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Frequently Asked Questions(FAQs)

1. What is the miraDry treatment?


miraDry is the 1st and only FDA-cleared non-surgical solution to permanently reduce
underarm sweat, odour and hair of all colours with immediate result. Over 360,000 miraDry
treatments have been performed worldwide.

2. How does it work?


miraDry utilizes microwave energy that is concentrated to the dermal-fat interface where
the sweat glands, odour glands and hair follicles reside, providing high patient satisfaction in
1-2 treatments.

3. How long does treatment take?


Treatment time is about an hour (30 minutes per underarm) plus local anaesthesia time.

4. What temperature is reached during treatment?


Up to 60-70C or 140-158F

5. What is Microwave energy?


Microwave energy is an electromagnetic non-ionizing energy which is no different than
radiofrequencies and lasers. Microwave energy is used for medical applications across
healthcare industry including keratoconus, hyperthermia, benign prostatic hyperplasia and
other procedures. miraDry, Inc. holds the proprietary for removing sweat and odour glands
of the underarms.
6. What results can I expect?
You can expect immediate and lasting results. Once the miraDry treatment eliminates the
sweat glands, they’re gone for good. Clinical studies show an average of 82% sweat
reduction. As with any aesthetic treatment results, patient results and experience vary.

7. What does average of 82% sweat reduction mean?


Based on our clinical study via gravimetric assessment (objective measure of sweat
production), miraDry treatment has an average of 82% sweat reduction. Average of 18%
sweat glands remain.

As you can see from the bar graph, most patients will have substantial % of sweat reduction
compared to baseline and the average is 82%.

a. 70% (18/26) of patients had higher sweat reduction than average 82%.
b. 23% (6/26) of patients had lower sweat reduction than average 82% but higher than
50% sweat reduction.
c. 8% (2/26) of patients had lower than 50% sweat reduction.

However, during consultations in a real practice it is not possible to anticipate which patient
will have 99% reduction (as patient # 26) or 30% reduction (as patient # 1) or any reduction
in between (as patient # between 2-25). What we know is 1-2 out of 10 patients will require
2 treatments to reach close to average of 82% sweat reduction. For this reason, miraDry is
consulted as 1-2 treatment for lasting result.

8. How many treatments are recommended?


With miraDry, most patients will see results in one treatment. However, some patients may
benefit from a 2nd treatment to further reduce the amount of sweating.
9. Who are candidates for 2nd treatment?
Either dissatisfied patients after one treatment (need starch-iodine test before 2nd
treatment) or those patients satisfied with one treatment but would like additional sweat
and odour reduction.

10. How many additional sweat glands can be eliminated after 2nd treatment?
Additional average of 82% sweat glands will be removed from the remaining sweat glands
from the 1st treatment, which is an average of 18%. Most patients are happier and
experience a much more drastic sweat and odour reduction after 2nd treatment.

11. How soon can I provide a 2nd treatment?


When all side effects have resolved. Generally, this takes about 3 months.

12. What is the protocol for excessive sweat (hyperhidrosis) and excessive odour
(osmidrosis) suffering patients?
The vast majority of providers are offering 2 treatments for heavy sweat and odour suffering
patients and seeing satisfactory results.

13. Would a 3rd treatment be beneficial?


A very small subset of patients may benefit from a 3rd treatment. If you have chosen the
largest appropriate template for the axilla and selected EL5 for both previous treatments,
the benefit may be negligible. Prior to a 3rd treatment, we highly recommend a starch-iodine
test to determine the sweat pattern. If the sweating is occurring outside the treatment area,
subsequent treatments would not improve the outcome.

14. The patient reports minimal results after 2-3 treatments.


In our studies, every patient experienced sweat & odour reduction, with the average
reduction being 82%. If results are minimal after 2 or even 3 treatments of miraDry, this
could be due to the following reasons:
• Although most glands are within 2-5mm underneath the skin, some glands may lie too
superficial or too deep, in which case the heat will not destroy them, even at the highest
energy level.
• Sweating may be occurring outside the treatment area (upper arm or side of chest) and
going to the underarm in which case the patient may feel like they are sweating from
the underarm.
• If lower settings were used for previous treatments, not all glands may have been
destroyed.
• Sweating may be related to use of drugs and toxins, and/or any predisposed conditions
and diseases such as thyroid disease. It is best to discuss the most suitable course of
action with the miraDry provider.

