by International Biophysics
The AffloVest Advantage. The Proof is in the Data.
Patents Pending – USA & Worldwide
Portable, battery operated, fully mobile during use,
HFCWO therapy
Breathe Better. Be Free.Clear your Chest with AffloVest.™
AffloVest: Clinical Advantage2
International Biophysics brings to market innovative, disruptive medical devices and technologies that improve treatment therapies and patient outcomes. Centered on a precision ISO 13485 certified, FDA registered, quality controlled manufacturing facility in Austin, Texas, International Biophysics has a 25 year pedigree of successful medical product and technology launches around the globe.
We discover, make and deliver science inspired medical innovation, creating custom pathways to success in multiple markets, spanning direct-from-manufacturer sales to product line and company spin-off acquisitions.
www.afflovest.com 3
The Proof is in the Data.
In a clinician paper by Michelle Tackett, RRT and Vivian Henderson, RRT A total of 25 patients were set up on
the AffloVest. The data presented in this
clinician paper is from twelve patients
(48%) who experienced increases in
their lung function scores after adopting
AffloVest technology into their Airway
Clearance Treatment (ACT) regimen. The
remaining 13 patients (52%) saw no
significant increase, and no decrease,
in their lung function. All patients
had the benefit of increased mobility,
convenience, ACT therapy and comfort
of the AffloVest. The 12 patients ranged
in age from 11 to 18 years old and they
all used the AffloVest for periods ranging
from less than a month to almost a full
year. Eleven (11) of the 12 had been using
air bladder style vests previously. One
patient had previously used no ACT until
adopting the AffloVest. The lung function
scores collected were FVC, FEV1, and
FEF 25-75. Average FVC, FEV1, and FEF
25-75% increased 15.22%, 17.41%, and
11.21% respectively with the AffloVest.
Patient 1 Patient 2 Patient 3 Patient 4 Patient 5 Patient 6 Patient 7 Patient 8 Patient 9 Patient 10 Patient 11 Patient 12
FVC (L)
FEV1 (L)
FEF 25% - 75% (L/sec)
1.5
2
2.5
3
3.5
4
4.5
5
5.5
0 50 100 150 200 250 300 350
Days Using AffloVest
1
1.5
2
2.5
3
3.5
4
4.5
0 50 100 150 200 250 300 350
Days Using AffloVest
Days Using AffloVest
0
1
2
3
4
5
6
0 50 100 150 200 250 300 350
Patient 1 Patient 2 Patient 3 Patient 4 Patient 5 Patient 6 Patient 7 Patient 8 Patient 9 Patient 10 Patient 11 Patient 12
Patient 1 Patient 2 Patient 3 Patient 4 Patient 5 Patient 6 Patient 7 Patient 8 Patient 9 Patient 10 Patient 11 Patient 12
** Both patients 4 and 8 had invalid test results due to erroneous spirometry output data. The erroneous data were not included in scoring calculations.
Download the paper at:www.afflovest.com/lungfunctionimprovement
AffloVest: Clinical Advantage4
And, in an evidence-based study of adolescents with cystic fibrosis by Michael Cooper, RT the AffloVest® by
International Biophysics contributed to
improved lung function scores. The data
demonstrates the AffloVest improved
breathing scores in the five patients
followed in this study. Average FVC:
0.308L, 09.5% Increase Average Fev1:
0.312L, 11.5% Increase Average FEF 25-
75%: 0.744L, 21.3% Increase The overall
usage between tests was 3–5 months.
The clinician performing this study
concluded that the AffloVest showed
improvement in each patient’s condition.
The Proof is in the Data.
Improvements with the AffloVest were noted as follows:
FVC increased 14.9%, FEV1 increased 17.3%, and FEF
increased 23.8%. In addition, his mother states that her
son enjoys wearing the AffloVest and it has helped him
increase his basketball performance.
FVC (L) FEV1 (L) FEF 25–75% (L/sec)
Predicted Value 3.33 3.06 3.44
Air Bladder Vest 2.62 2.08 1.93
Afflovest 3.01 2.44 2.39
Patient 2 Age: 14 yearsSex: male
Download the paper at:www.afflovest.com/lungfunctionimprovement
www.afflovest.com 5
Additional Clinical Data
Location of Study: Bad Reichenhall Clinic
Neurological and Orthopedic Rehabilitation
Salzburger Strasse 9-11, 83435 Bad Reichenhall
This study is an interventional analysis of the effect the introduction of the AffloVest as a therapeutic aid has on the patient’s ability to cough more productively. With every single patient, a dramatic improvement in cough productivity and bronchial secretion viscosity was observed in combination with the pulmonary and orthopedic regimen of care. It became fundamentally easier for the patients to cough out mucus, because of the more fluid secretions and more productive cough provided by the introduction of High Frequency Chest Wall Oscillation treatment with the AffloVest.
