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

Key Takeaways

  • Today FDA made history and marked a major milestone for Alzheimer's patients.
  • 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.

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. Darmiyan’s proprietary technology using brain MRI is patented in the US; patents are pending in Europe, Japan and China.

Quotes

“
This is a big day in the history of Alzheimer's disease. Now it's more important than ever to detect the disease early when treatments have the hi...
Padideh Kamali-Zare — CEO
“
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 questio...
Kaveh Vejdani — Chief Medical and Technology Officer
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Related Bios

Padideh Kamali-Zare
CEO
The founding CEO of Darmiyan, Padideh is a 2020 Fortune 40 under 40 global healthcare leader/ influencer, and a 2018 TEDMED Hive Innovator. She has been leading the Company for the past 5 years, taking the technology through multiple stages of development, from conception to a functioning product. Under her leadership, Darmiyan team has achieved widespread recognition in the biomedical and life science communities, through numerous awards and partnerships. Padideh is a world-renowned geometrical modeling expert with an outside-the-box thinking approach to complex problems. Her major skill is to put things into context and visualize the big picture (story-telling). Prior to starting Darmiyan, she was an Adjunct Assistant Professor at New York University, School of Medicine, where she previously completed three years of postdoctoral training in biophysical neuroscience, 2010-2013, under supervision of Professor Charles Nicholson, the scientific father of brain microstructure modeling. Padideh got her PhD in biological physics from Royal Institute of Technology (KTH) in Stockholm, Sweden in 2010. Her PhD thesis entitled “Biophysical mechanisms underlying cellular homeostasis” provided a non-classical explanation for the relationship between cell structure and function. In her free time Padideh enjoys teaching Persian classical music and writing blogs, including the Psychology Today
series on Cognitive Future.
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Kaveh Vejdani
Chief Medical and Technology Officer
Kaveh is a nuclear medicine physician, sub-specialized in PET/CT and PET/MR from Stanford University and NYU Langone Medical Center. He has been a savvy computer programmer since the age of 13, coding numerous projects in computational mathematics, physical simulations, and medical image processing.
Kaveh received his MD degree in 2003 and performed his postdoctoral research at UCSF, followed by clinical specialty training in nuclear medicine at St. Louis University. His professional experience ranges from tissue engineering (stem cells and biomaterials) to radiology and molecular imaging. In his free time, Kaveh enjoys playing violin and chess and making iPhone apps.


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Key Takeaways

  • Today FDA made history and marked a major milestone for Alzheimer's patients.
  • 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.

Contacts

Ilyse Veron
ILYSE@DARMIYAN.COM
Chief of Communications/Head of US Strategic Partnerships