This document discusses Jade's proprietary modified hyaluronic acid (CMHA-S) technology for ophthalmic applications. CMHA-S can be used as a standalone therapy for dry eye and corneal repair, or as a drug delivery vehicle for sustained release of small and large molecules to treat ocular diseases. Preclinical studies show CMHA-S eye drops improve dry eye symptoms compared to HA solution. The management team has extensive ophthalmic drug development experience. Near-term goals include clinical studies and regulatory approval of a CMHA-S ocular lubricant in the US and EU, as well as partnering opportunities and a Series A financing round to advance the CMHA-S platform.
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Anterior Segment Company Showcase - TearScience at OIS@AAO 2016.
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Struggling with intense fears that disrupt your life? At Renew Life Hypnosis, we offer specialized hypnosis to overcome fear. Phobias are exaggerated fears, often stemming from past traumas or learned behaviors. Hypnotherapy addresses these deep-seated fears by accessing the subconscious mind, helping you change your reactions to phobic triggers. Our expert therapists guide you into a state of deep relaxation, allowing you to transform your responses and reduce anxiety. Experience increased confidence and freedom from phobias with our personalized approach. Ready to live a fear-free life? Visit us at Renew Life Hypnosis..
India Clinical Trials Market: Industry Size and Growth Trends [2030] Analyzed...Kumar Satyam
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Growing Prevalence of Lifestyle Diseases
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1. Direct Patient Care:
Objective: Provide comprehensive and compassionate care to infants, children, and adolescents in various healthcare settings (hospitals, clinics, etc.).
This includes tasks like:
Monitoring vital signs and physical condition.
Administering medications and treatments.
Performing procedures as directed by doctors.
Assisting with daily living activities (bathing, feeding).
Providing emotional support and pain management.
2. Health Promotion and Education:
Objective: Promote healthy behaviors and educate children, families, and communities about preventive healthcare.
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Administering vaccinations.
Providing education on nutrition, hygiene, and development.
Offering breastfeeding and childbirth support.
Counseling families on safety and injury prevention.
3. Collaboration and Advocacy:
Objective: Collaborate effectively with doctors, social workers, therapists, and other healthcare professionals to ensure coordinated care for children.
Objective: Advocate for the rights and best interests of their patients, especially when children cannot speak for themselves.
This includes tasks like:
Communicating effectively with healthcare teams.
Identifying and addressing potential risks to child welfare.
Educating families about their child's condition and treatment options.
4. Professional Development and Research:
Objective: Stay up-to-date on the latest advancements in pediatric healthcare through continuing education and research.
Objective: Contribute to improving the quality of care for children by participating in research initiatives.
This includes tasks like:
Attending workshops and conferences on pediatric nursing.
Participating in clinical trials related to child health.
Implementing evidence-based practices into their daily routines.
By fulfilling these objectives, pediatric nurses play a crucial role in ensuring the optimal health and well-being of children throughout all stages of their development.
How many patients does case series should have In comparison to case reports.pdfpubrica101
Pubrica’s team of researchers and writers create scientific and medical research articles, which may be important resources for authors and practitioners. Pubrica medical writers assist you in creating and revising the introduction by alerting the reader to gaps in the chosen study subject. Our professionals understand the order in which the hypothesis topic is followed by the broad subject, the issue, and the backdrop.
https://pubrica.com/academy/case-study-or-series/how-many-patients-does-case-series-should-have-in-comparison-to-case-reports/
1. Locally administered polymer technologies
Either on a standalone basis or to deliver drugs and
biologics in a sustained-release manner – for the
treatment and/or prevention of ophthalmic diseases,
conditions, and injuries
1Confidential
2. Jade’s Proprietary, Modified Hyaluronic Acid (HA)
Fulfills Two Broad Ophthalmology Needs
1. CMHA-S without added drug
HA solutions are the standard of care for dry eye and tear film stability
outside the U.S.
Major need for an efficacious dry eye therapy (especially in the U.S.)
