Therapik
®
for Insect Stings and Bites
Approved Claims
Canada – TPP
Therapik provides temporary relief of the pain, itch and inflammation resulting from the
most painful insect stings (hornets, bees, flies, jellyfish) and the most frequent bites
(mosquitoes, black flies), after application of 20-30 seconds.
United States – FDA
The Therapik is indicated for use to provide temporary relief of the pain and itching
resulting from insect stings and bites such as bees, wasps and mosquitoes by increasing
localized blood flow.
INDICATIONS FOR USE
The THERAPIK® is intended to be used to deliver heat to a localized area of the body
in order to relieve the pain associated with stings from insects and sea creatures that
deliver thermolabile venom. Such animals and insects include bees, wasps, hornets and
jellyfish. In addition, the soothing heat also provides effective relief from the itching and
irritation due to flea and mosquito bites and contact with stinging nettles.
The THERAPIK® in not indicated for the treatment of spider, scorpion or snake bites,
since these creatures do not deliver thermolabile venom. The THERAPIK® is also not
intended to replace prompt medical attention for those individuals with bee-sting or other
similar allergies. In the case of known allergies to insect stings, the user is instructed to
seek prompt medical attention. The user is also instructed to consult a physician if pain
from the sting or bite persists.
THERAPIK® is not intended for use in the eyes or on mucosal tissue.
DEVICE DESCRIPTION
THERAPIK® is a small, portable, hand-held, battery-powered device equipped with a
carrying wrist strap. It measures approximately 3cm x 3cm x 10cm and weighs less than
four ounces, including the battery. The heat is initiated by use of a simple, non-locking,
finger or thumb activated on/off switch. Heat is produced as long as the switch is
depressed; when pressure on the switch is released, the circuit is interrupted and heat is
no longer produced.
The source of the infrared heat is a small electric bulb with a nominal voltage rating of 5
volts. The bulb is driven by a user replaceable 9-volt alkaline battery, which effectively
overdrives the bulb to produce an energy output of approximately 1.25 watts. This
overdrive effect produces the desired heat output. The bulb is recessed approximately
2mm inside the ABS housing of the THERAPIK®; the light orifice is covered with a
metal mesh that is in turn also slightly recessed to prevent direct contact with the skin.
The mesh also avoids pushing a stinger further into the skin in the event that the stinger
has been left behind in the wound. Thus, treatment may be initiated to inactivate the
venom before attempting to remove the stinger.
The bulb is approximately 3mm in diameter, resulting in a nominal cross-sectional area
of about 7mm². The output of the 1.25-watt bulb, therefore, provides a total power
density of approximately 0.18W/mm². The light orifice is a circle with a nominal area of
28mm² located approximately 2mm from the closest point of the bulb. The metallic mesh
material effectively blocks a percentage of the orifice. When corrected to account for the
distance between the bulb and the light orifice and the blockage of a percentage of the
orifice by the mesh material, the actual heat flux density produced by the device is
approximately 0.03 W/mm².
The application of this power density to the skin using the THERAPIK® results in the
delivery of heat to a depth of approximately 2mm. The user is instructed to apply the
device for as long as the heat is bearable on the skin (approximately 20 – 30 seconds).
This effectively raises the temperature of the tissue up to 2mm beneath the skin to 50°C 60°C, which is the temperature, required to destroy the effect of thermolabile venoms.
Because the heat becomes uncomfortable well before a burn occurs, it is virtually
impossible to injure the skin through normal use of the THERAPIK®.
The user is instructed to replace the 9-volt battery at least once a year.
DEVICE MODE OF ACTION
The application of heat to relieve the effects of insect bites is an extremely old technique.
Eastern medicine has relied on heat treatment for insect stings for thousand of years. In
the western world, the application of localized heat has also been accepted and practiced
as a “home remedy”. Perhaps the most common example is the camper’s or fisherman’s
technique of bringing the tip of a lit cigarette close to a mosquito or black fly bite until
the itching sensation subsides. Scientific evidence supports the use of heat treatment for
insect stings due to the thermolabile properties of the venom. Thermolability is defined
as instability or the loss of characteristic properties when heated to or above 50°C.
