Vycor Medical, Inc.

Vycor Medical’s ViewSite™ Brain Access System (VBAS) is a specialized surgical device that enables safer access to brain tissue, especially in procedures involving deep-seated lesions. VBAS was developed to address long-standing challenges in neurosurgery, where traditional retraction systems have changed little in decades and can inadvertently damage healthy brain tissue by exerting excess pressure on the soft tissue during operations.

The VBAS device features a tubular design, which is a key departure from the flat blade or ribbon retractors commonly used in neurosurgery. These older systems, while still standard in many hospitals, apply concentrated pressure on surrounding brain tissue to maintain access. Over time, this pressure can cause white matter damage, ischemic complications, and prolonged recovery. In contrast, the VBAS tube distributes force more evenly around the surgical corridor, reducing trauma during insertion and retraction.

The tip of the device is blunt, allowing surgeons to gently separate tissue rather than cut through it, which helps preserve white matter pathways—critical for cognitive and motor functions. This is especially important in operations that involve reaching deep-seated brain lesions such as tumors, cysts, or hemorrhages, where minimizing collateral damage is essential.

Superior Shape

• The VBAS tubular shape disperses retraction forces over a greater surface area and has no edges where pressure build up is most common.

• Blunt tip allows for progressive dilation that permits the splitting of white matter rather than its transection.

• Lower risk of Ischemic complications and results in faster wound healing and shorter patient recovery period.

• Surgeon feedback also points to shorter Operating Room time as no target shift issues through pulling, less consumables needed and greater ease of use.

Market and Clinical Need for VBAS

• Since the introduction of the first operative microscope 50+ years ago, microsurgery (and more recently, endoscopic surgery) has become an indispensable technique in neurosurgery.

• In any surgical procedure adequate visualization of the operative field is critical.

• The standard of care has hitherto been so-called ribbon/blade retractors used to create and maintain visual corridors to access targets within the brain (Greenberg, Leyla and Budde Halo retractor systems).

• The brain, like other sensitive tissue, is subject to injury from retraction – most evident BUT NOT LIMITED TO approaches to deep-seated intracranial lesions.

VBAS is made of transparent polycarbonate, which significantly enhances visibility in the surgical field. Unlike metal retractors that can block the surgeon’s view or create glare under operating theater lights, the clear walls of VBAS allow for continuous monitoring of surrounding tissue during the procedure.

Superior Field of View

• Made of polished transparent polycarbonate.

• Significantly increases the surgeon’s vision through clear walls.

• Allows for continual monitoring of surrounding tissue and structures during insertion and surgery.

• Coated in biocompatible non-reflective ink does not suffer from reflection issues experienced with other retractors.

Its elliptical shape further improves the operating environment by providing a wider working channel without requiring a larger incision and allowing bifocal vision. Surgeons can insert two instruments at once and perform bimanual surgery, a technique that allows for greater control and precision. The enclosed channel not only creates more room but also protects peripheral tissue from accidental damage caused by surgical tools or heat.

Improved Working Channel

• Elliptical shape provides a widened working channel in one access, gives the surgeon greater working room allowing for bimanual surgical maneuvering.

• The contained working channel provides protection of peripheral anatomy from inadvertent instrumental or thermal damage.

• Provides an air instead of CSF medium that provides better intra-operative visualization.

In addition, the system is compatible with the largest neuronavigation platforms and computer-guided technologies that help surgeons accurately reach the pre-identified target in real time. The tip of the VBAS introducer can serve as the navigation pointer, and the VBAS Alignment Clip allows the neuronavigation pointer or probe to be locked into the body of the VBAS with the pointer and VBAS effectively becoming one unit.

Compatible with Neuronavigation

• The tip of the VBAS introducer literally becomes the “pointer” on the neuro-navigation system, allowing for real time monitoring of its position.

• Clip of the VBAS AC locks in place the most commonly used neuro-navigation pointers.

The real-world impact of VBAS has been demonstrated in numerous challenging cases. For example, a patient at Ohio State University was taking Avastin®, a drug that slows wound healing, which made her ineligible for standard surgery. With VBAS, the surgeon was able to access the lesion through a 3-centimeter incision, complete the procedure, and discharge the patient without complications. In another case at Lincoln Medical Center in New York, a bullet fragment lodged in the brain was successfully removed—an operation the chief neurosurgeon said would not have been attempted without VBAS.

