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 Company Profile:
www.andantemedical.com
Andante Medical Devices, Inc. develops, manufactures, markets and services
patented Functional Feedback Therapy (FFT) systems that use audio and visual
biofeedback to help re-train the brain to get rid of bad habits following a
trauma and to quickly re-learn how to walk correctly again. The Andante team
consists of experts in rehabilitative medicine, biomedical engineering, and
physical therapy.
 Reynald Bonmati
Chairman/CEO
Mr. Bonmati has served as
President/CEO of Andante Medical Devices, Inc. since October 1, 2008 and
Chairman/CEO since July 20, 2010. Mr. Bonmati is also serving as Chairman of
the Board of Directors of Orthometrix, Inc., a distributor of peripheral
Quantitative Computed Tomography systems (pQCT®) for bone and muscle
research, and as President of Bones L.L.C. a private investment firm. Mr.
Bonmati has thirty years of experience in the founding and management of
companies in the Life Sciences. He has participated in the development of a
number of companies in the Life Sciences, including DNAX Research Institute
of Molecular & Cellular Biology (now part of Schering Plough, Inc.), Chiron
Corporation (now owned by Novartis), Codon Corporation (became Berlex
Biosciences and is now part of Bayer AG), Columbia Laboratories, Inc. (NasdaqGM:
CBRX), and Norland (now part of Cooper Surgical, the women’s healthcare unit
of the Cooper Companies – NYSE:COO). Mr. Bonmati holds B.S. and M.S. degrees
in Chemical Engineering from Institut National Superieur de Chimie
Industrielle in France, an M.S. degree in Petrochemical Engineering from
Ecole Nationale Superieure du Petrole et des Moteurs in France, as well as
an M.B.A. from University of Paris. In 1977, he moved to the United States
where he settled with his family and became a citizen. He started his first
company in 1980. |
Healthcare
Medical Devices
(Private)
Andante Medical Devices, Inc.
445 Hamilton Avenue, Suite 1102
White Plains, NY 10601
Phone: 914-694-2285
www.andantemedical.com
Andante Medical Devices
Print Version
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Click Below for
Video
Presentation
 Smart
StepTM is an innovative biofeedback and monitoring device designed to help
clinicians effectively guide patients with lower limb injuries due to
orthopedic or neurological disorders towards optimal functional
performance. It records and analyzes key parameters
during functional activities and provides instantaneous and accurate audio
and visual feedback.
Interview conducted by:
Lynn Fosse, Senior Editor,
CEOCFO Magazine,
Published – September 3, 2012
CEOCFO:
Mr. Bonmati, you have a long history in the industry; what is special for
you about Andante Medical Devices?
Mr. Bonmati: Andante attracted my attention 4 years ago when it was
developing the SmartStep® in Israel for orthopedic rehabilitation at the
hospital, particularly in sports medicine. At that time, Andante was
starting to look at the US market. Because of my history in the field, I
recognized that SmartStep was more than a device. It was a broad technology
platform, capable of producing a number or devices for a number of large
markets. I personally invested in the company and led its restructuring as a
US entity. I expanded its reach from orthopedic rehabilitation to the larger
neurological rehabilitation market; from the hospital market to the much
larger homecare market; and from the Israeli market to the US and Japanese
markets. Hopefully soon, we will expand to China and Europe. For example, in
the US alone, at $500 million total market potential for the SmartStep
Clinic model and $10 million consumable potential per year, the hospital
market is large. However, several segments of the homecare market are as
large or even larger, and per year. Just to name a few, the stroke market is
$2 billion per year in SmartStep potential sales. The hip and knee surgery
market is $500 million per year in rental and the orthopedic injuries market
is over $1 billion in rental, in the US alone.
CEOCFO: Would you tell us about SmartStep?