Up to 20,000 species of insects and sea creatures are known to have thermolabile venoms
that may be destroyed by the application of heat. The most common sources of painful
venomous stings are hymenopterous insects (wasps, bees, hornets, etc.) and sea creatures
such as jellyfish, weaver fish and scorpion fish. The pain from such stings is produced by
small biogenic amines (principally, histamine and serotonin) or peptides, which stimulate
the release of histamine by cells in the organism that has been stung. Prompt destruction
or inactivation of the venom interrupts the release of histamine, thus preventing or
relieving the discomfort of the sting.
Certain other insects cause itching, pain and/or irritation that are not caused by
thermolabile venom, but are still relieved by the application of heat. In these cases,
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heating the skin appears to soothe such irritating effects by increasing blood flow and
improving the cutaneous defense mechanism.
THERAPIK® achieves its desired effect of destroying thermolabile venoms by raising
the temperature of the tissue up to 2mm beneath the skin to 50°C - 60°C at the point of
application. Mathematical modeling has been performed to demonstrate that the
application of topical heat at a power density of 0.03W/mm² raises the temperature of the
tissue up to 2mm beneath the skin at the point of heat application to approximately 60°C
such that the heat can be comfortably sustained for the 20 – 30 seconds required to
inactivate the venom. The application of heat as produced by THERAPIK® from 20 –
30 seconds is sufficient to relieve the discomfort of most insect bites. Because the venom
of certain sea animals can be somewhat more resistant, the user is advised to gently
massage the affected area with the device for an extended application time as required.
EFFICACY DATA
To demonstrate the efficacy of THERAPIK® for its intended use, clinical evaluations
were conducted in Venezuela, France, Italy and Reunion (Mascarene Islands). In
Venezuela, a total of thirty-five individuals were treated over a four-month period in
1988-89. Thirty-two of the thirty-five users have received hymenopterous insect stings
and the remaining three users were using the device to treat mosquito and flea bites.
Most commonly, THERAPIK® was used to treat a single sting. In some cases,
however, multiple stings were treated including a thirty-year-old male who incurred a
total of thirty wasp stings. Here, the THERAPIK® was used to provide palliative pain
relief during transportation to the hospital for further medical treatment. The specific
breakdown of the injuries treated in the Venezuelan study is as follows:
Bee stings:
6 subjects/12 stings
Wasp stings: 25 subjects/63 stings
Ant stings:
1 subject/2 stings
Mosquito bites:
Flea bites:
2 subjects/20 – 25 bites
1 subject/10 bites
The individual users in this study included both male and female subjects ranging in age
from eighteen months to fifty-three years. Users were asked to record the number and
type of stings or bites, the time elapsed between the sting and the THERAPIK®
treatment, and the duration of heat application. Users were also asked to rate the efficacy
of the device on a scale from 1 (very good) to 4 (no effect), and to detail any side effects.
In thirty-three of the thirty-five cases, the efficacy of THERAPIK® was rated as “very
good”. The remaining ratings consisted of a “good” rating for a total of ten mosquito
bites, and a “moderate” rating for the individual with thirty wasp stings. With the
exception of the man with thirty wasp stings and one thirty year old male with an allergic
reaction to a bee sting, no side effects were reported. A detailed summary of this study is
presented in a table included with this document.
In 1988, a similar four-month clinical study was conducted at various locations in France,
Italy and in Africa on the Mascarene Island of Reunion. In addition to insect stings and
bites, this study also included stings from various sea animals. A total of thirty-four
subjects of both sexes ranging in age from one year to seventy-eight years of age were
included in the study. The specific treatment breakdown is as follows:
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Bee stings:
Wasp stings:
Hornet stings:
Ant stings:
13 subjects/13 stings
4 subjects/4 stings
2 subjects/2 stings
2 subjects/7 stings
Mosquito bites:
Spider bites:
Nettle bites:
Tick bites:
3 subjects/11 bites
1 subject/1 bite
2 subjects/18 stings
1 subject/1 bite
Sea Creatures
Weaver fish stings: 3 subjects/3 stings
Jellyfish stings:
2 subjects/17 – 25 stings
Scorpion fish stings: 1 subject/1 sting
As in Venezuelan study, the users were asked to record the number and type of stings or
bites, the time elapsed between the sting and the THERAPIK® treatment, and the
duration of heat application. Users were also asked to rate the efficacy of the device on a
scale from 1 (very good) to 4 (no effect), and to detail any side effects.
