Transcript Intratracheal Aerosol Delivery

Please welcome our guest…
Jane Century
VP Operations, Penn-Century Inc.
PCCI sponsors:
An all-volunteer,
non-profit organization
PCCI sponsorship …
An all-volunteer,
non-profit organization
PENNCENTURY™
Expanding the reach of aerosol medicine
Targeting aerosol medicine directly to the lungs
and other inaccessible places in the body
Penn-Century, Inc. - At a Glance
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Incorporated in 1997 by Ted Century PhD, President &
Chief Scientific Officer, and Jane Century, VP
Operations
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10 patents issued; 11th filed
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Highly profitable, cash-flow positive, self-funded
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Large, growing, loyal global customer base
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Lean organization by design; Mostly outsourced
manufacturing with final assembly in 3500 sq ft facility
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Seeking M&A exit, strategic partnership, or licensing
agreements
Penn-Century, Inc.
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Evolved organically to meet an unmet need
for a safer, less wasteful and more precise
method of developing and testing respiratory
and other drugs
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Completely mechanical, hand-held
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Used in animal and in vitro models
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Product line includes - liquid and dry powder
drug delivery devices
The advantages of pulmonary
drug delivery
THE PLUSES
 Lungs offer the body’s broadest
exposure to the vascular system
 Can treat both pulmonary and
systemic diseases
 Far faster than pills – avoids
metabolic changes
 Shots hurt!
 Avoids systemic side affects common
to IV drugs
 Higher concentration in lungs
Two major hurdles to pulmonary
drug delivery
ANATOMICAL :
- We are not designed to have anything in our
lungs but air
- Particles must be 1-5ul to bypass nose and
throat
TECHNOLOGICAL :
- To make particles of an inhalable size, most
nebulizers and inhalers depend on compressed
air, propellant, heat or ultrasound
- This creates a lot of air and not much drug
moving at high momentum
The two most common methods of
pulmonary drug delivery:
Inhaler/Nebulizers
• Slow, wasteful, inefficient
• Typically for symptom
management
• Hard to determine how much
got in
•High momentum
• Cannot target a lobe or lesion
• Can contaminate atmosphere
or expose clinicians
Liquid bolus/droplet
Fast - but harsh
• Limited tolerance
• Poor distribution in the lung
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Current pulmonary
drug delivery methods
Nasal sprayers
MDIs
Nebulizers/Masks
Liquid bolus (droplet)
delivery via an ET tube
Penn-Century MicroSprayer® offers
best of both worlds
Nasal sprayers
MDIs
Nebulizers
Liquid bolus delivery via
an ET tube
MicroSprayer® Aerosolizer
Intratracheal Aerosol
Delivery
Aerosol medicine that is administered
- not inhaled
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Fast at high volumes
Not dependent on breath
capacity of subject
Targeted, local drug delivery
Low momentum, but high
concentration
Precisely quantifiable
More uniform distribution
Faster, safer delivery of
larger, clinically effective
volumes
Highly efficient at smaller
doses
MicroSprayer® Aerosolizer: Key features
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Liquid device is purely
mechanical, hand-held aerosol
drug delivery platform
No air
No heat
No vibrating mesh
Works with vast array of
drugs, biologics, suspensions
Narrow enough to target the
lungs, as well as other areas stomach, sinuses, colon,
bladder, uterus
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MicroSprayer Aerosolizer
Model IA-1C
 Narrow flexible tubing
 Operates at 3000 psi
with patented FMJ-250
High Pressure Syringe
 Can be made to any
length, inserted via ET
tube or bronchoscope
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MicroSprayer Aerosolizer
Model IA-1B
 Larger, less flexible tubing
 Larger particle sizes
 Operates at 700 psi with a
1 ml disposable
polycarbonate syringe
 Can be inserted directly or
via a catheter
Dry Powder Insufflator™
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Delivers a cloud of dry
powder directly to lungs
Can deliver particles of
nano- to macro-scale
Manually operated with
air syringe or air pump
Custom lengths for use
in ET tube or
bronchoscope
Widely used and trusted for pulmonary
drug development
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In wide use by 700+
leading pharmaceutical
and biotech companies,
medical research centers,
universities, government
military labs, and CROs
around the world
Cited in more than 800
peer-reviewed research
publications and drug
patents
Penn-Century devices successfully deliver
pharmaceutical and bioactive formulas
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Anesthetics
Antibiotics
Anti-inflammatories
Bronchodilators
Chemotherapy
COX-2 inhibitors
DNA and siRNA formulas
Epinephrine
Gene therapy
Heparin
Hormones
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L-dopa
Liposomes
Monoclonal antibodies
Nanoparticles
Peptides
Proteins
Radio-opaque imaging
Surfactant
Suspensions
Vaccines
Viral vectors
Multiple clinical applications
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Interventional bronchoscopy
Acute care, EMT settings
Rapid, local high-volume
delivery of chemotherapy,
antibiotics, biotech drugs
nanomedicine and more
Diagnostic applications
Imaging
Targeted anesthesia
Safer, faster, effective
therapies for:
 Lung cancer
 Emphysema/COPD
 Cystic fibrosis
 Pneumonia
 Tuberculosis
 Infectious diseases
 Organ transplant
Delivering a cure for lung cancer?
Pulmonary administration of
chemotherapy by MicroSprayer®
could:
• Dramatically shrinks tumors
• Far greater drug efficacy at
half the dose of IV delivery
• Spare patients painful and
debilitating side effects
• Reduce hospital costs
• Avoid contamination and toxic
exposure of “inhaled
chemotherapy”
Penn-Century, Inc. seeks to
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Scale manufacturing - under design controls
Further expand our preclinical/R&D business
Develop and pursue regulatory and
reimbursement pathways
Attract an acquirer, strategic partner or
licensee able to take the technology forward to
fully commercialize the devices for a myriad of
human and veterinary clinical applications
Penn-Century, Inc. - Questions
1) Our production capacity is limited but demand continues to
grow. How do we find time to expand our production
capacity, which is largely centered in one person - without
upsetting our customers?
2) We have had excellent success with an innovative
technology in animal models. What will a strategic partner
or acquirer be looking for from us to make the case for
clinical commercialization? (How important is it to get a
510K on our own?)
3) We are a self-funded company of three people. Is there
some way we can attract an investor who could bring not
only additional resources, but become a part of the team with added management, financial, regulatory and med
device experience?
PENNCENTURY™
Expanding the reach of aerosol medicine