Longevity and Neuro Growth Equity

Sector Definition and Market Structure

Longevity and Neuro is one of the five sectors inside LeverVenture's Life Sciences and Healthcare mandate. It covers therapeutics for neurodegenerative, neurological and psychiatric disease; neurotechnology devices, from neuromodulation to implanted brain-computer interfaces; diagnostics and biomarkers for brain disease and biological aging; and software-delivered treatment for mental and behavioral health. The longevity half of the sector is defined by its biology, the mechanisms of aging, and the neuro half by the organ it treats. The two meet in the diseases of later life, which is why we hold them in one sector.

Disease Burden and Payer Concentration

The Global Burden of Disease Study 2021, published in The Lancet Neurology in 2024, found that conditions affecting the nervous system were the leading group cause of disability-adjusted life-years worldwide in 2021 and affected 3.40 billion people, 43.1 percent of the global population. In the United States, the Alzheimer's Association's 2026 Alzheimer's Disease Facts and Figures estimates that 7.4 million Americans age 65 and older are living with Alzheimer's in 2026.

The same Alzheimer's Association report projects that health and long-term care costs for people living with dementia will reach $409 billion in 2026, with Medicare and Medicaid expected to cover $263 billion of that amount, or 64 percent. It also projects that the number of Americans age 65 and older with Alzheimer's may grow to 13.8 million by 2060, barring medical breakthroughs. For a company in this sector, those figures mean the decisive customer is usually a public payer, and we underwrite the coverage decision as closely as the clinical result.

Public Research Funding

We track federal research funding because it pays for much of the science that companies in this sector later commercialize. According to the National Institute on Aging's May 2026 Director's Status Report, the fiscal year 2026 appropriation, H.R. 7148, signed as Public Law 119-75 on February 3, 2026, allocates $4.518 billion to NIA and provides an additional $100 million for Alzheimer's and related dementias research across NIH. The same report states that the President's fiscal year 2027 budget proposes $4.217 billion for NIA, and that the proposal is a starting point for negotiation with Congress and not a final budget.

Market Segments

The sector divides into four segments with different evidence and payment profiles. Disease-modifying therapeutics carry the heaviest clinical risk and the longest path to revenue. Neurotechnology devices answer to FDA device law and, for Medicare patients, to coverage decisions that follow authorization. Brain and aging biomarkers sit between laboratory regulation and device regulation. Digital treatment for mental and behavioral health earns payment through specific billing codes and a supervising clinician. We treat each segment as its own underwriting problem, even when one company spans two of them.

Investment Criteria and Underwriting

LeverVenture invests at the growth stage, between venture capital and buyout, in companies where technical and clinical risk has been substantially retired and execution risk remains. We take minority positions and make no leverage claims. Every opportunity is scored on the six LeverRating dimensions, Team, Market, Product, Traction, Financial and Thesis fit. For a device, a diagnostic or a therapeutic, the six expand to ten so that regulatory position, clinical evidence, reimbursement and freedom to operate are each scored on their own. Under ROI², the second return in this sector is healthy life extended, tracked against a named clinical or real-world endpoint from entry.

Indication Discipline for Longevity Therapeutics

Section 505(d) of the Federal Food, Drug, and Cosmetic Act directs FDA to refuse a new drug application that lacks substantial evidence, meaning adequate and well-controlled investigations, that the drug will have the effect it purports to have under the conditions of use in its proposed labeling. A therapy aimed at the biology of aging therefore reaches patients through a labeled use. We underwrite a longevity therapeutic on the named disease, population and endpoint that can support that label, and we treat expansion into further age-related conditions as upside to the base case.

Accelerated Approval and the Amyloid Antibody Record

Under 21 CFR 314.510 for drugs and 21 CFR 601.41 for biological products, FDA may approve a product on an effect on a surrogate endpoint reasonably likely to predict clinical benefit, subject to a requirement that the applicant study it further to verify that benefit. FDA's accelerated approval records show both outcomes of that bargain in Alzheimer's disease. Aducanumab (Aduhelm) received accelerated approval on June 7, 2021, and FDA lists that indication as withdrawn on November 1, 2024. Lecanemab (Leqembi) received accelerated approval on January 6, 2023, and FDA converted it to traditional approval on July 6, 2023, after the confirmatory CLARITY AD trial verified clinical benefit.

Coverage followed a separate track. CMS National Coverage Determination 200.3, effective April 7, 2022, covers FDA-approved monoclonal antibodies directed against amyloid only under coverage with evidence development: in randomized controlled trials for products approved on a surrogate endpoint, and in CMS-approved prospective comparative studies, which may collect data in a registry, for products approved on a direct measure of clinical benefit. As of October 2026, the Medicare Coverage Database shows NCD 200.3 in effect with no end date and its national coverage analysis, CAG-00460N, closed. For every neuro therapeutic, we model the Medicare evidence requirement alongside the FDA pathway.

Neurotechnology and Diagnostics Gates

FDA's Breakthrough Devices Program is open to devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating disease and meet at least one of four further criteria, and FDA reports 1,320 designations granted as of June 30, 2026. FDA describes the benefits as interactive feedback and prioritized review of the submission; the evidence standard is unchanged, so we underwrite the pivotal study.