Source: Company Documents

VBAS is more than a novel device; it is backed by a growing body of clinical evidence with over 40 peer-reviewed studies and numerous additional clinical papers published involving over 500 patients. These studies report consistently positive outcomes, including shorter operating times, reduced brain damage, and faster hospital discharge. These advantages not only improve patient safety but also reduce overall treatment costs for hospitals.

Source: Company Documents

VBAS has been approved and used in over 300 hospitals in the United States and numerous countries internationally, including major markets such as Japan, Canada, the United Kingdom, and countries in the European Union. Vycor supports this footprint through a network of 104 U.S. independent neuro-surgical sales representatives and international distributors specializing in neurosurgical devices. Over 45,000 neurosurgical procedures have been carried out utilizing VBAS.

Looking ahead, one of the most promising areas for further VBAS adoption is in the treatment of intracerebral hemorrhage (ICH)—a condition in which bleeding occurs within the brain. This condition often requires precise access to remove the blood clot and relieve pressure. With increased focus from the clinical community on using minimally invasive tubular retractors for ICH evacuation, VBAS is well-positioned to support this evolving standard of care.

Together, the device’s design innovations, clinical support, and surgeon feedback point to its growing role in modern neurosurgery. Vycor continues to improve the system, refine its applications, and expand its use globally.

NovaVision, a business unit of Vycor Medical, offers a suite of digital therapies designed to help patients recover from visual defects resulting from neurological brain damage such as stroke or traumatic brain injury (TBI). These therapies are not substitutes for eyeglasses or contact lenses; instead, they are intended to improve visual processing in the brain, where the damage has occurred.

There are two core offerings within the NovaVision platform: Vision Restoration Therapy® (VRT) and NeuroEyeCoach ® (NEC). These FDA-registered, home-based programs work together to address different aspects of neuro-vision loss. VRT focuses on restoring lost visual function by stimulating the brain’s ability to detect visual stimuli in the damaged area of the visual field.

Similar to recovery from motor deficits after brain injury, where repetitive stimulation has proven effective in the recovery of patient functions such as movements of lower limbs, systematic, repetitive visual training can also lead to recovery. Patients who have suffered neurological brain damage that has resulted in a visual field deficit have additional difficulties with eye movements.

NEC, on the other hand, helps patients compensate for their vision loss by training them to make more effective eye movements, improving their ability to scan and interpret their environment.

Source: Company Documents

VRT is the only commercially available, FDA-cleared therapy for vision restoration following stroke or brain injury. It is a prescription-based therapy that patients complete at home using a computer. The program is customized for each individual, delivering visual stimuli in the areas of their visual field affected by damage. Over time, the brain’s visual processing systems may adapt to these stimuli, helping to restore some degree of functional vision. VRT is supported by 15 years of research across 20 clinical studies, including a 302-patient trial in which over 70% of participants showed meaningful improvement.

NeuroEyeCoach is designed to complement VRT by helping patients make faster, more accurate eye movements. Many people with visual field loss are unaware of how much their scanning and search behaviors have been affected. NEC trains patients to make larger, more efficient eye movements and reduce scanning time, which improves their ability to navigate daily tasks. The program can be completed either in a clinic or at home under supervision. A 2020 study involving 296 patients, published in the journal Cortex, found that over 80% of patients improved, regardless of age, gender, side of blindness, or time since injury. This makes NEC one of the most widely validated neuro-vision rehabilitation programs currently available.

Source: Company Documents

Taken together, these therapies provide real-world benefits. Many patients report being able to resume daily activities that were previously difficult or impossible, including shopping, crossing the street unaided, and even driving.

NovaVision has collected a substantial library of patient testimonials highlighting the personal impact of these therapies. One patient described passing a driving test and being able to enjoy life again, while another referred to the program as a “lifesaver.”

Although NovaVision’s therapies have shown significant clinical and functional benefits, broader market adoption requires further development. The company’s leadership has outlined several next steps:

• Refining therapy protocols with input from medical advisors.

• Generating new clinical data based on updated versions of the therapy.

• Updating software for compatibility with all operating systems.

• Exploring new delivery methods, such as wearable goggles.

• Seeking FDA clearance for updated versions.

• Evaluating reimbursement pathways based on new evidence.

Beyond traditional healthcare applications, NovaVision also sees potential to adapt NEC for non-medical markets, such as sports, aviation, gaming, and security, where rapid visual processing and scanning ability are critical. These use cases could represent additional sources of growth with relatively low development risk, especially through potential joint ventures or licensing opportunities.

NovaVision believes there is potential to move into non-healthcare markets possibly even through a JV:

• Strong potential for NeuroEyeCoach technology given its strong clinical data.

