it determines that the data and information in the PMA constitute valid scientific evidence and that there

is reasonable assurance that the device is safe and effective for its intended use(s).

FDA may approve a PMA with post-approval conditions intended to ensure the safety and effectiveness of the device, including, among other

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in demonstrating a reasonable assurance of safety and effectiveness.

Both the VenoValve and enVVe will require the approval of a PMA.

The enVVe System will require PMA approval before it can be market

and sold in the U.S.

Trials in Support of PMA

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All clinical investigations of devices to determine safety and effectiveness

must be conducted in accordance with the IDE regulations, which govern investigational

device labeling, prohibit promotion of the investigational device and specify an array of recordkeeping, reporting and monitoring responsibilities

of study sponsors and study investigators.

If the device presents a “significant risk,” to human health, as defined by the

FDA, the FDA requires the device sponsor to submit an IDE application to the FDA, which must become effective prior to commencing human

clinical trials.

A significant risk device is one that presents a potential for serious risk to the health, safety or welfare of a patient

and either is implanted, used in supporting or sustaining human life, substantially important in diagnosing, curing, mitigating or treating

disease or otherwise preventing impairment of human health, or otherwise presents a potential for serious risk to a subject.

The VenoValve

required IDE applications prior to human testing in the United States, and we believe any future products such as the enVVe will also

require IDE applications before human testing in the United States.

must be conducted in accordance with the IDE regulations, which govern investigational device labeling, prohibit promotion of the investigational

device and specify an array of recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators.

the device presents a “significant risk,” to human health, as defined by the FDA, the FDA requires the device sponsor to

submit an IDE application to the FDA, which must become effective prior to commencing human clinical trials.

A Class III medical device

is one that presents a potential for serious risk to the health, safety or welfare of a patient and either is implanted, used in supporting

or sustaining human life, substantially important in diagnosing, curing, mitigating or treating disease or otherwise preventing impairment

of human health, or otherwise presents a potential for serious risk to a subject.

The enVVe System will require IDE approval before human

testing in the United States.

IDE application must be supported by appropriate data, such as animal and laboratory test results, showing that it is safe to test the

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approved, for the following reasons:

have extensive experience of proprietary processing and manufacturing methodology specifically applicable to the design, processing,

manufacturing and sterilization of our biologic tissue devices.

operate a 14,507 square foot manufacturing facility in Irvine, California.

Our facility is designed expressly for the manufacture

of Class III tissue based implantable medical devices and is equipped for research and development, prototype fabrication, current

good manufacturing practices (cGMP), and manufacturing and shipping for Class III medical devices, including biologic cardiovascular

have attracted senior executives who are experienced in research and development and who have worked on numerous medical devices

that have received FDA approval or CE marking.

We also have the advantage of an experienced board of directors and scientific advisory

board who will provide guidance as we move towards market launch.

We have extensive experience

of proprietary processing and manufacturing methodology specifically applicable to the design, processing, manufacturing and sterilization

of our biologic tissue devices.

We operate a 14,507 square

foot manufacturing facility in Irvine, California.

Our facility is designed expressly for the manufacture of Class III tissue based

implantable medical devices and is equipped for research and development, prototype fabrication, current good manufacturing practices

(cGMP), and manufacturing and shipping for Class III medical devices, including biologic cardiovascular devices.

We have attracted senior

executives who are experienced in research and development and who have worked on numerous medical devices that have received FDA

approval or CE marking.

We also have the advantage of an experienced board of directors and scientific advisory board who will provide

guidance as we move towards market launch.

possess an extensive proprietary processing and manufacturing methodology specifically applicable to the design, processing, manufacturing

4 unchanged sentences

We have filed numerous patent applications

for the VenoValve with the U.S.

for the VenoValve and enVVe System with the U.S.

Patent and Trademark Office (“USPTO”) and throughout the world.

We currently have thirty-nine (39) patents

granted from agencies around the world including eight (8) from the USPTO.

of February 25, 2025, we had thirty-seven (37) full-time employees.

None of our employees are represented by a collective bargaining

agreement, and we have never experienced any work stoppage.

have forty-two (42) patents granted from agencies around the world including nine (9) from the USPTO.

of March 24, 2026, we had thirty-three (33) full-time employees.

None of our employees are represented by a collective bargaining agreement,

and we have never experienced any work stoppage.

We believe we have good relations with our employees.

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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-K

Item 1. Business