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Infographic – Q3 2021 Venture Funds Continue Banner Year

Q3 2021 venture funds

Click on image for full-size view (CB Insights)

23 Oct. 2021. Venture investors worldwide continue to look past the pandemic as investments in start-up enterprises rose to new levels in the U.S., Asia, and elsewhere. Data compiled by technology market intelligence company CB Insights (registration required) show venture investors are placing more capital overall and per transaction this year, with the third quarter of 2021 eclipsing the first two record-setting quarters.

In the July to September 2021 period, venture investments totaled $158.2 billion worldwide, gains of nearly $30 billion and $7 billion respectively over the first and second quarters, both quarters setting dollar volume records. Likewise, the number of venture deals rose to 9,363 in the latest quarter, another three-month record surpassing the roughly 7,000 and 8,000 deals in the first and second quarters. So far this year, with one quarter yet to go, venture investors placed $$437.7 billion, well exceeding the $284.2 billion invested for all of 2020 and $286 billion invested in 2018, the highest annual investment total.

U.S. and Asia leading the way

Venture investments in U.S. companies reached $72.3 billion in the third quarter of 2021, up from $70.3 billion in the second quarter. And investments in Asian companies, particularly China and India, rose to $50.2 billion in Q3, a sharp increase from nearly $40 billion in the previous quarter. While still at historically high levels, investment totals for the third quarter fell somewhat in Europe, Latin America, and Canada after setting records in the previous quarter.

From July through September, the U.S. led Asia in dollars invested in Q3, but Asia jumped ahead of the U.S. in number of deals. In the quarter, Asia recorded 3,815 venture deals or 41 percent of all transactions, while the U.S. had 3,210 or 34 percent. Europe and other regions divided the remaining 25 percent of venture deals.

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Clinician Guidance App Designed for Depression

Columbia Psychiatry Pathways app

Columbia Psychiatry Pathways app (avoMD)

22 Oct. 2021. Neuroscientists and a software company designed a smartphone app to help front-line professionals diagnose and start treatment for patients with depression. The Columbia Psychiatry Pathways app, released this week, is developed by researchers at Columbia University medical school and the clinical decision-support software company avoMD, both in New York.

Columbia Psychiatry Pathways aims to assist medical professionals like primary care physicians and nurse practitioners when confronted with patients exhibiting symptoms of depression. Depression is a widespread condition, which when it becomes persistent or severe, is called major depression, and can interfere with normal family and work life, and lead to disability or suicide. National Institute of Mental Health estimates in 2019, 19.4 million adults in the U.S., or 7.8 percent of the adult population, suffered a major depressive episode in the previous 12 months.

The Columbia Psychiatry Pathways app contains algorithms representing the latest treatment guidelines for depression, compiled by Columbia’s John Mann, professor of neuroscience, and Ravi Shah, chief innovation officer in the university’s psychiatry department. The software captures a patient’s symptoms, evaluated with built-in rating scales and algorithms that guide the clinician’s decisions. The app also has assessments for bipolar disorder and suicide risk, as well as details of seven approved and well-tolerated generic medications for depression.

Provides options for next steps and referrals

Data entered by clinicians are evaluated by the app, which provides options for next steps and referrals. “This app is designed to help clinicians treat depression more effectively,” says Mann in a university statement. “It also helps them monitor the patient response and when a referral may be indicated.”

The Columbia Psychiatry Pathways app is free and available in Apple/iOS and Android, as well as desktop versions. The university’s collaborator avoMD develops decision-support software for medical professionals, particular for clinical decision-making. The company says its software provides updated treatment guidelines for medical decisions at the point of care, replacing static and inaccessible documents and flowcharts.

“Scientific papers and clinical guidelines are constantly evolving. It’s difficult for health care providers to stay up to date,” notes Shah. “This app combines the world-class expertise of Columbia Psychiatry with avoMD’s next-generation decision support technology to put the latest scientific knowledge in the hands of clinicians, serving as an interactive playbook to treat depression quickly and effectively.”

Early identification of patients with depression by first-line medical professionals can sharply reduce suicides, according to a review of research by Mann and colleagues published earlier this year. Their review shows routine screening for depression has generally not reduced suicide rates in the U.S. The exception, however, is training primary care physicians to recognize depression and prescribe medications, which can cut the rate by up to half.

