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Paul Zalesky
Ph.D. ·
east greenwich, Rhode Island
Biomedical Engineering
patent infringement
regulatory (FDA) malfeasance associated with oximetry and waveform analysis
patent infringement associated with selective compliance of balloons used in angioplasty
medical technology companies
real-time image guidance of structural and rhythm heart procedures
percutaneous mitral valve
clinical/regulatory strategy & execution
patent validity / detail / strength and related science / claim basis
specialty medical technology and business
Product Development
pre-clinical and clinical study
regulatory submission planning and execution
cerebral protection during TAVR
Business Development
Financing
FDA and other regulatory body strategy planning
Intellectual Property Planning and protection
Product Development
New Technology
Intellectual Property
pre-market document packages for FDA review and dialog
Consulting Expert Witness
Medical Specialty Consultant
intellectual property analyses
key organization changes and recommended practices to realize business opportunities with medical devices and associated technologies
Vascular Access
chronic hemodialysis patients
least invasive vascular procedures
fast Regulatory approval path
electrophysiology / cardiology
least invasive treatment of cardiac arrhythmias
atrial fibrillation (subsequently acquired by Medtronic)
FDA review requirements and associated submission details
heparin-additive, drug-eluting coronary stent
prevention of sub-acute and late stent thrombosis
obesity therapies
wireless cardiovascular implants
in vitro diagnostics
aorta implants for aneurysm treatment
non-vascular applications of intravascular imaging
gastroenterological least invasive therapies
light-based therapy in Gastroenterology
private equity financing
clinical/regulatory/Quality and Marketing
photo-optic consultants
clinical, regulatory and re-imbursement strategies and plans
financial accounting and reporting system
patent application filings
business development
new financing support
clinical/regulatory strategies
interventional cardiology
cancer therapy
wound and skin care
GI therapies
Intellectual Property
patent Portfolio
hardware/software bedside system with disposable catheters
Acute MI
skin & wound care
cancer therapy
private capital
FDA and CE Mark approvals
clean room manufacturing of disposables and electromechanical control + delivery systems
multi-phase clinical studies in US and Europe
opinion-leading SAB
international technology consultants for breakthrough developments
development and management of all intellectual property (primarily patents)
product development
advanced manufacturing
clinical
technical support
cardiopulmonary bypass
group R&D and strategic planning
interventional cardiology
growth and diversification strategies
operating efficiencies
FDA interaction
intracoronary ultrasound for interventional cardiology
venture capital
SAB and Clinical Investigator array with opinion-leading Interventional Cardiologists in the US and Europe
FDA approval for marketing
ISO certification
aggressive early marketing
pilot in-house manufacturing capability
Intellectual Property development
Executive R&D management
cardiopulmonary research with human subjects for development of life support systems for high performance aircraft
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