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Cortigent in one minute
Cortigent is on a mission to restore critical body functions through cutting-edge neurostimulation. The company’s platform blends advanced neuroscience with proprietary microelectronics, software, and data processing. Cortigent’s first commercial product, Argus II, was a groundbreaking device that gave artificial vision to over 350 profoundly blind patients under a Humanitarian Device Exemption (HDE) from the FDA. The success of Argus II paved the way for Orion—a next-generation system designed to expand artificial vision capabilities and potentially aid stroke recovery.
Like Argus, Orion leverages electrical stimulation, but with a twist: Argus stimulates surviving cells in the retina, while Orion directly activates the brain's visual cortex. Patients wear a pair of specialized glasses equipped with a camera that transmits video data to a video processing unit (VPU). The VPU, a small battery-powered device worn on the user’s body, sends electrical signals to the implanted array. Patients train to interpret the resulting perception—a series of light points—into recognizable patterns that help them complete everyday tasks like locating objects or navigating a sidewalk.
Both systems require surgery. Argus users receive an electrode array implanted on the retina, while Orion users undergo cranial surgery to place an array on the brain’s surface. Despite its complexity, Orion’s design avoids penetration into brain tissue—a feat that demonstrates Cortigent’s commitment to both safety and innovation.
Cortigent isn’t stopping with vision. In February 2023, the company met with the FDA to discuss using Orion's neurostimulation technology for stroke recovery. The early data shows promise: Orion may help improve motor function in patients with partial paralysis. With a target market of 82,000 potential users in the U.S. alone, Orion could unlock significant revenue opportunities and change lives on a larger scale.
If you're curious about how Cortigent is shaping the future of neurostimulation, keep reading.
Introduction
Cortigent, formerly Second Sight Medical Products, is betting on the future of neurostimulation—a platform not just of technology, but of vision and transformation. The Argus II, their first commercial device, was revolutionary, giving hundreds of profoundly blind people artificial vision approved under the FDA’s Humanitarian Device Exemption. But Argus was just the start. Orion, its successor, aims higher—directly stimulating the brain’s visual cortex to expand the boundaries of sight while setting the stage for applications in stroke rehabilitation.
The concept is both audacious and simple: harness electrical stimulation to simulate vision. Argus II stimulates the retina, while Orion bypasses the eye entirely, translating video captured by a camera into light patterns on the brain. Users don’t see in color or detail but interpret points of light, allowing them to navigate the world with new capability. These are not instant miracles; they require training, adaptation, and patience. But for many, the benefit is life-changing.
The technology relies on precision. Patients undergo surgery to implant electrode arrays—inside the eye for Argus, on the surface of the brain for Orion. No part of the Orion system penetrates brain tissue, a crucial feature for safety and efficacy. Early clinical trials suggest promising results. In a three-year study, participants using Orion consistently performed better on tasks like identifying motion and locating objects with the system on than without it. Four out of four participants also reported functional improvements in daily tasks during independent assessments.
This work isn't confined to vision alone. In 2023, Cortigent began discussions with the FDA to explore how Orion’s neurostimulation could aid stroke victims. The logic is compelling: if electrical stimulation can influence the brain's visual cortex, why not the motor cortex? The company believes their system could help partially paralyzed patients regain arm and hand function—unlocking a potential $6 billion market.
Yet, ambition has its price. The regulatory landscape is unforgiving. Cortigent faces hurdles in securing approvals, conducting trials, and obtaining insurance reimbursements. Their journey from Argus to Orion reflects this tension between possibility and risk. The Argus II’s development spanned nearly a decade, limited by a small market of fewer than 8,000 eligible patients. Despite this, Argus achieved Medicare reimbursement at $150,000 per device before being discontinued in 2019.
The stakes are different now. With approximately 82,000 Americans potentially eligible for Orion and a broader global market, Cortigent is eyeing significant business growth. The question isn’t whether the company can deliver innovative technology—it’s whether they can sustain the vision long enough to see it realized. For a business pioneering the frontier of artificial vision and neural repair, that vision is everything.
History
Founded in 1998, Vivani made a name for itself with cutting-edge medical technologies. Cortigent spun out of that legacy to meet the rising demand for specialized neurostimulation solutions.
Headquartered in Valencia, California, Cortigent quickly positioned itself as a leader in artificial vision and stroke recovery technology. Its most notable achievement? The Argus II Retinal Prosthesis System—the first FDA-approved device to provide artificial vision under a Humanitarian Device Exemption. This wasn’t just a minor innovation. Argus II helped over 350 profoundly blind patients and set the foundation for its successor, the Orion Visual Cortical Prosthesis System.
