An all-volunteer,An all-volunteer,non-profit organizationnon-profit organization
Please welcome our guest…Please welcome our guest…
Jane CenturyJane CenturyVP Operations, Penn-Century Inc.VP Operations, Penn-Century Inc.
PCCI sponsors:PCCI sponsors:
An all-volunteer,An all-volunteer,non-profit organizationnon-profit organization
PCCI sponsorship …PCCI sponsorship …
Targeting aerosol medicine directly to the Targeting aerosol medicine directly to the lungs and other inaccessible places in the lungs and other inaccessible places in the
bodybody
Penn-Century, Inc. - At a GlancePenn-Century, Inc. - At a Glance
Incorporated in 1997 by Ted Century PhD, President & Incorporated in 1997 by Ted Century PhD, President &
Chief Scientific Officer, and Jane Century, VP OperationsChief Scientific Officer, and Jane Century, VP Operations
10 patents issued; 1110 patents issued; 11thth filed filed
Highly profitable, cash-flow positive, self-fundedHighly profitable, cash-flow positive, self-funded
Large, growing, loyal global customer baseLarge, growing, loyal global customer base
Lean organization by design; Mostly outsourced Lean organization by design; Mostly outsourced
manufacturing with final assembly in 3500 sq ft facilitymanufacturing with final assembly in 3500 sq ft facility
Seeking M&A exit, strategic partnership, or licensing Seeking M&A exit, strategic partnership, or licensing
agreementsagreements
Penn-Century, Inc.Penn-Century, Inc.
Evolved organically to meet an unmet need for a Evolved organically to meet an unmet need for a
safer, less wasteful and more precise method of safer, less wasteful and more precise method of
developing and testing respiratory and other drugsdeveloping and testing respiratory and other drugs
Completely mechanical, hand-heldCompletely mechanical, hand-held
Used in animal and Used in animal and in vitro in vitro modelsmodels
Product line includes - liquid and dry powder drug Product line includes - liquid and dry powder drug
delivery devicesdelivery devices
The advantages of pulmonary The advantages of pulmonary drug deliverydrug delivery
THE PLUSESTHE PLUSES Lungs offer the body’s broadest Lungs offer the body’s broadest
exposure to the vascular systemexposure to the vascular system Can treat both pulmonary and Can treat both pulmonary and
systemic diseasessystemic diseases Far faster than pills – avoids Far faster than pills – avoids
metabolic changesmetabolic changes Shots hurt!Shots hurt! Avoids systemic side affects Avoids systemic side affects
common to IV drugs common to IV drugs Higher concentration in lungsHigher concentration in lungs
Two major hurdles to pulmonary Two major hurdles to pulmonary drug deliverydrug delivery
ANATOMICAL ANATOMICAL ::
- We are not designed to have anything in our - We are not designed to have anything in our lungs but air lungs but air
- Particles must be 1-5ul to bypass nose and throat - Particles must be 1-5ul to bypass nose and throat
TECHNOLOGICAL TECHNOLOGICAL ::
- To make particles of an inhalable size, most - To make particles of an inhalable size, most nebulizers and inhalers depend on compressed air, nebulizers and inhalers depend on compressed air, propellant, heat or ultrasound propellant, heat or ultrasound
- This creates a lot of air and not much drug - This creates a lot of air and not much drug moving at high momentummoving at high momentum
The two most common methods ofThe two most common methods ofpulmonary drug delivery:pulmonary drug delivery:
Inhaler/Inhaler/NebulizersNebulizers
Liquid bolus/dropletLiquid bolus/droplet
• Slow, wasteful, inefficientSlow, wasteful, inefficient• Typically for symptom Typically for symptom managementmanagement• Hard to determine how Hard to determine how much got inmuch got in•High momentumHigh momentum• Cannot target a lobe or Cannot target a lobe or lesionlesion• Can contaminate Can contaminate atmosphere or expose atmosphere or expose cliniciansclinicians
• Fast - but harshFast - but harsh• Limited tolerance Limited tolerance • Poor distribution in the Poor distribution in the lunglung
Current pulmonary Current pulmonary drug delivery methodsdrug delivery methods
Nasal sprayersNasal sprayers
MDIsMDIs
Nebulizers/MasksNebulizers/Masks
Liquid bolus (droplet) Liquid bolus (droplet) delivery via an ET delivery via an ET tubetube
Penn-Century MicroSprayerPenn-Century MicroSprayer®® offers offers best of both worldsbest of both worlds
Nasal sprayersNasal sprayers
MDIsMDIs
NebulizersNebulizers
Liquid bolus delivery Liquid bolus delivery via an ET tubevia an ET tube
MicroSprayerMicroSprayer®® AerosolizerAerosolizer
Aerosol medicine that is Aerosol medicine that is administeredadministered - not inhaled - not inhaled
Fast at high volumesFast at high volumes Not dependent on breath Not dependent on breath
capacity of subjectcapacity of subject Targeted, local drug Targeted, local drug
deliverydelivery Low momentum, but high Low momentum, but high
concentrationconcentration Precisely quantifiablePrecisely quantifiable More uniform distributionMore uniform distribution Faster, safer delivery of Faster, safer delivery of
larger, clinically effective larger, clinically effective volumesvolumes
Highly efficient at smaller Highly efficient at smaller dosesdoses
MicroSprayerMicroSprayer®® Aerosolizer: Key Aerosolizer: Key featuresfeatures
Liquid device is purely Liquid device is purely mechanical, hand-held mechanical, hand-held aerosol drug delivery aerosol drug delivery platform platform
No airNo air No heatNo heat No vibrating meshNo vibrating mesh Works with vast array of Works with vast array of
drugs, biologics, drugs, biologics, suspensionssuspensions
