Darmiyan BrainSee 2

Pat & Dennis Bender Early Dementia Diagnosis & Prognosis Fund

 

J. Dennis Bender

Office, Home & Cell Phone: 859-391-5226

5726 La Jolla Blvd. – Suite 311

La Jolla, CA 92037-7345

&

Office - 100 Riverside Pl. - Suite 303

Covington, KY 41011-5711

 

We support the development of improved diagnostic methods for the early detection and diagnosis of MCI, Alzheimer’s, vascular and other dementias, their likely prognosis, and best treatment options. We focus on the development of Bayesian-based medical-decision-support systems, comparative-effectiveness research, and the better utilization of these for the above. (After incorporating in KY as a 501(c)(3) in 2002, we dissolved that entity for a simplified form of two entirely self-financed, private philanthropies utilizing a Vanguard Charitable Trust for making $100K annual-research-grants for early-dementia-detection and its correct differential-diagnosis and likely-prognosis. They will continue on, after I am long gone, either mentally or physically. Prof. Randall Bateman is the first of our fund’s research advisors, KMK Law is our legal advisor and David J. Bender is my Estate Rep. (See: https://www.alz.org/alzheimers-dementia/research_progress/earlier-diagnosis)

 

 This email address is being protected from spambots. You need JavaScript enabled to view it.

www.JDBender.com – EMS/eVTOL  & Educational Experimental Aviation Fund (Vanguard Charitable Trust)

www.JDBender.org – Dementia Diagnosis Fund (Vanguard Charitable Trust)

 

January 13, 2024

 

 

It appears that Darmiyan has finally begun what I have been trying to help get started for years now with my dementia-research endowment fund to promote just this sort of dementia-diagnostic approach incorporating multiple biometrics. I, like many others, have had multiple MRI brain-scans and I have the CDs with all that data, plus all their specified standard routine multiple annual cognitive tests that they mention and that I continually criticize for their lack of sensitivity and specificity. If all of this proves out, it should represent a major step forward.

 

I want to investigate whether the addition of other bioindicators would further improve their ability to forecast the probability of dementia of some sort and, if so, the conditional-probability as to its type and its specific-prognosis using a Bayesian-based, decision-analysis framework.

 

I’m checking further into all this now and will proceed with trying it out myself as soon as I return home to La Jolla, later this month, from my office here in Covington/Cincinnati. (This sounds like a potential ‘show-stopper,’ so I’m hoping it turns out to be as good as it sounds from their press-release!)

 

 

[BSIP via Getty Images]

 

The FDA Has Reportedly Approved an AI Product That Predicts Cognitive Decline

BrainSee Assigns a Score Forecasting the Advancement of Memory Loss Within 5-Years

Will Shanklin - ·Contributing Reporter - January 12, 2024

The US Government has reportedly approved AI-based memory-loss-prediction-software for the first time. Darmiyan, a San Francisco-based brain imaging analytics company, says the FDA has granted De Novo approval for its product BrainSee. The software platform assigns “an objective score that predicts the likelihood of progression from aMCI to Alzheimer’s dementia within 5 years,” according to the medical company. Fierce Biotech first reported the announcement.

Darmiyan says BrainSee can predict-memory-loss-progression using clinical-brain-MRIs and cognitive-tests, which are already standard for patients worried about early-signs-of-decline. After the program analyzes the imaging and cognitive-assessments, it assigns a predictive-score indicating the patient’s odds of memory deterioration within the following-5-years. At least in theory, that would lead to early treatment for some and peace-of-mind for others.

“This shifts the patient experience from prolonged anxiety to proactive management, which is crucial in an era of emerging Alzheimer’s treatments where accurate prognosis can help determine suitable treatment candidates,” Darmiyan wrote in a press-release announcing the FDA-approval. “The economic impact of BrainSee will be significant for all stakeholders in healthcare, promising to reduce the billions of dollars annually spent on Alzheimer’s-care, through more-effective-management and treatment.”

