1) Ocata Therapeutics presented a corporate presentation on their RPE cell therapy for macular degeneration.
2) Their phase 1/2 clinical trials showed signs of safety and efficacy, with anatomical and functional evidence of repair. Some patients showed visual acuity gains after over 3 years.
3) They are initiating pivotal trials for Stargardt's Macular Degeneration and a phase 2 trial for dry AMD to further evaluate the safety and efficacy of their RPE transplantation therapy.
Anterior Segment Company Showcase - IvantisHealthegy
Anterior Segment Company Showcase - Ivantis at OIS@AAO 2016.
Presenter:
Dave Van Meter, President & CEO
Powered by:
Healthegy
For more ophthalmology innovation
Visit us at www.ois.net
Ophthalmic Innovation 2016 - "A View From The AAO"Healthegy
Ophthalmic Innovation 2016 - "A View From The AAO"
Presenter:
David Parke, II, MD, CEO
Powered by:
Healthegy
For more ophthalmology innovation
Visit us at www.ois.net
Anterior Segment Company Showcase - Mynosys Cellular DevicesHealthegy
Anterior Segment Company Showcase - Mynosys Cellular Devices at OIS@AAO 2016.
Presenter:
John Hendrick, President & CEO
Powered by:
Healthegy
For more ophthalmology innovation
Visit us at www.ois.net
earSight Innovations is developing new technologies that allow accurate measurement of the eye with the ability to move cataract surgery outcomes to a new level. Cataract surgery is the most commonly performed surgery in the world with over 20 million surgeries conducted annually.
Conferencia: "Superando la brecha entre Investigación y Aplicación", a cargo del Dr. Ander Ramos, investigador de TECNALIA.
TECNALIA Perspectives 2015. “Industria y Tecnología: Investigación traslacional, de la ciencia al mercado” es el título del evento que contó con la participación del Dr. Niels Birbaumer, experto mundial en el desarrollo de interfaces cerebro-computador y del investigador Dr. Ander Ramos, Premio al Mejor Investigador Joven de Alemania en 2014 por la Academia Alemana para las Ciencias y las Letras.
También presentamos dos novedosas iniciativas de TECNALIA como son un dispositivo de estimulación eléctrica funcional para rehabilitación de pacientes de ictus y el robot quirúrgico con visión 3D y sensaciones táctiles.
Más información en http://www.tecnalia.com
SciSparc is a specialty pharmaceutical company developing unique cannabinoid technologies for treatment of central nervous system disorders. The proprietary compounds capitalize on the biochemistry of receptors that specialize in modulating the central nervous system (CNS) to create therapeutics that mitigate the adverse symptoms associated with CNS disorders.
Presentation from OIS@ASCRS 2016
Mark Packer, MD, Chief Medical Officer
Video Presentation:
https://www.youtube.com/watch?v=CWwqmEDJOhM&index=20&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw
Second Sight Medical Products, a recognized global leader in neuromodulation devices for blindness, announced a definitive agreement on February 7, 2022, under which privately held Nano Precision Medical (NPM) will merge with a wholly owned subsidiary of Second Sight in an all-stock transaction. NPM will be the surviving company and owned by Second Sight. The resulting company will focus on development of innovative drug and device medical implants that treat chronic diseases with high unmet medical need.
Presentation from OIS@ASCRS 2016
Mike Judy, CEO
Video of Presentation:
https://www.youtube.com/watch?v=G5ZfnPKlBSY&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw&index=13
Anterior Segment Company Showcase - IvantisHealthegy
Anterior Segment Company Showcase - Ivantis at OIS@AAO 2016.
Presenter:
Dave Van Meter, President & CEO
Powered by:
Healthegy
For more ophthalmology innovation
Visit us at www.ois.net
Ophthalmic Innovation 2016 - "A View From The AAO"Healthegy
Ophthalmic Innovation 2016 - "A View From The AAO"
Presenter:
David Parke, II, MD, CEO
Powered by:
Healthegy
For more ophthalmology innovation
Visit us at www.ois.net
Anterior Segment Company Showcase - Mynosys Cellular DevicesHealthegy
Anterior Segment Company Showcase - Mynosys Cellular Devices at OIS@AAO 2016.
