Bronchoscopic Thermal Vapor Ablation (BTVA) Now Part of the 2019 GOLD Clinical Guidelines for Treating Severe Emphysema

Seattle, WA - Uptake Medical Inc, the developer of the InterVapor® System for Bronchoscopic Thermal Vapor Ablation (BTVA), today announced the inclusion of BTVA in guidelines for the management of chronic obstructive pulmonary disease (COPD) published by the Global Initiative for Chronic Obstructive Lung Disease (GOLD).  

The recently published 2019 GOLD guidelines now include Bronchoscopic Thermal Vapor Ablation (BTVA) as a lung volume reduction therapy that may be suitable “In selected patients with heterogeneous or homogenous emphysema and significant hyperinflation refractory to optimized medical care”. The GOLD guidelines state that “Vapor ablation therapy is the only lung reduction therapy that has been reported to be successfully performed at segmental rather than lobar level.”  

The GOLD guidelines for the diagnosis, management, and prevention of COPD are the most referenced guidelines for physicians, insurance agencies, and regulators.

Uptake Medical’s InterVapor System for delivery of BTVA is a non-surgical and non-implantable therapy developed for lung disease including emphysema and lung cancer. Vapor ablation is simply the application of heated pure water (steam) to tissue.

BTVA is a simple, quick, and non-invasive procedure that typically takes less than 15 minutes. The procedure can be performed under light sedation. A thin tube (bronchoscope) is navigated down the airway to the diseased areas of the lung. Vapor is then delivered through the tube to these diseased regions. The vapor ablates the diseased tissue and the body removes the ablated tissue through the natural healing process.

In patients with severe emphysema, vapor ablation of the most diseased areas of the lung may result in clinically meaningful improvement in breathing by increasing pulmonary function. Improved breathing can result in a better quality of life for patients suffering from severe emphysema. 

Robert Barry, Founder and Inventor of the BTVA therapy stated that “being included in the GOLD guidelines means that BTVA is now recognized by the medical community as a legitimate proven treatment for patients with GOLD stage III & IV emphysema.  This is a major milestone for BTVA therapy and is the result of over 12 years of diligent clinical studies culminating with the successful completion of the multi-national STEP-UP randomized controlled study” ¹.  

The GOLD Guidelines’ objective is to provide a non-biased review of the current evidence for the assessment, diagnosis and treatment of patients with COPD.   For details visit: www.goldcopd.org.

CAUTION: The BTVA InterVapor System is not approved for use in the United States.

For further information contact:
Uptake Medical
Todd Cornell
President
Broncus Medical, Inc./Uptake Medical Technology, Inc.
Cell: +1-770-363-7053
Email: tcornell@broncus.com

About Uptake Medical
Uptake Medical®, a Broncus Company, is a commercial-stage medical device company based in Seattle, WA, USA.  Uptake Medical is dedicated to improving the lives of patients suffering from pulmonary disease with vapor ablation.
To learn more about Bronchoscopic Thermal Vapor Ablation (BTVA), please visit: www.uptakemedical.com

About Broncus Medical, Inc.
Broncus Medical, Inc. is dedicated to the development of diagnostic and therapeutic technology for lung disease. Founded in 2012, the company’s primary technology platforms focus on the diagnosis of lung cancer. Its lung cancer portfolio includes the Archimedes™ System, Archimedes™ Planner, LungPoint® Virtual Bronchoscopic Navigation (VBN) System, LungPoint® Planner and FleXNeedle®.  

¹ Herth et a. Lancet Respir Med 2016, http://dx.doi.org/10.1016/S2213-2600(16)00045-X

Uptake Medical Announces the Enrollment of the First Emphysema Patient into the NEXT STEP Feasibility Study

Seattle, WA - Uptake Medical Inc., the developer of the InterVapor® System for Bronchoscopic Thermal Vapor Ablation (BTVA®), today announced the enrollment of the first emphysema patients into the NEXT STEP feasibility study at the Thoraxklinik in Heidelberg, Germany. 

The NEXT STEP study is designed to validate the safety and efficacy of treating a patient in the most diseased segment of the lung regardless of where it is located.  The BTVA procedure is currently indicated for use in upper lobe emphysema. 

“The majority of patients we see have diseased segments dispersed throughout the lung.  BTVA is the first therapy to offer a tailored solution of only treating those most diseased segments.  If the study is successful it has the potential to more optimally treat many emphysema sufferers.”  said Professor Felix Herth, lead author of the study and chairman of the Department of Pneumology and Critical Care Medicine at Thoraxklinik University of Heidelberg, Germany.

