Pharma Articles & MedTech Blog | Topia Life Sciences

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March, 2024

Topia's first repurposed drug study for Alzheimer

TOP-RPBE001 blocks enzymatic hydrolysis in-vitro and facilitates Ach transportation.

New Hope for Alzheimer’s Patients

At Topia, we harness the transformative power of Artificial Intelligence (AI) to innovate in drug discovery. Our team is a dynamic blend of experts: cheminformatics professionals who navigate complex molecular landscapes, bioinformatics specialists who decode…

August, 2024

Milestone in Alzheimer's Treatment

Repurposed Drug TOP-RPBE001 Reveals BBB Cross-Affinity in Animals.

Introduction

Alzheimer’s disease (AD) presents one of the most formidable challenges in modern medicine, with its complexity and resistance to conventional treatments. Traditional drug discovery methods, often hindered by high costs and extended development timelines, have struggled to keep pace with the…

September, 2024

Discover Our Advanced Model for Alzheimer’s Detection

Introduction

At Topia Life Sciences, we are excited to share our latest advancement in Alzheimer’s Disease (AD). Our new model leverages state-of-the-art deep learning techniques to offer precise segmentation and volumetric analysis of the hippocampus from brain MRI scans. This innovation is designed…

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WORKING HERE

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· 1710 East Franklin Street #1137, Chapel Hill, NC 27514

· info@topialifesciences.com

· (880) 230 750 009

Pharma Intelligence (PI Solutions)

Project Number

Project Name

Description

TOP-PI-202301

PMS ++

Planning and tracking of drug development across entire life cycle with AI enabled smart features with intuitive interface, best practices, techniques, and methodologies that automate and optimize critical path analysis, multiple scenarios, budgeting, reporting, and forecasting

TOP-PI-202302

QMS ++

Quality management system with AI enabled smart features and intuitive interface that automate and optimize interface, engagement, process, CAPA, change control, electronic training and document management.

TOP-PI-202303

PV ++

a comprehensive pharmacovigilance platform which enables pharmaceutical manufacturers to make faster and better safety decisions, optimize global compliance and easily integrate risk management.

TOP-PI-202304

RA ++

Effectively managing documents, data and processes in compliance with varying regulatory standards around the world is complex and time-consuming.

TOP-PI-202305

eCTD ++

web-based dossier creation, management, and publishing tool designed to meet the ICH eCTD standard while also allowing for best practice processes to be employed. deep understanding of the requirements for meeting and maintaining compliance with FDA 21 CFR Part 11 and other international standards.

TOP-PI-202306

AI ECG APP & Portal

A platform where users can access real time ECG data generated by the ECG patch.

Drug Discovery

Compound Name

Mechanism of action Target

Indication

Phase of Discovery

TOP-VAE1

AKT

AML

Synthesis

TOP-BL1

AKT

AML

Lead identification

TOP-BL2

AKT

AML

Lead identification

TOP-Alz1

Beta secretase

Alzheimer’s Disease

Lead optimization

TOP-Alz2

Beta secretase

Alzheimer’s Disease

Lead optimization

Hit-Lib1

AKT (35)

AML

Hit identification

Hit-Lib2

Beta secretase (12)

Alzheimer’s disease

Hit identification

Hit-Lib3

EGFR (>40)

Colorectal cancer

Hit identification

Pharma Intelligence (PI Solutions)

Software designed by Life Science development people for Life Science development.

Our cloud-based and Artificial Intelligence powered pharma intelligence platform provides insights and strategic guidance to life science companies looking to navigate the complex landscape of the industry with efficiency and demonstrative compliance. By leveraging advanced data analytics and industry expertise, we provide our clients with the information and tools they need to make informed decisions and stay ahead of the competition. Our differentiators versus existing software are outlined below.

Our products are Annex 11 and CFR Part 11 compliant and designed to follow life science life cycle management workflows and processes.
Monitoring and compliance are automated and mapped to audit ready workflows and processes.
Pre-populated actions enable intuitive adoption and greater efficiencies and controls.
Resource allocation and forecasting is optimized through predefined change controls on actions/timelines so assignment of tasks can be according to individual employee available capacity and utilization targets.
Employee training is automatically tracked to enable mapping of assigned tasks to individual capabilities.