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Population Study Finds Genetic Links for Vertigo

Population genetics

(National Human Genome Research Institute, NIH)

21 Oct. 2021. A large-scale population genetics study finds several genetic variants associated with vertigo, a condition marked by dizziness and loss of balance. Findings from the HerediGene study — a joint initiative of Intermountain Healthcare, a western U.S. hospital system, and the genetic analytics company deCode Genetics in Reykjavik, Iceland — appear in the 7 Oct. issue of the journal Communications Biology.

The HerediGene study is recruiting 500,000 participants in Intermountain Healthcare’s service area to provide blood samples for whole genome analysis by deCode Genetics. Intermountain is a regional health care system of 24 hospitals, 160 clinics, and some 23,000 clinicians serving the U.S. Mountain West. The network, headquartered in Salt Lake City, also includes a health insurance company and the Intermountain Biorepository storing some 4.5 million biological samples connected to decades of patient health records.

deCode Genetics, a subsidiary of drug maker Amgen, collects data from 160,000 volunteers in Iceland, more than half the country’s adult population. The company also assembles a genealogical database for the entire country going back 1,000 years to Iceland’s founding as an independent nation. These extensive data sets, combined with the high quality of universal health care in Iceland, says deCode, makes it possible to study most common diseases on a large scale, minimizing the selection bias that can occur in larger and more diverse populations.

Six genetic variations associated with vertigo

Researchers are using HerediGene data to find connections between genetics and disease. Participation in the study is free of charge and voluntary, with data provided to deCode Genetics de-identified to maintain participants’ privacy. Intermountain says the study analyzes entire genomes of participants, a much more comprehensive analysis than commercial genetics services that reveal ancestry and selected disease conditions. Science & Enterprise reported on the beginning of the study in June 2019.

In their paper, the HerediGene researchers focused on vertigo, a condition marked by dizziness caused by illusion of rotational motion. Vertigo is a symptom of disorders in the inner ear and brain that process sensory information for controlling balance. People with vertigo can experience dizziness from a few seconds to several days, and are at a high risk of falls. The researchers cite data showing the disorder affects some 6.5 percent of the population and increases in prevalence with age.

The study team performed a genome-wide analysis blood samples in the U.S., Iceland, the U.K., and Finland, with about 48,000 cases of vertigo, compared to some 894,500 controls. The analysis revealed, among people of European origin, variants of six separate genes associated with vertigo cases: ZNF91, OTOP1, OTOG, OTOGL, TECTA, and ARMC9. And while the researchers found more vertigo cases among people with age-related hearing loss and motion sickness, the team did not find a strong correlation between the six genetic variations linked to vertigo, and hearing loss or motion sickness.

“Vertigo is one of the leading causes of emergency room visits across our health system,” says Lincoln Nadauld, chief of precision health and academics for Intermountain Healthcare in a statement. “This discovery means we now have a much better understanding for why portions of our population experience these symptoms.” Nadauld adds that the findings can lead to tests and treatments for patients with vertigo.

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AI-Designed Antibodies for Start-Up Sought in Open Call

Computational biology illustration

(Lawrence Livermore National Lab)

20 Oct. 2021. An international consortium is seeking teams of scientists using algorithms to design new therapeutic antibodies, to form and fund a start-up company. AION Labs, a coalition of Israeli, European, and American pharmaceutical and technology companies, and BioMed X, a biomedical research institute in Germany connecting academic labs to industry, are sponsoring the crowd-sourcing competition.

AION Labs, formed just last week in Rehovot, Israel, is a collaboration of drug makers AstraZeneca, Merck, Pfizer, and Teva, with the Israel Biotech Fund and Amazon Web Services. The coalition aims to encourage use of artificial intelligence and data science to design and develop new therapies, by creating and financing new enterprises commercializing these technologies. AION Labs expects these technologies will speed design and development of new treatments, minimize use of animals, and create therapies that better meet the precise molecular makeup of patients.

BioMed X, located at Heidelberg University, studies molecular, cell, and computational biology in projects sponsored by pharmaceutical companies. The institute does its work both on-site and through global crowd-sourcing with early-career researchers worldwide. BioMed X is a partner of AION Labs, also announced last week.