Robert Barry, Founder and Inventor of the BTVA therapy stated that “The CT scan data for Gold stage III & IV patients indicates that most patients have emphysematous segments randomly distributed with healthier segments throughout the lung.  These hyperinflated emphysematous segments not only have poor gas exchange, but also impinge upon healthier segments. Targeted precise segmental ablation reduces the volume and mass of these hyperinflated emphysematous segments.  This allows the healthier segments to expand resulting in clinically meaningful improvement in pulmonary function and quality of life¹. This treatment concept has been proven in upper lobe segments by virtue of the successful completion of the STEP-UP multi-national randomized controlled trial.  As the name implies, the “NEXT STEP” study takes the next step of applying this treatment concept to all lobes (the entire lung).  If successful, most GOLD stage III & IV patients will be eligible for BTVA treatment.”  

BTVA is a simple, quick, and non-invasive procedure that typically takes less than 15 minutes. The procedure can be performed under light sedation. A thin tube (bronchoscope) is navigated down the airway to the diseased areas of the lung. Then vapor is delivered through the tube to these diseased regions. The vapor ablates the diseased tissue and the body removes the ablated tissue through the natural healing process.

CAUTION: The BTVA InterVapor System is not approved for use in the United States.

For further information contact:
Uptake Medical
Todd Cornell
President
Broncus Medical, Inc./Uptake Medical Technology, Inc.
Cell: +1-770-363-7053
Email: tcornell@broncus.com

About Uptake Medical Inc.
Uptake Medical®, a Broncus Company, is a commercial-stage medical device company based in Seattle, WA, USA.  Uptake Medical is dedicated to improving the lives of patients suffering from pulmonary disease with vapor ablation.
To learn more about Bronchoscopic Thermal Vapor Ablation (BTVA), please visit: www.uptakemedical.com

About Broncus Medical, Inc.
Broncus Medical, Inc. is dedicated to the development of diagnostic and therapeutic technology for lung disease. Founded in 2012, the company’s primary technology platforms focus on the diagnosis of lung cancer. Its lung cancer portfolio includes the Archimedes™ System, Archimedes™ Planner, LungPoint® Virtual Bronchoscopic Navigation (VBN) System, LungPoint® Planner and FleXNeedle®.  

¹ Herth et a. Lancet Respir Med 2016, http://dx.doi.org/10.1016/S2213-2600(16)00045-X

Prof. Dr. med. Ralf Eberhardt Presents “Heidelberg Algorithm” for Bronchoscopic Lung Volume Reduction Patient Selection at ERS 2017

Milan, Italy -- At the annual European Respiratory Society (ERS) meeting last week in Milan, Italy, Prof. Dr. med Ralf Eberhardt of Thoraxklinik at Heidelberg presented the algorithm (Figure 1) used in clinical practice to select the appropriate lung volume reduction technique based on current published data.  Lung volume reduction is a procedure intended to treat late stage emphysema patients to improve their pulmonary function, exercise tolerance ,and quality of life.  After identifying a patient with severe emphysema, patients at Heidelberg are scanned with a high-resolution CT, which is then sent for a quantitative CT analysis (QCT). The QCT returns fissure integrity and emphysema disease distribution at the segmental level.  Patients with upper lobe predominant disease where all segments are more diseased than the lower lobe, and no collateral ventilation (CV-) are offered valves or surgery for treatment.  The remainder of upper lobe predominant diseased patients are offered Uptake Medical's InterVapor Bronchoscopic Thermal Vapor Ablation (BTVA) or surgery.  This includes both CV+ patients, and patients that have a healthy upper lobe segment in the treatment lobe. 

”The recent sub-group analysis of the BTVA STEP-UP RCT1 shows very clearly that patients with collateral ventilation have significant and clinically meaningful improvement in lung function and quality life with a very low rate of major medical complications. In these patients, BTVA has been shown to have the best efficacy to safety profile, which is why BTVA is our first choice in patients with collateral ventilation. Additionally, the fact that BTVA can target disease at the segmental level is an advantage in certain patients due to the individual presentation of disease within a targeted lobe.  We now have the therapies that allow us to assess each patient individually and offer the most effective treatment based on the presentation of their individual disease” says Professor Ralf Eberhardt.

The BTVA InterVapor System is CE-Marked and approved for sale in the European Union.  CAUTION: The BTVA InterVapor System is not approved for use in the United States.

1)      Gompelmann, D., Eberhardt, R., Schuhmann, M., Valipour, A., Shah, P. L., Herth, F. J. F., & Kontogianni, K. (2016). Lung Volume Reduction with Vapor Ablation in the Presence of Incomplete Fissures: 12-Month Results from the STEP-UP Randomized Controlled Study. Respiration; International Review of Thoracic Diseases, 92(6), 397–403. https://doi.org/10.1159/000452424

HeidelbergAlgorithm

Figure 1.  Algorithm presented at ERS 2017, Milan, Italy.

