- 670 participants across 70 U.S. sites in the HOPE clinical trial, the largest medical device pivotal trial focused exclusively on Alzheimer's disease.
- June 2027 anticipated FDA approval date for Spectris AD, contingent on positive HOPE trial results.
- Breakthrough Device Designation from the FDA, expediting the regulatory pathway for Spectris AD.
Experts would likely conclude that Cognito Therapeutics' strategic leadership hires and completed pivotal trial position it strongly for commercializing an innovative, non-invasive Alzheimer's treatment with a potentially streamlined regulatory pathway.
Cognito Therapeutics Bolsters Leadership Team to Steer Growth and Commercialization of Alzheimer's Treatment
CAMBRIDGE, MA – November 12, 2026 – Cognito Therapeutics, a neurotechnology company pioneering non-invasive therapies for brain health, has announced a significant expansion of its executive leadership team. The appointments of Joe Perekupka as Chief Commercial Officer, Urvashi Tyagi as Chief Technology Officer, and Dave Watson as Chief Operating Officer mark a critical step as the company prepares to transition from clinical development to commercialization of its innovative Alzheimer's disease treatment, Spectris AD.
These strategic hires come at a pivotal moment for the Cambridge-based company. Having recently completed its pivotal HOPE clinical trial for Spectris AD, Cognito is now firmly focused on the next phases: securing regulatory clearance, establishing a robust commercial infrastructure, and scaling its operations to meet the anticipated demand for this novel therapeutic approach.
"We are building Cognito not simply to advance a promising technology, but to create an entirely new therapeutic platform capable of reaching patients at scale," said Christian Howell, Chief Executive Officer of Cognito. "Joe, Urvashi, and Dave each bring experience that is highly relevant to what comes next for Cognito. Joe has built markets and reimbursement pathways for novel neurotechnology, Urvashi has scaled connected health platforms serving millions of patients, and Dave has helped build the organizational infrastructure required to take a biotechnology company through extraordinary growth. Together, they add tremendous depth to a leadership team preparing Cognito for its next chapter."
Preparing for Commercialization: Securing Market Access
Joe Perekupka’s appointment as Chief Commercial Officer is a strong signal of Cognito's intent to navigate the complex landscape of market access and reimbursement. Perekupka brings over two decades of leadership experience across medical technology, digital therapeutics, and neuromodulation. His track record includes spearheading commercial and reimbursement strategies that have successfully navigated the often-challenging waters of Medicare and Medicaid coverage.
Notably, during his tenure as CEO of Freespira, Perekupka was instrumental in securing a distinct Healthcare Common Procedure Coding System (HCPCS) Level II code and a new national coding classification for biofeedback-based digital therapeutics from the Centers for Medicare & Medicaid Services (CMS). This experience is invaluable for Cognito, as securing favorable reimbursement is a critical hurdle for any new medical device, particularly in the rapidly evolving field of digital therapeutics and neuromodulation.
"Cognito has the opportunity to establish an entirely new model for how neurotechnology reaches patients, physicians and health systems," Perekupka stated. "I was drawn to Cognito by its compelling science, it’s at-home treatment model and a team that has been planning for access and real-world adoption well before launch. I’m excited to build on that foundation and help translate the potential of Spectris into broad patient access."
The reimbursement landscape for non-invasive neuromodulation and prescription digital therapeutics (PDTs) is complex and constantly evolving. While some companies have achieved unique HCPCS codes, CMS has sometimes reimbursed these therapies at rates comparable to generic devices, despite higher development costs. However, recent developments, such as Medicare's decision to cover certain digital therapeutics for mental health treatment starting in 2025, suggest a growing acceptance of these technologies. Perekupka's expertise will be crucial in positioning Spectris AD within this developing framework and ensuring it is accessible to the patients who need it.
