The AffloVest Advantage. The Proof is in the Data.

Transcription

1 by International Biophysics The AffloVest Advantage. The Proof is in the Data. Portable, battery operated, fully mobile during use, HFCWO therapy Patents Pending USA & Worldwide Breathe Better. Be Free. Clear your Chest with AffloVest.

2 International Biophysics brings to market innovative, disruptive medical devices and technologies that improve treatment therapies and patient outcomes. Centered on a precision ISO 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. 2 AffloVest: Clinical Advantage

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 Average FVC, FEV1, and FEF 25-75% increased 15.22%, 17.41%, and 11.21% respectively with the AffloVest. FVC (L) Days Using 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 FEV1 (L) Days Using 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 FEF 25% - 75% (L/sec) Days Using 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 ** 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: 3

4 The Proof is in the Data. And, in an evidence-based study of adolescents with cystic fibrosis by Michael Cooper, RT the AffloVest by International Biophysics contributed to Patient 2 Age: 14 years Sex: male FVC (L) FEV1 (L) FEF 25 75% (L/sec) Predicted Value Air Bladder Vest Afflovest 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. 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. Download the paper at: 4 AffloVest: Clinical Advantage

5 Additional Clinical Data Location of Study: Bad Reichenhall Clinic Neurological and Orthopedic Rehabilitation Salzburger Strasse 9-11, 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. < Very Fluid Secretions Very Thick Secretions > Productivity of Cough # of Patients # of Patients Productivity of Cough 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** Stay mobile during use, live your life Patents Pending USA & Worldwide * 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. 5

6 How many of your chronic lung infection patients have Bronchiectasis? 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 highfrequency 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 Demographics It is estimated that bronchiectasis is under diagnosed 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 bronchiectasis (8 million). Prevalence per 100,000 Population Prevalence of Bronchiectasis Age > 75 Average 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 6 AffloVest: Clinical Advantage

7 Potential Causes: Lung infections that damage the bronchi such as bacterial pneumonia, whooping cough (pertussis) or tuberculosis Chronic Obstructive Pulmonary Disease (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 Infection As 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 Retained Secretions Airway Inflammation Infection Airway Injury The Benefits of HFCWO Therapy In 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 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) Ctrl BCSS before and after treatment CPT CAT before and after treatment HFCWO Ctrl CPT HFCWO Figure 2. Dot-plot that shows BCSS score and CAT score change-values before and after treatment in HFCWO and CPT groups. ml ml Ctrl Forced vital capacity before and after treatment CPT HFCWO Forced expiratory volume 1 sec before and after treamtent Ctrl CPT HFCWO Figure 3. Dot-plot that shows FVC and FEV1 change values (ml) before and after treatment in HFCWO and CPT groups. 7

8 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. An X-ray of Bronchiectasis. 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. 8 AffloVest: Clinical Advantage

9 Targeted treatment, increased patient use, improved lung function The AffloVest Solution 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 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 * 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. Patents Pending USA & Worldwide 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 References: 1,4. Braverman, J., Miller, H. (2008). High-Frequency Chest Compression: A Practical Therapy for Patients with Bronchiectasis. Respiratory Therapy. Vol. 3(1), Schraufnagel, D.E. (2010). Bronchiectasis, Breathing in America: Diseases, Progress and Hope, (pp ). 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 9

10 No Carts No loud, heavy generators or being tethered to hoses and electrical outlets COMPETITIVE COMPARISON CHART Features by 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 Weight 5-12 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 Targeting of Specific Lobe or Chest Wall Region Yes No No No Yes No No No Mode of Operation No Generator Required 8 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** Available to all Home Medical Equipment Companies Yes Yes Yes Yes Yes No No No * 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. AffloVest vs. Hill-Rom s the Vest Noise Levels in Decibels Decibels at 1 Meter (3.3 feet) AffloVest Hill-Rom 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 10 AffloVest: Clinical Advantage

11 Portable, battery operated, fully mobile during use, HFCWO therapy by International Biophysics What you get with every AffloVest Clear your Chest with AffloVest AffloVest Rechargable Battery (Li-Ion) AC Power Supply Controller Battery Charger Carrying Case 11

12 You asked. And we delivered these improvements to the AffloVest. New digital programmable controller monitors compliance Fully mobile during use Longer life battery Made in the USA New look and colors TO More sizes added (Fits chest circumference from 18 to 65+ ) Adjustable to all shapes and sizes for better fit New go-anywhere travel case More ergonomic shape for shoulders and neck Posturally independent Thousands in use Breathe Better. Be Free. Clear your Chest with AffloVest. Patents Pending USA & Worldwide 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: lungfunctionimprovement * Cooper,Michael, RT. An evidence-based study of adolescents with cystic fi brosis demonstrated that AffloVest By International 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 perspective on PFT score data from 25 patients with cystic fibrosis. Knoxville, TN. Learn more at afflovest.com, or call us at Hear what AffloVest users are saying at ibcafflovest and afflovest 2101 E. St. Elmo Rd. Austin, TX (T) (F) info@biophysicscorp.com Copyright International Biophysics Corporation MKT0024 Rev C