We are a medical technology company focused on developing and commercializing
products utilizing our proprietary microwave technology platform.
Our first commercial product, the miraDry System, is designed to ablate axillary,
or underarm, sweat glands through the precise and non-invasive delivery of energy
to the region where sweat glands reside. The energy generates heat which results
in thermolysis of the sweat glands. At the same time, a continuous hydro-ceramic
cooling system protects the superficial dermis and keeps the heat focused at
the sweat glands. Because sweat glands do not regenerate after the treatment,
we believe the results are lasting. Microwaves are the ideal technology as the
energy can be focused directly at the fat and dermal junction where the glands
reside.
We developed the miraDry System to noticeably and measurably reduce the sweat
in the underarm for patients with sweat ranging from excessive to average. In
our pivotal U.S. clinical trial involving 120 patients, 89% of patients experienced
reduction in their sweat with no reported deaths, injuries requiring immediate
medical attention to prevent death, or permanent impairment. In a second study
involving 31 patients, patients reported an average of 82% sweat reduction at
12 months and 100% of patients reported being no longer bothered by their hyperhidrosis
at 24 months.
We received clearance from the U.S. Food and Drug Administration, or FDA, in
January 2011 and received CE mark approval in December 2013 to market the miraDry
procedure for the treatment of primary axillary hyperhidrosis, or a condition
characterized by abnormal sweating in excess of that required for regulation
of body temperature. Additionally, we have received approval of the miraDry
treatment in several other countries since our FDA clearance in 2011.
The miraDry System consists of a console and a handheld device which uses consumable
single-use bioTips. We sell our miraDry System and bioTips only to physicians,
including dermatologists, plastic surgeons, aesthetic specialists and physicians
specializing in the treatment of hyperhidrosis. Aesthetic specialists are physicians
who elect to offer aesthetic procedures as a significant part of their practices
but are generally not board-certified dermatologists or plastic surgeons.
Hyperhidrosis is a medical condition of varying degree in which a person sweats
excessively. A study published by Strutton et al. in June 2004 in the Journal
of the American Academy of Dermatology, titled “US prevalence of hyperhidrosis
and impact on individuals with axillary hyperhidrosis: Results from a national
survey,” estimated that 2.8% of the general population has hyperhidrosis
(in this paper defined as excessive or abnormal sweating) with 50.8% thereof
having axillary hyperhidrosis. Additionally, the general consensus of medical
practitioners is that the definition of hyperhidrosis includes anyone who is
bothered by their sweat. As such, the definition of axillary hyperhidrosis is
broad in scope and the condition depends upon whether patients have determined
that their sweating is excessive or abnormal. Because this assessment is subjectively
determined by the patients themselves, there is no quantifiable standard that
medical practitioners use to determine whether a patient is suffering from axillary
hyperhidrosis. If patients subjectively determine that their sweating is excessive
and as such are bothered by their sweating, such patients are considered to
be suffering from axillary hyperhidrosis.
We developed the miraDry treatment to provide patients with a non-invasive and
durable procedure to selectively ablate underarm sweat glands for both severely
hyperhidrotic patients and those that are bothered by their underarm sweat.
However, since our FDA clearance only permits us to market the miraDry System
for the treatment of primary axillary hyperhidrosis, a condition characterized
by abnormal sweating, we are limited in our ability to market the miraDry System
for the treatment of average sweating. In other words, our FDA clearance only
allows us to market the miraDry System for the treatment of patients who subjectively
determine that their sweating is excessive and are therefore bothered by it.
To the extent we were to market the miraDry System for use by patients who did
not determine their sweating to be excessive or abnormal, we would not be marketing
the miraDry System in compliance with its labeling. The miraDry treatment is
clinically proven to reduce sweat in a one or more 60-minute procedures, allowing
most patients to achieve immediately noticeable and durable results without
the pain, expense, downtime, or repeat visits associated with surgical and other
minimally-invasive procedures. The sweat glands in the treated area are ablated
through targeted heating of the tissue, and because the body does not regenerate
sweat glands, we believe the results will be lasting, although some patients
may need to repeat the miraDry procedure to achieve the lasting results. Due
to these advantages, we believe that the miraDry treatment is appealing to a
wide range of individuals seeking a lasting solution to underarm sweat.