Other Clinical Advantages of the AffloVest:
• The AffloVest is the first truly portable, battery operated, fully mobile during use, High Frequency Chest Wall Oscillation (HFCWO) vest.
• The AffloVest promotes airway clearance and lung secretion mobilization prescribed in the treatment of respiratory diseases like Bronchiectasis, Cystic Fibrosis, MS, MD, ALS, and other neuromuscular diseases.*
• Targeting all 5 lobes of the lung including upper lobes both front and back
• With its three modes of operation, Percussion, Vibration and Drainage, the AffloVest more accurately mimics Chest Physical Therapy
• Programmable controller makes it easier for patient to do their therapy
• Eight (8) oscillating motors create eight (8) individual pressure wave forms to help produce shearing forces in the lungs
• With AffloVest’s unique technology, the patient can take full deep breaths during therapy
• Reimbursed by Medicare, Medicaid and private insurance**
* AffloVest requires a doctor’s prescription for treatment by High Frequency Chest Wall Oscillation (HFCWO). The AffloVest has received the FDA’s 510k clearance for U.S. market availability, and is approved for Medicare and private health insurance reimbursement under the Healthcare Common Procedure Coding System (HCPCS) code E0483 – High Frequency Chest Wall Oscillation.
** Patients must qualify to meet eligibility requirements.
Productivity 0 1 2 3 4 5of Cough
# of Patients 4 5 6 3 0 2
0 1 2 3 4 5
< Very Fluid Secretions
6
5
4
3
2
1
0
Very Thick Secretions >
# o
f Pa
tien
ts
Productivity of Cough
Patents Pending – USA & Worldwide
Stay mobile during use, live your life
AffloVest: Clinical Advantage6
300 –
275 –
250 –
225 –
200 –
175 –
150 –
125 –
100 –
75 –
50 –
25 –
0 –15–34
Prev
alen
ce p
er 1
00,0
00 P
opul
atio
n
Prevalence of Bronchiectasis
35–44 45–54 55–64
Age
65–74 > 75 Average
Bronchiectasis is a chronic condition that causes airways to widen and become scarred. This often occurs
from infection or injury and prevents airways from properly clearing mucus. The inability to clear mucus
results in repeated lung infections from a build up of bacteria and toxins in the lungs.
Frequent infections will cause incremental damage to the lungs. Such damage can reduce oxygen
exchange over time, resulting in breathing difficulties, chronic cough and chest pain. Regardless of the
underlying cause, the common denominator in bronchiectasis is a breakdown of the lung defense system
– especially airway clearance mechanisms.1
Although there is no cure for bronchiectasis, it can be effectively treated. Treatment can greatly improve
quality of life for affected patients and reduce healthcare costs. Studies have shown that using high-
frequency chest wall oscillation (HFCWO) devices for chest oscillation therapy is highly effective in
eliminating mucus from the lungs, increasing airway flow and improving pulmonary function.
Patient DemographicsIt is estimated that bron-chiectasis is under diag-nosed due to its variable symptoms. Bronchiectasis increases with age and is more common in women than in men. It often begins in childhood and becomes more chronic in later years.2
It is estimated that 30% of COPD patients in the USA (24 million) may have bron-chiectasis (8 million).
Figure 1. Prevalanece of Bronchiectasis. Bronchiectasis increases with age. It is likely to be much
more common than reported here because it is not usually detected, reported, or treated.2
How many of your chronic lung infection patients have Bronchiectasis?
www.afflovest.com 7
The Benefits of HFCWO TherapyIn a study published in BioMed Central Pulmonary Medicine 2013, by Nicolini et al.,3 researchers concluded that HFCWO therapy provides an improvement in both pulmonary function and quality of life related parameters in patients with chronic hypersecretive disease. Since those patients need daily airway clearance, this treatment should be considered among the principal options in chest physiotherapy.
The study showed that patients with dyspnea and quality of life (BCSS, MMRC, CAT) showed a significant improvement in BCSS (p ≤0.001) and CAT (p ≤0.001) than CPT.
In addition, HFCWO showed significant improvements in pulmonary function scores (FVC and FEV1) after treatment (p ≤0.006 and p≤0.001). Blood testing shows a significant reduction of C-reactive protein compared to CPT (p≤0.019). Finally, sputum production increased after HFCWO treatment. Compared to the control group, HFCWO produced the greatest increase in sputum volume and a significant reduction of neutrophile percentage (p≤0.002) and a significant increase in macrophages percentage (p≤0.012).