Scaling the Technology: From Clinical Trials to Broad Deployment
Urvashi Tyagi, the newly appointed Chief Technology Officer, brings over 20 years of experience in building and scaling technology platforms across healthcare, commerce, and financial services. Her recent role as CTO of ResMed, where she oversaw engineering, product, design, data, artificial intelligence, and machine learning across a global organization, is particularly relevant to Cognito's goals. At ResMed, Tyagi played a key role in unifying hardware, software, AI, and data across more than 21 million cloud-connected devices and advanced digital platforms supporting patients and healthcare providers.
"Cognito sits at a fascinating intersection of neuroscience, connected technology, data and patient care," Tyagi said. "There is an opportunity to build technology that does much more than deliver a therapy – it can create a connected experience around patients, caregivers, and providers; generate meaningful insights; and continually improve how care is delivered. I’m thrilled to join the team at this stage and help build the technology foundation for the Spectris platform and its future applications."
Tyagi's expertise will be essential in developing the digital infrastructure necessary to support Spectris AD. As an at-home therapy, the device will likely rely on connected technologies to monitor patient adherence, collect data on treatment efficacy, and provide feedback to both patients and healthcare providers. Building a robust, secure, and user-friendly platform will be critical to the success of the therapy in a real-world setting.
Building the Organizational Infrastructure for Growth
Dave Watson, the new Chief Operating Officer, brings extensive experience in building and scaling organizations in the biotechnology and life sciences sectors. His decade-long tenure at Apellis Pharmaceuticals, where he served as General Counsel and Secretary, saw him play a key role in the company's evolution into a global publicly traded biotechnology company with two FDA-approved drugs. His responsibilities spanned governance, litigation, intellectual property, compliance, international operations, strategic transactions, and organizational growth, culminating in a significant role in Apellis's acquisition by Biogen for $5.6 billion.
"Cognito has reached the inflection point where its strong science and compelling product opportunity require an organization capable of executing at scale," Watson noted. "I look forward to working across the company to build the systems, processes, and operating discipline for Cognito as it grows, prepares for commercialization, and expands the potential of its platform."
Watson's operational expertise will be vital in ensuring that Cognito can seamlessly transition from a research-focused organization to a commercial entity capable of manufacturing, distributing, and supporting Spectris AD on a large scale. His experience in navigating the complex regulatory and compliance landscape of the life sciences industry will also be invaluable as the company moves closer to FDA review.
The HOPE Trial and the Path to FDA Approval
The expansion of Cognito's leadership team coincides with the completion of the pivotal HOPE clinical trial for Spectris AD. This trial, which enrolled 670 participants across 70 U.S. sites, is the largest medical device pivotal trial exclusively focused on Alzheimer's disease. Results from the HOPE trial are expected in mid-2026, and will be crucial in determining the therapy's path forward.
Spectris AD utilizes precisely timed sensory stimulation—specifically, synchronized light and sound at a 40Hz gamma frequency—to generate coordinated activity across brain networks. This non-invasive approach aims to engage the brain's own biology to support and sustain brain health. The therapy builds upon positive results from the earlier OVERTURE feasibility study, which demonstrated significant reductions in cognitive and functional decline, as well as reduced brain atrophy, in patients with mild-to-moderate Alzheimer's disease.
Importantly, the OVERTURE study reported no serious treatment-related adverse events and, notably, no Amyloid-Related Imaging Abnormalities (ARIA), a common and potentially serious side effect associated with anti-amyloid monoclonal antibodies like Leqembi and Kisunla. This safety profile, combined with the convenience of an at-home treatment model, could position Spectris AD as a compelling alternative or complement to existing pharmacological therapies.
Cognito has already received Breakthrough Device Designation from the FDA for Spectris AD, a status intended to expedite the development and review of devices that provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases. This designation suggests a potentially streamlined regulatory pathway, with FDA approval anticipated by June 2027, contingent on positive results from the HOPE trial.
As Cognito Therapeutics prepares for this critical phase of its development, the addition of Perekupka, Tyagi, and Watson to its executive team signals a clear commitment to building the commercial, technological, and operational infrastructure necessary to bring Spectris AD to market and potentially transform the treatment landscape for Alzheimer's disease.
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