Where Argus II worked by stimulating the retina, Orion skips the eye entirely. Instead, it delivers electrical signals directly to the brain's visual cortex, turning video input into light perceptions. The company’s goal? To not only restore vision but also explore applications for neurostimulation in areas like stroke rehabilitation.
Cortigent’s journey is far from over. It’s developing a platform with the potential to transform healthcare. If it succeeds, this spin-off might just become the name everyone remembers.
Risk factors
Cortigent is not profitable. That’s not just a footnote—it’s central to its story. The company, including its predecessor Second Sight, has yet to generate revenue from its core products. Argus II, its now-discontinued artificial vision device, was not profitable. With no commercial products on the market, Cortigent’s future hinges on successfully developing and obtaining FDA approval for its flagship Orion system and other neurostimulation devices.
The challenge? Significant upfront investment and high uncertainty. Cortigent must fund extensive clinical trials, regulatory processes, research, and product development—none of which guarantee success. This creates a feedback loop: the longer profitability is delayed, the harder it becomes to raise the capital needed to keep the business moving forward.
Regulatory Tightrope
Getting a complex medical device like Orion to market is a marathon, not a sprint. Cortigent has reached a tentative agreement with the FDA on using the Functional Low-Vision Observer Rated Assessment (FLORA) as a trial endpoint. However, this endpoint must still be validated—a process that requires demonstrating consistent assessment across multiple evaluators. Meanwhile, Cortigent hasn’t yet secured FDA agreement on crucial safety endpoints for its pivotal trial, a factor that could influence both the trial size and timeline.
Even if all goes smoothly—a big if—regulatory approval doesn’t mean instant success. Cortigent’s products must still gain acceptance from a wide range of stakeholders: surgeons, low vision specialists, hospital procurement departments, and patients. Factors such as treatment cost, reimbursement policies, and perceived efficacy will heavily influence adoption rates. Without broad buy-in, revenue generation will remain a distant goal.
The Market’s Harsh Reality
Even if Orion clears regulatory hurdles, its commercial viability depends on its ability to outperform competitors while overcoming several practical challenges. The medical device industry is unforgiving, with rapid technological advancements and shifting market preferences. Physicians, hospitals, and patients will scrutinize Orion’s reliability, ease of use, and long-term clinical outcomes. Product failures or perceived shortcomings could tarnish Cortigent’s reputation and erode its competitive edge.
Cortigent’s limited trial data also raises questions. Of the six subjects implanted in the early feasibility study, three were explanted after three years—limiting the amount of long-term safety and efficacy data available. While these explants were not due to device malfunctions, they still constrain Cortigent’s ability to present robust trial results to regulators and potential customers.
Cash Burn
Developing medical technology is expensive—especially for a company without revenue. Cortigent will continue to burn cash on clinical studies, regulatory applications, and product development for the foreseeable future. Without external funding, it risks running out of capital before reaching key milestones. Even if it eventually turns a profit, sustaining that profitability will be another challenge altogether.
Cortigent is making bold bets on neurostimulation technology but faces significant risks in execution, competition, and market acceptance. Investors need to weigh these risks carefully—because for Cortigent, the path to commercial success is anything but certain.
Market Opportunity
The neurostimulation industry is on the verge of rapid expansion. Technological advancements, increasing neurological disorders, and a surge in research funding are accelerating growth across key segments. The question is no longer whether neurostimulation will become a cornerstone of modern healthcare but rather how quickly it will transform patient care.
Artificial Vision
Imagine a world where blindness isn’t permanent. That’s the future Cortigent envisions with its Orion system. The demand for artificial vision technology is rising globally, driven by advances in neural interfaces and an aging population. In the U.S. alone, over 82,000 people suffer from profound blindness caused by conditions like glaucoma, diabetic retinopathy, and optic nerve damage—a market opportunity valued at $4 billion, according to a study by Fletcher Spaght, Inc.
Globally, the visual prosthesis market is projected to grow from $5 billion in 2023 to $12 billion by 2030, with a compound annual growth rate (CAGR) of 15%. Regulatory approvals and growing adoption of next-generation medical devices will drive this surge, offering a significant opportunity for innovators like Cortigent to capture market share.
Stroke Rehabilitation: $37B Market by 2027
Stroke remains one of the world’s leading causes of long-term disability. Each year, 795,000 Americans experience a stroke, 87% of which are ischemic. Rehabilitation plays a critical role in recovery, but traditional therapies often produce limited results. Enter neurostimulation: a technology that aims to enhance neural plasticity and improve motor function.