Potential Causes:
• Lung infections that damage the bronchi such as bacterial pneumo-nia, whooping cough (pertussis) or tuberculosis
• Chronic Obstructive Pulmonary Dis-ease (COPD)
• Non-tuberculosis mycobacteria
• Inability to produce antibodies
• Inadequate immune systems or autoimmune diseases
• Gastroesophageal reflux disease (GERD) with gastric aspiration
• Asthma
• Cystic fibrosis and other inherited genetic conditions
Bronchiectasis Cycle of Chronic InfectionAs bronchiectasis progresses, it becomes difficult to break the cycle of infection. Repeated infections produce scarring and lung function becomes progressively diminished. This results in breathing difficulties, chronic coughing and discomfort for affected patients.
Bronchiectasis Cycle of Chronic Infection
Ctrl CPT
BCSS before and after treatment
CAT before and after treatment
HFCWO
Ctrl CPT HFCWO
-4
-2
0 2
4-1
5 -1
0 -5
0
5 10
15
Ctrl CPT
Forced vital capacity before and after treatment
Forced expiratory volume 1 sec before and after treamtent
HFCWO
Ctrl CPT HFCWO
-100 0
100 2
00 3
00
-300
-100
0
100
30
0
ml
ml
Infection
AirwayInflammation
RetainedSecretions
Airway Injury
Figure 2. Dot-plot that shows BCSS score and CAT score change-values before and after treatment in HFCWO and CPT groups.
Figure 3. Dot-plot that shows FVC and FEV1 change values (ml) before and after treatment in HFCWO and CPT groups.
AffloVest: Clinical Advantage8
How the AffloVest benefits Bronchiectasis Patients
The AffloVest offers physicians and patients a medical device that clears your chest airways. The AffloVest gives patients a device that they can use at home or anywhere on a preventative type of therapy which could help to prevent mucus buildup and subsequent lung infections. In other words, if patients use this therapy as prescribed by their doctor, typically 1 to 2 times per day for only 30 minutes at home, it may help prevent lung infections which lead to hospitalization and subsequent re-admissions.
Because the AffloVest is quiet, portable, and fully mobile during use, this device may more likely be used by an older patient population with bronchiectasis.An X-ray of Bronchiectasis.
www.afflovest.com 9
The AffloVest SolutionThe AffloVest is the first truly portable, battery operated, fully mobile during use, High Frequency Chest Wall Oscillation (HFCWO) vest. The AffloVest promotes airway clearance and lung secretion mobilization in physician prescribed treatment of respiratory diseases like Bronchiectasis, Cystic Fibrosis, MS, MD, ALS, and other neuromuscular diseases.*
Afflovest is different. It does not use air generator and air bladder technology first developed in the 1980’s. No loud and heavy air generators. No air hoses and electrical cords to connect and slow you down. With AffloVest’s 21st century technology it gives doctors a new tool to help manage their patients utilizing the latest in oscillation therapy, portability and mobility during use. The AffloVest features built-in oscillating modules that allow for freedom of movement to travel, go for a walk in the park, move around the house, or relax in front of the television. Patient treatment plans can be customized using the targeted motors for specific lung lobes or chest wall zones using different levels of intensity.
• AffloVest has eight oscillating motors creating eight individual pressure wave forms, providing disruption in the lungs and mobilizing secretions
• These individual oscillating motors allow AffloVest to target different areas of the lungs
• AffloVest is completely postural independent and can be used sitting, standing or lying down
• The AffloVest is the only HFCWO device that clinicians can easily incorporate postural drainage techniques to help their patients improve lung function
• Three treatment programs allow for a customized patient experience. Choose from Percussion, Vibration and Drainage
• Choose from three treatment levels – Soft (5 Hz), Medium (13 Hz) and Intense (20 Hz)
• Portable design provides full mobility during use to enhance patient compliance with treatment plans
In bronchiectasis, long-term use of a HFCWO may prove to be the most effective
component of care. The human and economic benefits are even greater if mechanical
ventilation, lung reductions surgery and lung transplantation can be avoided.4
* AffloVest requires a doctor’s prescription for treatment by High Frequency Chest Wall Oscillation (HFCWO). The AffloVest has received the FDA’s 510k clearance for U.S. market availability, and is approved for Medicare and private health insurance reimbursement under the Healthcare Common Procedure Coding System (HCPCS) code E0483 – High Frequency Chest Wall Oscillation.
