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.

IQWIG.PNG

Press Release

Shanghai, China - August 31st, 2016 - Broncus Holding Company (BHC), announced today that it has acquired the assets of privately held Uptake Medical Corp, the manufacturer of vapor technology for the bronchoscopic ablation of emphysema and lung cancer. Vapor ablation has been shown to result in clinically meaningful improvement in lung function and quality of life in a recent randomized controlled trial published in the Lancet RM (July 2016). The acquisition positions BHC as the leader in providing the complete solution for the two most devastating lung diseases.

BHC's Chairman Michael Zhao explains: "Our plan is to deliver a solution through combination of the technologies from our two companies, Broncus Medical Inc. and Uptake Medical Technology Inc.  Broncus Medical Inc. will focus on the complete treatment for Lung cancer and Uptake MedicalTtechnology will focus on the complete treatment for emphysema. Together these two companies represent complete answers for the number one and two leading causes of pulmonary disease."

"We are very excited to be able to offer an impeccable solution to bronchoscopic-based lung cancer treatment through the integration of Uptake's vapor technology and our products, LungPoint and Archimedes", said Henky Wibowo, President of, Broncus Medical Inc., San Jose, CA. "We are elated to have the additional resources and infrastructures that Broncus provides to rapidly extend our commercialization coverage in the EU and Asia. Additionally, Broncus’ products will complement and extend the InterVapor system and further simplify the procedure for treating emphysema patients." said Robert Barry, President of Uptake Medical Technology, Seattle, WA.

Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 related to the acquisition of Uptake Medical Corp. assets. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Broncus Holding Company, Broncus Medical Inc. and Uptake Medical Technology. Risks and uncertainties include, but are not limited to: challenges related to integrating the assets, as well as the ability to ensure continued performance or market growth of the company's products; the potential that the expected benefits and opportunities related to the transaction may not be realized or may take longer to realize than expected; challenges inherent in product research and development, including the uncertainty of obtaining regulatory approvals; uncertainty of commercial success for new and existing products; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes to applicable laws and regulations, including global health care reforms; and changes in behavior and spending patterns or financial distress of purchasers of health care products and services.