1. Executive Summary
The following summary is detailed information and schedules that will appear. Novamed is a Korea Domestic Corporation
involved primarily in developing and applying of Radio Frequency scientific technological advances to the medical field, with
initially targets in Aesthetic, Obesity, Sports Medicine and many other medical fields.
Identity of the Business
The company was established under the laws of Republic of Korea in June, 2015, under the name of Novamed and doing
business as Novamed (Herein after called The Company).
The Company has its foreign Corporation, Medex Technologies, Inc. in California USA who has a subsidiary; Medex Clinical
Service. The Company is a subsidiary company of Medex Technologies.
The Company has 1 patent assigned by Sonic Surgical System,Inc located in Escondido, California and 4 patents pending in US
to receive appropriate domestic & International regulatory clearance and to manufacture commercial prototypes and intends to
manufacturing, market and sell worldwide, radio frequency assisted medical device system for Aesthetic, Obesity and Sports
Medicine applications.
2. TECHNOLOGIES OF PATENTS
INTRODUCTION
1. LONG WAVE RF HYERTHERMIA
The company introduced a RF hyperthermia method that provides all the advantages of a deep thermal increase to Increase of
tissue temperature (41ºC and Up) – melting adipose tissue and the duration of tissue heat stimulates collagen synthesis
affecting tissue tightening.
Increase of arterial circulation – vasodilatation -giving rise to increased oxygenation and a decreased acidity of the tissues.
Increase of venous drainage with greater re-absorption of catabolites and decreasing of the edema in areas with inflammatory
processes.
Increase of the permeability of the cellular membrane, allowing better transfer of metabolites through it.
Stimulation of the immune system and decrease of free radicals.
Radiofrequency (RF) devices have been
used since the last century in various
specialized fields such as cardiology for the
removal of ectopic foci responsible for
arrythmiae, oncological surgery for the removal of hepatic and renal tumors, and in pediatric surgery for the removal of cephalic
neurofibromas in children suffering from neurofibromatosis type 1.
No nablative remodeling of tissues with RF is a technique recently introduced into dermatologic practice and has proved to be a
valid alternative to the nonablative laser technologies currently on the market. RF energy is part of the electromagnetic spectrum
like visible light. Visible light is normally characterized by a particular wavelength, but RF is characterized by a specific frequency
measurable in Hz. Medical devices that emit RF energy produce a change in the electrical charges of the treated skin creating an
electron movement. The resistance of the tissue to the electron movement generates heat, as is indicated by Ohm's law
(E=[I.sup.2] x Z x T). The amount of heat generated thus depends on the impedance of the treated skin, the intensity of the
3. current applied in the treatment, and on the length of time (T) of exposure to the RF energy. Tissues where impedance is greater,
such as areas of skin with abundant subcutaneous adipose tissue, develop higher temperatures for the same current intensity
and exposure time and show greater clinical and histological improvements than areas of skin with less impedance.
RF devices can be classified in 2 categories: monopolar systems and bipolar systems. The main difference between these 2
categories lies in the configuration of the electrodes applied to the skin, with important repercussions on how the energy is
conveyed into the skin itself and into the underlying tissues.
The monopolar configuration consists of an active treatment electrode and a passive one, which acts as the grounding electrode.
The chief advantage of the monopolar devices is the high penetration of the current emitted. However, this aspect of the device,
coupled with the high energy levels originally used to create an effect, constituted the chief drawback of the original description
for monopolar RF, namely pain associated with the treatment and a small incidence of soft tissue deformities, thought mainly to
be as a result of fat necrosis. The pain threshold for many of the original patients resulted in many clinicians utilizing various
anesthetic techniques to make the treatments more palatable. These included topical therapies, intravenous sedation, and
general anesthesia. Newer protocols employed with the monopolar RF device have addressed these concerns.
Now, lower frequencies (484 KHz) are employed by The Company resulting in no
pain and adverse events, and multiple passes are used to achieve the desired
effects such as visceral fat reduction.
The treatments with this device are much more predictable and patient friendly.