Blank

PMS ++

Documentation filing and management (e.g., Trial Master Files) are integrated into the Project
Management System
Creation, review, and approval of documentations are embedded into the PMS.
Protocol design is integrated into the PMS.
Critical path optimization through automation of task completion both sequential and parallel
Documentation can be collected through scanning by mobile phone in addition to scanners.
Budgets are embedded in PMS to enable controls versus actuals with reporting out on realization
versus target.
Dashboards at multiple levels (activity, project, department) to enable visibility on performance to all
stakeholders internal and external.
Design is intuitive even for new staff in terms of workflow, tracking of changes, and impact.
Substantial reduction in the use of emails and ease of budget reconciliation

QMS ++

Effectiveness checks are automated within the system to track and assess whether CAPAs were
effective; historical analysis and recommendations based on specific deviations.

PV ++

US/EU regulatory interface developed with AI algorithm with data from the public domain, thereby
automating and substantially reducing the literature searching and inputting time.
This enables employees to focus on create/review/approve functions.

RA ++

FDA/EMA/MHRA documentation and data flow aligns with development activities.
Standard sections are auto filled and loaded from the PMS; variable sections can be programmed by
the user.
The dossier compilation is automated to enable expedient publication.

Mr Shriram Baheti

Mr Shriram Baheti is a master’s in analytical chemistry. Mr Baheti brings 11 years of expertise in analysing small molecules.

He has earlier worked with well-known pharmaceutical industries in the analytical department. He is an expert in handling the instruments like HPLC, UPLC, UPHPLC, LCMS and IR. He has previously worked with the analysis of new chemical entities (NCE). He is well-versed in the planning and execution of analytical activities, including operation, calibration, troubleshooting and safety-related operations.

Rushang Patel

Rushang has a proven track record over the past 9 Years in the pharmaceutical Industry where he gained experience in manufacturing, Admin, HR and Finance.

Rushang holds a university degree in Civil Engineering from Gujarat Technological University.

Dr Hitesh Sharma

Dr Hitesh Sharma is an experienced synthetic chemist with more than 26 years of experience in research and development, product and process development, yield optimisation and impurity profiling.

Dr Sharma holds a doctorate in synthetic organic chemistry. In his earlier role, Dr Sharma has worked as department head, principal scientist and Sr Manager at different pharmaceutical firms. He holds keen expertise in API process development and Scale-up. At Topia, he is currently leading a team of synthetic chemists.

Sunny Bhatia

SMD, MMM, FACHE, FACC, FSCAI | Chief Executive Officer, Region I | Corporate Chief Medical Officer, Prime Healthcare

Sunny Bhatia, MD is the CEO of Prime Healthcare's Region I and the Corporate Chief Medical Officer for Prime Healthcare. Region I includes Prime Healthcare's 17 hospitals located in California and Nevada. Dr. Bhatia also serves as the Chief Medical Officer at Sherman Oaks Hospital and Encino Hospital Medical Center, two of Prime Healthcare's acute care located in Los Angeles County. Under Dr. Bhatia's leadership, Sherman Oaks has been recognized multiple times as a "100 Top Hospital" in the nation by IBM Watson Health. Sherman Oaks and Encino Hospitals, combined, have received numerous clinical awards and five-star achievements from Healthgrades, including the Healthgrades Patient Safety Excellence Award™ for both facilities.

Dr. Bhatia is an interventional cardiologist quadruple board-certified in Internal Medicine, Cardiovascular Disease, Nuclear Cardiology, and Interventional Cardiology. He is a Fellow of the American College of Cardiology as well as the Society for Cardiac Angiography and Interventions. Dr. Bhatia is also a Fellow of the American College of Healthcare Executives. He has authored numerous publications and presented his research at national and international conferences. Dr. Bhatia is also involved in charitable causes including the World Children's Initiative and the Uganda Heart Project, which provides cardiac care for children with congenital heart disease. Additionally, Dr. Bhatia established the Bhatia Family Scholarship for Future Community-Based Physicians at his alma mater, the University of Minnesota Medical School.

Dr. Bhatia has been recognized by Becker's Hospital Review as among the "100 CMOs to Know" for several years. In addition, he received recognition as the 2019 Healthcare Innovator of the Year by The Millennium Alliance and as a "Top Doctor" in the LA Business Journal for multiple years. Dr. Bhatia has also led Prime Healthcare through the COVID-19 pandemic as Chair of the National COVID-19 Committee and COVID 24/7 Command Center.