Presenter:
John Hendrick, President & CEO
Powered by:
Healthegy
For more ophthalmology innovation
Visit us at www.ois.net
earSight Innovations is developing new technologies that allow accurate measurement of the eye with the ability to move cataract surgery outcomes to a new level. Cataract surgery is the most commonly performed surgery in the world with over 20 million surgeries conducted annually.
Conferencia: "Superando la brecha entre Investigación y Aplicación", a cargo del Dr. Ander Ramos, investigador de TECNALIA.
TECNALIA Perspectives 2015. “Industria y Tecnología: Investigación traslacional, de la ciencia al mercado” es el título del evento que contó con la participación del Dr. Niels Birbaumer, experto mundial en el desarrollo de interfaces cerebro-computador y del investigador Dr. Ander Ramos, Premio al Mejor Investigador Joven de Alemania en 2014 por la Academia Alemana para las Ciencias y las Letras.
También presentamos dos novedosas iniciativas de TECNALIA como son un dispositivo de estimulación eléctrica funcional para rehabilitación de pacientes de ictus y el robot quirúrgico con visión 3D y sensaciones táctiles.
Más información en http://www.tecnalia.com
SciSparc is a specialty pharmaceutical company developing unique cannabinoid technologies for treatment of central nervous system disorders. The proprietary compounds capitalize on the biochemistry of receptors that specialize in modulating the central nervous system (CNS) to create therapeutics that mitigate the adverse symptoms associated with CNS disorders.
Presentation from OIS@ASCRS 2016
Mark Packer, MD, Chief Medical Officer
Video Presentation:
https://www.youtube.com/watch?v=CWwqmEDJOhM&index=20&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw
Second Sight Medical Products, a recognized global leader in neuromodulation devices for blindness, announced a definitive agreement on February 7, 2022, under which privately held Nano Precision Medical (NPM) will merge with a wholly owned subsidiary of Second Sight in an all-stock transaction. NPM will be the surviving company and owned by Second Sight. The resulting company will focus on development of innovative drug and device medical implants that treat chronic diseases with high unmet medical need.
Presentation from OIS@ASCRS 2016
Mike Judy, CEO
Video of Presentation:
https://www.youtube.com/watch?v=G5ZfnPKlBSY&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw&index=13
2014 MFDS Global Biopharmaceutical Forum: "Clinical and Preclinical Researches in Human Pluripotent Stem Cells"
Human ES Cell Product – RPE Program for Blindness
(CHA & ACT-Ocata)
2014 MFDS Meeting - 2014. 7. 9~10.
Hyung Min Chung
Konkuk University, College of Medicine, Seoul, Korea
What are stem cells? This presentation provides an overview of multiple different stem cells including embryonic stem cells, mesenchymal stem cells, cancer stem cells, induced pluripotent stem cells, hematopoietic stem cells and neural stem cells.
Public Device & Biopharma Ophthalmology Company Showcase - QLTHealthegy
Public Device & Biopharma Ophthalmology Company Showcase - QLT at OIS@AAO 2016.
Presenter:
David Saperstein, MD, Chief Medical Advisor
Powered by:
Healthegy
For more ophthalmology innovation
Visit us at www.ois.net
$ATHX @athersys Corporate Overview - Investor Presentation (dated 08-10-18 / 32 slides) - http://www.athersys.com/static-files/df957fcc-48c5-46aa-8ae4-c254e18e05ee As found by "imz72", with growing, insightful shareholder's comments at reddit - https://redd.it/98b693 #MultiStem #Stroke Company Website -http://www.athersys.com/ As posted at Twitter - https://twitter.com/twenty2John/status/1030883310082318337
9/11/2017 Revised Bocce Courts 4 HB (Huntington Beach). This report, given in book form, to each of the seven members of the HB City Council (including, Mayor), and two copies to David Dominguez - Facilities, Development & Concessions Manager (HB).
Special Note: All links should be CLICKABLE (Tap link twice), EXCEPT links on first (3) pages. Links, on first (3) pages of this report are not accessible.
Human embryonic stem cell-derived retinal pigment epithelium in patients with age-related macular degeneration and Stargardt's macular dystrophy: follow-up of two open-label phase 1/2 studies
Published Online: 15 October 2014
Including Comment By, Anthony Atala
Q2 2015 ARM - Alliance for Regenerative Medicine
Quarterly Data Report: Q2 2015 provides an in-depth look at regenerative medicine and advanced therapies sector trends and metrics compiled from more than 580 leading therapeutic companies worldwide.