• Potential variants for non-medical use in sports, aviation, gaming and security markets among others.

• Medical applications in these sectors remains with NovaVision.

Collectively, VRT and NeuroEyeCoach position NovaVision as a pioneer in neuro-vision rehabilitation, with a platform that aligns with the global movement toward digital, home-based therapy. As populations age and the prevalence of stroke and brain injury rises, the need for effective, accessible vision rehabilitation will only increase.

VRT and NeuroEyeCoach are well suited to capitalize on the global trend towards digital health: digitally delivered at-home treatment:

• Need to discharge patients from in-patient and out-patient facility care.

• Health systems duty to provide care and rehabilitation.

• At-home treatment for ageing population as preventative care.

US Market Opportunity

• NovaVision estimates theoretical potential market to be significant.

• Only real “competition” is lack of awareness and broad physician acceptance.

• NovaVision’s scientific advisors believed that, with the required development outlined and correct KOL buy-in, the therapies should be able to capture 4-6% of the market: $80-120 million.

Vycor Medical has prioritized both clinical validation and intellectual property protection as part of its long-term strategy to support adoption and differentiate its products. These efforts provide surgeons and healthcare systems with confidence in the company’s solutions and reinforce Vycor’s position in the neurosurgical and neurorehabilitation markets.

VBAS: Peer-Reviewed Evidence Supporting Efficacy

The ViewSite™ Brain Access System (VBAS) has been evaluated in a significant body of published research. The device has been featured in over 40 peer-reviewed studies and numerous other clinical papers involving over 500 patients. These studies have shown that VBAS is associated with reduced white matter damage, improved patient outcomes, and shorter hospital stays compared to traditional retraction tools. The clinical findings also align with surgeon-reported benefits such as improved visualization, fewer complications, and more efficient procedures.

This growing body of data supports VBAS as a viable alternative to older blade- and ribbon-style retractors, particularly for procedures involving deep-seated brain lesions or minimally invasive approaches. Vycor management has made continued research a central part of its strategy for expanding adoption.

Source: Company Documents

NovaVision: Backed by Independent Research

NovaVision’s therapies are also supported by extensive clinical validation. Visual Restoration Therapy (VRT) has been studied for over 15 years and cited in 20 clinical publications, including one with 302 patients showing improvement in more than 70% of participants. These results are especially meaningful given that many patients face limited options after vision loss due to stroke or traumatic brain injury.

NeuroEyeCoach (NEC), NovaVision’s complementary scanning training program, is supported by 14 clinical studies involving 591 patients. Unlike general-purpose vision apps, NeuroEyeCoach is based on decades of research into eye movement training and visual search behaviors. The therapy has been shown to improve the ability to detect objects and scan the environment, which translates into better outcomes for daily activities.

Patent Protection Across Core Technologies

Vycor has also built a strong patent portfolio to protect its innovations. The VBAS system is covered by 46 issued patents and 11 pending applications, spanning both the U.S. and key international markets. These patents cover essential aspects of the product’s design and usage, creating legal and technical barriers for competitors. Intellectual property protections help preserve Vycor’s market position while supporting potential licensing or partnership opportunities.

While fewer patent specifics are disclosed for NovaVision, its software and therapy protocols are proprietary and protected under applicable IP frameworks.

Vycor Medical is positioned to address sizable and underpenetrated markets in both neurosurgery and neuro-vision rehabilitation. Both areas are experiencing increased clinical attention and long-term demand growth, driven by aging populations, rising incidence of neurological conditions, and shifts toward minimally invasive and home-based care.

Neurosurgical Access: Expanding VBAS Adoption

The ViewSite™ Brain Access System (VBAS) has already been approved and used in more than 300 hospitals in the U.S. and numerous countries internationally, including Japan, Canada, the UK, and EU member countries. Its primary use is to access deep-seated brain lesions, a category of procedures that has historically posed challenges for traditional retraction tools. More recently, VBAS has gained visibility for its application in intracerebral hemorrhage (ICH) evacuation, a growing area of interest among neurosurgeons.

ICH is a life-threatening condition that involves bleeding within the brain, and it requires timely and precise intervention. Tubular retractors like VBAS offer a minimally invasive option for evacuating blood clots and relieving intracranial pressure. As the neurosurgical community continues to evaluate the use of these tools for ICH, Vycor sees a significant opportunity to position VBAS as a preferred device in this evolving treatment landscape.