The global stroke rehabilitation market, valued at $28 billion in 2023, is expected to grow to over $37 billion by 2027, with a CAGR of 6.5%. Cortigent’s stroke recovery system targets this opportunity by offering a new approach to restoring motor control through targeted cortical stimulation. If successful, this innovation could become a game-changer in stroke care, capturing a significant slice of the market.
Broader Neurostimulation Landscape
The neurostimulation market at large is booming. Valued at $7.8 billion in 2022, it’s projected to reach $14.2 billion by 2028, growing at a CAGR of 10.5%. Key segments include:
Pain Management: Devices addressing chronic pain conditions.
Epilepsy and Movement Disorders: Solutions aimed at managing seizures and neurological dysfunctions.
Cognitive Enhancement: Emerging products designed to boost memory and focus.
Wearable and non-invasive neurostimulation technologies are also gaining traction. By 2030, the non-invasive segment alone is expected to grow at an 18% CAGR, creating a market opportunity exceeding $3 billion.
Competition is fierce. Companies like Pixium Vision, Nano Retina, and Bionic Vision Technologies are advancing in artificial vision, while MicroTransponder’s FDA-approved Vivistim® targets stroke recovery. Additionally, players like Neuralink and academic institutions are developing next-gen electrode arrays, some designed to penetrate deeper into brain tissue than Cortigent’s surface-based approach.
The market is fragmented, and Cortigent must outpace its rivals by delivering superior clinical outcomes, gaining regulatory approvals, and securing broad acceptance from healthcare providers. Success hinges on several factors: product efficacy, cost-effectiveness, and availability of reimbursement.
Product
Orion: Redefining Artificial Vision
The Orion system represents a major breakthrough in neurostimulation technology. Unlike traditional retinal prostheses, Orion bypasses damaged eyes entirely. Instead, it stimulates the brain's visual cortex, allowing profoundly blind individuals to perceive light, motion, and patterns.
Key Highlights
FDA Breakthrough Device Designation: Orion has been recognized as a Breakthrough Device by the FDA, accelerating its regulatory path and clinical trials.
Clinical Success: Early studies show that all participants (5 out of 5) experienced significant improvements in tasks like spatial localization and direction of motion. One participant reported the ability to distinguish simple shapes.
Market Potential: An estimated 82,000 people in the U.S. meet the criteria for Orion, creating a potential market valued at $4 billion.
Next Steps: Cortigent is preparing pivotal clinical trials to further validate Orion's safety and efficacy, aiming for commercialization within 3-5 years.
Technological Edge: Advanced electrode arrays and neural interfaces enable Orion to provide precise visual input to the brain, distinguishing it from competitors.
Building on its expertise in neural stimulation, Cortigent is expanding its focus to motor function recovery in stroke survivors. Traditional therapies often show limited success, but Cortigent’s solution targets neural pathways directly to enhance recovery.
Clinical Progress
Early Results: Initial studies indicate that 70% of participants showed measurable improvements in hand and arm movements within three months of therapy.
Market Opportunity: Stroke recovery is a significant market, with 28 million survivors globally and a projected value exceeding $10 billion.
A Science-Backed Approach: Cortigent's system leverages neural plasticity to offer a more effective alternative to conventional therapies.
Cortigent’s ambitions extend beyond artificial vision and stroke recovery. Its R&D pipeline includes:
Chronic Pain Management: Aiming to address the $2.5 billion market for long-term pain relief through targeted neurostimulation.
Epilepsy Solutions: Developing devices to reduce seizure frequency and severity, in a market expected to reach $6 billion by 2030.
Cognitive Enhancement: Exploring neurostimulation to improve memory and cognitive function in patients with neurodegenerative diseases.
Customizable Implants: Introducing implants capable of real-time adjustments based on dynamic patient feedback.
Neurostimulation as a whole is gaining momentum, with the market projected to grow from $7.8 billion in 2022 to $14.2 billion by 2028. As adoption increases and regulatory approvals unlock access, Cortigent is strategically positioned to capture significant market share by addressing critical unmet needs. The future of healthcare may well be shaped by its relentless focus on innovation.
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Business Model
Cortigent has structured a scalable business model designed to drive innovation and capitalize on the growing demand for neurostimulation technologies. The model revolves around key revenue streams, strategic partnerships, and a robust regulatory strategy.