The AION Labs/BioMed X competition, called De Novo Computational Design of Therapeutic Antibodies, seeks proposals from research teams working in computational biology, bioinformatics, or antibody engineering. Many therapeutic antibodies today, say AION Labs and BioMed X, are derived from large existing protein libraries, using expensive and laborious processes that nonetheless don’t always result in working treatments.

Funding and facilities for start-up company

The sponsors are seeking proposals for a computational platform that allows for design of new antibodies to meet antigen structure and sequence specifications that bind to precise epitope, or antigen binding site, targets. And the sponsors encourage ideas that show more originality and go beyond today’s state-of-the art. Drug makers taking part in AION Labs are offering data to train A.I. models, as well as their industry expertise.

The sponsors expect proposal team leaders to be Ph.D. researchers with four to eight years of experience, and willing to develop into company founders. Team participants should be postdoctoral researchers or with completed Ph.D. studies and equivalent experience in computational biology, bioinformatics, or antibody engineering, as well as related disciplines.

The winning team will receive equity funding and facilities for a start-up company in Israel to develop and commercialize the researchers’ proposal. Funding includes $1 million for the first two years with an option for another $1 million to fund two more years. The new company will reside at AION Labs in Rehovot, including both wet and computational labs. The company will also receive guidance and mentorship from executives in the pharmaceutical and technology industries, venture capital, and academic science.

“We look forward to providing the chosen startup,” says AION Labs CEO Mati Gill in a BioMed X statement, “with our strong resources and mentorship as we work together to develop a cutting-edge solution to overcome the pharmaceutical challenge of selecting drug candidates from antibody sequences.”

Initial proposals are due by 12 Dec. 2021. From the first round of proposals, finalists will be chosen to attend a five-day innovation boot camp, 30 Jan. to 3 Feb. 2022. At the session, finalists will present their finished proposals to a jury, which will select the winning team.

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Disclosure: The author owns shares in Pfizer.

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European Life Science Venture Fund Raises €472M

Euro investments

(Gerd Altmann, Pixabay. https://pixabay.com/illustrations/euro-seem-currency-ball-bullet-447214/)

19 Oct. 2021. A venture capital company raised €472 million ($US 548 million) for investments in life science and medical device start-ups in Europe. Sofinnova Partners in Paris says with its new Capital X fund, the company has now raised more than €1 billion in the last 12 months.

Sofinnova Partners says it looks for early stage enterprises with disruptive technologies for its investments. The company identifies new companies developing biopharmaceuticals, medical devices, or industrial biotechnology solutions to  sustainability issues. Sofinnova Partners says its funding targets are often technologies spun off from academic labs or assets developed in and later spun off from corporate labs.

The company says it invests in start-ups at various stages from seed to later-stage rounds. Moreover, says Sofinnova Partners, it will take the lead in forming new companies and a primary role in financing a new company’s first venture round, known as series A. While most of its investments are made in Europe, Sofinnova Partners says it also invests in companies in other parts of the world.

Investors from Europe, Asia, and North America

Capital X is Sofinniva Partners’ tenth fund in its series of investment funds, which the company says is raised from pension funds, insurance companies, foundations, endowments, corporate investors, and prominent family offices — private wealth management advisory services from across Europe, Asia, and North America. Sofinniva Partners says in the past 12 months it has raised more than €1 billion for its various investment funds, the most recent being its Medtech Acceleration Fund in July supporting medical device start-ups.

Henrijette Richter, managing partner of Sofinnova Partners, says in a company statement, the €472 million Capital X is “the largest fund dedicated to early-stage health care investments in Europe.” Richter adds, “This is an important milestone for Sofinnova Partners. Capital X will allow us to leverage over 30 years of cumulative experience perfecting this strategy.” Sofinnova Partners says it has more than €2.5 billion in total assets under its management.

Science & Enterprise reported on several Sofinnova Partners investments since 2012. The most recent Sofinnova Partners story is on its participation in a €60 million ($US 73 million) investment in Muna Therapeutics in Copenhagen, Denmark, in July 2021, a start-up discovering treatments for neurodegenerative diseases.

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Trial Shows Wearable Device Reduces Migraine Symptoms

Hands covering face

(Victoria Borodinova, Pixabay. https://pixabay.com/photos/cover-your-face-with-your-hands-hide-6599123/)

18 Oct. 2021. Results from a clinical trial show a smartphone-wearable system relieves pain and reduces other symptoms in adult patients with chronic migraine. The Nerivio system is made by Theranica Bio-Electronics Ltd. in Netanya, Israel that sponsored the study, with results published in the current (November/December 2021) issue of the journal Pain Reports.