In the bipolar configuration, the current passes between 2 identical electrodes
located a short distance apart from each other. They are applied to the area to be
treated and the propagation of the current is limited to the area between the
electrodes themselves. The depth reached by the current is equal to
approximately half the distance separating the 2 electrodes. Bipolar systems thus
ensure a better controlled distribution of energy, and the patients treated with
these devices tolerate the session with ease. Compared to the monopolar
configuration, however, the depth of penetration of the current is less and for this
reason it is difficult for it to reach the deep dermis and subcutaneous tissues
4. LONG WAVE ADVANTAGE VS SHORT WAVE
Temperature is generally raised in tissues by dissipating energy (often electrical) generated by special appliances. Methods
commonly used would include:
Induction through an inductive coil system: Ultrasound Short wave radio frequencies (20-30 MHz) Infrared radiation (0.79
microns).
Red light therapy Systems with frequencies above 27 MHz
Ferromagnetic absorbers working by induction of large magnetic systems
Electrodes implant systems absorbing high frequency currents.
Different methods have been used to create Hyperthermia.
For example: The "natural" method of increasing fever using drugs. Methods of "global corporal hyperthermia" using immersion
were developed.
Ultrasounds producing deep heat but with the risk of creating "hot spots" on bone structures and of therefore producing energy
dispersion upon reflection.
Microwaves (300 - 2450 MHz) and RF (>2MHz)
produce an internal thermal increase by
molecular friction but with the resulting
destructive effect on the tissue. They can be
useful on surface lesions but in deep lesions
invasive methods are required - interstitial
treatment with coaxial antennae or electrodes -,
with complex guiding methods, strict temperature
controls and in some cases with associated
refrigeration systems.
5. The non-invasive Novamed LONG WAVE RF method gives rise to an internal thermal increase with none of the disadvantages of
other hyperthermia systems, meaning that it can even be applied to the eyes, brain and spinal column, areas that are completely
out of bounds to the other methods.
BIOLOGICAL EFFECTS
1. Increase of arterial circulation - vasodilatation -, giving rise to increased oxygenation and a decreased acidity
of the tissues.
2. Increase of venous drainage with greater re-absorption of catabolites and decreasing of the edema in areas
with inflammatory processes.
3. Increase of the permeability of the cellular membrane, allowing better transfer of metabolites through it.
4. Speeding up of cicatrization of wounds.
5. Stimulation of the immune system and decrease of free radicals.
6. 2. ELECTRONIC SOFT PAD
This invention is about a flexible electrode pad. In detail, the flexible (articulated) patch electrode fits well to concave body area,
so it can improve the treatment results and protect patients from a burn.
Especially high-frequency therapy devices apply an electric current over a treatment area and induce endogenous body heat
without stimulating the nervous system, so it could heat a targeted area without discomfort and muscle contraction.
These hyperthermia therapy devices are generally composed of a main power supply, electrodes and return pads. An electric
current supplied from a main body (power supply) flows from electrodes to return pads, inducing endogenous body heat and
treating the patient.
.
However, such high-frequency therapy devices usually cause burns when using a small-diameter electrode with a fixed mass of
current.
First of all, those existing electrodes are composed of hard metals such as stainless metal; therefore, it cannot adhere closely to
skin when applying on articulated areas, incurring low efficiency.
7. 3. RF CUFF PAD
Utilizing a flexible electromagnetic electrode pad sealed by di-electric rubber or silicon, The Company applied the utility
patent for complete contact with treatment areas. It will be patient-friendly, comfortable, safer and more efficient.
Based on this flexible Pad aid invention, the company developed various kinds of automatic treatment systems to ease
operating fatigue safely and efficiently.
This system can be used not only to remove fat and for body contouring but also for other applications, such as pain
management, urological and gynecological issues, and diabetes. Research has been underway in these areas.
8. OVERVIEW BY MODEL/APPLICATION
OBECURE : Obesity & Visceral Fat Reduction
INDUSTRY OVERVIEW
The past three decades, the prevalence of obesity has risen to reach epidemic proportions in the United States and Europe.
Despite public health efforts, no marked shift towards healthier lifestyles is likely over the next ten years; rather, the health
problems of obese and overweight people will increase. The number of obese adults in the seven major markets (United States,
France, Germany, Italy, Spain, United Kingdom and Japan) is expected to grow from 115 million in 2005 to 139 million in 2010.
Less than 25% of potential patients are formally diagnosed as obese, and less than 20% of those who are diagnosed are treated
with various kinds of medical treatments and therapies, however, those treatments contribute to the small percentage of treated
patients: achieve only an average5–10% loss of initial body weight in less than 50% of patients.