The FDA’s “De Novo” designation means the product has no clear market predecessors but has proven its effectiveness and safety in clinical-trials. BrainSee first received FDA “breakthrough” designation in 2021, an earlier-stage of the approval-path for a first-of-its-kind treatment.

Darmiyan says BrainSee is fully-automated and provides results on the same day the scans and cognitive-test-scores are entered. The Company views the tech as shifting the treatment of mild/early-cognitive-decline from biomarker-based-methods to “non-invasive and actionable forecasts of future improvement or progression.”

“BrainSee generates an objective-score that predicts the likelihood-of-progression from aMCI to Alzheimer's dementia within-5-years. . . FDA's De Novo approval of BrainSee represents a major advancement in Alzheimer's diagnostics. Utilizing cutting-edge image-processing and medical-AI, BrainSee establishes a new standard for predicting progression from amnestic-mild-cognitive-impairment (aMCI) to Alzheimer's-dementia. This breakthrough is a significant step in proactive-brain-health management, offering a fully non-invasive, convenient, and globally-accessible screening-solution, to be prioritized before other tests or treatments. . . BrainSee shifts the paradigm in aMCI-workup from biomarker-based-methods that have limited real-world capabilities due to their invasiveness, non-specificity, cost, and inaccessibility, to non-invasive and actionable forecasts of future-improvement or progression.”

San Francisco, Jan. 12, 2024 Newswise — /PRNewswire/

FDA Approves BrainSee, First-in-Class Test to Predict Progression of Alzheimer-Disease

January 12, 2024 - Ashley Gallagher, Associate Editor

BrainSee creates a new standard for progression prediction in Alzheimer-disease, marking a step forward in brain health management with non-invasive screening.

The FDA has approved a first-in-class clinical-test, BrainSee, which uses imaging-processing and medical-artificial-intelligence to predict the progression from amnestic mild cognitive impairment (aMCI) to Alzheimer dementia. According to a press-release, BrainSee creates a new standard for progression prediction in Alzheimer-disease (AD), marking a step-forward in brain-health-management with a non-invasive-screening-process.¹

According to the Alzheimer’s Association, aMCI primarily affects an individual’s memory, causing them to start forgetting important information that they used to easily recall, such as appointments, conversations, or recent events in their lives. The organization added that approximately 12%-to-18% of individuals-aged-60-or-older have some form of MCI, with about one-third developing-AD within-5-years. Additionally, they added that more than 80% of Americans know little or are not familiar with MCI, which can be a sign of early-stage-AD.²

"Our vision is to redefine brain health screening and monitoring standards and impact the lives of patients and their family members in a meaningful way. BrainSee is the first product of this vision, backed by our solid technological infrastructure that is capable of driving further transformations and scalable innovations in the brain health landscape," Padideh Kamali-Zare, PhD, Founder and CEO of Darmiyan, said in the press-release.¹

The clinical-test is a fully-automated-software-platform, combining standard-magnetic-resonance-imaging (MRI) and cognitive-assessments.¹ Using MRI-data, BrainSee can pull information related to brain-tissue-degeneration, according to the Company website.³ The platform can generate scores that predict-the-likelihood-of-progression-from-aMCI-to-AD-within-5-years, according to the press-release.¹ The score can be between 0-to-100, with a lower-score being positive, and physicians can use this information to determine the likelihood-of-progression.³ The platform was designed based on approximately 40-years of neuroscience and thousands of real-world-patient-data, according to the product website.³

With early-screening and risk-stratification, the program helps to get individuals at risk of progression to AD timely and personalized treatments, which could help delay dementia onset and [perhaps] lower-risk-of-progression. According to the press-release, this would also reduce costly and invasive tests as well as the financial and emotional burdens for patients. BrainSee also provides accurate same-day-results, with integration-into-clinical-workflow. Further, the platform shifts the paradigm in aMCI workup from biomarker-based-methods with invasiveness and inaccessibility to a non-invasive-method to determine-progression.¹