CMS's August 2024 final notice on Transitional Coverage for Emerging Technologies anticipated up to five candidates a year, but CMS paused TCET for new candidates on August 11, 2026, when it proposed the RAPID coverage pathway, 91 FR 51710. RAPID, not finalized as of October 10, 2026, is limited to certain Breakthrough-designated devices still at the IDE pre-submission stage. For implanted brain-computer interfaces, FDA guidance issued in May 2021 sets out nonclinical testing and the design of feasibility and pivotal studies under an investigational device exemption.

According to FDA, the Quality Management System Regulation took effect on February 2, 2026, amending 21 CFR Part 820 to incorporate ISO 13485:2016 by reference, and we read a device company's quality system as part of its product. On May 16, 2025, FDA cleared the first in vitro diagnostic device that tests blood to aid in diagnosing Alzheimer's disease, for adults aged 55 and older with signs and symptoms of the disease. Biomarker tests run within a single laboratory follow a different path: FDA's final rule at 90 FR 45134 records that a federal district court vacated FDA's May 2024 rule on laboratory-developed tests on March 31, 2025, and it reverted the regulation effective September 19, 2025.

Digital Treatment for Mental and Behavioral Health

Medicare pays for some software-delivered treatment through billing codes tied to device classification. According to CMS's MLN summary MM14315 of the calendar year 2026 Physician Fee Schedule final rule, CMS expanded HCPCS codes G0552, G0553 and G0554 to digital therapy devices for attention deficit hyperactivity disorder classified under 21 CFR 882.5803, when furnished incident to professional behavioral health services under a behavioral health treatment plan of care. We underwrite a digital neuro company on whether its device classification, its supervising clinician and its renewal economics hold together.

Artificial Intelligence as the Accelerant

Artificial intelligence is the accelerant across all five LeverVenture sectors, never a sixth sector. In Longevity and Neuro it compresses the slowest steps: reading imaging and electrophysiology, selecting trial populations by biomarker, and decoding neural signals in implanted interfaces. Crossing sectors is the thesis. A healthcare-driven company that is also deep tech in its instrumentation, that is also digital in its endpoints, or that carries a clean tech dimension, with an artificial intelligence layer that makes it work, is the company we look for, and we underwrite the whole company as a single object. The evidence standard does not change: a model claim must meet the same evidentiary standard as the product it sits in.

Reference Entries

• AI Diligence in Life Scienceshow an artificial intelligence claim is tested against FDA device and drug guidance, change control plans and the regulatory record.
• Software as a Medical Device (SaMD)the FDA pathways that govern neurotechnology software, including 510(k), De Novo, premarket approval and the Breakthrough Devices Program.
• Laboratory-Developed Tests and CLIAhow a brain or aging biomarker test run in a single laboratory is regulated under CLIA after the 2025 vacatur of FDA's rule on laboratory-developed tests.

Related Analysis

• Life Sciences and HealthcareFunding the Longevity Economy: A Growth Capital Guide for Longevity and Neuro Foundersthe validation, regulatory and data questions growth-stage investors put to longevity and neuro founders.
• Life Sciences and HealthcareMental Health Tech: Breaking Down Treatment Access Barrierswhy access to mental health care is a workforce and licensure problem, and which models expand clinical capacity.
• Growth EquityGrowth Equity in Life Sciences: 2026 Market Studywhere growth equity sits between venture and buyout in life sciences and healthcare, and where the mid-market gap lies.

Governing Authority and Sources

• 21 U.S.C. 355(d), Federal Food, Drug, and Cosmetic Act section 505(d), substantial evidence
• 21 CFR 314.510, accelerated approval of new drugs (eCFR, current 2026)
• 21 CFR 601.41, accelerated approval of biological products (eCFR, current 2026)
• FDA, Accelerated Approval Program (2026)
• FDA, Withdrawn Accelerated Approvals: Non-Malignant Hematological, Neurological and Other Disorder Indications (2026)
• FDA, Verified Clinical Benefit Accelerated Approvals: Non-Malignant Hematological, Neurological and Other Disorder Indications (2026)
• FDA, FDA Converts Novel Alzheimer's Disease Treatment to Traditional Approval (2023)
• CMS, NCD 200.3, Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease (2022)
• FDA, Breakthrough Devices Program (data as of June 30, 2026)
• CMS, Final Notice: Transitional Coverage for Emerging Technologies, CMS-3421-FN (2024)
• CMS, Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway, notice with comment, 91 FR 51710 (August 11, 2026)
• FDA, Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation: Non-clinical Testing and Clinical Considerations (2021)
• FDA, Quality Management System Regulation (2026)
• FDA, FDA Clears First Blood Test Used in Diagnosing Alzheimer's Disease (2025)
• FDA, Medical Devices; Laboratory Developed Tests; Implementation of Vacatur, 90 FR 45134 (2025)
• CMS, MLN MM14315, Medicare Physician Fee Schedule Final Rule Summary: CY 2026 (2025)
• National Institute on Aging, Director's Status Report (May 2026)
• Alzheimer's Association, 2026 Alzheimer's Disease Facts and Figures (2026)
• GBD 2021 Nervous System Disorders Collaborators, The Lancet Neurology 23(4):344-381 (2024)