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BIONICA
was originally founded in 1980, and effectuated its move from Australia
to Sacramento, CA under the new ownership of Mr. Gregory Gilbert.
BIONICA and Gregory Gilbert (“Licensors”) have “Licensed” the BIONICA
pump technology under an “EXCLUSIVE LICENSING AGREEMENT” to CAT Clinic,
LLC, founded by Mr. Gregory Gilbert and Associates in 2002, as the
“Licensee” of the “Bionica Pump Technology” for Cellular Activation
Therapy (CAT) Clinics. In October of 2007, CAT Clinics, LLC, entered
into a “Stock Exchange” Agreement and “Licensing” agreement with
VitalCare Technology Enterprises. Further, Mr. Gregory Gilbert, CEO of
CAT Clinics, LLC and Founder of BIONICA International became the VP of
Research and Development and a member of VitalCare Technology’s Board of
Directors, to assist with the overall direction of the Company. BIONICA
International, Inc. and Mr. Gregory Gilbert are the “exclusive” owners
of both the U.S. Patents as well as the FDA approval for the BIONICA
pump (iCAT infusion pump; aka: Micro pump) through the acquisition
completed in 2005 from AMSys Corporation and Connecticut Innovations,
Inc., which includes the T. Aoki Patents, along with the extensive
intellectual and proprietary property (data) used in building the
equipment, and lastly, the algorithms used in the micro-chip technology
which analyzes a patient’s blood sugar level and end-tidal CO2 levels in
“real time” in order to calculate and deliver exact pulsatile dosages of
insulin intravenously during each iCAT therapy session.
The iCAT infusion device (the
“BIONICA” pump) has been continuously in use in a few hospitals as well
as “Licensed” CAT Clinics, plus there are a few patients who’ve been
clinically managed in the homecare setting now for over 25 years, with
not one documented adverse reaction or complication to date.
Patients who’ve been treated with the pump using iCAT therapy have
ranged from age seven (7) upwards of eighty (80) years of age, pregnant
mothers and breast feeding mothers as well. This is a perfect safety
record, unheard of in the medical industry, which is due, in part, to
the expert engineering of the patented internal pump mechanism. This
total avoidance of mechanical and software failures, limited moving
parts and the lack of any recalls, show that the BIONICA pump platform
is extremely stable and dependable, critical to this group of patients.
The BIONICA Pump system is also uniquely suitable for the
new fluid
micrometer pre-filled insulin cartridge system, a modification that will
allow greater accuracy as well as a bi-directional pumping mechanism,
giving healthcare providers a means to sample the patient’s blood for
biological measurements of their blood sugar (glucose) level, as they
receive their iCAT therapy, again, an industry first. Having a
proprietary cartridge technology, bi-directional capability, with
superior accuracy and performance allows the Company to deliver
pre-filled disposable cartridges direct to the consumer. And with the
planned next generation homecare pump, it will allow for the integration
of a glucose sensor, to make the home therapy easy, safe, affordable,
with the ability for remote monitoring of all homecare patients.
As of 2007, a little over $14 million dollars has been raised through
private “angel” investors for iCAT therapy research and development.
The majority of the capital was used in research, therapeutic protocol
development, product design, FDA approval and operational costs.
Additional capital was spent on administrative and legal work for
obtaining U.S. and Foreign Patents, insurance approvals and
reimbursement, developing the training programs and quality assurance
standards in addition to R&D for the homecare pump, for homecare iCAT
therapy.
Intellectual property protection for the Company’s license through CAT
Clinics, LLC and BIONICA International, Inc. is divided into the
following:
Patent Protection: Generally the Company is protected by a complete
set of US Patents which cover the use of iCAT for several reasons.
First, these patents are pending in all PTO countries, and are being
applied for in non-treaty countries on a country by country basis, and
include inventions, improvements, and techniques as they relate to the
US patents, US patents pending and patents pending in PTO countries,
used for the delivery of insulin for the treatment of diabetes, which
includes US Patent Number 6,565,535 (2003) under USFDA # 3004435660 /
BIONICA and EU # CE0470; US Patent Applications for Quantitative
Chronological Medical Infusion Device, Serial No 10/834.466 filed April
2004 and August 2004, with Patent Convention Treaty elections, by
Gregory Ford Gilbert to include any and all improvements thereto
developed, whether patentable or not, which may now or may hereafter
develop; the Development Purchase Agreement by BIONICA International,
Inc. and Connecticut Innovations Inc. includes all Aoki Patents and
other intellectual property as described herein. A complete list of
issued, pending and intended patents can be provided with a signed
“Non-disclosure Agreement”.
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