Painmaster Fact Sheet Frp

FACT SHEET

Company. The Painmaster™ MCT (micro current therapy) Patch is a proprietary, non-invasive pain relief and healing stimulation product. Painmaster™ was developed by Newmark, Inc., an innovative medical products company focused on the discovery, development, manufacture and marketing of disposable medical components and medical devices. The company was founded in 1993 as a Connecticut corporation dedicated to producing precision components for the ECG electrode and IV catheter markets. In 1999, Newmark began development of a portfolio of patented products incorporating a broadly useful technology platform. The intellectual property and clinical developments of Newmark are based on micro current electrical nerve stimulation (MENS). Micro current flows through the body between electrodes

Technology. The Painmaster™ MCT Patch uses MENS as its foundation, delivering a sustained flow of low amperage electrical current. Uniquely, the Painmaster™ design incorporates the combination of using the body as the electrical “switch” mechanism coupled with a user interface indicator for positive evidence of current flow. These patented features are employed in all variations of the Painmaster™. The result is a diverse range of micro current devices that deliver clear differentiation from today’s other medical methodologies, and provide a scalable platform to deliver straight DC current, as well as pulsed monophasic and biphasic currents at levels from 1 microamp (µA) up to 937 microamps (µA) within a frequency range of 0.5 hertz (Hz) up to 500 hertz (Hz).

Product Portfolio. The design platform of the Painmaster™ MCT Patch provides the latitude to apply the technology as a modality for pain relief, wound healing and iontophoresis by offering differentiated products targeted to specific markets.

The lower operating current and frequency devices give Painmaster™ the ability to address a wide range of chronic pain applications. In the wound care market, applying the Painmaster™ higher current, lower frequency devices to treat post operative wounds can accelerate healing and ultimately reduce recovery and rehabilitation time. The Painmaster™ advanced technology models; an Impedance Adjusted device and a User Interface Programmable device provide the basis for iontophoretic applications. These models have the capability to automatically adjust current levels by instantaneously measuring the impedance of the patient being treated and adjusting the corresponding current output, while incorporating a microchip that is programmable to an unlimited number of current output levels.

Market. There are three distinct markets for the use and application of the Painmaster™ MCT Patch technology; pain relief, wound healing, and the transdermal delivery of drugs via iontophoresis. The market for pain relieving remedies is one of the largest in the world, estimated to reach $75 billion by 2010. An estimated 89% of adults in the U.S. experience pain every month and 50% or more do not achieve sufficient relief. This high degree of dissatisfaction with the current pain relief choices creates a very large population of pain sufferers who are ready to try something new and very willing to switch to a different therapy. By contrast, the Painmaster™ MCT Patch enters an entirely new arena of value as an advanced wound care device. Clinical studies have demonstrated the effectiveness of MENS in post-operative wound care. The aging population is the key driver of the advanced wound market as the elderly account for a significant 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 accelerate normal physiological function and assist the body’s natural current in healing wounds. tm

Painmaster Markets (in billions)

$7.0 Pain Relief Wound Care $12.0

$28.0

Iontophoresis

Iontophoresis and the market for advanced drug delivery technologies are expanding exponentially, providing companies the opportunity to develop second-generation drugs based on proprietary delivery systems. Strategic alliances between device manufacturers and pharmaceutical companies provide a pathway to enhance value and meet the strategic needs of all parties. Drug delivery systems employing transdermal technology extend the duration of a drug's action, increase delivery to target sites, reduce delivery to unwanted sites, and maximize drug absorption.

As the micro current driver for concentrations of medications over a period of time to a specific location without the use of needles, and without the gastrointestinal side effects of oral ingestion, Painmaster™ can be an integral part of an innovative pharmaceutical delivery system.

Clinical Data. A pilot study was conducted during 2004-05 by Timour El-Husseini and Mahmoud ElSebai, Professors of Orthopedics at Ain Shams University in Cairo, Egypt. The objective was to determine the effects of MCT therapy on post-operative pain for patients who had undergone total knee arthroplasty.

The study results indicated a 60% reduction in pain medications on day 1 and a 90% reduction by day 10 for the Painmaster™ patients as compared to the control group. Wound healing also was significantly better after 10 days of micro current therapy treatments. Another study was conducted in 2006 at the Pain Center of the University of Utrecht in the Netherlands under Drs. van Wijck and von Wagner. This was a double blind, crossover, placebo controlled study of ten patients referred by their primary care physicians after long 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 pain and the dosage and frequency of pain medication.

Intellectual Property. The Painmaster™ MCT Patch is approved as a Class II medical device by the FDA for prescription use only. Newmark has enjoyed significant success in obtaining approvals internationally as well. Patents. • U.S. Patent No. 6,408,211 • U.S. Patent No. 6,606,519 • European Patent Organization No. 0194441.3 • 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 • Korea KFDA Approval No. 45077180 • Israel Ministry Approval No. 5680008 • Canada CMDCAS Approval No. 67242 • Mexico Registration No. 04390802187 • Brazil Registration No. 59.053.488/0001-68 • Argentina - Provisional Approval • Japan - Provisional Approval Contact: Francis R. Powell Newmark, Inc. 203-272-1158 [email protected]

The Healing Science of Micro Current Therapy (MCT)