Part 2 Of 2 Comment/Reply on ACT/Ocata Lancet Report (Oct. 2014)
Reply by, *Steven D Schwartz, Eddy Anglade, Robert Lanza, on behalf of the Ocata
Macular Disease Investigator Group
schwartz@jsei.ucla.edu
Jules Stein Eye Institute Retina Division, and David
Geffen School of Medicine, University of California,
Los Angeles, CA 90095, USA (SDS); and Ocata
Therapeutics Inc, Marlborough, MA, USA (EA, RL)
Source Material: http://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(15)61203-X.pdf
March 23, 2015 Sheraton Silver Spring Hotel - Silver Spring, Maryland USA
Bioassays 2015: Scientific Approaches & Regulatory Strategies
Bioassay Development for Human Stem Cell-derived Retinal Pigment Epithelium: Progress and Challenges
Irina Klimanskaya, Ocata Therapeutics, Inc., Marlborough, MA USA
BIOASSAYS 2015: SCIENTIFIC PROGRAM
March 23 - 24, 2015 at the Sheraton Hotel in Silver Spring, Maryland.
Irina Klimanskaya, Ocata Therapeutics, Inc., Marlborough, MA USA - Monday March 23, 2015 10:05 – 10:30 Bioassay Development for Human Stem Cell-derived Retinal Pigment Epithelium: Progress and Challenges
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
CDSCO and Phamacovigilance {Regulatory body in India}NEHA GUPTA
The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. Operating under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, the CDSCO is responsible for approving new drugs, conducting clinical trials, setting standards for drugs, controlling the quality of imported drugs, and coordinating the activities of State Drug Control Organizations by providing expert advice.
Pharmacovigilance, on the other hand, is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. The primary aim of pharmacovigilance is to ensure the safety and efficacy of medicines, thereby protecting public health.
In India, pharmacovigilance activities are monitored by the Pharmacovigilance Programme of India (PvPI), which works closely with CDSCO to collect, analyze, and act upon data regarding adverse drug reactions (ADRs). Together, they play a critical role in ensuring that the benefits of drugs outweigh their risks, maintaining high standards of patient safety, and promoting the rational use of medicines.
The Gram stain is a fundamental technique in microbiology used to classify bacteria based on their cell wall structure. It provides a quick and simple method to distinguish between Gram-positive and Gram-negative bacteria, which have different susceptibilities to antibiotics
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
2. Cautionary Statement Concerning Forward-Looking Statements
These slides and the accompanying oral presentation contain statements that are not historical facts and are
considered forward-looking information. In some cases you can identify these statements by forward-looking
words such as “anticipate,” “believe,” “could,” “continue,” “estimate,” “expect,” “intend,” “may,” “should,” “will”,
“would,” ”plan,” ”projected,” or the negative of such words or other similar words or phrases. Investors are
cautioned not to unduly rely on forward-looking statements because they involve risks and uncertainties and
statements related to future events or our future financial performance, and involve known and unknown
risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or
achievements to be materially different from any future results, levels of activity, performance or
achievements expressed or implied by these forward-looking statements. These statements are also subject to
a number of material risks and uncertainties that are described more fully in the prospectus and the
preliminary prospectus supplement filed with the SEC, including without limitation our most recently filed
Annual Report on Form 10-K, as amended, and our most recently filed Quarterly Report on Form 10-Q, as
filed with the SEC. These forward-looking statements speak only as of the date on which the statements were
made and are not guarantees of future performance. Except as may be required by applicable law, we do note
undertake or indent to update any forward-looking statements contained herein or in our public filings with
the SEC.
