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INSPIROMATIC™

Inspiromatic™ dry powder inhaler is easy to use and offers any patients improved drug deposition and physicians real-time data for follow-up and patient monitoring.

Young children, the elderly and the seriously ill will especially benefit from the advantages of Inspiro Medical’s dry powder inhaler.

Inspiromatic works with extremely low inhalation flow rates and assures optimal drug delivery by providing the appropriate powder quantity, at an optimal flow, at the right time. The Inspiromatic dry powder inhaler incorporates:

  • an active powder de-agglomerator based on a micro-pump and vortex to deliver fine particles, independent of the patient’s inhalation abilities;
  • sensors to monitor patient inhalation; and
  • a microcontroller to calculate the optimal time for drug delivery.

For users who find it difficult to follow instructions on how to use inhalers properly, Inspiromatic™ offers a unique real-time feedback interface that guides the patient and assures proper inhalation technique.

For physicians, Inspiromatic™ provides a built-in data logger that stores all data whenever the patient uses the device. The physician can access and review the data to make sure the prescribed drug was taken and delivered successfully, greatly improving physician follow-up capabilities and patient compliance.

SUCCESSFUL STUDY RESULTS

In May 2013, Inspiro successfully concluded an FIM study in which both primary and secondary endpoints were met. Statistically, the Inspiromatic™ performed significantly better than the market gold standard inhaler. (This study served as confirmation of the successful in vitro studies Inspiro Medical conducted in July 2012, which clearly demonstrated Inspiromatic’s cutting-edge technology for improved drug deposition in the lung.)

The aim of the FIM study, which was conducted at Schneider Children’s Medical Center, in Petach Tikva, Israel, was to objectively assess the efficacy and safety profiles of bronchodilator treatment via Inspiromatic™ in 30 asthmatic children, as compared to its delivery via a gold-standard inhaler.

  • The results demonstrated superior performance by Inspiromatic in pulmonary delivery of the active drug.
  • Lung function test (FEV1) demonstrated a statistically significant improvement following drug delivery via the Inspiromatic.
  • Successful delivery of the API was achieved on patients with poor inhalation technique and even those with a low-flow inhalation rate.
  • Patients rated Inspiromatic very high.

Inspiromatic demonstrated better lung function results at 15, 30, and 60 minutes post inhalation over the gold-standard DPI. (Source: Inspiro Medical)

Following this successful trial, Inspiro Medical will continue its partnering efforts with global pharmaceutical companies to jointly develop combination products.

The company is scheduled to complete Inspiromatic’s final device development by the end of 2013.

 
 

INSPIRO MEDICAL’s FIM AT A GLANCE

Site: Schneider Children’s Medical Center, Petach Tikva, Israel

Completed: May 2013

Study type and design: Crossover, double blind study, comparing inhalation of a bronchodilator with Inspiromatic and a market-leading DPI

Number of participants: 30 asthmatic patients ages 8 to 18

Protocol: PK, blood pressure, electrolyte baseline and 60 minutes post inhalation

Primary endpoint: Change in FEV1 after 15, 30, 60 minutes post inhalation

 
 
INSPIRO Medical Ltd. +972.72.260.7051 info@inspiromedical.com