15. Patient complains that sweat had reduced immediately and was restored weeks
after treatment.
Patients will generally experience a significant reduction immediately post treatment. Some
patients may experience 100% dryness for a few days to weeks following treatment due to
edema (swelling) blocking sweat from coming out. As swelling subsides from post treatment,
any glands that were not eliminated (average of 18%) will begin to produce sweat. The
amount of sweat should be dramatically reduced from the patient’s baseline, but some
sweat is expected. To determine whether a patient is sweating from the treated or
untreated area, a starch-iodine test may be performed.
16. How long does the results last?
miraDry procedure eliminates sweat and odour glands. Once destroyed, these glands do not
regenerate so results are permanent. This can be seen in our histology data and 2-year
clinical data with multiple metrics to show stability of results.

17. When is the best time to see the actual results?


3 months following treatment once the tissue healing process is complete or nearly
complete. Every patient’s recovery time varies.

18. Don’t I need sweat glands?


While your body does need sweat glands to cool itself, your body has 2-4 million sweat
glands and only about 2% are found in your underarms. Eliminating this 2% of sweat glands
does not affect your body’s ability to cool itself. With miraDry, you will experience the many
benefits of reducing sweat in the underarm area, but you will continue to sweat in other
areas of your body.

19. How many treatments will I need?


You can see results in as little as one treatment. However, as with any aesthetic treatment,
you may need a 2nd treatment as patient results and experience vary.

20. My patient has a defibrillator. Can they be treated with miraDry?


(an electric implant or defibrillator, pacemaker, insulin pumps etc.)
Treating a patient with an electronic implant of any kind is a contraindication. It is unknown
if the electromagnetic waves emitted by miraDry will interfere with the implanted device
and we have not conducted a clinical study on patients with electronic implants.

21. Contraindicated for patients who:


• Have a heart pacemaker or other electronic device implant
• Use supplemental oxygen
• Have had prior problems with locally injected anaesthesia
(e.g. lidocaine with epinephrine, medications that interfere with numbing, etc.)

22. Considerations
Not contraindicated but would be at the discretion of the physician to proceed with
treatment.
• Immune-compromised or taking medications that might interfere with healing post-
procedure
• Previous axillary surgery (e.g. lymph node dissection) that may have changed the skin &
fat interface in the treatment area
• Pregnancy

23. Why HVA?


We recommend the use of High Volume Anaesthesia (HVA) to create a greater separation,
pushing the nerve bundle branch further away from the energy. By creating this distance,
the highest energy levels can be utilized throughout the treatment zone providing a high
patient satisfaction in as little as one treatment.
24. What is the recommended anaesthesia solution?
• 250cc bag of normal saline (0.9% Injection USP)
• 50cc of 1% lidocaine with epinephrine (1:100,000)
• 2.5cc of sodium bicarbonate (8.4% Injection USP)

25. What if only 2% lidocaine with epinephrine is available?


Use 25cc of 2% lidocaine with epinephrine (halving the recommended 50cc of 1% lidocaine
with epinephrine)

26. Can another numbing agent such as Marcaine be used?


We do not have studies to support the recommendation for using other numbing agents.
Pain management is ultimately at the discretion of the treating physician.

27. Can miraDry be administered with only a topical numbing cream?


No, a numbing cream does not provide adequate pain control at the depth at which the
energy will penetrate (2-5mm).

28. Do I have to use all of the volume recommended?


We highly recommend using the minimum amounts shown on the anaesthesia table.
Administering the recommended volume limits potential for nerve interaction and respects
safe lidocaine dosages.