According to the Company website, reassurance can be provided to patients who are at low risk for progression and also offer early-interventions to delay-the-onset-of-dementia for those at high-risk. BrainSee can also be repeated-annually to further provide reassurance and monitoring-of-progression. The program also includes a printable-report with prognostic-scores and provides instructions on how to interpret the scores.³

The FDA previously granted BrainSee breakthrough-designation in 2021. The approval coincided with the JP Morgan HealthCare conference, according to the press-release.¹

References

1. Darmiyan receives FDA approval for BrainSee, the first prognostic test for predicting likelihood of progression to Alzheimer's dementia. News release. PR Newswire. January 12, 2024. Accessed January 12, 2024. https://www.prnewswire.com/news-releases/darmiyan-receives-fda-approval-for-brainsee-the-first-prognostic-test-for-predicting-likelihood-of-progression-to-alzheimers-dementia-302033616.html
2. Alzheimer’s Association. Mild Cognitive Impairment (MCI). Accessed January 12, 2024. https://www.alz.org/alzheimers-dementia/what-is-dementia/related_conditions/mild-cognitive-impairment
3. BrainSee. Updated January 2024. Accessed January 12, 2024. https://brainsee.ai/

Darmiyan Receives FDA Approval for BrainSee, the First Prognostic Test for Predicting Likelihood of Progression to Alzheimer's-Dementia

by Darmiyan

Today marks a turning-point in the battle against Alzheimer's-disease as Darmiyan, Inc., a leading company in brain-health innovation announces the FDA's approval of its first-in-class (De Novo) clinical-test, BrainSee. This approval marks a pivotal advancement in brain-health and opens the door to untapped market potential in brain-disease-diagnosis-and-management.

BrainSee is the first clinical application of Darmiyan's patented-core-proprietary-technology that is based on 40+ years of cutting-edge brain-science, powered by advanced whole-brain-image-analysis and medical-AI. It is a highly-scalable and fully-automated software-platform that combines standard-clinical-brain-MRI and cognitive-assessments – part of the routine, non-invasive workup of patients concerned with memory-loss – and generates an objective-score that predicts the likelihood-of-progression from aMCI to Alzheimer's dementia within-5-years. BrainSee addresses a critical unmet need for over 10 million Americans and over 100 million patients worldwide grappling with aMCI. With an aging global population, the socio-economic impact of BrainSee is expected to grow rapidly and exponentially.

"Our vision is to redefine brain-health-screening-and-monitoring-standards and impact the lives of patients and their family members in a meaningful way. BrainSee is the first product of this vision, backed by our solid technological infrastructure that is capable of driving further transformations and scalable innovations in the brain-health landscape," stated Dr. Padideh Kamali-Zare, Founder and CEO of Darmiyan.

Early screening and risk-stratification by BrainSee enables timely and personalized treatments for those aMCI patients at high-risk-of-progression-to-Alzheimer's-dementia, aiming to delay-dementia-onset, while reassuring those at lower-risk-of-progression, hence reducing the need for costly and invasive tests and the heavy burdens of financial and emotional abuse. This shifts the patient-experience from prolonged-anxiety to proactive-management, which is crucial in an era of emerging Alzheimer's-treatments where accurate-prognosis can help determine-suitable-treatment-candidates. The economic-impact of BrainSee will be significant for all stakeholders in healthcare, promising to reduce the billions of dollars annually spent on Alzheimer's-care, through more-effective-management-and-treatment.

BrainSee was previously granted FDA breakthrough-designation in 2021. It stands-out for its prognostic-accuracy, patient-convenience, same-day-test-results and seamless-integration into the clinical-workflow. Global-availability-of-MRI significantly-enhances BrainSee's clinical-utility. Most-notably, BrainSee shifts the paradigm in aMCI-workup from biomarker-based-methods that have limited real-world capabilities due to their invasiveness, non-specificity, cost, and inaccessibility, to non-invasive and actionable forecasts of future-improvement or progression.

