The Future of InterVapor: Q&A with Uptake’s Chief Medical Officer Steven Kesten

The Future of InterVapor: Q&A with Uptake’s Chief Medical Officer Steven Kesten

The InterVapor system is comprised of three components: the InterVapor Personalized Procedure Program™ (IP3™), InterVapor Catheter and InterVapor Generator. These components work together to create a user friendly treatment option for pulmonologists. The IP3 recommends diseased lung areas to be treated by precise, physician-controlled doses of thermal energy created by the Generator and delivered by the Catheter (in the form of heated water vapor) through a standard bronchoscope.

(a) The InterVapor Personalized Procedure Program (IP3) is a proprietary application that provides preferred treatment locations and times based on the patient’s CT scan. This personalized information is computed for each procedure and is securely delivered to the physician on a tablet PC.

(b) The InterVapor Generator is digitally controlled to precisely produce heated water vapor at specific amounts, temperature and pressure. A typical InterVapor procedure treats between 3-8 lung segments from one lobe.

(c) The InterVapor Catheter delivers the prescribed vapor dose into the targeted lung segments. Each vapor delivery is computed by IP3 and is between 3-10 seconds in duration.

InterVapor, from Uptake Medical (Tustin, CA), is a non-surgical endoscopic lung volume reduction procedure that uses thermal ablation without leaving foreign materials in the lung. In clinical studies of patients with severe emphysema, InterVapor has demonstrated clinically meaningful improvements in breathing function, exercise capacity and quality of life. The company has now closed a Series C funding round, which will support commercialization of InterVapor for treatment of severe emphysema. This news comes on the heels of Uptake Medical receiving CE mark approval for InterVapor in September, completing the first commercial use of InterVapor in Germany in November, and recently announcing TGA approval for InterVapor to be marketed in Australia.

Steven Kesten, Chief Medical Officer at Uptake Medical, answered our questions about the company and its technology:

1. How did the idea of InterVapor come about?

InterVapor device 1st prototype The Future of InterVapor: Q&A with Uptakes Chief Medical Officer Steven Kesten

1st Prototype InterVapor Device

The idea for Uptake Medical’s InterVapor™ technology was based on the body’s healing response to thermal energy. Early research was based on the hypothesis that if we were able to trigger a temporary Localized Inflammatory Response (LIR) that the associated healing process would ultimately develop a scar that would remodel and reduce the diseased lung tissue. Early experiments were conducted using various forms of heat energy, such as radio frequency, but the energy could not travel out to the diseased areas of the lung due to a lack of available lung mass. Experimentation ultimately lead to the discovery that heated water vapor (steam) was the optimal form of heat energy as it is in gas form and could easily travel through the airways to the diseased parenchyma. The development team made a prototype, proved the theory with ex-vivo animal lungs and this is the basic theory which has been ultimately proven in both animal and human clinical studies.

2. Can you describe the process of delivering the heated vapor to the diseased lung?

In advance of the InterVapor procedure, a personalized treatment plan is developed specifically for the patient to be treated. A high-resolution CT of the patient’s lungs is analyzed by the Uptake Medical core lab. This analysis includes a quantitative assessment of several factors to determine the degree of heterogeneity and to identify the lung regions where the best opportunity for lung volume reduction may be successfully achieved. These recommendations are forwarded to the treating pulmonologist as an InterVapor Personalized Procedure Program™ (IP3™).

For the procedure itself, a bronchoscope is inserted into the lungs and the physician, following the blue print provided by the IP3, reviews the patient’s lungs and determines the course of treatment. The InterVapor Catheter is inserted through the working channel of the bronchoscope into the targeted airway. The treatment time specific to the target airway is obtained from the IP3 and keyed into the InterVapor Generator. This airway is briefly occluded by the inflation of a balloon at the end of a catheter and a dose of heated water vapor is delivered to the lung tissue. The balloon is then deflated, the catheter is removed and additional airways are treated as appropriate. The entire procedure, on average, takes 30 minutes.

A brief animation illustrating this process can be accessed via the Uptake Medical website at www.uptakemedical.com or at http://www.uptakemedical.com/iet-animation .

intervapor step by step The Future of InterVapor: Q&A with Uptakes Chief Medical Officer Steven Kesten

The InterVapor Procedure

InterVapor Mechanism of Action:

Treatment: The delivery of heated water vapor triggers a temporary Localized Inflammatory Response (LIR) which sets the body’s natural healing process in motion.

Healing: This LIR is usually resolved within 4-12 weeks as the lung begins the healing and remodeling process.

Response: InterVapor has been shown to lead to clinical improvements in lung function, exercise capacity and health-related quality of life.

interfapor mechanism of action The Future of InterVapor: Q&A with Uptakes Chief Medical Officer Steven Kesten

3. What meaningful clinical improvement above and beyond medical therapy can we expect with InterVapor, especially in terms of exercise function and quality-of-life?

In the VAPOR trial patients received optimal medical management prior to treatment with InterVapor. InterVapor therapy resulted in clinically relevant improvements in lung function, quality of life and exercise tolerance in upper lobe predominant emphysema. At 6 months, airflow as assessed by FEV1, FEV1 improved by 141 ml, air trapping as assessed by residual volume (RV) was reduced by 406ml. Health-related quality of life, as assessed by the St. George’s Respiratory Questionnaire (SGRQ) total score improved by 14.0 units with a 4 unit improvement having been reported as the minimal clinically important difference. Exercise capacity, as assessed by the 6-minute walk test, improved by 46.5 m and breathlessness, as measured by the modified Medical Research Council (mMRC) dyspnea scale improved by 0.9 units. All of the above endpoints were associated with p values less than 0.05. The results were clinically and statistically significant.

The results of the VAPOR trial are available online, ahead of publication, in the European Respiratory Journal. (Snell, G., et al. Bronchoscopic Thermal Vapor Ablation Therapy in the Management of Heterogeneous Emphysema. Eur Respir J 2012; DOI 10.1183/09031936.00092411)

4. Is this a one-time procedure or can this be repeated multiple times to different diseases segments of the lungs?

The InterVapor System is intended for use in patients with heterogeneous severe emphysema to achieve bronchoscopic upper lobe lung volume reduction by the application of heated water vapor to the lung segments targeted for treatment. The clinical results observed in the VAPOR trial were achieved as a single, unilateral procedure. In a typical InterVapor treatment, 3-8 airways within a lung are treated.

5. Where is InterVapor therapy currently available? Is it available in any capacity in the United States?

Uptake Medical has received the CE mark and TGA approval for InterVapor and we are focusing our commercial efforts in both Germany and Australia at this time. We plan to extend our commercialization throughout Europe during 2012. At this time InterVapor is not available in the US.

Source : http://www.uptakemedical.com/about-intervapor/the-intervapor-system

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