Furthermore, the treatments have the potential to increase heart rate and blood pressure, so physicians are reluctant to
recommend it to patients with uncontrolled hypertension, coronary heart disease, arrhythmias, congestive heart failure or stroke
ironically, conditions that often result from obesity.
The Company’s obesity system is unique in that it is already been proved in the market but which differentiates it from the
methods currently used for obesity clinic.
The Company believes its product will offer the health professional and patient certain distinct advantages including enhanced
aesthetic results due to more precise control of the patient.
In 1998 the medical costs of obesity were estimated to be as high as $78.5 billion, with roughly half financed by Medicare and
Medicaid. This analysis presents updated estimates of the costs of obesity for the United States across payers (Medicare,
Medicaid, and private insurers), in separate categories for inpatient, non-inpatient, and prescription drug spending. We found that
the increased prevalence of obesity is responsible for almost $40 billion of increased medical spending through 2006, including
$7 billion in Medicare prescription drug costs. We estimate that the medical costs of obesity could have risen to $147 billion per
year by 2008.
9. The study showed that the costs of overweight and obesity could have been as high as $78.5 billion in 1998 and that roughly half
of this total was financed by Medicare and Medicaid. This analysis updates those previous findings.
Our overall estimates show that the annual medical burden of obesity has risen to almost 10 percent of all medical spending and
could amount to $147 billion per year in 2008. Other studies have also quantified the extent to which obesity influences
aggregate health spending. For example, Kenneth Thorpe and colleagues2 found that obesity was responsible for 27 percent of
the rise in inflation-adjusted health spending between 2011 and 2017
VISCERAL FAT
Visceral fat or abdominal fat (also known as
organ fat or intra-abdominal fat) is located
inside the abdominal cavity, packed between
the organs (stomach, liver, intestines, kidneys,
etc.). Visceral fat is different
from subcutaneous fat underneath the skin,
and intramuscular fat interspersed in skeletal
muscles. Fat in the lower body, as in thighs
and buttocks, is subcutaneous and is not
consistently spaced tissue, whereas fat in
the abdomen is mostly visceral and semi-fluid.
Visceral fat is composed of several adipose
depots, including mesenteric, epididymal white adipose tissue (EWAT), and perirenal depots. Visceral fat is considered adipose
tissue whereas subcutaneous fat is not considered as such.
An excess of visceral fat is known as central obesity, or "belly fat", in which the abdomen protrudes excessively. Excess visceral
fat is also linked to type 2 diabetes, insulin resistance, inflammatory diseases, and other obesity-related diseases.
10. Men are more likely to have fat stored in the belly due to sex hormone differences. Female sex hormone causes fat to be stored
in the buttocks, thighs, and hips in women. When women reach menopause and the estrogen produced by the ovaries declines,
fat migrates from the buttocks, hips and thighs to the waist; later fat is stored in the abdomen.
High-intensity exercise is one way to effectively reduce total abdominal fat. One study suggests at least 10 MET-hours per week
of aerobic exercise is required for visceral fat reduction.
STATUS & SCHEDULE
The company completed clinical trials for visceral fat reduction in Korea in 2009 at Severance Hospital, part of Wonkwang
University Hospital. The device for the clinical trial was LipoTron-3000. The CT scan shows all positive results for visceral
/subcutaneous fat, including weight loss.
As far as we know, there is no medical device to reduce VISCERAL FAT currently on the market. The visceral fat cannot be
removed by INVASIVE SURGERY.
Other Non-Invasive RF fat reduction devices are only for subcutaneous fat.
11. The Company has been researching this medical technology for more than five years and planning clinical trials in the U.S. in
early 2016 when its protocol approved by the FDA.
The complete system for the clinical trial will be ready before the end of 2015 for U.S. clinical trials. The Company feels
comfortable to pass the clinical result by FDA because of previous positive result in Korea.
Once The Company clears the FDA 510K for Visceral Fat Reduction, The Company has the only medical device to reduce
visceral fat for the first time in the industry. This is a multi-hundred-billion-dollar market. Moreover, in 2011, physicians voted
overwhelmingly to label obesity as a disease that requires a range of interventions to advance treatment and prevention in the
U.S.