Dr. Bhatia received his bachelor's degree from the University of Pennsylvania. He obtained his medical degree from the University of Minnesota Medical School and completed an Internal Medicine Residency at the Mayo Clinic in Rochester, Minnesota where he received the Internal Medicine Outstanding Achievement Award. After completing a Cardiology fellowship at the University of Southern California, Dr. Bhatia pursued further specialty training in Interventional Cardiology. Dr. Bhatia also earned a Master of Medical Management from the USC Marshall School of Business, holds a Certificate in Healthcare Strategy from Harvard Business School, and serves as Associate Professor of Medical Education at the California University of Science and Medicine, School of Medicine.

Sandeep Sharma

Sandeep Sharma is an IT professional with expertise in software development, from the feasibility study to the implementation stage.

He possesses strong interpersonal skills and is competent in client interaction and requirement analysis. Mr. Sharma's technical skills include proficiency in DOT NET, ASP.NET, ASP.NET MVC, EF6, ADO.NET & LINQ Query, VB6, MySQL, Oracle, SQL Server, and MS-Access. He is also familiar with third-party tools like Dev Express and Telerik Control, as well as scripting languages such as VBScript and JavaScript and markup languages like HTML, CSS, and XML. Sandeep holds a Master's degree in Computer Applications from Sikkim Manipal University and completed his Bachelor's in Computer Science from Gujarat University. He has extensive experience in software and ERP projects, as well as client-server development in diverse fields. His strong technical skills and ability to analyze requirements make him a valuable professional in the IT industry.

Debanjan Parbat

Debanjan Parbat is an experienced researcher in the higher education industry with a focus on exploring IoT and AI in healthcare technology.

With expertise in Python, Sensors, and Bluetooth low energy as well as familiarity with various software like MATLAB, Origin, and Microsoft Office, Mr. Parbat is skilled in the development of wearable medical devices. Currently pursuing a Ph.D. in Biomedical Instrumentation, he is specializing in Nonlinear Time Series Analysis techniques on Cognitive Neuro-dynamics, Cardiovascular dynamics, and Muscle control dynamics for applications in medical device and computer-aided diagnosis using AI and ML. Mr. Parbat has worked at Jadavpur University as a Senior Research Fellow for five years, where he contributed to various research projects related to medical technology. Debanjan has more than 10 research paper publications in international peer reviewed journals and conferences and strong research experience in the field of Medical Devices and Biomedical Signal Processing with extended focus on Artificial Intelligence and Internet of Things. Debajan is a Professional Member of IEEE Engineering in Medicine and Biology Society. Mr. Parbat's knowledge of IoT and AI in medical technology makes him a valuable contributor to the industry.

Dr. Pushpendra Singh Sisodia

Dr. Pushpendra Singh Sisodia is the program leader for Topia Life Sciences’ Drug Discovery platform.

Dr. Pushpendra holds a Ph.D. in Computer Science Engineering, specializing in the applications of Artificial Intelligence in healthcare. With over 16 years of professional experience across industry, academia, and research, he demonstrates expertise in applying Artificial Intelligence algorithms within the multidisciplinary realm of healthcare. Dr. Pushpendra boasts sixteen publications in reputable SCI Q1/Q2/Q3 and Scopus-indexed international journals and conference proceedings. In 2022, he served as a mentor for undergraduate students in the Smart India Hackathon-2022, earning the first prize from the Government of India. Additionally, Dr. Pushpendra guided another undergraduate students' team in the Azadi Ka Amrit Mahotsav Hackathon-2022 organized by SSIP, Government of Gujarat, securing the first prize from the Government of India. Previously, Dr. Pushpendra held the position of Associate Professor in the Computer Engineering Department at Indus University.

Dr. Hardik Bhatt

Dr. Hardik Bhatt is a skilled and committed professional with a wealth of experience in the pharmaceutical industry.

