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FACT SHEET

Company. The Painmaster™ MCT (micro current The lower operating current and frequency devices give
therapy) Patch is a proprietary, non-invasive pain relief Painmaster™ the ability to address a wide range of
and healing stimulation product. Painmaster™ was chronic pain applications. In the wound care market,
developed by Newmark, Inc., an innovative medical applying the Painmaster™ higher current, lower
products company focused on the discovery, frequency devices to treat post operative wounds can
development, manufacture and marketing of disposable accelerate healing and ultimately reduce recovery and
medical components and medical devices. The company rehabilitation time. The Painmaster™ advanced
was founded in 1993 as a Connecticut corporation technology models; an Impedance Adjusted device and
dedicated to producing precision components for the a User Interface Programmable device provide the basis
ECG electrode and IV catheter markets. In 1999, for iontophoretic applications. These models have the
Newmark began development of a portfolio of patented capability to automatically adjust current levels by
products incorporating a broadly useful technology instantaneously measuring the impedance of the patient
platform. The intellectual property and clinical being treated and adjusting the corresponding current
developments of Newmark are based on micro current output, while incorporating a microchip that is
electrical nerve stimulation (MENS). programmable to an unlimited number of current output
levels.
Micro current flows through the
body between electrodes

Technology. The Painmaster™ MCT Patch uses


MENS as its foundation, delivering a sustained flow of Market. There are three distinct markets for the use and
low amperage electrical current. Uniquely, the application of the Painmaster™ MCT Patch technology;
Painmaster™ design incorporates the combination of pain relief, wound healing, and the transdermal delivery
using the body as the electrical “switch” mechanism of drugs via iontophoresis.
coupled with a user interface indicator for positive The market for pain relieving remedies is one of the
evidence of current flow. These patented features are largest in the world, estimated to reach $75 billion by
employed in all variations of the Painmaster™. The 2010. An estimated 89% of adults in the U.S.
result is a diverse range of micro current devices that experience pain every month and 50% or more do not
deliver clear differentiation from today’s other medical achieve sufficient relief. This high degree of
methodologies, and provide a scalable platform to dissatisfaction with the current pain relief choices
deliver straight DC current, as well as pulsed creates a very large population of pain sufferers who are
monophasic and biphasic currents at levels from 1 ready to try something new and very willing to switch to
microamp (µA) up to 937 microamps (µA) within a a different therapy.
frequency range of 0.5 hertz (Hz) up to 500 hertz (Hz). By contrast, the Painmaster™ MCT Patch enters an
entirely new arena of value as an advanced wound care
Product Portfolio. The design platform of the device. Clinical studies have demonstrated the
Painmaster™ MCT Patch provides the latitude to apply effectiveness of MENS in post-operative wound care.
the technology as a modality for pain relief, wound The aging population is the key driver of the advanced
healing and iontophoresis by offering differentiated wound market as the elderly account for a significant
products targeted to specific markets. portion of the cases related to chronic wounds. Medical
studies indicate the addition of MENS to a moist

The Healing Science of Micro Current Therapy (MCT)


FACT SHEET

environment with devices such as the Painmaster™ can The study results indicated a 60% reduction in pain
accelerate normal physiological function and assist the medications on day 1 and a 90% reduction by day 10 for
body’s natural current in healing wounds. the Painmaster™ patients as compared to the control
tm
group. Wound healing also was significantly better after
Painmaster Markets 10 days of micro current therapy treatments.
(in billions) Another study was conducted in 2006 at the Pain Center
of the University of Utrecht in the Netherlands under
$7.0 Drs. van Wijck and von Wagner. This was a double
Pain Relief blind, crossover, placebo controlled study of ten patients
Wound Care referred by their primary care physicians after long
$12.0 $28.0 Iontophoresis periods of unsuccessful treatment for chronic back pain.
100% of the patients in the study responded to
treatment, indicating reductions in both their level of
Iontophoresis and the market for advanced drug delivery pain and the dosage and frequency of pain medication.
technologies are expanding exponentially, providing
companies the opportunity to develop second-generation Intellectual Property. The Painmaster™ MCT Patch
drugs based on proprietary delivery systems. Strategic is approved as a Class II medical device by the FDA for
alliances between device manufacturers and prescription use only. Newmark has enjoyed significant
pharmaceutical companies provide a pathway to success in obtaining approvals internationally as well.
enhance value and meet the strategic needs of all parties. Patents.
Drug delivery systems employing transdermal • U.S. Patent No. 6,408,211
technology extend the duration of a drug's action, • U.S. Patent No. 6,606,519
increase delivery to target sites, reduce delivery to • European Patent Organization No. 0194441.3
unwanted sites, and maximize drug absorption. • Canadian Patent No. 2,410,342
• Mexican Patent No. PA/a/2002/012168
• Brazil Patent No. P10111738-6
Approvals:
• U.S. FDA Class II Medical Device - K013167
• European Union EC Directive Reg. No.
HD 60004373
• P. R. of China SFDA Approval No.
20042261127
As the micro current driver for concentrations of • Korea KFDA Approval No. 45077180
medications over a period of time to a specific location • Israel Ministry Approval No. 5680008
without the use of needles, and without the • Canada CMDCAS Approval No. 67242
gastrointestinal side effects of oral ingestion,
• Mexico Registration No. 04390802187
Painmaster™ can be an integral part of an innovative
• Brazil Registration No. 59.053.488/0001-68
pharmaceutical delivery system.
• Argentina - Provisional Approval
• Japan - Provisional Approval
Clinical Data. A pilot study was conducted during
2004-05 by Timour El-Husseini and Mahmoud El-
Sebai, Professors of Orthopedics at Ain Shams Contact:
University in Cairo, Egypt. The objective was to Francis R. Powell
determine the effects of MCT therapy on post-operative Newmark, Inc.
pain for patients who had undergone total knee 203-272-1158
arthroplasty. fpowell@newmarkinc.com

The Healing Science of Micro Current Therapy (MCT)

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