InterVapor® Bronchoscopic Thermal Vapor Ablation (BTVA®) is Back on the Market

Seattle, WA -- The InterVapor® Bronchoscopic Thermal Vapor Ablation (BTVA®) is back on the market after a brief hiatus as the asset sale of Uptake Medical Corporation was being completed to Broncus Holding Co. A new company, Uptake Medical Technology, Inc was formed in Seattle, WA, USA and has received a new CE Mark for the technology based on the clinically meaningful improvement in pulmonary function and quality of life for severe emphysema sufferers.¹ BTVA is now commercially available and patients are being treated in several European countries. Uptake Medical expects to expand global BTVA sales to Australia as well as Asian countries by the end of 2017.

“2018 promises to be an exciting year for the new Uptake Medical,” says company founder and president Robert Barry, “with the recent outstanding STEP-UP multi-center randomized controlled trial results and the backing of Broncus, we are posed for success. In addition, we have very exciting bronchoscopic lung cancer ablation clinical studies underway. When you combine San Jose, CA based Broncus Medical’s Archimedes system for accessing and diagnosing lung disease, with BTVA you start to see our vision of a complete Interventional Pulmonology Company come to life.”

“I am happy to finally have a solution for emphysema patients with positive collateral ventilation. Previously these patients did not have good options with proven benefit,” says STEP-UP trial PI Prof. Felix Herth. “I especially like the ability to focus just on the most diseased segments and stage the procedure as I see best for the patient.  I am also looking forward to continued work with Broncus/Uptake Medical on developing a quick and effective bronchoscopic treatment for lung cancer.”

Expanding the commercial availability isn’t all that Uptake Medical is doing. “We also have plans to continue our research of BTVA for emphysema patients and expand the scope of patients that qualify. We are also continuing clinical research and development of our adaptation of the technology for the ablation of several other lung diseases,” says VP of R&D Erik Henne.

Uptake Medical will be at ERS this year in Milan sharing a booth with their partner company, Broncus Medical.

¹ Herth, F. J. F., Valipour, A., Shah, P. L., … (2016). Segmental volume reduction using thermal vapour ablation in patients with severe emphysema: 6-month results of the multicentre, parallel-group, open-label, randomised controlled STEP-UP trial. The Lancet Respiratory Medicine, 2600(16), 1–9.

Uptake Medical’s BTVA has best safety profile per German Institute for Quality and Efficiency in Healthcare (IQWiG)

Berlin, Germany – Germany’s Institute for Quality and Efficiency in Healthcare (IQWiG) recently published a commissioned study that assessed the available surgical and bronchoscopic lung volume reduction options for patients with severe pulmonary emphysema. Uptake Medical’s recent randomized controlled trial (STEP-UP) of its Bronchoscopic Thermal Vapor Ablation (BTVA) InterVapor therapy was included in the German analysis.

The report included an analysis of patient relevant safety outcomes for each method analyzed. Of the bronchoscopic methods actively being used in Germany (vapor, EBV valves, IBV valves, and coils) vapor has the strongest safety profile. The comparison in Table 13 of the report concludes that coils and valves have “evidence [or] indication of harm to the treatment group as compared to the control group” in the category of “other adverse effects and complications of therapy.” This is related to the high rates pneumothorax, hemoptysis, and other complications following successful LVR in valve and coil patients. In the same category, vapor is concluded to have “no indication of harm”. This is due to the appreciably lower rate of pneumothorax and other severe complications following BTVA. In the other categories of safety comparison there are also “no indications of harm” or the effect is comparable to the other methods for the BTVA therapy.

Additionally, the report shows that BTVA has “evidence of benefit” in the quality of life category of the comparison table.

STEP-UP RCT Principle Investigator Prof Felix Herth, Thoraxklinik Heidelberg, Germany stated “This report further validates the STEP-UP trial results which showed an improvement to the side effect profile of BTVA by treating individual segments in a more targeted and staged step-wise manner, while maintaining the strong functional improvements seen in pulmonary function and quality life from previous lobar only approach trials. The report indicates that BTVA vapor has the safest bronchoscopic lung volume reduction profile on the market in Germany, thanks in large part to its low risk of pneumothorax or other major medical complications.” BTVA is also the only technology that allows physicians to tailor the treatment to each patient.  The physician can target the most diseased lung segments over multiple procedures, thus creating a personalized treatment for the patient to achieve a clinically significant improvement in pulmonary function and quality of life.

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