With a strong background in drug product life cycle management, Dr. Bhatt has expertise in various areas such as drug discovery, pre-clinical and clinical trials, medical and regulatory writing, risk management, and pharmacovigilance. Dr. Bhatt's technical skills include using Artificial Intelligence-based models for toxicity prediction, pharmacodynamics, and ADME, as well as analyzing complex data to improve pharmacovigilance and clinical trials' efficiency. Demonstrating strong work ethics, Dr. Bhatt is committed to achieving successful outcomes every time. Skilled in regulatory strategy development, Dr. Bhatt has worked in pharmaceuticals specialized in Oncology, Diabetes, Immunology, Respiratory, and other crucial disease management. Dr. Bhatt's delivery of regulatory compliance, regulatory strategy development, and risk-mitigation strategies to maximize drug efficiency and minimizing the toxicities makes him an expert in the pharmaceutical domain.

Akshay Sojitra

Akshay Sojitra is a highly experienced professional with over 18 years of experience working in the technology sector in the UK, USA, and India.

Akshay has a degree in Computer Science Engineering from Sardar Patel University and a PG Diploma in Computer Science from the London College of Business Management & Computing. Mr. Sojitra’s certifications include Oracle 11g database administration, Oracle 10g Real Application Clusters Administrator, and Red Hat Linux 6 Certified Engineer. His extensive technical expertise includes proficiency in numerous operating systems and databases as well as programming languages such as C, C++, Java, and Python. Akshay also has experience and knowledge in AI, Data Science, and Machine Learning libraries and algorithms. With exceptional skills, Mr. Sojitra is well-equipped to manage complex projects, and has contributed to Topia’s technology-driven and competitive organization. Akshay has a strong academic background and vast experience in various areas of technology.

Mary Gunn

PhD, MBA, LLM, CEO and Co-Founder - Topia Life Sciences; Chair of the Board of Advisors.

Mary is a global board leader with 30 years of public and private governance experience in high growth life science, financial services, and education sectors; during which she provided fiduciary and strategic oversight, identified areas of growth (including organic international expansion, licensing agreements, co- development with strategic partners, global M&A), supported fundraising, worked with activists, led successful exits, leveraged debt and other financial instruments, ensured compliance and ethics, and hired/evaluated the CEO/CCO/CMO. Gunn has been an advisor and partner to publicly traded diversified funds, private equity, venture capital, sovereign wealth, and family offices for 15 years supporting the deployment of $20B+ across 150 investments. She also served on the advisory board of Brown University, Neurogensis Life Science, Modelis, Lumiio, and as the Chairman for SpotArt Foundation (Cultural Diplomacy). Gunn currently serves on the Board of Directors of Edinburgh Worldwide Investment Trust, Burst Therapeutics, Welwaze Medical, the University of Edinburgh, as a Senior Advisor for Hillhouse Capital, and as a US National Security Fellow at NWC. Gunn’s background is that of a scientist, lawyer, and global CEO with 27 years of leadership, ranging from startups to Fortune 100 in private and public companies (Pfizer, Becton Dickonson, Crucell/J&J, Health Decisions, and ICON Plc), operationally overseeing up to 75 countries, 4200 employees, and a $2.4 Billion portfolio. She has a network of more than 54,000 contacts in life science, completed 11 corporate M&A transactions, and helped develop a biologic human cell line from which several mAbs and vaccines derive. Dr. Gunn is passionate about market access to innovation and started a MedTech trade association (APACMed) in Asia. Gunn is a value creation/turnaround/transact and commercialization expert and serves as an industrial advisor for private equity, supporting the full investment cycle from deal sourcing, due diligence, board representation, managing external consultant engagements, post M&A activity, interim management, deal execution, to liquidity events. She is an author (10X10 Women’s Health) and renowned speaker for news organizations and conferences such as BBC World News and the Financial Times. Dr. Gunn has contributed to the development of many lifesaving medicines, biologics, diagnostics, and medical devices in oncology, neurology, vaccines, women’s health, and other therapeutic areas. Her global business expertise includes leading international expansion while based out of Europe (UK, Austria, Germany, Switzerland), Asia (China, Singapore), and the USA. She has served on the executive leadership, governance, enterprise risk management, strategic planning, and tax committees as well as country legal representative. Prior to healthcare, Gunn worked for US Senator Jeff Bingaman, as a journalist for the Albuquerque Journal, and in conservation for the Smithsonian Institute. Gunn was an Eve and Simon Colin Foundation Scholar, a US President’s Scholar, and a NM Regent Board Scholar.

Dr. Smith

Active clinical cardiologist and clinical researcher.