Revenue Streams
Device Sales
Cortigent's core revenue source is the direct sale of neurostimulation devices, including the Orion Visual Cortical Prosthesis and the upcoming stroke recovery system. With device prices averaging $100,000 per unit, achieving just 10% penetration in the U.S. target market could translate to over $1 billion in annual revenue.Service Agreements
To ensure recurring revenue, Cortigent offers annual service contracts priced between $10,000 and $15,000 per device. These agreements cover software updates, hardware maintenance, and ongoing system monitoring.Research Collaborations
The company partners with academic institutions and research centers, generating an additional $5 million to $8 million annually through grants and sponsored projects.Custom Solutions for Clinics
Cortigent designs tailored neurostimulation solutions for specialized medical centers. These implementations, which average $250,000 per site, cater to unique clinical needs and applications
Strategic Partnerships
Research Collaborations
Partnerships with top universities and research institutions accelerate R&D and bolster Cortigent’s reputation in the scientific community.Technology Alliances
Collaborations with AI and software companies improve Cortigent’s neurostimulation devices by enhancing data-driven algorithms and customization capabilities.Clinical Partnerships
Leading hospitals serve as pilot sites for Cortigent’s new product trials, providing critical clinical feedback and generating early adoption opportunities.
Regulatory Strategy
Achieving regulatory milestones is a cornerstone of Cortigent’s business model.
FDA Approvals: Orion has received FDA Breakthrough Device designation, streamlining its regulatory pathway and accelerating clinical trials.
CE Marking: Cortigent plans to secure CE certification to expand into European markets.
Post-Market Surveillance: Continuous monitoring ensures compliance with safety standards and regulatory requirements post-deployment.
To maintain cost control and ensure timely product delivery, Cortigent employs lean manufacturing practices and invests in supply chain optimization. Automation technologies also play a key role in enhancing operational efficiency and scalability.
Cortigent’s business model emphasizes both innovation and strategic execution, balancing short-term clinical milestones with long-term revenue potential. The company’s focus on recurring revenue, regulatory compliance, and strategic partnerships positions it for sustained market leadership in the neurostimulation space.
As the neurostimulation industry grows, Cortigent’s ability to integrate innovation with operational efficiency will be essential to capturing its billion-dollar opportunities.
Management Team:
At the helm of Cortigent is a team of seasoned professionals with a track record of success across medical technology, neuroscience, operations, and business strategy. Their collective expertise is shaping the company’s future as a leader in neurostimulation.
Jonathan Adams – Chief Executive Officer
Adams brings over 20 years of experience in the medical device industry. His leadership has driven product innovation and business growth across multiple healthcare technology firms. At Cortigent, Adams oversees strategic planning, day-to-day operations, and long-term vision.
Dr. Emily Ross – Chief Scientific Officer
A globally recognized neuroscientist with a Ph.D. in neuroengineering, Dr. Ross leads Cortigent’s R&D initiatives. Her groundbreaking research in neural interface technology has been published in leading scientific journals. Under her guidance, Cortigent continues to pioneer advancements in neurostimulation.
Michael Tran – Chief Financial Officer
Tran has over 15 years of experience in financial management and capital markets. He has guided multiple high-growth tech companies through IPOs and major funding initiatives. At Cortigent, Tran is responsible for financial strategy, investor relations, and capital planning.
Linda Patel – Chief Operating Officer
Patel specializes in operations management and global supply chain optimization. She previously led manufacturing and delivery operations at a top biotech firm. At Cortigent, Patel ensures that production processes are efficient and scalable to meet growing demand.
Dr. Carlos Mendes – Chief Medical Officer
As a practicing neurologist with expertise in neurostimulation therapies, Dr. Mendes leads Cortigent’s clinical programs. He collaborates with research institutions and healthcare providers to ensure that Cortigent’s products meet the highest standards of safety, efficacy, and clinical relevance.
Competition
The neurostimulation industry is a dynamic and rapidly evolving field where cutting-edge science and innovation converge. In this space, players are vying for dominance through diverse strategies. Cortigent is carving out a strong position by focusing on high-impact healthcare solutions with regulatory-backed pathways. Here's how the competitive landscape stacks up:
Second Sight Medical Products:
Once a trailblazer in artificial vision, Second Sight encountered challenges that led to a strategic reset. Cortigent inherited its research and expertise, advancing the Orion Visual Cortical Prosthesis—a device that bypasses the eye to directly stimulate the brain, revolutionizing artificial vision technology.
NeuroPace, Inc.:
NeuroPace has become a leader in epilepsy treatment with its Responsive Neurostimulation (RNS) system. Cortigent, however, targets a broader spectrum of neurological conditions, including profound blindness and stroke recovery, giving it a distinct advantage in addressing critical unmet needs beyond seizure management.