Narrow enough to target Narrow enough to target the lungs, as well as other the lungs, as well as other areas - stomach, sinuses, areas - stomach, sinuses, colon, bladder, uteruscolon, bladder, uterus
MicroSprayerMicroSprayer®® Aerosolizer Aerosolizer
Model IA-1CModel IA-1C Narrow flexible tubing Narrow flexible tubing Operates at 3000 psi Operates at 3000 psi
with patented FMJ-250 with patented FMJ-250 High Pressure SyringeHigh Pressure Syringe
Can be made to any Can be made to any length, inserted via ET length, inserted via ET tube or bronchoscopetube or bronchoscope
MicroSprayerMicroSprayer®® Aerosolizer Aerosolizer
Model IA-1BModel IA-1B Larger, less flexible Larger, less flexible
tubing tubing Larger particle sizesLarger particle sizes Operates at 700 psi Operates at 700 psi
with a 1 ml disposable with a 1 ml disposable polycarbonate syringepolycarbonate syringe
Can be inserted directly Can be inserted directly or via a catheteror via a catheter
Dry Powder InsufflatorDry Powder Insufflator™™
Delivers a cloud of Delivers a cloud of dry powder directly dry powder directly to lungsto lungs
Can deliver particles Can deliver particles of nano- to macro-of nano- to macro-scalescale
Manually operated Manually operated with air syringe or air with air syringe or air pumppump
Custom lengths for Custom lengths for use in ET tube or use in ET tube or bronchoscopebronchoscope
Widely used and trusted for Widely used and trusted for pulmonary drug developmentpulmonary drug development
• In wide use by 700+ In wide use by 700+ leading pharmaceutical leading pharmaceutical and biotech companies, and biotech companies, medical research medical research centers, universities, centers, universities, government military government military labs, and CROs around labs, and CROs around the worldthe world
• Cited in more than 800 Cited in more than 800 peer-reviewed research peer-reviewed research publications and drug publications and drug patentspatents
Penn-Century devices successfully deliver Penn-Century devices successfully deliver pharmaceutical pharmaceutical andand bioactive formulas bioactive formulas
AnestheticsAnesthetics AntibioticsAntibiotics Anti-inflammatoriesAnti-inflammatories BronchodilatorsBronchodilators ChemotherapyChemotherapy COX-2 inhibitorsCOX-2 inhibitors DNA and siRNA DNA and siRNA
formulasformulas EpinephrineEpinephrine Gene therapy Gene therapy HeparinHeparin HormonesHormones
L-dopaL-dopa LiposomesLiposomes Monoclonal antibodiesMonoclonal antibodies NanoparticlesNanoparticles PeptidesPeptides ProteinsProteins Radio-opaque imaging Radio-opaque imaging SurfactantSurfactant SuspensionsSuspensions VaccinesVaccines Viral vectorsViral vectors
Multiple clinical applications Multiple clinical applications
Interventional Interventional bronchoscopybronchoscopy
Acute care, EMT settingsAcute care, EMT settings Rapid, local high-volume Rapid, local high-volume
delivery of delivery of chemotherapy, chemotherapy, antibiotics, biotech drugs antibiotics, biotech drugs nanomedicine and morenanomedicine and more
Diagnostic applicationsDiagnostic applications ImagingImaging Targeted anesthesiaTargeted anesthesia
Safer, faster, effective Safer, faster, effective therapies for: therapies for: Lung cancerLung cancerEmphysema/COPDEmphysema/COPDCystic fibrosisCystic fibrosisPneumoniaPneumoniaTuberculosisTuberculosisInfectious diseasesInfectious diseasesOrgan transplant Organ transplant
Delivering a cure for lung cancer?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 toPenn-Century, Inc. seeks to
Scale manufacturing - under design controlsScale manufacturing - under design controls Further expand our preclinical/R&D businessFurther expand our preclinical/R&D business Develop and pursue regulatory and Develop and pursue regulatory and
reimbursement pathwaysreimbursement pathways Attract an acquirer, strategic partner or Attract an acquirer, strategic partner or
licensee able to take the technology forward licensee able to take the technology forward to fully commercialize the devices for a to fully commercialize the devices for a myriad of human and veterinary clinical myriad of human and veterinary clinical applicationsapplications
Penn-Century, Inc. - Penn-Century, Inc. - QuestionsQuestions
1)1) Our production capacity is limited but demand continues to Our production capacity is limited but demand continues to grow. How do we find time to expand our production capacity, grow. How do we find time to expand our production capacity, which is largely centered in one person - without upsetting our which is largely centered in one person - without upsetting our customers? customers?
2)2) We have had excellent success with an innovative technology We have had excellent success with an innovative technology in animal models. What will a strategic partner or acquirer be in animal models. What will a strategic partner or acquirer be looking for from us to make the case for clinical looking for from us to make the case for clinical commercialization? (How important is it to get a 510K on our commercialization? (How important is it to get a 510K on our own?)own?)
3)3) We are a self-funded company of three people. Is there some We are a self-funded company of three people. Is there some way we can attract an investor who could bring not only way we can attract an investor who could bring not only additional resources, but become a part of the team - with additional resources, but become a part of the team - with added management, financial, regulatory and med device added management, financial, regulatory and med device experience?experience?
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