** Patients must qualify to meet eligibility requirements.
References:1,4. Braverman, J., Miller, H. (2008). High-Frequency Chest Compression:
A Practical Therapy for Patients with Bronchiectasis. Respiratory Therapy. Vol. 3(1), 22-26
2. Schraufnagel, D.E. (2010). Bronchiectasis, Breathing in America: Diseases, Progress and Hope, (pp. 37-46). American Thoracic Society, New York, NY
3. Nicolini et al. (2013). Effectiveness of Treatment with High-Frequency Chest Wall Oscillation in Patients with Bronchiectasis. BMC Pulmonary Medicine 13:21
Targeted treatment, increased patient use, improved lung function
Patents Pending – USA & Worldwide
AffloVest: Clinical Advantage10
AffloVest vs. Hill-Rom’s the Vest™
COMPETITIVE COMPARISON CHART
0
15
30
45
60
75
AffloVest Soft Medium Intense(P2-Vibrate) 45 dB 47 dB 48 dB-––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––--–––Hill-Rom™ 5 Hz 13 Hz 20 Hz(Setting of 10) 62 dB 65 dB 70 dB
AffloVest Hill-Rom™
45 47 4862
6570
Dec
ibel
s at
1 M
eter
(3.
3 fe
et)
Noise Levels in Decibels
* The AffloVest has a limited lifetime warranty, excluding the battery & accessories which have a five (5) year warranty. The travel case has a 1 year warranty. For information on warranty coverage from other manufacturers, please contact that manufacturer for details.
** AffloVest requires a doctor’s prescription for treatment by High Frequency Chest Wall Oscillation (HFCWO). The AffloVest has received the FDA’s 510k clearance for U.S. market availability, and is approved for Medicare and private health insurance reimbursement under the Healthcare Common Procedure Coding System (HCPCS) code E0483 – High Frequency Chest Wall Oscillation. Patients must qualify to meet eligibility requirements.
No Carts
No loud, heavy generators or being tethered to hoses and electrical outlets
Featuresby International Biophysics
SmartVest® Electromed, Inc.
The Vest® Hill-Rom
inCourage® RespirTech®
Fully Mobile During Use Yes No No No
Multiple Power Supply Options
Yes Rechargeable Battery, AC & DC
No AC Only
No AC Only
No AC Only
Weight5-12 Lbs depending on size (Including 8 oz. battery)
17 Lbs (Generator only)
17 Lbs (Generator only)
17 Lbs (Generator only)
DC Charging Capabilities Yes No No No
Air Generator Required No Yes Yes Yes
Hoses Required No hoses required Yes Yes Yes
Electrical Outlet Required No Yes Yes Yes
Can Easily Use with Postural Drainage Techniques
Yes No No No
Targeting of Specific Lobe or Chest Wall Region
Yes No No No
Mode of Operation
No Generator Required8 Oscillation motors positioned into AffloVest creating 8 individual oscillation pressure waves
External oscillation generator and hoses connected to air bladder vest
External oscillation generator and hoses connected to air bladder vest
External oscillation generator and hoses connected to air bladder vest
Air Filter No (Air filter not required) Yes Yes Yes
Warranty* Yes Yes Yes Yes
Easy-Read Hand-Held Digital Programmable Controller
Yes Attached to AffloVest
No No No
Medicare, Medicaid and Private Insurance Reimbursed**
Yes Yes Yes Yes
Available to all Home Medical Equipment Companies
Yes No No No
www.afflovest.com 11
by International BiophysicsPortable, battery operated, fully mobile during use, HFCWO therapy
What you get with every AffloVest
AffloVest
AC Power Supply
Battery Charger
Rechargable Battery (Li-Ion)
Controller
Carrying Case
Clear your Chest with AffloVest™
Learn more at afflovest.com, or call us at 888-711-1145
Hear what AffloVest users are saying at ibcafflovest and afflovest 2101 E. St. Elmo Rd. | Austin, TX 78744 | (T) 888-711-1145 | (F) 888-793-2319 | [email protected]
New digital programmable controller monitors compliance
New go-anywhere travel case
You asked. And we delivered these improvements to the AffloVest.
Patents Pending – USA & Worldwide
* Cooper,Michael, RT. An evidence-based study of adolescents with cystic fi brosis demonstrated that AffloVest By Internation-al Biophysics contributed to improved lung function scores. Chicago, IL. Tackett, Michelle, RRT, Henderson, Vivian, RRT. Lung function improvement with AffloVest HFCWO use: a clinician’s perspec-tive on PFT score data from 25 patients with cystic fibrosis. Knoxville, TN.
The proof is in the data.Multiple clinician papers have demonstrated quantitative improvements in patient lung function through the use of AffloVest*
Download the papers at:
www.afflovest.com/lungfunctionimprovement
© Copyright 2016. International Biophysics Corporation | MKT0024 Rev C
Breathe Better. Be Free.Clear your Chest with AffloVest.™
Fully mobile during use
Longer life battery
Made in the USA
New look and colors
More sizes added (Fits chest circumference from 18” to 65+” )
Adjustable to all shapes and sizes for better fit
More ergonomic shape for shoulders and neck
Posturally independent
Thousands in use
Therapeutic treatments in just minutes a day*
TO
