Cnd Life Sciences, Inc.

- Synuclein-One Study plenary session on Monday, April 15 at 9:15 a.m. MT will report the detection of cutaneous phosphorylated alpha-synuclein in patients with dementia with Lewy bodies and mild cognitive impairment - Multiple abstracts accepted, including one abstract of distinction, demonstrating the significance of using small skin biopsies in combination with advanced laboratory techniques to detect the misfolded protein that causes Parkinson’s disease and other synucleinopathies SCOTTSDALE, Ariz.--(BUSINESS WIRE)-- CND Life Sciences (CND), a medical technology company pioneering the development of cutaneous neurodiagnostic tests and associated biomarker services, today announced that six abstracts related to the identification of phosphorylated alpha-synuclein (P-SYN) in cutaneous nerve fibers in the skin will be presented at the American Academy of Neurology 2024 Annual Meeting (AAN) on April 13-18 in Denver at the Colorado Convention Center. One abstract describes the first subgroup analysis from the Synuclein-One Study, an NIH-funded 30-site multicenter trial. The results are focused on patients with dementia with Lewy bodies (DLB) and mild cognitive impairment (MCI). This abstract was selected as a 2024 Abstract of Distinction based on the quality of the study and interest to the neurologic community and will be presented during the Contemporary Clinical Issues Plenary Session by Christopher Gibbons, MD, Senior Scientific Advisor and Co-Founder of CND Life Sciences and Professor of Neurology at Harvard Medical School on Monday, April 15 at 9:15 am MT. A second abstract being presented describes the utility of the synuclein skin biopsy in the initial diagnosis and evaluation of Parkinsonian disorders in everyday clinical practice. This abstract will be presented during the Emerging Science 2 Session by Jonathan Ross Isaacson, MD, Neurophysiology Fellow at Beth Israel Deaconess Medical Center on Tuesday, April 16 at 5:36 p.m. MT. Other abstracts include: A single center retrospective review of essential tremor patients with a clinical phenotype of ‘Parkinsons plus’. The study focuses on patients demonstrating evidence of cutaneous phosphylated alpha-synucelin (P-SYN) deposition in the setting of normal dopamine transporter (DaTscans); A study describing the utility of skin biopsy detection of P-SYN in patients with suspected drug-induced Parkinson’s with normal DaTscans; A summary of patients with pure autonomic failure (PAF) from our Synuclein-One Study, an NIH-funded 30-site multicenter trial. PAF is a neurodegenerative disorder of the autonomic nervous system clinically characterized by orthostatic hypotension and commonly involving bladder and bowel dysfunction; and A platform presentation unveiling CND’s groundbreaking NerValence™ technology that enables quantification of cutaneous phosphorylated alpha-synuclein using high resolution, high-throughput confocal imaging combined with artificial intelligence supported protein detection algorithms. “All of the research that will be presented during AAN supports the groundbreaking diagnostic advances using skin biopsies to detect, quantify, and monitor neurodegenerative disease progression. As the population of neurodegenerative disease patients continues to grow, the need for accurate diagnostic tools is increasingly important to provide better care for patients,” said Dr. Gibbons. “The demand for convenient, objective, and precise diagnostic tools and reliable biomarkers has never been greater, and the data presented at the AAN meeting will highlight our growing portfolio of work around the utility of our Syn-One Test® through its potential to disrupt neurogenerative disease diagnoses and help biopharma companies move their scientific research forward,” said Todd Levine, MD, Chief Medical Officer of CND Life Sciences. Details on relevant presentations are as follows: Abstract Title: Cutaneous Phosphorylated Alpha-synuclein Deposition in Dementia with Lewy Bodies and Mild Cognitive Impairment Lead Author: Christopher Gibbons, MD, FAAN, Beth Israel Deaconess Medical Center Presentation Details (MT): Program # PL4.004, Plenary Session, April 15, 9:15-9:25 a.m., Bellco Theatre Abstract Title: Clinical Utility of Synuclein Skin Biopsy in the Initial Diagnosis and Evaluation of Parkinsonian Disorders Lead Author: Jonathan Ross