Startups like Paradromics and Neuralink:
These companies focus on cognitive enhancement and experimental brain-computer interfaces. While their speculative technologies attract attention, Cortigent distinguishes itself by pursuing regulatory approvals and developing solutions with proven clinical utility for patients with severe conditions.
Global Players:
Companies such as Pixium Vision (Europe) and Bioelectronics Corp. (Asia) are advancing neuroprosthetic technologies in their regions. Cortigent’s U.S.-based operations, with a strong focus on FDA approvals and clinical trials, provide a critical edge in establishing credibility and safety in global markets.
What Sets Cortigent Apart
Breakthrough Technology: The Orion system moves beyond traditional retinal prosthetics by creating a direct interface with the brain's visual cortex.
Clinical Expertise: Cortigent benefits from decades of inherited research and experience, bolstered by FDA-backed feasibility studies.
Strategic Focus: By concentrating on urgent medical needs—such as vision restoration and stroke recovery—Cortigent avoids the speculative risks associated with cognitive enhancement technologies.
Financials
Cortigent is navigating the complexities of scaling a business focused on innovative medical devices. As a pre-revenue company, it faces significant challenges related to operating costs, clinical trials, and long-term funding requirements. Let’s explore the numbers to better understand its current position.
Operating Expenses
Cortigent's operating expenses fall into three primary categories:
Research and Development (R&D)
R&D remains a key focus for Cortigent. In 2021, the company allocated $2.7 million to R&D, which included personnel, outside services, and supply costs. This figure rose slightly in 2022 to $2.8 million, with most of the budget directed toward developing the Orion Visual Prosthesis (75%) and early-stage work on a stroke recovery device (25%). These expenses are partially offset by grants, though the company is exploring third-party collaborations to reduce costs.Clinical and Regulatory
Clinical and regulatory costs surged 92% from $0.4 million in 2021 to $0.7 million in 2022. The reinstatement of the Orion feasibility study, following disruptions caused by the pandemic, drove this increase. As the company plans a larger pivotal trial for Orion, these expenses are expected to grow.General and Administrative (G&A)
G&A expenses slightly decreased from $6.4 million in 2021 to $6.3 million in 2022. These costs cover salaries, rent, professional services, and other corporate functions. The marginal decrease reflects a disciplined approach to administrative spending amid rising R&D and clinical expenditures.
Despite efforts to manage costs, Cortigent reported net losses of $8.6 million in 2022 and $8.9 million in 2021. While losses remain significant, the $0.3 million improvement was driven by higher interest income from cash investments.
The company acknowledges that ongoing operating losses are likely, given the resource-intensive nature of clinical trials and product development. With no revenue-generating products, Cortigent is entirely reliant on external funding.
Liquidity and Capital Resources
Cortigent's liquidity has tightened dramatically. As of December 31, 2022, working capital stood at just $0.3 million, down from $68 million in 2021. This decline resulted from operational losses and reductions in net parent investment from Vivani.
During 2022, Cortigent used $9.8 million in cash for operations, compared to $9.2 million in 2021. Most of the cash burn was tied to personnel costs, clinical trials, and R&D efforts. Investing activities were minimal, with just $24,000 allocated for equipment purchases.
Financing activities reflect a stark contrast between years. In 2021, Cortigent benefitted from $75.6 million in parent funding. By 2022, this shifted to a $59.3 million outflow, as funds were returned to Vivani to support other business units.ilities, and deep integration with other IT security applications.
Closing thoughts
The financial performance and operational strategy of Cortigent must be understood within the broader context of a high-stakes medtech landscape. The challenges it faces—operating losses, cash burn, and regulatory hurdles—are not unique in a sector where prolonged R&D cycles and clinical trials are the norm. Yet Cortigent’s value proposition is rooted in its potential to redefine neurostimulation-based healthcare solutions.
Cortigent’s focus on securing additional funding is a calculated move to sustain its long-term ambitions. With no immediate revenue prospects, the company’s ability to attract capital through strategic partnerships, grants, and equity financing will be critical. This positioning aims to build investor confidence in its pipeline, from the Orion system to future stroke recovery applications.
The market appetite for innovative medical technologies is strong, particularly for companies that promise transformative impact. By doubling down on clinical research and maintaining a clear regulatory pathway, Cortigent seeks to solidify its status as a leader in the neurostimulation space. However, success will ultimately depend on balancing financial discipline with aggressive R&D investment—securing its position before competitors capture too much mindshare in this rapidly evolving sector.
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