Migraine is a common neurological syndrome causing severe headaches along with nausea, vomiting, and extreme sensitivity to light and sound. In some cases, migraines are preceded by warning episodes called aura including flashes of light, blind spots, or tingling in arms and legs. According to Migraine Research Foundation, some 1 billion people worldwide, including 39 million in the U.S., experience migraines. The disorder affects nearly one in four U.S. households, with three times as many women experiencing migraines than men, as well as 10 percent of children.

The Nerivio system consists of a patch worn on the upper arm, with electrodes sending out neuromodulation pulses that electronically stimulate C-fiber nerves and block pain signals from reaching the brain. C-fiber nerves are one of the pain pathways in the nervous system. When a migraine occurs, the individual straps on the Nerivio patch and activates nerve stimulation through an accompanying smartphone app for about 20 minutes. The app’s software also checks for proper placement of the patch, monitors the neuromodulation session, and can link to health care providers that need to be alerted.

As reported by Science & Enterprise, FDA in May 2019 cleared the Nerivio system to treat acute migraines in adults. Since then, FDA extended clearance for Nerivio to chronic migraines in adults in October 2020, and acute migraines in adolescents in January 2021.

Medication overuse contributes to the problem

Because Nerivio therapy does not involve drugs, the treatments address a drawback of other therapies, namely overuse of medications to treat the disorder. Migraine Research Foundation says medication overuse is the most common reason for migraines evolving from an episodic condition into a chronic disease.

The clinical trial assessed the Nerivio system in 126 adult participants at nine sites in the U.S. with chronic migraines, defined as experiencing migraines at least 15 days a month. The vast majority of participants (87%) were women. Individuals were asked to use the system for four weeks, starting treatment with the device within an hour of first experiencing symptoms.

Participants then completed an online diary indicating pain levels on a four-point scale from none to severe, at the time of treatment, then 2 and 24 hours after treatment. In addition, participants recorded presence or absence of other symptoms: nausea, vomiting, light and sound sensitivity, and functional ability or disability. The study had no control or comparison group.

Of the 126 initial participants, 91 completed the trial. Results show among those completing the study, six in 10 (59%) reported less pain within two hours of treatment, the trial’s main success measure, and 21 percent said their pain disappeared. Roughly six in 10 participants reported sustained pain relief for the next 24 hours (64%) and improvement in functional abilities (59%). Likewise four to five in 10 participants reported disappearance of their nausea or vomiting (49%), or sound and light sensitivity symptoms (41% and 45% respectively). One participant reported an adverse event from Nerivio, mild pain in the arm where the device was worn, resolved within 24 hours without medication.

“To the best of our knowledge,” says Theranica’s chief scientist Liron Rabany in a company statement released through Cision, “this was the largest clinical trial of acute treatment of migraine specifically targeting chronic migraine patients.” Rabany, a co-author of the paper adds, “All people with migraine, adults or adolescents, should have the option of discussing a non-pharmacological therapy with their health care providers, as a first-line treatment option, or as an adjunct.”

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On the Road Again

Route 66 sign

(LSC, Pixabay)

15 Oct. 2021. We’re taking some personal time on Friday and Saturday, 15-16 Oct., so we will have no Science & Enterprise editorial posts for those days. Regular posts will resume on Monday, 18 Oct.

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NIH Funds Brain-Computer Implant Device

Brain circuits

(NIH.gov)

14 Oct. 2021. A developer of implanted devices to record signals from brain cells received funding to advance a smaller and more durable electrode array. National Institute of Mental Health or NIMH, part of National Institutes of Health, awarded a three-year, $3.2 million grant to Paradromics Inc. in Austin, Texas to build the device.

Paradromics creates devices that connect the human brain to computer systems, enabling high-volume transfers of data between neurons in the brain and computers for diagnosing and treating brain disorders. The company says its current technology now supports more than 65,500 electrode channels sampled simultaneously. As reported by Science & Enterprise in July 2020, a team led by Paradromics founder and CEO Matt Angle demonstrated a device with high-density arrays of microwires made of platinum and irridium that sense, connect, and transfer data to and from complementary metal–oxide semiconductor, or CMOS amplifier circuits.