At UNC, he performs invasive cardiology procedures to assist with the management of a broad variety of cardiovascular problems, including coronary heart disease and valvular heart disease. He is also an attending physician for cardiac rehabilitation. He is a world-recognized expert on developing national and international guidelines for assessment of cardiovascular risk and for treatment of cardiovascular disorders including hypertension, cholesterol abnormalities, and acute coronary syndromes. He has been honored numerous times for his important contributions to addressing the impact of cardiovascular disease.

Dr Smith is a past president of the American Heart Association (AHA) and the World Heart Federation (WHF). He has served as a Senior Advisor and Chair of the Executive Committee for the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health’s(NIH) Integrated Guidelines for the prevention of cardiovascular disease. He and has also served as the Chief Science Officer for the AHA. He chaired the ACC/AHA Task Force on Practice Guidelines, the ACC/AHA committee to revise PCI guidelines, the AHA/ACC Guidelines on Secondary Prevention for patients with atherosclerotic vascular disease and served on the ACC/AHA guideline committees for the management of acute myocardial infarction (STEMI), Blood Cholesterol, Risk Prediction, Lifestyle and Hypertension. Dr. Smith was Co-Chair of the ACC/AHA Bethesda Conference on Professionalism and Ethics.

Dr. Smith’s many awards include the AHA’s Physician of the Year Award, Distinguished National Leadership Award, Gold Heart Award, Eugene Drake Award, Joseph Stokes Award in Preventive Cardiology, Council of Clinical Cardiology Distinguished Achievement Award, Chairman’s Award, the James Herrick Distinguished Clinician Award, and the Ron Haddock International Impact Award as well as the Brazilian Cardiology Society International Teaching Award. Dr. Smith was also the recipient of the NHLBI/NIH Award of Special Recognition.

World Heart Federation presented Dr. Smith with the WHF Lifetime Achievement Award for his remarkable contribution to the mission of the World Heart Federation and the entire CVD community over the entirety of his illustrious career.

Dr. Smith has authored or co-authored close to 500 publications and has served on the editorial boards for the Journal of Cardiovascular Medicine, Journal of Clinical and Experimental Cardiology, Journal of the American College of Cardiology, Circulation and JAMA Cardiology. In 2017 he was noted on Thomson Reuters list of Highly Cited Researchers, which recognizes the top 1 percent of researchers in their field. He has spoken about heart disease and stroke in interviews with CNN, CBS, and NBC, and is quoted widely by multiple national and international media.

Each year since 1998, Dr. Smith has been elected to Best Doctors in America.

G Stephen DeCherney

MD, MPH. Professor of Medicine - Endocrinology/Metabolism – UNC

Stephen is board certified in Internal Medicine and Endocrinology, Diabetes, and Metabolism and was named one of the Best Doctors in America. Dr. DeCherney is also the Co-Founder & Chairman of Helios Clinical, a company that provides its biopharmaceutical partners high quality research and data. Earlier in his career, Stephen was the CEO& a board member of Health Decisions, Inc., a full service CRO specializing in clinical studies of therapeutics for women’s health. He also served as President, Global CRO at Quintiles Transnational Corporation and was an Independent Director of Theorem Clinical Research Company. Currently, Stephen serves on the Board of KNOW Bio, a subsidiary of Novan that develops and produces nitric oxide-based therapies, and the Board of Directors of Robert F. Kennedy Human Rights. He also serves as a Trustee of the University of Delaware Research Foundation and the Christiana Care Health System, and he is and he is a US Representative for the William Harvey Research Foundation, Queen Mary University, London. Previously, Stephen was a Board Member of Symyx Corporation, also serving on their Audit Committee. He was a senior advisor to the London Genetics Company, Member of the Farmer Food Share Board of Trustees and Chairman of their Finance Subcommittee. DeCherney received a B.A. in Biology from Columbia College. He was awarded the Columbia College Alumni Achievement Award granted to the “Senior Adjudged Most Outstanding in Qualities of Mind, Character, and Service to the College.” He received his medical degree from Temple University in Philadelphia and completed his internal medicine residency at the Graduate Hospital of the University of Pennsylvania. DeCherney received his endocrinology training at Vanderbilt University and a master’s in public health from Columbia.

