NIA Small Business Showcase: i-Function

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Only 16% of older adults say that they receive regular cognitive assessments. This is due to several factors, including a lack of specialists and inadequate assessment tools. Current commonly used neuropsychological cognitive tests do not capture the earliest stages of mild cognitive impairment (MCI) before multisystem brain degeneration has occurred. The best current options — biomarker assessments, either blood-based or via positron emission tomography (PET) scan — are quite expensive, costing from $450 to more than $3,500 and typically not covered by insurance and not always available.

The LASSI-L (the Loewenstein-Acevedo Scales for Semantic Interference and Learning) is a validated cognitive challenge test, well documented with research supported by NIH and published in several high-impact scientific journals. The LASSI-D is a shorter, self-administered digital version of the LASSI-L that can be delivered in person or remotely. It is cloud-based and available on computers or tablets. The LASSI-D is currently undergoing equivalency studies with the LASSI-L, and the results of these studies are expected in Q2 2024.

The LASSI-L can differentiate between older adults who are cognitively normal and those in the earliest stages of amnestic MCI and pre-MCI more effectively than other traditional neuropsychological measures. The tool is highly sensitive to the risk for transition to dementia within an approximately two to three years, compared with cognitively stable individuals. Only around 11% of progressing cases are not detected (89% sensitivity), and only about 14% of cases receive scores in the potentially impaired range and do not progress (86% specificity). Preliminary LASSI-D results indicate equivalency with the LASSI-L. Unlike the LASSI-L, which can be administered only by trained psychologists or health care providers, the LASSI-D records all responses and scores and profiles the results, so it can be administered by people without formal clinical or assessment credentials, significantly increasing its potential for use in settings such as community clinics, large clinical pharma trials, and primary care practices.

Company Milestones

Scientific and Clinical

  • 2020: Completed an NIH Small Business Innovation Research (SBIR) I–supported study for the FUNSAT (i-Function-developed second-generation device-resident Functional Skills Assessment and Training software).
    • Demonstrated that older adults with MCI and normal cognition can improve their functional skills 40% to 60% and achieve confidence levels in “real-world use” of more than 97% with two hours per week of in-person training. For publications, please see https://i-function.com/funsat-publications/ .
  • 2023: Completed an NIH SBIR II-supported study for the FUNSAT SaaS software (third generation).
    • Demonstrated that older adults with MCI and normal cognition can improve their functional skills 30% to 70% with two hours of at-home (remote) training per week. Conducted first study to demonstrate “real-world” transfer of functional skills results for both trained and untrained tasks. For publications, please see https://i-function.com/funsat-publications/ .
  • 2022/2023: Designed and developed the NIH SBIR II-supported LASSI-D self-administered software version of the LASSI-L. Began and significantly progressed the equivalency study (with the LASSI-L).
  • 2024 (expected): Conclude the LASSI-D equivalency study.
    • Show equivalency with the well-validated LASSI-L paper-and-pencil version. Publish results and initiate relevant U.S. Food and Drug Administration (FDA) action.
  • 2024/2025 (expected): Design and program the fourth generation of the FUNSAT software.
    • Show clinical effectiveness in early Alzheimer’s disease and use artificial intelligence to design and develop an even more individually tailored and effective training program for individuals challenged by the training tasks.

Business

  • 2018: Developed the second generation of the FUNSAT software with an NIA SBIR I grant and got the first paying customer (big pharma) for the software.
    • Basic proof of concept: Documented highly effective Functional Skills Assessment and Training results for in-person training for older adults with normal cognition and with MCI.
  • 2021/2022: Developed the third generation of the FUNSAT software (SaaS) with an NIA SBIR II grant and started/continued building relationships and selling to more verticals including mental health.
    • Documented highly effective Functional Skills Assessment and Training results for at-home (remote) training for older adults with normal cognition and with MCI, as well as results transfer to “real life.” Was part of the MassChallenge early-stage accelerator 2022 cohort.
  • 2023: Concluded the FUNSAT third-generation study and initiated paid pilots in several verticals.
    • Aging: Senior/community centers, independent and assisted living facilities, memory clinics, primary care facilities, and university research
    • Mental health: New York State Office of Mental Health (OMH), multiple locations, inpatient and outpatient
    • Other: Traumatic brain injury clinics
  • 2022/2023: Designed and developed the NIH SBIR II supported LASSI-D self-administered software version of the LASSI-L.
    • Started selling the LASSI-L to research institutions across the United States as well as to selected clinics for clinical use in preparation for the launch of the LASSI-D.
  • 2023/2024 (expected): Conclude the LASSI-D equivalency study and offer the test for both clinical and research and development use. Design, develop and launch the fourth generation of the FUNSAT software.
    • Start to accelerate sales, raise initial capital, and build a small sales organization.

Financial Overview

To date, i-Function has raised $4.35 million in NIH SBIR grants. The company will start active fundraising in Q2 2024. For future funding, i-Function is seeking $2 million focused on accelerating growth by establishing a small sales organization for Years 1 to 2 and $4 million to $5 million focused on continuing sales growth and internalizing software development for Years 3 to 5.

Intellectual Property

i-Function has an exclusive licensing agreement with University of Miami for the LASSI-L, developed by David Loewenstein, Ph.D., and the original LASSI-BC, developed by Rosie E. Curiel Cid, Psy.D., and Dr. Loewenstein. This includes product development and updates within the same defined scope of usage. There are currently copyrights to all material developed before and after the licensing agreement. i-Function intends to submit patent applications where possible as the software is further refined. The company will attempt to protect all rights to the maximum extent possible.

Product Development and Regulatory Strategy

The LASSI-D is a digital version of the LASSI-L, designed to be a cloud-based (Microsoft Azure), self-administered cognitive assessment program available on computers or tablets with internet access. The software has been programmed and tested with a high degree of speech-to-text accuracy (approximately 98%), and i-Function has completed usability testing. Additionally, two digital alternate versions of the LASSI-D (identical in the stimulus content but different in order) have been created and are also being validated for equivalence to the legacy paper form and the computer version of the original form. i-Function is hoping to complete this work by Q2 2024 and expects that, in combination with previously completed studies with the legacy instrument (LASSI-L), it will be sufficient for an FDA approval. An FDA strategy analysis project to further guide clinical development has been initiated in Q4 2023 (via Technical and Business Assistance funding).

Commercialization Strategy

i-Function is planning to make the LASSI-D available to pharmaceutical companies and contract research organizations as a way of screening individuals for inclusion/exclusion in large clinical trials, as it is an excellent screener for MCI that will be significantly more practical than current strategies. In addition, i-Function hopes to make the LASSI-D available to clinicians (not just neurologists and psychologists) and other health care professionals to screen for MCI, including early and pre-MCI. Essentially every individual older than 60 is a candidate for screening with the LASSI-D. An affordable, self-administered, well-documented solution is likely to expand current access significantly.

Company Details

i-Function, Inc.

Miami, FL

Industry: Digital Health

Management Team:

  • Co-founder and CEO: Peter Kallestrup, M.S.
  • Chief scientific officer (neuropsychological conditions): Philip D. Harvey, Ph.D.
  • Chief scientific officer (aging): Sara J. Czaja, Ph.D.

Point of Contact:
Peter Kallestrup
pkallestrup@i-Function.com
(954) 253-9839