The researchers tested the device with lab animals, implanting the electrode array in the cerebral cortex, the outer layer of the brain that governs a person’s motor and sensory activity, and conscious thought. Angle and colleagues published their findings in February 2021 in Journal of Neural Engineering (paid subscription required). In an earlier NIMH-funded project, Paradromics built and demonstrated its microwire-to-CMOS architecture with devices of 1,200 electrodes implanted in lab rats, and more than 30,000 electrodes implanted in sheep.

Feasibility of human surgical implants

The new project, a second phase of the first award, aims to develop a more compact and efficient device with fewer electrodes for testing in sheep and humans. Paradromics proposes fabricating a sensor array with 400 to 1,600 electrodes, no more than 400 micrometers deep and one millimeter long. The company plans to test the new device for feasible implantation in humans already undergoing brain surgery, and to determine any initial reactions to the implants. Paradromics is partnering with Massachusetts General Hospital for the clinical phases of the study, working with neuroscientists Sydney Cash and Leigh Hochberg.

The company also proposes testing the device implanted in live sheep for up to six months. Those tests will look for scarring of glia cells or loss of neurons in the animals’ brains at several points during that period.

Paradromics says the new NIMH award is a major step in development of a brain-computer interface or BCI, leading to clinical trials testing the device as a way to to restore communication for patients who have lost the ability to speak due to severe paralysis. “Our mission,” says Angle in a Paradromics statement released through Cision, “is to is create a new industry where brain-computer interfaces transform unmet medical needs into solvable technical problems. This new award, together with our recent venture round, not only means that we have the resources to execute on this vision, but that others are seeing the same bright future for BCI.”

The award is a Small Business Innovation Research or SBIR grant made under NIH’s small business programs that set aside a part of the agency’s research funding for U.S.-based and owned companies. SBIR grants fund work by research companies in the U.S., and in most cases are made in two parts: a first phase to determine technical and commercial feasibility, and a second phase to develop and test a working prototype or prepare for clinical trials. This grant is a phase 2 award that runs through August 2024.

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Crispr Licensed for Eye Disease Gene Therapies

Retinal gene therapy

(National Human Genome Research Institute, NIH)

13 Oct. 2021. A developer of inherited eye disease therapies is acquiring rights to the gene editing technology Crispr for treatments that work inside the eyes. The deal with SparingVision in Paris could bring biotechnology company Intellia Therapeutics Inc. in Cambridge, Massachusetts as much as $600 million as well as an equity stake in SparingVision.

SparingVision develops treatments for retinitis pigmentosa, a progressive genetic disorder that destroys photoreceptor cells in the retina, leading to total blindness in some cases, which affects some 1 in 4,000 people worldwide. The company has three candidate therapies for the disease, all delivered with adeno-associated viruses, or AAVs. These viruses are benign, naturally occurring microbes that infect cells, but do not integrate with the cell’s genome or cause disease, and generate at most a mild immune response. One of SparingVision’s treatment candidates code-named SPVN06 is in preclinical development, while the other two therapies are in discovery stage.

Crispr, short for clustered, regularly interspaced short palindromic repeats, is adapted from a natural process used by bacteria to protect against attack by viruses, where an enzyme that deactivates or replaces genes binds to targeted RNA molecules generated by the genome. The RNA molecules then guide an editing enzyme, known as Crispr-associated protein 9 or Cas9, to specific genes needing changes.

Intellia Therapeutics is developing treatments with Crispr-Cas9 that remove disease-causing genes or mutations, repair genes with mutations found in small regions of DNA, and insert corrected or functioning genes when mutations are found in larger DNA regions. The company says its treatments are being designed to be either administered directly to work in vivo, i.e.  inside patients’ bodies, or delivered to cells taken from the patient, then cultured outside the body and transplanted back. In June 2021, Science & Enterprise reported on early clinical trial data from Intellia demonstrating the feasibility of in vivo Crispr delivery, with few adverse effects.

Jointly study and develop new Crispr-Cas9 delivery methods

In their agreement, SparingVision gains an exclusive license to Intellia’s Crispr-Cas9 technology for up to three disease targets affecting the eyes. SparingVision will lead preclinical work and clinical trials of therapy candidates developed by the two companies. Plus, the two companies will jointly study and develop more delivery methods for Crispr-Cas9 therapies to the retina: AAVs that self-deactivate and lipid nanoparticles.