2
3. Addressing Macular Degeneration with Groundbreaking RPE Therapy
The Regenerative Ophthalmology™ Company
3
Safety observed, in addition
to anatomical and functional
evidence of repair and
restoration in Phase 1 studies
for dry AMD and SMD
• Data published in The Lancet,
October 14, 2014
• Data in Asian patients published
in Stem Cells, April 30, 2015
Initiating Pivotal and Phase 2
studies:
• Stargardt’s Macular
Degeneration (SMD) – Pivotal
- Q3 2015
• Dry Age-related Macular
Degeneration (AMD) – Phase 2
- Q3 2015
Addressing Macular
Degeneration with two
product candidates:
• An orphan indication in
SMD, followed by a
• Larger market potential in
AMD, based on patient
populations in the US and
EU
• ATMP status in Europe
Organ Transplantation is Well-Established, Our RPE Products are Simple Micro Transplants of
Support Cells required for Functioning Infrastructure at the Back of the Eye
4. Recent Milestones Demonstrate Continued Execution Against Plan
Milestone Significance
• Completion of P1/2 studies at highest dose (200k cells)
• SMD pivotal trial protocol agreed with EMA
• Up-listing of company stock to NASDAQ
• Publication of data in Asian patients (SMD & AMD)
• Expanded technology to include IPSCs via Allele Deal
• Three US patents issued covering RPE Program
Positive safety signals in 44 patients, some with >3 years of post-transplant follow up
Confidence in commercial timing (2019), if pivotal trial results are positive
Increased liquidity, index funds and broader investor audience
Supportive of US/UK trials, independently managed trial
Bolsters pre-clinical pipeline and diversifies platform
Potential to block all current competitors
4
Milestones in 1H 2015 Position Company for Success in Next 12 – 18 Months…
5. Future Milestones to Bolster Position as
The Leading Regenerative Ophthalmology Company
Year Period Goal
2015
Q3
• Dry AMD Phase 2 Study: First subject enrolled
• Special Protocol Assessment meeting with FDA
• SMD Pivotal Study: First subject enrolled
• Further strengthening of IP portfolio
Q4
• Publication of data on pre-clinical photoreceptor studies
• Partnership of non-core asset (e.g. platelet program)
2016
Q2 • Dry AMD P2 Study: First Cohort with 3 month data
Q3
• Dry AMD P2 Study: Second Cohort with 3 month data
• Partnership of core program in ex-US region (e.g. Asia, South America)
5
As Milestones are Achieved, Ocata will Continue to Broaden Market Awareness
6. RPE Damage and Subsequent Photoreceptor Degeneration Leads
to Loss of Central Visual Acuity
6
7. The First Evidence of Long-term Safety and Efficacy Signal Following
Transplantation of RPE Cells – October 2014
7
“What we did is transplant the cells into patients
who have a disease where those particular cells are
dying; and we replaced those dying tissues with
new tissue that's derived from these stem cells. In a
way it's a retinal transplant.
- Steven Schwartz, eye specialist, UCLA
8. Further Evidence of Long-term Safety and Efficacy Signal in Asian Patients with
SMD and AMD – April 2015
Four Korean patients: two with dry AMD and two with SMD
Patients were followed for 1 year
– No evidence of adverse proliferation, tumorigenicity, ectopic tissue
formation, or other serious safety issues related to the transplanted cells.
– Visual acuity improved 9–19 letters in three patients and remained
stable (+1 letter) in one patient.
Total of 44 patients safely treated worldwide with RPE Therapy.
Independent trial in Asian population supports previously reported safety and efficacy signals
8
9. World Leaders in Terminal Differentiation of Pluripotent to Target Cells with
Proprietary DeltaCellTM Technology
9
Pluripotent
Stem Cells
Starting Source
Stem Cells are the Starting Material but Fully Differentiated Cells are the Treatment
hESC
iPSC
Corneal
Retinal Ganglion
Photoreceptor
Retinal Pigment Epithelium
Terminally
Differentiated
Cells For
Transplantation
10. 1
2
3 4
10
Addressing a Spectrum of Ocular Disorders with other Terminally Differentiated Cells
Photoreceptor Progenitor Cells
• Macular Degeneration -
dry AMD, SMD, MMD
• Retinitis Pigmentosa
Retinal Ganglion Progenitor Cells
• Glaucoma
Mesenchymal Stem Cells
• Uveitis