Mr. Bonmati: SmartStep is a patented technology platform, initially
used for gait training. It is used to help patients who have suffered from
an orthopedic or neurological trauma, get back to a normal life faster, and
not only at the hospital, but also at home. We are talking about quickly
regaining normal mobility after a sports injury, hip and knee surgery or
replacement, but also a stroke. There is also Parkinson’s and eventually
Diabetic Neuropathy. Unlike current technologies that are all passive and
more expensive, the SmartStep is unique in a sense that it interacts with a
patient and uses audio and visual biofeedback to help retrain the brain to
re-learn how to walk correctly, and also provide motivation to help speed up
recovery.
CEOCFO: What are the methods that have been used traditionally for
these applications and why is the SmartStep superior?
Mr. Bonmati: Despite the growing impact on our lives, this is a
sector that has seen very little innovation over the years. Current methods
are subjective. They use qualitative verbal instruction by physical
therapists, mirrors, bathroom scales and the famous “calibrated eyeball” of
the physical therapist. The current methods of measuring progress are
passive and have no biofeedback to retrain the brain. They cost between two
and twenty times more than the SmartStep. In addition, they are not mobile,
so you cannot bring them into the home environment.
CEOCFO: How widespread is the use today, where is the most use of the
SmartStep and how do you reach the markets that are not using it today?
Mr. Bonmati: Despite the low awareness of the market as we did not
have a US sales force until this year, we have sold the SmartStep Clinic
model to over 100 prominent hospitals in the US alone, to both their ortho
trauma and neuro trauma departments. We also received a contract from the
Veteran’s Administration to supply the 153 VA hospitals in the US. We
received market approval in Japan last year and we have now shipped over 100
units to Japan. We also expect market approval in China by the end of the
year. Regarding Europe, we already have the CE mark and have sold the
SmartStep passively to clinicians who came to the US for a trade show and we
plan an active approach shortly. We are also looking for a European
strategic partner to speed up market access. In the US, we started renting a
sale force in February of this year (2012). Our partner is called MedPro. It
distributes half a dozen devices from much larger companies in the US like
Smith & Nephew, Welch Allyn and Schiller. It is the first time that MedPro
teamed up with a small company like Andante. They love the device and they
think that it can penetrate not only the hospital, but also the long term
care market.
CEOCFO: When professionals are introduced to Andante Medical Devices,
do they get it right away and understand immediately how it works or do they
need convincing?
Mr. Bonmati: When you see the unit and try the unit, it is very easy
to appreciate immediately its impact, particularly on the patient. When we
show the unit to a group of therapists, we usually ask them to bring a
patient and most of the time they bring the most difficult patient for them
to treat and the patient usually wants to take the SmartStep home. The
concept sells itself and since it is a very small machine, it is easy to
transport, so demonstrations are easy to make. If you are talking about the
medical community, it is well documented that the overwhelming reason for
failures in lower limb surgery like the hip and the knee, of which there are
one million hip and knee replacement surgeries in the US per year, have
nothing to do with the surgeon or the implant. It usually has to do with the
lack of compliance of the patient with the limited weight bearing
instructions of the surgeon post surgery. The orthopedic surgeon will
prescribe increasing weight bearing on the affected limb post surgery. Say
you can only put 30% of your body weight for a week, and then increase that
to 60% and so on until putting your full weight on the affected limb. Not
enough weight can be as bad as too much weight too soon. There is no device
that can help the clinician determine, with minimum reliability, whether the
patients are actually putting the 30% weight as prescribed by the doctor.
Orthopedic surgeons have bought the SmartStep Clinic model and demonstrated
the medical necessity of the SmartStep to enforce such compliance. The first
study was published by Yale earlier this year and two more hospital studies
are in the process of being published. The next step is to do a home study,
where the focus would be to secure reimbursement for the prescription by
orthopedic surgeons of the use of the SmartStep to protect their surgery. A
reimbursement of $600 over 12 weeks, to protect surgeries costing between
$15,000 and $50,000 seems a no brainer.
CEOCFO: You recently launched the iSmartStep for use with the iPhone
and iPod; would you tell us how that will work and what it adds for you?