BrainSee's FDA approval coincided with the JP Morgan HealthCare conference in San Francisco. The platform is now available to physicians via a secure and HIPAA-compliant web-portal. For more information visit brainsee.ai.

About Darmiyan: Darmiyan  is a pioneering brain technology (deep-tech) company in San Francisco, California, focused on developing innovative and rapidly-scalable products for brain-health-screening-and-monitoring. The Company's mission is to enhance brain-health, equipping physicians with tools for precise and personalized patient-care, thereby optimizing health outcomes.

1. Most patients diagnosed with amnestic-mild-cognitive-impairment (aMCI) experience one of two outcomes:
   • Remain stable or improve
   • Progress to Alzheimer’s-Dementia 

 

2. BrainSee helps your doctor to assess your prognosis more-accurately. This can help guide better care and treatment plans.
3. Brain-MRI (magnetic-resonance-imaging) is the key-input for BrainSee. MRI is a generally safe medical imaging procedure and does not involve radiation exposure (unlike CT or PET scans). 

Acquire a “quantitative”, non-contrast, T1-weighted brain MRI with the following specifications:

A - 3D, T1-weighted

B - Non-contrast

C - 1-mm isotropic-resolution

D - Either 1.5-Tesla or 3-Tesla

How to get a BrainSee test?

1.  Talk to your doctor and ask them to arrange a BrainSee test for you.  Doctors who can request a BrainSee test include neurologists, geriatricians, primary-care physicians, family-doctors, and psychiatrists.
2.  Your doctor will perform two initial cognitive-function-tests and will prescribe a brain-MRI-scan. [Of which I have already had many and already have the CDs.]
3.  Once your brain MRI-scan is done, get a copy on a CD and upload it into your BrainSee portal (coming soon). 
4.  Or bring a copy of the scan-files on a CD to your doctor’s office.
5.  You will get an email from BrainSee to pay for the test. For financial assistance or discount request, email   This email address is being protected from spambots. You need JavaScript enabled to view it.
6.  Check back with your doctor to discuss your BrainSee test results.

Clinical Workflow Summary

Now for a much deeper-dive into this very-promising-sounding development. The following brain-atrophy-measurement software was mentioned in the article. I assume that BrainSee is using the MRIs to simply measure brain-atrophy, but I need to check that assumption.

Emerging AI Software for Brain-MRI Gets FDA Nod

November 21, 2023 - Jeff Hall – News - Article

Pixyl.Neuro reportedly leverages generative artificial-intelligence (AI) technology to accelerate brain-MRI-assessment and improve early-detection-of-abnormal-atrophy.

The Food and Drug Administration (FDA) has granted-510(k)-clearance for Pixyl.Neuro^™, an adjunctive-artificial-intelligence (AI)-powered-software that may enhance magnetic-resonance-imaging (MRI) detection and follow-up of patients with neurological-disorders including Alzheimer’s-disease and multiple-sclerosis (MS).

Reportedly providing automated-brain-MRI-analysis in less-than-5-minutes, Pixyl.Neuro may help quantify-brain-region-volume to aid in the differential-diagnosis and facilitate-earlier-identification-of-atrophy, according to Pixyl, the developer of the software.

Lotfi Hacein-Bey, M.D, said adjunctive-AI-support reinforces radiology workflows for the assessment of patients with neurological-disorders.

“The recent FDA approval of Pixyl's software is a very-positive-step-toward-improved-diagnosis, management and longitudinal-follow-up of neurodegenerative and neuroinflammatory disorders, especially with the advent of disease-modifying treatments for MS, NMO (neuromyelitis-optica) and Alzheimer's-disease,” noted Dr. Hacein-Bey, the Director of the Division of Neuroradiology at the University of California, Davis (UC Davis) School of Medicine in Sacramento, Calif.

Pixyl added that the Pixyl.Neuro software, currently utilized in more than 12 countries, has seen a four-fold increase in use since December 2022.