Intellia is eligible for developmental and commercial milestone payments of some $200 million for each of the three products developed under the partnership, and royalties on sales. And Intellia is receiving a 10 percent equity stake in SparingVision. Intellia also has an option to obtain commercialization rights for up to two of the new products developed by the companies, with Intellia paying SparingVision opt-in fees, reimbursing or sharing development costs, and paying royalties on sales in the U.S.

“Intellia is the first company in history ” says Stéphane Boissel, president of SparingVision, in a statement, “to present clinical data supporting precision editing of a disease-causing gene within the body following a single, systemic dose of Crispr-Cas9 and we are honored to have been selected as a strategic partner.”

“We believe,” adds Intellia CEO John Leonard, “SparingVision will be an excellent partner to expand our genome editing capabilities into the field of ophthalmology and we look forward to our new partnership.”

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Small Biz Grant to ID Digital Biomarkers for Alzheimer’s

neurons

(NIH.gov)

12 Oct. 2021. National Institutes of Health is awarding a grant to identify indicators of Alzheimer’s disease in a company’s collecting of life stories from older people. LifeBio Inc. in Marysville, Ohio is receiving a one-year, $448,462 award from National Institute on Aging, part of NIH, for advancing the company’s technology to detect digital biomarkers of early-stage Alzheimer’s disease and track its progression.

LifeBio offers a service that enables older individuals to capture their life stories through telephone interviews and interactive online apps. The life stories are used to capture personal histories, but also to offer assisted living facilities and health care providers with details of an older person’s life to help provide more personalized care. The stories can be particularly useful for individuals with cognitive or communications disabilities. In addition, LifeBio offers a related service offering weekly telephone calls to older individuals, to combat loneliness and social isolation.

The company and researchers on aging recognize the value of these collected stories for better understanding and dealing with cognitive decline in older individuals. Last year, LifeBio and Benjamin Rose Institute on Aging in Cleveland, Ohio received a two-year $2.4 million grant from NIA to develop LifeBio Memory, a technology platform for capturing and converting narrated speech into text, supplemented with images and video, to prepare personalized memory exercises. These exercises are designed to help people with dementia reconstruct memories of their lives. The company says a pilot test with Benjamin Rose Institute shows the system helps reduce depressive symptoms among participants.

“Reminiscence therapy has been an effective tool in dementia care and in addressing social determinants of health,” says LifeBio founder and CEO Beth Sanders in a company statement released through Cision. “Our current LifeBio Memory solution as well as this new tool, LifeBio-ALZ, will use artificial intelligence to take person-centered care and contextualized health to a new level.”

AI tools in a patient-centered app

The new NIA award funds enhancements in the LifeBio system to identify digital biomarkers, or indicators of Alzheimer’s disease called LifeBio-ALZ, when collecting the company’s life stories. The project calls for applying artificial intelligence tools in a patient-centered app that analyzes eye movements and responses to questions in recorded audio and video. Algorithms developed in the project will evaluate awareness, engagement, cognition, reaction time, speech patterns, and emotional state in the analyzed recordings to construct the app.

The project aims to determine feasibility and development of a prototype LifeBio-ALZ system, including a patient app. After initial verification, LifeBio-ALZ will be deployed for field testing, with collected data used to build an artificial intelligence engine that detects early-stage Alzheimer’s disease and assesses disease progression.

Brown University in Providence, Rhode Island is partnering with LifeBio on the project. “Communication changes can be difficult to measure for people living with dementia, especially when cognitive symptoms are mild,” notes Brown psychiatry professor Gary Epstein-Lubow, who adds, “We will be testing if LifeBio-ALZ can assist clinicians in better understanding speech patterns, eye movements, emotional changes, and other factors to aid in earlier detection and assessing changes over time.”

The award is a Small Business Innovation Research or SBIR grant made under NIH’s small business programs that set aside a part of the agency’s research funding for U.S.-based and owned companies. SBIR grants fund work by research companies in the U.S., and in most cases are made in two parts: a first phase to determine technical and commercial feasibility, and a second phase to develop and test a working prototype or prepare for clinical trials. This grant is a phase 1 award that runs through August 2022.

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