In twenty-eight of the thirty-four cases in this study, the efficacy of THERAPIK® was
rated as “very good”. Five users rated the efficacy of the device as “good”; these subjects
had received stings from a hornet, a scorpion fish, a weaver fish, a jellyfish and a spider.
One subject rated the efficacy as “moderate” for a single bee sting. Two users reported
itching following the THERAPIK® treatment, and the spider bite victim reported the
presence of a vesicle at the site of the injury. A detailed summary of this study is
presented in a table included with this document.
There was a slight difference in the data recording between the two studies in that the
Venezuelans recorded the duration of application as the time for which a sensation of
heat was actually felt, while the subjects at all other sites counted the application period
as the time during which the power button was actually depressed. The data may be
adjusted by adding approximately ten seconds to the Venezuelan data.
More Power 2 U Corp. wishes to stress that none of the users reported a burn or other
skin injury resulting from the use of THERAPIK®. In fact, no device-related side
effects at all were noted. It is believed that the data collected during these clinical trials
effectively documents the device’s utility and efficacy for the treatment of pain and
discomfort resulting from a variety of insect and sea animal stings. In addition, the
device appears to provide relief from the itching and discomfort of other non-venomous
insect bites.
TESTIMONIALS
Therapik® was field tested by the “North American Fishing Club” and “The National
Home Gardening Club” and received both of their Seals of Approval. Here is what their
Members had to say:
Keith Thomas, Bozeman, Montana says …. “I was not sure of the products claims at
first, but when the mosquitoes started to bite I found this to be a great product. I found
all the manufacturers claims to be true. Easy to carry, Easy to use, and EFFECTIVE.”
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Kelly Russell, Three Oaks, Michigan says … “Unbelievable! It really works. This really
takes the itch away. Especially from those mosquitoes that always find an area that you
missed with bug spray.”
Marie King, South Lyon, Michigan says … “I also welt up and itch terribly with
mosquito bites. After I got bitten, I used the Therapik and immediately the itching
stopped. No welts were present, it was as if I had never been bitten.”
Eleanor Branch, Tucson, Arizona says … “I have never used anything that stopped bite
itches so quickly or permanently.”
Debbie Ertmer, Larsen, Wisconsin says … “I am allergic to mosquito bites and they
swell up between the size of a nickel and a quarter and they itch excessively. I had eight
bites on one arm and I tried the Therapik, within a couple of minutes, the itching was
gone, the bite never swelled and the next day you couldn’t even tell where the bites had
been.”
Edie Ruedy, Saint Paul, Minnesota says …”Our mosquitoes here in Minnesota are the
size of B-29’s. At first I let one bite me and waited a bit and used Therapik. It worked!
It’s like it drew the sting right out!”
Ryan Gray, Flin Flon, Manitoba says … “Tried it out on bites a couple of days old and it
gave me relief from scratching them.”
Lauren Dautel, Montgomery, Alabama says … “This product worked wonderful on our
red ant bites, it took the sting and the bumps away, I highly recommend this product.”
Michael Schowen, Anchorage, Alaska says … “The Therapik lives up to it’s advertised
performance. Where I live mosquitoes, bees and especially during silver season (late
August to early September) “no see – ums” can be very abundant and very aggressive.
The Therapik has worked well in eliminating the annoyance of these types of bites.”
Karen Grimm, Cologne, Minnesota says … “Although I had my reservations, I was
pleasantly surprised by how well this product worked. It does remove the itch and pain
of insect bites!”
Rosella Glynn, White River, South Dakota says … “I was amazed - mosquito bites just
go away and deer fly bites has always made me swell-up badly and itch for days, but
with the Therapik all signs of the bite were gone.”