Isaacson, MD, Neurophysiology Fellow, Beth Israel Deaconess Medical Center Presentation Details (MT): Program # ES2.002, Scientific Platform Session, Poster/Presentation #002, April 16, 5:36-5:42 p.m., Bluebird 1A Abstract Title: Essential Tremor with Parkinsonism with Normal Dopamine Transporter Imaging: Majority Have Evidence of Peripheral Synucleinopathy Lead Author: Virgilio Gerald Evidente, MD, FAAN, Movement Disorders Center of Arizona Presentation Details (MT): Program # P3.001, Poster/Presentation #3-001, April 14, 5:30-6:30 p.m., Exhibit Hall B-E Abstract Title: Cutaneous Phosphorylated Alpha-synuclein Deposition in Pure Autonomic Failure Lead Author: Roy Freeman, MD, Beth Israel Deaconess Medical Center Presentation Details (MT): Program # P5.002, Poster/Presentation #3-002, April 15, 5:30-6:30 p.m., Exhibit Hall B-E Abstract Title: Peripheral Synucleinopathy in Patients Diagnosed with Drug-induced Parkinsonism with Normal Dopamine Transporter Imaging Lead Author: Virgilio Gerald Evidente, MD, FAAN, Movement Disorders Center of Arizona Presentation Details (MT): Program # P3.018, Poster/Presentation #3-018, April 14, 5:30-6:30 p.m., Exhibit Hall B-E Abstract Title: A Novel Diagnostic Method for Detection and Quantitation of Cutaneous Phosphorylated Alpha-synuclein Lead Author: Christopher Gibbons, MD, FAAN, Beth Israel Deaconess Medical Center Presentation Details (MT): Program #S26.004, Scientific Platform Session, Platform Presentation #004, April 16, 4:06-4:18 p.m., Mile High 4F About CND Life Sciences CND Life Sciences supports the care of patients facing the potential diagnosis of a neurodegenerative disease and other neurological conditions. Operating a CLIA-certified and CAP-accredited laboratory in Scottsdale, Arizona, CND provides the Syn-One Test® to clinicians and patients nationally as the world's only commercially available test to detect, visualize, and quantify phosphorylated alpha-synuclein located in cutaneous nerves. The test uses small skin biopsies collected from the patient in a clinician’s office through a 15-minute minimally invasive procedure and includes an assessment of intraepidermal nerve fiber density and other important pathologic evaluations in the skin. The Company also collaborates with biopharmaceutical companies on clinical trials for investigational therapies targeting neurodegenerative diseases. Syn-One is supported by technology licensed from Beth Israel Deaconess Medical Center in Boston and has demonstrated high accuracy in detecting phosphorylated alpha-synuclein in patients with a suspected synucleinopathy including Parkinson’s disease, dementia with Lewy bodies, and multiple system atrophy. CND has been awarded three prestigious NIH SBIR grants to advance the validation and clinical utility of its Syn-One Test, including assessing the test’s ability to provide early disease detection and prognostic insights. For more information, visit cndlifesciences.com or connect with us on LinkedIn. SOURCE: CND Life Sciences Disclosure: Research reported in this publication was supported by the National Institute of Neurological Disorders and Stroke and the National Institute on Aging (NIA) of the National Institutes of Health under Award Numbers R44NS117214, R44AG076072, and R44NS127696. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

- Study demonstrates alpha-synuclein biomarker can be detected in 93-100% of patients with clinically defined pathologies using simple skin biopsy procedure - Syn-One Test addresses key unmet needs by supporting accurate diagnoses for patients and serving as a reliable biomarker for clinical trials SCOTTSDALE, Ariz.--(BUSINESS WIRE)-- CND Life Sciences (CND), a medical technology company pioneering the development of cutaneous neurodiagnostic tests and associated biomarker services, today announced a pivotal peer-reviewed publication entitled, “Skin Biopsy Detection of Phosphorylated α-Synuclein in Patients with Synucleinopathies”1 in the Journal of the American Medical Association (JAMA). The publication by Gibbons et al. (2024) was a cross-sectional study of patients in academic and community-based neurology practices in people with a clinical diagnosis of Parkinson’s disease (PD), dementia with Lewy bodies (DLB), multiple system atrophy (MSA), and pure autonomic failure (PAF), collectively known as synucleinopathies, and healthy subjects to evaluate the