Beyond ICH, broader demand for safer, tissue-sparing neurosurgical access tools is rising alongside advances in neuronavigation and minimally invasive techniques. With established distribution channels and strong relationships with key opinion leaders (KOLs) in neurosurgery, Vycor is well-positioned to increase VBAS's market share organically and through future product enhancements and product lines.

Neuro-Vision Rehabilitation: A Large and Underserved Market

NovaVision targets patients who have experienced visual field deficits due to stroke or brain injury, conditions that affect millions of people worldwide each year. The current market is characterized by a lack of widely adopted, clinically validated solutions. NovaVision’s therapies—Visual Restoration Therapy (VRT) and NeuroEyeCoach (NEC)—are among the few options designed specifically to restore or compensate for visual deficits caused by neurological brain damage.

Following the development work management believes is required, with the right mix of clinical and KOL support and physician engagement, the company’s therapies could achieve a 4–6% share of the eligible patient population in the U.S. That level of penetration would represent a potential $80–$120 million market opportunity. Importantly, the therapies are designed for at-home use, aligning with healthcare trends that emphasize remote care, reduced hospital dependency, and cost-effective recovery options for aging populations.

Additionally, NovaVision has identified non-healthcare applications for its NEC technology in industries like sports, aviation, gaming, and security, where enhanced visual scanning and response time are valuable. While exploratory, these adjacent markets could provide new revenue opportunities with limited incremental risk.

Vycor Medical focuses on product innovation, targeted marketing, and regulatory oversight while outsourcing operations such as manufacturing and sales. This lean structure reduces fixed costs and enables Vycor to scale efficiently as demand for its products grows.

Rather than maintaining in-house manufacturing facilities, Vycor partners with qualified subcontract manufacturers to produce the ViewSite™ Brain Access System (VBAS). The company's approach reduces capital requirements and enables flexibility in scaling production.

For sales and marketing, Vycor uses an established network of specialized distribution partners:

• In the U.S., VBAS is sold through 11 distribution groups comprising a total of 104 independent sales representatives, many of whom maintain a daily presence in hospital operating rooms and specialize in neurosurgical devices.

• In international markets, the company works with local distributors who are already established in the neurosurgical field. These partners are responsible for navigating local regulatory environments and maintaining clinical relationships.

By adopting this structure, Vycor has national and international reach while keeping internal staffing and overhead low.

Corporate Strategy: Growth Through Expansion and Uplisting

Vycor’s broader corporate objective is to uplist from the OTCQB to a recognized national exchange. Management believes that reaching this next stage of growth will require achieving greater scale, which it plans to pursue through a combination of:

• Organic product growth through continued adoption of VBAS and incremental product improvements and new product development.

• Strategic acquisitions or mergers that bring complementary technologies, expand distribution, or enhance financial metrics.

• Developing NovaVision through strategic partnerships and program development with partners.

Vycor’s current structure supports this strategy. As an SEC-reporting company with experience in mergers and integration, Vycor has the operational and financial systems in place to serve as a platform for expansion. The company also maintains in-house expertise in regulatory compliance, including ISO 13485:2016 certification, participation in the Medical Device Single Audit Program (MDSAP), and familiarity with FDA, EU, and Health Canada requirements.

For the NovaVision business, Vycor is taking a more flexible approach. The company has stated that it has delayed significant investment in product development until it is in a position to implement it. Management is open to partnering with a third party (or parties) focused on digital health or telehealth to help develop and expand the platform, including therapy protocols, delivery systems, and commercial reach.

Together, these strategies reflect Vycor’s intent to scale efficiently while expanding the reach of both business units.

Vycor Medical is led by a small executive team with experience in corporate management, healthcare operations, and financial oversight. The team oversees both Vycor’s business units, Vycor Medical and NovaVision, and executes the company’s growth and uplisting strategy.

• Peter Zachariou, Chief Executive Officer

Peter leads Vycor’s overall corporate strategy, including business development, operations, investor relations, and sales and marketing. He brings a background in corporate leadership and financial markets.

• David Cantor, President

David oversees day-to-day operations and strategic planning. He has prior financial experience in both private and public company acquisitions and business development. At the Company, he is directly responsible for patent protection, manufacturing, and new product development.

• Adrian Liddell, Chief Financial Officer

Adrian manages Vycor’s accounting, financial strategy, and SEC reporting and is also responsible for regulatory. He has extensive financial management and accounting experience and mergers & acquisitions expertise. 

Together, the leadership team is focused on increasing the adoption of VBAS, expanding NovaVision’s reach, and positioning Vycor as a scalable platform within the medical device and neurotherapeutic markets.

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