Ben Yerxa

CEO at Opus Genetics

Dr. Yerxa has more than 30 years of pharmaceutical/biotechnology and nonprofit leadership, including experience in the ophthalmology, pulmonary, rare disease, cardiovascular and HIV fields from drug discovery through product launches. He has been involved with the discovery and development of nine INDs, four Phase 3 clinical programs, two NDAs and two drug approvals. He spent 10 years as a corporate officer reporting to the CEO of a top 50 public biotech company (Inspire) from IPO through multiple follow-on financings raising over $350M. He is an entrepreneur with more than 50 issued US patents and was involved with the creation of the ophthalmic commercial infrastructure and the launch of ELESTAT and AZASITE. He has led both in- and out-licensing deals as well as university technology transfer and manufacturing agreements. In addition to supervising drug discovery, clinical, preclinical, regulatory, drug safety and biostatistics functions, he has also supervised business development, manufacturing, and technical operations groups. He has built several R&D and corporate functions from inception and served on many joint committees with corporate partners. He has more than 10 years of experience in working with Japanese pharmaceutical and manufacturing companies. As CEO of Foundation Fighting Blindness, he championed and launched the Retinal Degeneration Fund, a strategic venture philanthropy vehicle for making mission-related investments.

In 2004, Dr. Yerxa received the Southeastern Region American Chemical Society Industrial Innovation Award for discoveries related to his work with P2Y2 receptors. Dr. Yerxa received the Triangle Business Journal's "40 under 40" award, recognizing his contributions in business and leadership. He was also a finalist for Ernst & Young's Entrepreneur of the Year award (NC) in 2003.

Dr. Yerxa serves on the Board of Directors of Opus Genetics, Clearside Biomedical, the North Carolina Biotechnology Center, Nacuity Pharmaceuticals and Sharefish.

Ruth Wexler

Scientific and Drug Discovery Advisory Board member, Former Scientific VP, Small Molecule Drug Discovery at Bristol Myers Squibb

Accomplished pharmaceutical R&D executive with a passion for discovering transformational small molecule therapeutics to help patients address unmet medical need. Currently serving as a R&D executive scientific advisor/drug discovery consultant. Significant experience leading medicinal chemistry teams and setting research strategies across a broad range of therapeutic areas, and target classes spanning, cardiovascular, neuroscience, fibrosis, metabolic and immunology drug discovery. Track record of successfully building and leading high achieving discovery teams that advanced 38 clinical candidates, including two marketed drugs for the treatment of cardiovascular disease; losartan, to treat hypertension, and Eliquis® (apixaban), a novel oral anticoagulant. Recognized as a highly collaborative scientific leader, passionate about mentoring, and developing next generation leaders and scientists with a strong commitment to diversity and inclusion. Broad experience in leading multifunctional diverse and global teams both internally, and externally with academic and biotech partners. Innovation and productivity documented by numerous awards, invited lectureships, and >250 manuscripts and patents.

Specialties: Cardiovascular Drug Discovery | Leadership and Mentoring | Medicinal Chemistry | Additional leadership experience in Metabolic Diseases, Neuroscience, Fibrosis, and Immunology | In-licensing and Alliance Partnerships.

Drug Discovery

Specification

Competitor Drug Discovery AI

Topia

Drug design techniques

Structure based.

Combining Structure Based and Ligand Based.

Business model

Repurposing failed drugs from the clinical trials and generating novel molecules around existing molecules.

Focusing on the novel molecules for different targets.

Clinical trials

7 years

2-3 years*

Toxicity analysis

No information available.

Building toxicity prediction

MedTech

Product

Current Solutions

Topia

Competitor 1 ECG skin patch

Disposable single lead patches

Reusable 4 electrode 3 lead ECG patch.

Competitor 2 Bluetooth/Wi-Fi & inbuilt memory

Bluetooth only

Bluetooth with smartphone or Wi-Fi without smartphone or simply on device recording and alert mechanism.

Competitor 3 Cross platform Mobile and Desktop App

Data Visualization only in smartphone

Data Visualization in smartphone or PC/Laptop/Tablet.

Competitor 4 AI ECG model

Arrhythmia detection based on HRV and QRS detection

Arrhythmia detection and sudden cardiac arrest detection based on 3 to 6 leads of long-term or short-term ECG data with Nonlinear Dynamical systems-based analysis.