positivity rate of phosphorylated alpha-synuclein (P-SYN) detection through a skin biopsy test. Supported by the National Institutes of Health (NIH), this blinded, 30-site, 428-patient study has the potential to unlock a new era in diagnostic testing and address urgent unmet needs by reducing common misdiagnoses while enhancing clinical drug development efforts. The primary goal of this study was to define the positivity rate of skin biopsies to detect P-SYN deposition in clinically confirmed cases of PD, MSA, DLB, and PAF. The proportion of patients with P-SYN was 92.7% in those with PD, 98.2% in those with MSA, 96.0% in those with DLB, and 100% in those with PAF. The proportion of healthy subjects with P-SYN was only 3.3%. The results from this study demonstrate the opportunity to use alpha-synuclein detection in cutaneous nerves as a reliable and convenient diagnostic tool for clinical practice and as a quantifiable biomarker to evaluate disease severity and progression. “This study validates the role of skin biopsy detection of phosphorylated alpha-synuclein as an important diagnostic tool for physicians and patients,” said lead author Christopher Gibbons, MD, Senior Scientific Advisor and Co-Founder of CND Life Sciences and Professor of Neurology at Harvard Medical School. “Accessibility to accurate testing modalities that pinpoint the pathology of these diseases has been a real challenge for both clinical practice and clinical trials, so we are quite pleased to see the strong positivity and specificity results of using skin as a reliable diagnostic method.” Scientific literature has suggested that synucleinopathies, including PD, may be misdiagnosed over 30% of the time, particularly earlier in the disease course. Furthermore, in a recent study of Medicare patients diagnosed with PD (published in npj Parkinson’s Disease in 2023), barriers to more specialized neurology care have created significant health disparities for patients. Future disease-modifying therapies will require convenient, accurate, and precise diagnostic tools to reach the right patients at the right time across a wide array of communities. “Detecting phosphorylated alpha-synuclein through cutaneous nerves is a more convenient pathway than other tests requiring spinal fluid or nuclear medicine imaging,” said Todd Levine, MD, Chief Medical Officer of CND Life Sciences and principal investigator on the study. “The Syn-One Test has been ordered by over 1,200 neurologists in 46 states to aid the diagnosis of 20,000 patients in the last few years. By providing objective, visual proof of the known pathological marker of Parkinson’s disease, dementia with Lewy bodies, and other synuclein disorders, the Syn-One Test is truly helping clinicians increase diagnostic confidence and provide better care to patients.” CND’s research team and collaborators continue to advance the science that underlies the Syn-One Test through a range of exploratory programs and clinical studies focused on early disease detection, biosignatures of specific disease subtypes, and correlations with other neurological biomarkers. “We believe this is a crucial decade of innovation for the neurodegeneration field, one that will result in major progress in precision diagnostics, new treatments, and more promising futures for patients and families,” noted Roy Freeman, MD, Senior Scientific Advisor and Co-Founder of CND Life Sciences and Professor of Neurology at Harvard Medical School. “The publication of this important NIH-sponsored study is one big step forward with many more milestones to come.” About CND Life Sciences CND Life Sciences is dedicated to supporting the care of patients facing the potential diagnosis of a neurodegenerative disease and other neurological conditions. Operating a CLIA-certified and CAP-accredited laboratory in Scottsdale, Arizona, CND launched the Syn-One Test® in 2019 as the world's first commercially available test to detect, visualize, and quantify phosphorylated alpha-synuclein located in cutaneous nerves. This laboratory-developed test analyzes three small skin biopsies collected from the patient in a physician’s office through a 15-minute minimally invasive procedure and includes an assessment of intraepidermal nerve fiber density and other important pathologic evaluations in the skin. The Syn-One Test is supported by technology and expertise licensed