Early Detection of Alzheimer’s Thanks to Groundbreaking Medical Technology

The $50,000 KTH Innovation Award 2023 Goes to Padideh Kamali-Zare

Published September 18, 2023, Text: Katarina Ahlfort, Photo: Patrik Lundmark

She is making a dream come true by contributing to the early detection of brain diseases like Alzheimer’s, as a creator of groundbreaking microscope-technology. Padideh Kamali-Zare is this year’s recipient of the KTH Innovation Award.

At 14 she took care of her grandmother, who was diagnosed with mild-dementia. Today, Padideh Kamali-Zare is the CEO and Founder of biotech company Darmiyan. “Just two days after my dear grandmother passed away, I started studying biological physics at KTH so I could help patients with brain diseases to enjoy longer, healthier and higher quality lives.”

The 2023 KTH Innovation Award goes to Padideh Kamali-Zare. She is head of the innovative Silicon Valley-based biotech company Darmiyan, and she has been able to realize her vision of helping patients with neurodegenerative-diseases like Alzheimer’s to access better health and care.

The KTH Innovation Award rewards three qualities: creativity, grit, and courage. “It feels amazing to be acknowledged like this. I would really encourage all young entrepreneurs to think outside the box, to execute their vision and have the courage to change things,” says Kamali-Zare.

The Company has developed BrainSee technology – a virtual-microscope that illuminates-brain-tissue-microstructure. “Darmiyan is focused on developing medical-technology that can detect Alzheimer’s in patients early on, and in a non-invasive and accurate way. Through geometric-modelling and cloud-based-AI-modelling, we can determine how the brain is likely to develop and work 5-years into the future,” says Kamali-Zare.

A Chance to Higher Quality of Life “Combined with factors such as age, gender and cognitive-ability, which is measured on a scale, the BrainSee-scoring makes it possible to predict-the-risk-of-brain-disease with a high-degree-of-accuracy.” Kamali-Zare explains that a low-score means the patient is less-likely to be at risk of developing Alzheimer’s-disease in the next 5-years. While a higher-score does indicate a higher-risk, it also means the disease has been identified at an early-stage.

“One of the major benefits of our technology is that it enables patients to plan their lives and future care in advance, before the disease has impaired their cognitive-ability severely. That planning can include important decisions about medications, familial-relations, insurance, support-systems and accommodation – decisions that in turn can mean a higher-quality-of-life for the patient as they age,” says Kamali-Zare.

According to her, the technology also means that patients with mild-cognitive-impairment do not have to worry needlessly about developing Alzheimer’s, since the risk-of-disease can be excluded on a yearly-basis for the next 5-years to come.

Avoid Unnecessary Waiting Time “Patients avoid having to endure invasive medical tests unnecessarily, when those tests are not even answering their critical questions about developing dementia. The simple BrainSee-analysis can be conducted every year, or more often if the person is at high-risk of developing the disease in the future,” says Kamali-Zare.

Kamali-Zare was born and raised in Iran and left for Sweden at age 23 to study Biological Physics and Neuroscience at KTH. “I like the culture and mentality of Sweden a lot. The social system is based on collaboration and the equal value of everybody, and I’m impressed by the important dimension of thinking. Sweden is one of the world’s top countries when it comes to equal opportunities for women and men.”

Kamali-Zare lived in Stockholm for 6-years between 2004 and 2010 and took her Doctorate in Biological Physics before moving to New York to do post-doctoral-research in computational-neuroscience. One year after starting Darmiyan in New York she took the Company to Silicon Valley in California.

“I started the company Darmiyan with friends and people whom I trusted the most. Now, we’re based in Berkeley, and on the cusp of large-scale-commercialization soon after the US Food and Drug Administration, FDA, approves BrainSee for clinical-use in 2024,” she says.

Kamali-Zare’s future plan is to lead the Company until it hits the growth-stage and then “introduce fresh, young energy” to rapidly grow and expand the business. “I want to focus less on administration and more on people and innovations, as a mentor and advisor, ideally with a link to KTH. I love sharing knowledge with other researchers and young entrepreneurs, and encouraging them to take the right path even thought it’s often the hard one.”