Mark Procoopio, Arvada, Colorado says … “The Therapik was put to the test! The test,
a three-day fishing tournament at Granly, Colorado. When I was done with treatment,
instant relief was achieved immediately.”
Al Ankrum, Kennewick, Washington says … “My 15 year old son was stung on the side
of his face by a wasp. He said that, in a matter of minutes, the sting did not hurt at all.”
Connie Fields, Warrens, Wisconsin says … “I found this little gadget to be very
effective. We have tried this on hawk fly bites, mosquito bites and bee stings.”
John Cain, Lugoff, South Carolina says … “I used this product on fire ant bites, black
fly, yellow fly and mosquito bites. It worked on all the bites that I had received.”
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William Harris, Santee, California says … “Therapik was tested while lake fishing in
San Diego. The product works on insect bites and bee stings. My friends and outdoors
contacts could not believe Therapik worked and all had to try it out. Results were
excellent even when used by non-believers.”
Francis Jones, Rayville, Missouri says … “This product works really well! The Therapik
is really effective for treating mosquito, sweet bee and honey bee stings and bites.”
Jon Brown, Columbus, Ohio says … “I think this is an excellent product. It relieved the
itching of mosquito bites as well as bee stings in one 30 second application.”
Peter Paiz, Antlope, California says … “I recently was stung by a wasp and tried the
Therapik and was amazed how quick and effective this product worked.”
Roger Key, White Settlement, Texas says … “Every angler or outdoors person should
make the Therapik a valuable addition to their trips afield.”
Larry Forton, Inglis, Florida says … “I was stung by a bumble bee and Joe used it on
me. It worked. Then Joe was stung by a wasp and I treated him, and I got stung by the
biggest hornet I’ve ever seen and that cinched it, the Therapik worked wonderful.”
Joseph Grigas, Derry, New Hampshire says … “I took it with me up north to my camp
in New Hampshire. The black flies and mosquitoes were really bad up there so the
Therapik was really great.”
Jeff Snead, Highland, California says … “I went camping last week for 6 days and was
stung numerous times, I used Therapik each time. I couldn’t believe how well it
worked.”
Brien Hefler, Severna Park, Maryland says … “I tested the Therapik while fishing and
on several camping trips, I found it easy to use, light and durable and very effective in
relieving the annoying side effects of bites.”
Jeff Barnes, Felton, California says … “When I first saw the product I said “ya.. right..”
But, amazingly it worked!”
Steve Esquivel, Ocean Springs, Mississippi says … “Being from the south we have a lot
of mosquitoes, gnats etc. I used the Therapik especially for fire ant bites. Usually they
swell and make sores, but not with the Therapik.”
Patricia Atkins, North Muskegon, Minnesota says … “Therapik works great for
mosquitoes, ants and sand fleas.”
Jack Lowas Sacramento, California says … “The only problem I had was getting it back
from my buddies!”
Philip Valkenburg, Redmond, Washington says … “Product removes itching right
away.”
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Bennett Durgeloh, Wasilla, Alaska says … “On a trip to pan for gold, several of us used
the Therapik. It does work.”
Craig Maxwell, Ashland, Oregon says … “I would highly recommend the Therapik to
anyone who is bothered by mosquito bites.”
Scott Dodge, Danville, Vermont says … “I used the product on many of my brook
fishing trips. There was plenty of action both with fish and biting insects. I was very
impressed. When I was bitten, I applied Therapik. It took out all the itching. This really
works and I recommend it for anyone.”
Steve Felts, Spring, Texas says … “A very simple and easy way of taking the sting out of
a bite. I used this on may wife and friends and all agreed that it worked!”
Robert Pucher, Beacon, New York says … “I had many bites on my hands and head
area, the product worked every time.”
Gavin Jensen, Crowder, Oklahoma says … “I found the Therapik to be just what the
manufacturers say it is.”
Kelso Jones, Birmingham, Alabama says … “It has now been used many times and
always with excellent results.”
Charlotte Cosby, Ragland, Alabama says … “The Therapik was great for relief of
itching and speeds healing. I recommend this product highly.”
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