• Management of Ocular Surfaces
Corneal Endothelial Therapy
• Corneal Disease
1
2
3
4
Rich preclinical pipeline of Regenerative Ophthalmology product opportunities
each addressing large unmet medical needs
11. Ophthalmic Development Pipeline Includes SMD, Dry AMD and MMD
Pre-
clinical IND Phase 1 Phase 2
SMD
Dry AMD
MMD
Photoreceptors
Ganglion Cells
Cornea
Phase 2 Study
for Dry AMD,
Pivotal Trial for
SMD (Orphan)
Opportunity for
additional IND’s
Potential Commercial Launch for Stargardt’s Macular Degeneration in 2019
Multiple Opportunities for Product Development and Commercialization
11
12. Immune privileged
– Less prone to rejection
Compact Structure
– Relatively small doses required
to treat
Straightforward delivery using
currently available technology
Validated tools for clinical outcome
assessment
The Eye is Well-Suited for Cellular Transplantation
12
Patients in the Ocata Studies with more than Three Years Post Transplant
Experience, Continue to Show Positive Safety Signals with Visual Acuity Gains
13. Well-defined prescriber base
– Patients are referred to retinal specialists (~2,500 in the US of which ~1,500 - 2,000 are vitreoretinal
surgeons) who diagnose and manage subsequent patient care
– Market penetration could be achievable with a small salesforce; ~50 reps in the US
Ease of administration: cellular transplantation performed with current technology
– Utilizes pars plana vitrectomy (more than 300,000 procedures in the US already being completed, p.a.) and
subretinal injection (~90 seconds added to vitrectomy procedure) modalities scalable to surgeons
Small dosage requirement
– Commercial scalability of manufacturing and distribution in process
Significant unmet medical need – no approved treatments for dry AMD or SMD
– Approximately 1.8 million new dry-AMD patients diagnosed per year in the US
– Approximately 90,000 patients currently suffering from SMD in US and EU
SMD, Dry AMD and MMD are Specialized Opportunities
and Feasible for an Emerging Biotech
13
A Viable Standalone Plan Creates Leverage with Potential Partners
15. Required for vision and maintenance of
photoreceptor health
Delivers and metabolizes Vitamin A
– Recycles photopigments
Phagocytosis of photoreceptor outer segments
Transport of metabolic waste from retina to
choriocapillaris
Absorbs stray light for improved image resolution
Secretes growth and survival factors needed for
photoreceptor differentiation
Retinal Pigment Epithelium: Vital for Photoreceptor Health
15
Loss of RPE Layer Results in Loss of Vision
Ocata’s Therapeutic Approach is to Transplant New RPE Layer and Help Restore Vision
16. Normal Physiology, RPE in Intimate Contact with Photoreceptors and
Provide Vital Life Support
16
21. D. Black dashed circle outlining area of subretinal transplantation
E. Green rectangle overlying white dashed arrow demonstrating optical coherence tomographic section at
baseline and at 6 months following subretinal MA09-hRPE injection
F. White arrows demonstrating persistence of subretinal pigment epithelial cells 12 months post-
transplantation
Phase 1/2 Studies Presented Evidence of Engraftment;
Transplanted Cells Take Residence, as Intended
21
Baseline* Month 6*
Anatomic Evidence of Successful Engraftment Illustrates that Transplant is
Rebuilding the Support Structure in the Back of the Eye
22. Interim Data for AMD and SMD Lancet Study Showed that BCVA Improved
and was Sustained Over the Long-Term
22
Efficacy Signal and Safety Persists in Treated Eyes
Lancet publication: May 2014
Dry AMD
0.0
5.8
7.8
9.0
9.8
0.0
5.4 5.2
4.2 4.6
-5.0
0.0
5.0
10.0
15.0
20.0
0 31 60 91 121 152 182 213 244 274 305 335
MeanChangefromBaselineinBCVA(letters)
Days After Transplant
5 Subjects with 12 Months Follow-up
Treated Eye Untreated Eye
Lancet publication: May 2014
SMD
0.0
16.1 15.6
14.3
12.4 12.0
0.0
7.3 7.3
1.8
2.6
0.6
-5.0
0.0
5.0
10.0
15.0
20.0
0 31 60 91 121 152 182 213 244 274 305 335
MeanChangefromBaselineinBCVA(letters)
Days After Transplant
8 Subjects with 12 Months Follow-up
Treated Eye Untreated Eye
23. Available Interim Data for AMD Study Showed that BCVA Improved
and was Sustained Over Two Years
23
Efficacy Signal and Safety Persists in Treated Eyes for Two Years