from Beth Israel Deaconess Medical Center in Boston through the Center for Autonomic and Peripheral Nerve Disorders and the research laboratory of Dr. Roy Freeman and Dr. Christopher Gibbons. The Company has research collaborations with multiple biopharmaceutical companies. It has been awarded three prestigious NIH SBIR grants to advance the validation and clinical utility of its Syn-One Test, including assessing the test’s ability to provide early disease detection and prognostic insights. For more information, visit cndlifesciences.com or connect with us on LinkedIn. Disclosure: Research reported in this publication was supported by the National Institute of Neurological Disorders and Stroke and the National Institute on Aging (NIA) of the National Institutes of Health under Award Numbers R44NS117214, R44AG076072, and R44NS127696. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. 1Gibbons CH, Levine T, Adler C, et al. Skin Biopsy Detection of Phosphorylated α-Synuclein in Patients With Synucleinopathies. JAMA. Published online March 20, 2024. doi:10.1001/jama.2024.0792

Arizona Bioindustry Association Selects CND as a 2023 Fast Lane Honoree for Outstanding Achievements SCOTTSDALE, Ariz., Nov. 16, 2023 /PRNewswire/ -- CND Life Sciences, a medical technology company pioneering the development of skin-based tests to help clinicians diagnose neurodegenerative diseases and other neurologic disorders, has been named a 2023 Fast Lane Honoree by the Arizona Bioindustry Association (AZBio). The award is given to a select few companies each year for achieving outstanding milestones in the previous 18 months. "We are incredibly grateful for being honored with a 2023 AZBio Fast Lane Award," said CND Chief Medical Officer and Co-Founder, Dr. Todd Levine. "The award affirms our tremendous growth as a company as we serve clinicians and their patients who face the potential diagnosis of a neurodegenerative disease, and we are proud to pursue this important mission here in Arizona." In the last 18 months, CND has registered several important advances for its business, including presenting results from an important NIH-supported clinical study demonstrating high accuracy of its groundbreaking Syn-One Test, which uses a simple skin biopsy to help clinicians diagnose Parkinson's disease and related disorders. Demonstrating over 95% sensitivity and specificity in the 30-site, prospective, blinded study, the Syn-One Test is now being used by nearly 1,000 neurologists nationally to aid in the diagnosis of these challenging, progressive neurological diseases. "For the progress it is making in building a growing Arizona medical technology company, CND Life Sciences was very deserving of the 2023 AZBio Fast Lane Award," said Joan Koerber-Walker, President and CEO of AZBio. "We look forward to witnessing and supporting CND's continued innovation and impact in the field of neurodegenerative medicine." AZBio supports the needs of Arizona's growing life science ecosystem by connecting those in the life science community, providing infrastructure support for growing businesses, building public awareness, and taking part in advocacy work. Arizona's bioscience industry employed 36,000 people across more than 2,900 businesses in 2021, and industry employment has grown at twice the rate of the US overall. About CND Life Sciences CND Life Sciences is on a mission to help transform the diagnosis and treatment of neurodegenerative diseases. Operating a CLIA-certified and CAP-accredited laboratory in Scottsdale, Arizona, CND launched the Syn-One Test in 2019 as the world's first commercially available test that detects and visualizes phosphorylated alpha-synuclein in cutaneous nerves with high accuracy to aid the diagnosis of Parkinson's disease and related disorders. The company has scientific collaborations with biopharmaceutical companies and has been awarded three NIH SBIR grants to advance the clinical utility of the Syn-One Test. For more information visit . Disclosure: Research reported in this publication was supported by the National Institute of Neurological Disorders and Stroke and the National Institute on Aging (NIA) of the National Institutes of Health under Award Numbers R44NS117214, R44AG076072, and R44NS127696. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Media Contact: Kendall Swanson, [email protected] SOURCE CND Life Sciences