29. Is there any pain or downtime?


Most patients describe the procedure as painless with little to no downtime. Local
anaesthesia is administered to the underarms prior to the treatment for patient comfort.
Most patients experience little to no downtime and return to regular activity (like returning
to work) immediately. Exercise is typically resumed within several days. You may experience
swelling, numbness, bruising and sensitivity in the underarm area for several days post-
treatment.

30. What skin types can be treated?


miraDry can be performed on all skin types. In our clinical studies, 10-20% of the patients
were skin types IV or V, with the remainder being skin types I to III. Microwave energy is
colour blind therefore, technology does not get impact from colour of the skin.

31. Odour reduction?


Patients can experience a reduction in odour in as little as one treatment.

32. Hair reduction?


Our clinical data shows an average of 70% hair reduction of all colours.

33. When do you perform starch-iodine test?


Before the 2nd treatment to evaluate how many sweat glands remain and their precise
location. After starch-iodine test, decision can be made to either retreat the entire area or
customize.

34. Why is starch-iodine test not recommended prior to 1st treatment?


The results of the starch-iodine test for the majority of patients prior to any sweat removal
treatment will look pretty much the same, like the below ‘Baseline’ photo. The black area
represents sweat. Therefore, a starch-iodine test is not required prior to first treatment.
35. Why am I unable or have difficulty applying the template?
• Is the axilla clean and free of antiperspirant/deodorant/lotions?
• Verify that you are using 70% isopropyl alcohol (ISOCOLTM).
• Verify that ink/print side is patient facing
• Squeeze the gauze to remove any excess alcohol. Dripping refers to too much alcohol.
Apply the gauze over the template with firm pressure by palm, not fingers.

36. What information should be provided during consultation and follow ups?
• Pre and Post procedure care
• Common side effects
• Less common side effects
37. What are the most common side effects?
Swelling, soreness and altered sensation in or around treatment area. Typically clears within
few weeks.

38. Swelling in treatment area


All patients can expect to experience some level of swelling that may last up to 8 weeks (it
may take longer for some patients). The treating miraDry physician may recommend taking
ibuprofen to help alleviate swelling. Icing the area for 48 hours post treatment is also
recommended (20 minutes on and off). To protect the skin, ensure that ice is wrapped with
a paper towel.
39. Swelling in adjacent arm and hand or torso
Most patients report mild to moderate swelling in the treated area. However, swelling of the
trunk, torso or adjacent arm may also occur post treatment. It is known that HVA can move
down the body due to gravity and will exit through natural bodily functions. Symptoms
typically resolve completely without any medical intervention and generally takes a week to
resolve. Refer to the treating miraDry physician regarding symptoms for any further
recommendations.

40. What is Lumps and Bumps?


Lumps and bumps are a known side effect of miraDry that patients may experience in the
axilla post miraDry. Lumps and bumps are known as fibrosis and scar tissue. As scar tissue
matures, it will generally soften and resolve. We are essentially causing damage with heat to
destroy the glands and hair follicles, thus causing scar tissue. Every patient is different during
the healing process. The usual inflammatory lumps and bumps generally will resolve in 4-6
weeks. However, some patient will hold on to scar tissue longer and will take longer than 6
weeks to resolve. If there is desire to hasten resolution, an intralesional steroid injection can
be considered at discretion of the treating physician.

41. Does miraDry cause enlarged lymph nodes?


Patients can experience lumps and bumps in the axilla post miraDry and these lumps and
bumps can be mistaken for enlarged lymph nodes. Lymph nodes are typically located much
deeper than the underarm sweat glands. The miraDry procedure targets the area where the
sweat glands reside and utilizes HVA and suction of the bioTip to protect the underlying
structures. In clinical studies that thoroughly monitored patient’s health, there was no
evidence of affected lymph nodes.

42. What is Tight Banding?


Tight banding is a known side effect of miraDry which may be due to subdermal scarring or
fibrosis from the procedure. It is more often seen in patients with a smaller frame. Common
complaints related to tight banding are:
• Tightness when lifting or extending the arm
• May be accompanied by pain or discomfort
• Tendon like protrusion which may be visible and extend from the axilla down to the
elbow
Proper positioning of the arms during the procedure plays an important role in preventing
tight banding. It is recommended to use the miraDry armrest and keep arms bent, with hand
slightly above the head and in a neutral position. Massaging and stretching may help and
some physicians have reported using an intralesional steroid to help aid resolution.

