NIA Small Business Showcase: Activas Diagnostics, LLC

There is poor efficiency in diagnosis in early stages of Alzheimer’s disease, termed mild cognitive impairment (MCI), such that less than 50% of patients are screened in their Medicare annual exams. Novel diagnostic methods for early diagnosis are needed to improve access to new therapeutic interventions. Health care costs are reduced substantially by early identification, as well as by access to treatments, clinical trials, and an aggressive program of care to maximize time at home and quality of life. In aging patients, sleep problems are a common presenting symptom in the primary care setting. Providers are often reluctant to pursue an in-hospital sleep study, which is challenging and uncomfortable for aging patients with cognitive challenges, as in MCI. Activas Diagnostics, LLC, has developed an overnight test done in the home bed

The SleepMove system is a patented, noninvasive, flat-surface (less than 1 mm thick) mattress overlay that fits under the bedsheet for home use. The patented technology and software algorithms integrate a time series for sensor-based recording of respiratory and movement arousals during sleep. The application permits home monitoring to evaluate, monitor, and predict neurological disease status in MCI and Alzheimer’s disease and related disorders (ADRD). Home recordings (n = 95 participants) classified diagnosed MCI versus normal cases with 88% specificity versus 87% specificity. The next stage will be to validate these findings with a new cohort.

The epidemic of ADRD is projected to affect 50 million people by 2050 and represents a $6.6 billion market share for diagnostics. Furthermore, there is a $236 billion health care cost for assessment and intervention. Early diagnosis of MCI/ADRD is often missed but is critically needed to enable access to new therapeutics and treatment. Poor primary screening tools and limited expertise can be addressed by using the SleepMove system as an adjunct diagnostic tool.

The SleepMove system is a novel adjunctive diagnostic tool for providers that is cost-efficient, is convenient for the patient and family, and offers novel sleep autonomic metrics for early MCI/ADRD detection, based on decades of medical and engineering research. Activas provides rapid home delivery of wireless, plug-and-play home sleep technology in which device data are collected wirelessly and transmitted to the diagnostic service hub. Monitoring requires one or two nights’ worth of data in the home bed. The non-contact home system is a “sleep-in-a-box” proposition that is inexpensive and provides rapid physician report, using novel metrics and artificial intelligence (AI) risk assessment. The system can be reused and may be purchased by provider networks and clinics for home or in-house studies.

Company Milestones

Scientific

• 2010: U.S. Department of Defense (DoD) Small Business Innovation Research (SBIR) grant, Phase 1.
• 2015, 2017: Patent award and revision.
• 2015: NASA crew health monitoring award.
• 2018: NIA SBIR grant, Phase 2 award and supplement.
• 2019: Maine Technology Institute commercialization award.
• 2020: Completion of sleep and aging study; tested 95 MCI and normal cognition participants on the SleepMove device and system; U.S. Food and Drug Administration (FDA) pre-submission completed; diagnostic confirmation of system performance and AI algorithms in MCI risk classification.
• 2021: Manuscripts submitted; Commercialization Readiness Pilot (CRP) resubmission in September.
• 2022: FDA full submission; manufacturing and production.
• 2023: Consumer product launch; FDA approval.
• 2024: Medical product launch.
• 2024: Revenue streams consistent with business viability.

Business

• 2010: Established Activas Diagnostics, LLC, with Phase 1 funding and started multiple stages of device design and development.
• 2018: Opened Activas laboratory and offices in UpStart Center and hired research and engineering team to pursue device development and clinical studies.
• 2019: Received $50,000 commercialization award from Maine Technology Institute.
• 2020: Had first investment meeting with scout for Boston Harbor; identification and collaboration established with manufacturing; regulatory; business partnerships; FDA de novo pre-submission meeting.
• 2021: Scale-up business model development for commercialization plan.

Financial Overview

Activas Diagnostics, LLC, has raised $1.4 million in funds to date. This includes the following:

• NIA SBIR Phase 2 and Supplement) R44AG059536 $1.1 million
• DoD SBIR Phase 1 (W81XWH-10-C-0188 $100,000
• Maine Space Grant Consortium (MSGC) EP-16-01 $100,000
• Maine Technology Institute commercialization award $50,000

Future funding will include a digital health consumer version of the SleepMove device and system and parallel needs for the medical version. This will involve the following funding, totaling $6.4 million:

• Manufacturing $2.4 million
• Software $1.1 million
• Marketing $1 million
• Business development $1 million
• Regulatory and technical support for Centers for Medicare & Medicaid Services (CMS) reimbursement $600,000
• Intellectual property (IP) protection $300,000

The $6.4 million for Series A will serve manufacturing, software and patent costs, business development, and marketing for the next five years. Regulatory and reimbursement costs (legal, regulatory firms are engaged) are included in estimate for product launch in two years. Exponential growth is expected when the medical ADRD market is penetrated by Year 5. Research and development (R&D) continues to expand autonomic bio-indicators using this model.

Intellectual Property

Activas has the following IP:

• U.S. Patent #10244977B2 was awarded in June 2015 and amended in April 2019 from the University of Maine. The original patent is exclusively licensed to Activas from the University of Maine. There is no identified infringement of other patents. Two additional patents are in development.
• Activas has discussed IP protection with the Wilson group (December 2018) through CAP advisor and counselor Charlotte Kim, who offered Activas a phased-cost arrangement that Activas can revisit in the future when the company’s funding permits.

Product Development and Regulatory Strategy

Efforts since the product’s inception have sought and engaged expertise in business strategy, CMS reimbursement, and marketing challenges. The FDA pre-Series A investment was successful (de novo status May 2020). The FDA de novo application will require 18 months.

Before regulatory approval, Activas has prepared a pivot plan to develop a consumer model in which its commercial device and service are sold separately or contracted with a “sleep-in-the-box” service plus a report. Several metrics currently programmed into the system will be reported without claims (e.g., time in bed, sleep fragmentation index, arousal intrusion, proprietary autonomic metrics). Early sales of the consumer version of the SleepMove device and system will be marketed to generate needed revenue.

Parallel to the FDA approval process, Activas will seek expertise to ensure regulatory approval and acceptance by CMS and the U.S. Department of Veterans Affairs (VA)/Medicare/Medicaid. The company’s revenue and reimbursement model depends on FDA approval and CMS ICD code assignment for indications for use (e.g., the billable code for “cognitive impairment” is G31.84 and would support reimbursement).

Revenue from the consumer product sales will support business development and is followed by FDA, CMS, and medical insurance carrier adoption as an adjunctive diagnostic tool for primary and neurology MCI/ADRD diagnosis.

Commercialization Strategy

Product sales of the consumer SleepMove version will be marketed to members of the aging public interested in tracking sleep difficulties with aging, as described above. In Year 1, the soft launch will sell 100 SleepMove systems at $10,000 ($1 million) and generate 400 service reports at $250 per report ($100,000) for $1.1 million revenue. Year 2 sales will expand the customer base through marketing to circa $3.5 million in sales. FDA approval is expected by Year 2. Parallel marketing will target physicians, clinics, and/or hospitals. Projected revenue is from Activas’ medical sleep diagnostics report ($250 per test report) and sale of full systems ($10,000) to medical services in primary and neurology care centers.

Company Details

Activas Diagnostics website

Orono, ME

Industry: Diagnostics

Management Team:

• Principal: Marie J. Hayes, Ph.D.
• Principal: Ali Abedi, Ph.D.
• Chief Engineer: Masoumeh Esfahani, BSEE

Point of Contact:

Marie J. Hayes, Ph.D.
Email Marie J. Hayes
(207) 852-4806