Now Moving to Controlled Phase 2 Study
March 2015
Dry AMD Data
0.0
6.0
5.4
4.4 4.2
7.2
8.2
0.0
1.8
5.0
4.6
-1.0
-3.0
-1.0
-4.0
-2.0
0.0
2.0
4.0
6.0
8.0
10.0
0 60 121 182 244 305 366 425 486 547 609 670 731
MeanChange(+/-SEM)inBCCVA(letters)
Days After Transplant
5 Subjects with 24 Month Follow-Up
Treated Eye Untreated Eye
25. Objectives
– Pivotal Controlled Trial to demonstrate safety and efficacy of RPE cell transplant therapy
– Designed to confirm efficacy signal seen in prior studies
– Will include untreated masked control group, consistent with EMA and FDA guidance
Design Highlights
– Double-masked study
– 1:1 Randomization (N=100, 50 treated : 50 control)
First patient treatment expected in 3Q 2015 following SPA meeting with FDA, full enrollment
expected in 2017 (Anatomy and Efficacy)
25
SMD Pivotal Trial, Planned Initiation in the Third Quarter of 2015
Trial Designed to Enable Potential Approval in 2019
26. Objectives
– Safety & tolerability of 3 different immunosuppressive regimens (13,7 and 1 week(s))
– Note - No evidence of any transplant rejection to date in patients treated up to four years
– Exploring efficacy signal seen in previous open studies
– Will include a “better vision” arm
Design Highlights
– Control group of untreated patients
– Three cohorts of 20 patients
– 3:1 Randomization (N=60, 45 treated : 15 control)
First Cohort Data read out expected Q2 2016 (Anatomy and Efficacy Signal)
AMD Phase 2 Safety & Proof-of-Concept, Planned Initiation - Q3 2015
26
Corporate
Success in this Controlled Study would support SMD Program and Further RPE Therapy as a
Transformational Therapy that Could Provide Benefit for Patients with SMD and Dry AMD
28. 28
Pre-Clinical Pipeline is Maturing - Ocata’s Technology Extends Beyond hESCs
and includes Induced Pluripotent Cells (iPSCs)
Photoreceptor Progenitors were transplanted into mice with
severe retinal degeneration
After 3 weeks, mice showed significant improvement with the
number of surviving cells in each animal strongly correlated
to magnitude of visual improvement
Similar efficacy using either human ESC or iPS cells
processed using our DeltaCell™ Technology
Pre-clinical Data Expected H2 2015, this Product could Complement RPE Therapy
as Viable Potential Solution for End-Stage Disease
29. 29
Systemic hESC-PhRPs Provide Neuroprotection in Mice and Rats
a-wave
(cones & rods) PhRP, 2 mo
PhRP, 1 mo
PBS, 1 mo
PBS, 2 mo
Prevent photoreceptor
degeneration in ELOVL4 mice
ONL→
PBS control
Intravitreal injection
missing OS
(P90)
PhPR-treated
(rod OS/rhodopsin)
Preserve outer segments of
photoreceptor in RCS rats
Tail vein injection
Healthy ONL
Missing ONL
PhRPs rescue photoreceptors in RCS rats
Healthy ONL
Missing ONL
0
10
20
30
40
50
60
PBS
NoInjection
RA2month
Increased ONL thickness after 2 months
PBS Ø Tx
31. Ocata Therapeutics DeltaCell™ Technology
Manufacturing Process in cGMP Environment
Continued Investment and Advances in Manufacturing and Delivery Generates Expansion of IP Estate
Cryopreserved – inexhaustible replicative capacity starting
material, stored at Ocata and in remote location
Master Cell Bank of
hESC’s
Induction of proliferation and cell culture expansion
Expansion of cells
~20 fold
In-process assays to ensure morphology and
sterility of cells
Shift to Terminal
Differentiation
to RPE cells
The process of re-passaging the cells can produce >1,000
fold increase of quantity of RPE cells
Purify RPE and
re-passage to
expand quantity
Available for patient dosing; one five month process
typically yields ~1,000 doses
Harvest bulk material
and cryopreserve
RPE inventory
12 full-time employees
dedicated to manufacturing,
quality control, quality
assurance & assay
development
FDA review of CMC accepting
of release criteria and
processes
Step
31
32. IP Coverage From Stem Cell Line to Patient Treatment
Single Blastomere Derivation of hESCs Methods of Manufacturing hESC-derived RPE cells
Product Release AssaysPharmaceutical PreparationsMethods-of-Treatment
3 Patent Families
• 13 Issued Patents
• 26 Pending Applications
Core Patent expiry – 2031 (with Patent Term Extension)
5 Patent Families
• 2 Issued Patents