43. Burns
miraDry employs a patented cooling system in the handpiece that cools and protects the
skin. However, some superficial burns have been reported. Never use gel (ultrasound or IPL
gel); they tend to be thick and in large amounts can potentially cause thermal injury. KY
Liquid or KY Jelly is the recommended lubricant to use.

44. Can I treat patients with hidradenitis suppurativa?


miraDry is not FDA cleared for the treatment of HS. In a study, microwave energy was shown
to aggravate mild forms of this condition. miraDry does not recommend treating patients
with HS. Ultimately it is up to the discretion of the physician to treat this patient.
45. Does my patient have to wait for their Botox to wear off before treating with
miraDry?
There is no need to wait. Be sure to inform the patient that they will still be experiencing the
benefits of Botox. It may be difficult to discern the full effect of miraDry until the effects of
Botox wear off.

46. My patient is taking Accutane. Can I treat them?


Accutane can make the skin more fragile and slow the natural healing process. We suggest a
3-6 month post Accutane period prior to having a miraDry procedure.

47. My patient is taking Rubinol. Can I treat them?


Rubinol should not interfere with the healing process of miraDry. It may be difficult for the
patient to assess the baseline sweating prior to treatment as well as the reduction post
miraDry.

48. Is it safe to treat patients with vitiligo?


miraDry has not been tested on patients with vitiligo. Vitiligo is not a contraindication and
miraDry has a cooling mechanism to protect the top of the skin during energy delivery. It is
at the discretion of the treating physician.

49. Is there compensatory hyperhidrosis after miraDry treatment?


There is no compensatory hyperhidrosis with the miraDry procedure. Compensatory
excessive sweating only occurs when sympathetic nerve located in the spinal column is cut
through a surgery called Endoscopic Thoracic Sympathectomy (ETS). ETS surgery is reserved
for only certain severe cases of palmar hyperhidrosis (excessive sweat of the palms) but not
recommended in other parts of the body including underarm excessive sweat as there
appears to be reduced benefit and greater risk. miraDry is a non-invasive treatment that
selectively removes sweat and odour glands located superficially under skin surface 2-5mm
and not the deep spinal sympathectomy nerves.

50. How to manage patients who believe they have compensatory hyperhidrosis after
miraDry treatment?
Reports of compensatory hyperhidrosis are very subjective and not quantified. The miraDry
procedure does not affect the major branches of the central nervous system (CNS), as it only
aims heat energy to target the location where axillary sweat and odour glands reside; 2-
5mm below the skin. Therefore, we highly recommend that during consultation, patient is
asked about sweating in other parts of the body.
Many times, a patient who is focused on their axillary sweating after miraDry treatment may
become more aware of other areas that are sweating which were already existing but less
self-conscious before miraDry treatment.

51. What if a patient complains of more potent and pungent odour post miraDry?
One reason these patients may think there is more odour could be related to healing from
the procedure. Another explanation is since we reduce the wetness in the underarm, we are
changing the “flushing” glands so odour may be more noticeable or different. We believe
once these patients have been fully healed from the procedure the odour should be
reduced. Note that some patients may be hyper-focused on the underarm after miraDry
treatment and noticing odour which may have been there before.
52. Is it safe to treat patients with extra-glandular breast tissue in the axilla?
miraDry does not have any data on treating patients who have extra glandular or accessory
breast tissue in the axilla. It is not a contraindication but would be at the discretion of the
physician to proceed with treatment.

53. Can miraDry be performed over a tattoo in or near the axilla?


We do not have any clinical data to provide on this subject. In some cases, patients have
experienced hyperpigmentation. Therefore, the colour of the tattoo may be affected. It is
the physician’s discretion to treat.