CMHA-S already meeting that need globally for veterinary markets
Potential additional use as a corneal repair gel and ocular surface bandage
2. CMHA-S as a sustained drug-release vehicle
Chronic eye therapy requires frequent and life-long drug administration
For AMD – monthly injections of protein-based drugs needs improvement
CMHA-S can be use to deliver drugs anywhere in the eye
Preclinical data show weeks-to-months delivery for large/small molecules
Confidential 2
3. Thiolated HA (CMHA-S) Technology
Proprietary, crosslinked, thiolated hyaluronic acid
(HA) hydrogel
Exclusively licensed from BioTime, Inc., for
human ophthalmic use (either by itself or to
deliver any and all drugs to the eye)
Currently marketed for dry eye and corneal
wound repair in animals by BayerDVM
Proven sustained-release of small and larger
molecules in animals
Formulation “tuned” to match desired drug
release profiles (proteins, oligonucleotides, and
small molecules)
pH neutral upon degradation (protein-friendly)
3Confidential
4. A Spectrum of Products
Approved New Chemical Entity
Biological rHGH
Small Molecule Antibiotics Anti-Angiogenic
Confidential 4Intravitreal
Mild/Moderate
Dry Eye (0.4 %)
Non-Drug Loaded
Drug Loaded
Eye Drop Lubricant
Moderate Ocular
Surface Injuries (0.75%)
Liquid/Gel
Severe Ocular
Surface Injuries
Film/Sponge
5. Opportunity as a Dry Eye Therapy
HA is standard-of-care in Asian and European countries
Topically administered CMHA-S drops
Better retention due to crosslinking
Improved compliance (fewer doses/day)
Increased tear film stability and decreased hyperemia
in animals
Veterinary dry eye product already on the market
<1 year/$1MM to CE Mark in EU (assuming funding)
Confidential 5
6. CMHA-S Eye Drops
• KCS Gel – 0.4% crosslinked CMHA-S, for veterinary use, SentrX Animal Care
• Hylovis – 0.18% HA solution, for human use, TRB Chemedica
• Celluvisc – 1% carboxymethyl cellulose, for human use, Allergan
• Clinadry – 0.2% HA solution, for veterinary use, IDPHAR Belgian Pharma
• HA 0.4% – standard solution of HA in PBS
Confidential 6
7. Successful Masked Dog Study of
CMHA-S Drops in KCS
Masked study in 20 dogs failing SOC cyclosporine
Statistically significantly better therapeutic efficacy with
CMHA-S gel than with a solution of non-cross-linked HA
Owners were happier with the outcome of using the
CMHA-S product than the HA solution
Confidential 7
Williams DL, Mann BK. PLoS ONE. 2014; 9(6): e99766
Williams DL, Mann BK. Intl J Biomat. Vol. 2013, Article
ID 460437
8. SentrX Products Now in Widespread Use
In over 1,000 clinics worldwide
Confidential 8
Remend® Eye Lubricating Drops help
support moisture and lubrication of the eye
surface in dogs and cats.
Composed of cross-linked, modified
hyaluronic acid in a preservative-free gel,
Remend® Eye Lubricating Drops help
maintain a normal, healthy environment of
the eye surface to support lubrication and
moisturization of the eye and to help
minimize potential dryness and irritation.
9. Testimonial from BayerDVM Regarding
the Lubricating Eye Drops
9Confidential
“Feedback from the vets regarding the lubricant for
the animals dry eye syndrome is very good…”
Dr. Birgit Pfost
CAP Marketing
10. Near-Term Ocular Lubricant Timelines
Early March 2015 – Submitted pre-IND package to the FDA
April 14, 2015 – Pre-IND meeting with FDA
May 2015 – File IND with the FDA
July/Aug ‘15 – Commence 40-patient crossover study in dry eye patients
* * * * * * * * * * *
H-1 ‘16 – CE Mark in Europe (assuming necessary funding)
Confidential 10
11. Experienced Management Team
Chief Executive Officer: Arthur Klausner, M.B.A.
o Former Partner at the life sciences-focused venture capital firms Domain Associates and
Pappas Ventures
o Significant and varied experience with start-up biopharmaceutical companies
Chief Operating Officer and Co-Founder: MaryJane Rafii, Ph.D., M.B.A.
o Medical lead on Sustained Release Xalatan at Pfizer
o Medical Director - Ophthalmology Business Unit at Pfizer
o Formerly Chief Medical Officer for Fovea Pharmaceuticals (France)
o Part of the development group for Vitrasert®: an intraocular sustained delivery of Ganciclovir
Chief Scientific Officer and Co-Founder: Barbara M. Wirostko, M.D.
o Prior Chief Medical Officer of Altheos Inc.
o Former Development Team Lead with Pfizer - originator of the Sustained Delivery Xalatan
o Clinical Adjunct Associate Professor, Moran Eye Center (U. of Utah)
o Recognized Ophthalmic drug development and delivery expert
o Fellow of the American Academy of Ophthalmology
11
Confidential
12. Jade’s Pillars of Success
Unique, versatile platform technology for
use in the ocular space
Full-spectrum development capabilities
GLP/GMP manufacturing (SentrX/BioTime)
Preclinical alliance
Clinical/regulatory alliance
Non-dilutive grant support for R&D
National Science Foundation (Phase II SBIR)
Department of Defense (Phase II SBIR likely)
U.S. Army (CRADA)
Near-to-market product (ocular lubricant)
CE mark in EU projected for early 2016
Solid internal/external team
Management
Board of directors
Scientific advisors
Confidential 12
13. Partnering and Financing Objectives
Partnering Objectives:
CMHA-S lubricant (especially in E.U. as a device )
CMHA-S as a drug delivery platform (esp. proteins)
Anterior segment
Posterior segment
Initial ophthalmic drug delivery project (rHGH)
Persistent corneal epithelial defects – orphan designation
Additional potential corneal repair indications
Financing Objective:
$6-10MM Series A venture capital round
Achieves Phase 2a and 2b data with lubricant; IND with rHGH
Confidential 13