Mr. Bonmati: I just mentioned how doctors tried to enforce compliance
in the hospital, but when the patients are discharged, there is nothing to
help them continue the treatment at home. Therefore, the iSmartStep Basic
“made for iPod” will help do that. The clinician uploads the treatment to
the patient’s iPod and the patient takes the therapy to his or her home. In
addition, we have developed a SmartStep Secure Server that allows the
clinician to monitor directly from his or her office, the patient’s
compliance at home through Wi-Fi, 3G or 4G.
CEOCFO: You mentioned Japan, China, Europe and the US; as a smaller
company, how do you stay focused and get everything accomplished when you
have such a wide market, both geographically and for different medical
conditions?
Mr. Bonmati: I have done that in the past in more than 40 countries
and it is not difficult with good distributors. Our focus is actually now on
the US, because we are actively providing clinical support to MedPro’s sales
force of about 55 members. This means going in the field and making
demonstrations to hospitals and clinics. This is really what is taking our
time. Internationally, we defer to excellent distributors that I have used
for years before Andante. The distributors handle everything and our
contribution is to train them in the use of the SmartStep and its
applications. The bulk of the work was to get clinical approval in each
country. We got approval in Japan in May of 2011, after 6 months of effort
with a distributor I have worked with for 20 years and is now owned by
Canon. Now that the approval has been obtained, the distributor does most of
the work and we mostly answer questions. Therefore, the international effort
is pretty light and it does not unfocus the company.
CEOCFO:
Are there any concerns with the new healthcare bill in the US and how it
will play into what you are doing?
Mr. Bonmati: The SmartStep will be a plus, no matter what happens
with the healthcare reform in the US. Although there is a CPT Code for
clinics still paid by the session to reimburse them for the use of the
SmartStep (the payback time is between one and three months) the
reimbursement trend is towards paying a fixed cost to cover the entire
spectrum of the patient’s treatment, from acute care to rehab, down to the
home. It is called “bundled payments” and it will be used by Medicare
starting in 2013, no matter who wins the election. This is also where the
SmartStep is the most valuable for hospitals receiving a fixed amount to
rehabilitate a patient and it is already happening. These hospitals can
increase their profitability, thanks to the SmartStep’s ability to shorten
recovery times. Through Tele-Rehab, the SmartStep Server that I mentioned
before helps homecare services paid a fixed costs to rehab a patient,
increase profitability by reducing or even eliminating the costs of onsite
visits. The message to take home here is that the SmartStep reduces costs,
which is really what we need to do in healthcare.
CEOCFO:
Development is certainly expensive; is Andante Medical Devices funded well
enough to get through all of the upcoming steps or will you be looking for
additional funding?
Mr. Bonmati: A company is never funded enough. Including the $3
million that I personally invested in Andante, we have been raising a total
of over $10 million in equity. The company has no debt other than from
shareholders advances in between rounds of equity financing. I have raised
quality money in units of $100,000 to $250,000 from successful
entrepreneurs, clinic owners and investment banking executives and I am
calling on them for advice and contacts. I will continue to do so for the
$500,000 we need this year to reach breakeven. We now have 19 individual
investors. Once we reach breakeven, we will be ready for funding by
institutions or strategic corporate partners. I have already retained an
investment banker to raise the $3 to $5 million that we will need next year
to support our four-year plan. This will include setting up a satellite
manufacturing facility in the US to serve the US market that will represent
a substantial share of our total sales.
CEOCFO: Why should investors pay attention to Andante Medical Devices
today?
Mr. Bonmati: There are four points to take home. (1) Our market is
huge and growing, due to an aging population, but also because obesity and
diabetes are on the rise. Sports activities and recreational activities are
also on the rise, because our aging population wants to live a more active
life. In summary, you have a large market that is growing. (2) We are fully
in the trend of cost reduction in healthcare, which is a very important
point. (3) Andante is fully integrated. It has its own R&D, manufacturing,
service, clinical support, sales and marketing. (4) finally, our gross
margin is strong at about 80% and we have no bank debt. I think all that
makes for a good company to invest into. Personally, I find it exciting to
help people achieve a better quality of life, while having a chance to make
a significant capital gain. That is what drives us.
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