54. Excessive sweating after pregnancy


Some patients who have given birth since receiving a miraDry treatment may notice
increased sweating. This is very common post-partum and is the effect of the body flushing
out excess fluids which had accumulated during pregnancy. While hormones directed your
body to hold onto liquid during pregnancy are redirecting to flush it out. Body is naturally
cleansing itself through sweat glands. It will taper off naturally, as the extra fluids make their
way out and hormone levels settle down, usually after about 6-8 weeks.

55. Stronger odour during breastfeeding?


Your body will emit a stronger odour through your underarm then normal to help your baby
find its source of food. This is your body’s response to naturally assist the baby in finding the
breast and will begin right after giving birth. It will taper off naturally, as the extra fluids
make their way out and hormone levels settle down.

56. Can a nursing patient be treated with miraDry?


There are no specific contraindications for patients who are nursing. The effects of the
energy are focalized and only penetrate 2-5mm underneath the skin. The physician should
evaluate whether the energy or local anaesthesia would have a negative impact on the
patient. During the healing process (several days) the patient’s underarms may become
swollen and tender which could make nursing and taking care of an infant difficult.

57. Can my pregnant operator perform miraDry?


The energy given off by the miraDry handpiece is very focused and localized to just a few
millimetres under the patient’s skin. The miraDry system was designed and independently
tested to international standards to verify that the stray microwave energy is below the
acceptable requirements. There should be no risk to the operator.

58. Nerve interaction during anaesthesia delivery


Some patients may feel a shooting pain or electrical sensation during needle insertion. Prior
to anaesthesia administration, the patient should be informed that if they feel a shooting
pain or electrical sensation to their elbow or hands, they should inform the operator
immediately. If this occurs, re-position the needle a few millimetres away and inject the
anaesthesia. This area should not be treated and skipped as it may be difficult for the
patient to assess if the energy is reaching the nerves once numbed.

59. Nerve interaction during energy delivery


Some patients may feel a shooting pain or electrical feeling during the delivery of energy.
The patient should be informed that if they feel a shooting pain, tingling or heat sensation to
their elbow or hands, they should inform the operator immediately. If this occurs, terminate
energy delivery immediately. Do not retreat this area.
60. A patient feels numbness or tingling or pain in the forearms and/or fingers
Although extremely rare, some patients may experience numbness or tingling or pain in the
forearms and/or fingers. There may have been interaction with the brachial plexus nerves
and may have occurred during anaesthesia administration and/or energy delivery. Generally,
symptoms will resolve spontaneously without intervention over time. This can take a few
weeks or months to resolve. Following the recommended volumes for HVA administration
will limit the potential for nerve interaction during treatment.

61. Does miraDry cause hyperpigmentation?


This may be more likely in patients with more melanin (darker skin). This usually resolves
over time; some physicians have reported prescribing skin lightening creams.
Hyperpigmentation usually resolves within 8 weeks and some patients may take longer.
Hyperpigmentation could be permanent in some patients. Many patients already have
hyperpigmentation in the axilla secondary to irritating antiperspirants and friction. We
recommend that if this is noted beforehand, that it is documented and pointed out to the
patient. Sometimes they are not aware of pre-existing hyperpigmentation.

62. Does miraDry cause scarring and/or keloids?


miraDry is a non-surgical procedure and should not cause any external scarring. There is a
cooling plate that protects the skin during the procedure. However, for patients with darker
skin, hyperpigmentation may occur which most often resolves. Those patients susceptible to
keloids are not recommended for miraDry.

63. I can’t obtain suction when trying to deliver energy.


• No lubricant: use KY Liquid or KY Jelly to aid in acquisition.
• Axilla too cold:
a. Place your hand (clean glove) on the axilla
b. Fill a glove with warm water, place on axilla
• bioTip may be clogged with too much lubricant. (KY Liquid or KY Jelly)
• Detach and rotate bioTip
• Restart the console

64. Does the bioTip expire?


The bioTip expires 3 hours after the first energy delivery. If no energy has been delivered,
the bioTip will expire within 24 hours of being attached to the handpiece.

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