• 34 Pending Applications
Core Patents - 2031
Formulation Improvements - 2032
Shipping Medium –2035
3 Patent Families
• 4 Issued Patents
• 26 Pending Applications
Core Patents - 2031
Improvements - 2032
2 Patent Family
• 11 Pending Applications
Expiry will begin 2031 & 2032
1 Patent Family
• 4 Issued Patents
• 12 Pending Applications
Expiry begins 2025
32
33. • Trades on Nasdaq – OCAT
• Currently funded from $30m equity line
with Lincoln Park Capital,
– $3.5m cash on hand, and
– $12.5m available for future draws
• ~35.6m shares outstanding
– no preferred stock
– no debt
– ~2.8m options and RSU’s held by
executive team, employees and
directors
33
Ocata Therapeutics Financial Overview as of March 31, 2015
34. Future Milestones to Bolster Position as
The Leading Regenerative Ophthalmology Company
Year Period Goal
2015
Q3
• Dry AMD Phase 2 Study: First subject enrolled
• Special Protocol Assessment meeting with FDA
• SMD Pivotal Study: First subject enrolled
• Further strengthening of IP portfolio
Q4
• Publication of data on pre-clinical photoreceptor studies
• Partnership of non-core asset (e.g. platelet program)
2016
Q2 • Dry AMD P2 Study: First Cohort with 3 month data
Q3
• Dry AMD P2 Study: Second Cohort with 3 month data
• Partnership of core program in ex-US region (e.g. Asia, South America)
34
As Milestones are Achieved, Ocata will Continue to Broaden Market Awareness
35. An Experienced Management Team
Name Position Experience
Paul K. Wotton, Ph.D. President & CEO
Edward (Ted) Myles
Chief Operating Officer &
Chief Financial Officer
Robert Lanza, M.D. Chief Scientific Officer
Eddy Anglade, M.D. Chief Medical Officer
LeRoux Jooste Chief Commercial Officer
PENWES
T
36. Experienced Corporate & Scientific Boards
Name Experience
Michael Heffernan,
(Chairman)
CEO – Collegium Pharmaceuticals
Robert Langer, Sc.D.
Institute Professor – Massachusetts Institute of
Technology
Greg Perry EVP & CFO – Eleven Biotherapeutics
Alan C. Shapiro
Finance Professor and Chairman, Department of
Finance and Business Economics (retired) –
University of Southern California
Zohar Loshitzer
President – Presbia, Inc., & Principal at Orchard
Capital
Paul K. Wotton, Ph.D. President and CEO, Ocata Therapeutics
Industry-leading Scientific Advisory Board
Name Experience
Robert Langer, Sc.D.
(Chairman)
Massachusetts Institute of Technology
Queen Elisabeth Prize for Engineering (2015); Member of
all 3 National Academies; President’s National Medal of
Technology and Innovation (2013)
Constance Cepko, Ph.D.
Harvard Medical School
National Academy of Sciences (elected 2002); Alfred W.
Bressler Prize in Vision Science (2011)
George Daley, M.D., Ph.D.
Harvard Medical School
NIH Director’s Pioneer Award (2004); E. Mead Johnson
Award from the American Pediatric Society (2009)
John Gearhart, Ph.D.
University of Pennsylvania
Director of the Institute for Regenerative Medicine; Science,
Board of Reviewing Editors
Michael Longaker, M.D.
Stanford University
Director, Institute of Stem Cell Biology and Regenerative
Medicine; Director, Children's Surgical Research
Joseph Vacanti, M.D.
Massachusetts General Hospital
Surgeon-in-Chief; Member, Institute of Medicine of the
National Academy of Sciences
Board of Directors – Broad Experience in Life Science Sector
37. Initiating Pivotal Trial for SMD and Phase 2 Trial for dry AMD with novel, potentially
curative therapy in areas where no approved products exist today
Dry AMD is an indication with a large potential market – a precursor to Wet AMD
where treatments include Eylea (Regeneron) and Lucentis (Novartis/Roche)
Safety observed, in addition to anatomical and functional evidence of repair and
restoration; data published in The Lancet, October 14th, 2014 and data in Asian
Patients published on April 30th 2015 in Stem Cell Reports
Established and growing IP position in major markets protecting the life span of the
cell therapy – from the origin of the cell to the delivery into patients’ eyes
Novel pre-clinical pipeline
Ability to produce fully differentiated cell types (e.g. RPE, PhRP) with DeltaCell™
Technology
Experienced management team, corporate and scientific advisory boards
Leading Regenerative Ophthalmology
37