In addition, the miraDry procedure is not technique-dependent, does not require
significant training or skill for the treatment provider, and the user-interface
guides the provider through each step of the procedure for each treatment. The
user-friendly nature of the miraDry System allows our physician customers to
easily delegate the treatment to physician assistants and nurse practitioners
thereby freeing up their time for other physician-dependent procedures.
We selectively market the miraDry System only to physicians, including dermatologists,
plastic surgeons, aesthetic specialists and those physicians specializing in
the treatment of hyperhidrosis who express a willingness to position miraDry
as a premium and differentiated treatment and participate in our global marketing
and support programs. Aesthetic specialists are physicians who elect to offer
aesthetic procedures as a significant part of their practices but are generally
not board-certified dermatologists or plastic surgeons.
We intend to market the miraDry System to physician practice sites on a global
basis. We utilize our direct sales organization to market and sell the miraDry
System in our North American market, which includes the United States and Canada.
In our markets located outside of North America, we market and sell the miraDry
System through a network of distributors.
Physicians can market the miraDry treatment as a premium, highly-differentiated,
non-surgical sweat reduction procedure. Based on our commercial data, we believe
physicians can recoup their capital expenditures within 12 months on average,
assuming modest use of the miraDry System, even though the cost of the miraDry
treatment is not reimbursed by any third party payors. We have sold the miraDry
System in over 40 international markets outside of North America, including
placements in Asia, Europe, the Middle East and South America.
We generate revenues from sales of our miraDry System and from the sales of
bioTips which are required for use for each miraDry procedure performed.
Our miraDry System utilizes microwave energy to deliver heat to the location
of the skin where most underarm sweat glands reside – at or just below
the skin-fat interface. We designed a proprietary handpiece that automatically
focuses the energy at the skin-fat interface, regardless of skin thickness.
When the physician or nurse practitioner places the handpiece to a specific
area of the underarm as instructed by the graphic user interface, the energy
is delivered automatically to the target tissue. The heat generated in the tissue
exceeds the threshold for cellular necrosis, thereby ablating the sweat glands
where the energy is focused. Surface cooling prevents the heat from damaging
the superficial tissue above the skin-fat interface. In the underarm, many of
the hair follicles are in the same relative location as the sweat glands. Therefore,
the heating will also cause destruction and elimination of the hair follicles
in those areas.
Our miraDry treatment has been clinically demonstrated to reduce sweat and hair
from the underarm without causing injury to critical surrounding structures.
The surface cooling protects the epidermis and the majority of the dermis from
damaging heat. The deeper underlying structures are protected by two mechanisms.
First, our anesthesia protocol calls for creating a distance barrier between
the underlying structures and the surface of the skin where the handpiece is
positioned. A significant volume of anesthesia fluid is administered between
the skin (and target tissue) and the underlying structures, which causes a separation
of the target tissue from the underlying structure. As the handpiece is positioned
just outside the skin, the underlying structures are further away from the handpiece,
keeping them safe from damaging heat. Second, we employ a vacuum suction system
in the handpiece where the skin is pulled up into a vacuum chamber within the
handpiece. Typically, the underlying structures either remain stationary or
move slightly with the vacuum action, thereby creating further distance between
the handpiece and the underlying structures.
The miraDry System and bioTips
We generate revenues from sales of our miraDry System and single-use bioTips.
Our proprietary consumable, the bioTip, is designed such that each bioTip is
encoded to be used only with our proprietary system and expires within a set
time and cannot be reused. We generate a recurring revenue stream from bioTips
that are required for each patient treatment.