Since its founding in 1827, KTH Royal Institute of Technology in Stockholm has grown to become one of Europe’s leading technical and engineering universities, as well as a key center of intellectual talent and innovation. They are Sweden’s largest technical research and learning institution and home to students, researchers, and faculty from around the world dedicated to advancing knowledge. [Pat and I very much enjoyed our last visit to Stockholm and touring in Sweden.]

Darmiyan's BrainSee Nabs Breakthrough Status From FDA

AuntMinnie.com staff writers - June 1, 2021

The U.S. Food and Drug Administration (FDA) has granted breakthrough-status to Darmiyan's artificial-intelligence-(AI)-based-software, BrainSee, which detects Alzheimer's-disease from MRI-scans.

BrainSee detects Alzheimer's disease at the early stage of mild cognitive impairment using a brain-MRI. The scan does not require an injection or radiation. The software will enable clinicians to select patients who are in the early-stages-of-neurodegeneration for clinical-trials, paving-the-way for potential new therapies and treatments.

Darmiyan Executives Call FDA's Accelerated Approval of Aducanumab a Big Step in the Right Direction

FDA Makes History, Shows New Openness to Alzheimer's-Disease Detection and Therapeutics, Today Marks Major Milestone for Alzheimer's Patients

San Francisco, CA, June 7, 2021

"This is a big day in the history of Alzheimer's disease. The past 10 days have seen new openness in the FDA’s approach towards this devastating disease. On May 28 FDA granted Darmiyan's BrainSee (AI-powered early detection and monitoring of Alzheimer's) with breakthrough designation, and today FDA granted accelerated approval for Aduhelm (aducanumab) as a treatment for Alzheimer's disease. Now it's more important than ever to detect the disease early when treatments have the highest chance of being effective. " - Darmiyan CEO Padideh Kamali-Zare, PhD

"This is a big step in the right direction. It brings hope and energy to patients, their families and the entire Alzheimer’s field. Now the question is, which patients should take the drug? Darmiyan’s BrainSee soon will help identify those patients who are most likely to benefit from this drug and others in the pipeline." -Darmiyan Chief Medical and Technology Officer Kaveh Vejdani, MD

Based in San Francisco, California, Darmiyan was incorporated in September 2016 and backed by Y-Combinator (YC) in Summer 2017. The Company has won numerous awards and recognitions including the TEDMED Hive Innovator in 2018, CABHI Innovation Award in 2019 and Fortune 40 Under 40 for healthcare in 2020 and in May 2021 an FDA Breakthrough designation for BrainSee. Darmiyan's most recent funding in 2020 was led by the global pharma giant Eisai with participation of YC and IT-Farm. Darmian’s proprietary technology using brain-MRI is patented in the US; patents are pending in Europe, Japan and China.

Patent Search: Found 5 trademark mentions under “BrainScan” and under “Darmiyan” I found the following patents: https://uspto.report/company/Darmiyan-Inc/patents

Patent	Date
Methods And Systems For Identifying Brain Disorders App 20200143948 - KAMALI-ZARE; Padideh ;   et al.	2020-05-07
Methods and systems for identifying brain disorders Grant 10,573,414 - Kamali-Zare , et al. Feb	2020-02-25
Methods And Systems For Identifying Brain Disorders App 20180268942 - KAMALI-ZARE; Padideh ;   et al.	2018-09-20

Determining a Disorder-State of Brain-Tissue Their patent provides an overview of their many steps in calculating their measure of “disordered-state” versus normal-state of brain-tissue in a MRI-voxel and then calculating an overall measurement that was used for separating normal from deteriorating brain regions that showed good separation between the two groups.

This is a good first-step, next it needs to be tried out on an out-of-sample set of fresh data to see how well it performs on subjects not used in constructing the model. I’m sure that they have already done exactly that, just looking for how well it works on data from other sources than the dataset used to calibrate the model.

Take a look at their patent-application for an overview of their calculations.

{Darmiyan BrainSee}