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Intersect ENT Rallies on FDA Submission for PROPEL Mini

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Intersect ENT Inc.XENT recently announced an FDA submission seeking expanded use of its PROPEL mini product on patients undergoing surgery for frontal sinusitis, post operation. The company has already filed a supplementary premarket approval (PMA) for the same. Following the announcement, shares gained 11.3% ($2.27) to close at $22.29 on Sep 29.

PROPEL mini is currently used in ethmoid sinuses located near the bridge of the nose. On the other hand, frontal sinuses are located behind the eyebrows. According to the company, one out of four of over 500,000 patients undergoing surgery for chronic sinusitis suffers from frontal sinus complications.

The PMA filing is based on the recent preliminary results of the PROGRESS trial, which demonstrated the effectiveness of PROPEL mini in the treatment of post-operative problems in frontal sinus surgery cases. Data showed that the product helped in lowering the number of patients (38% relative reduction in the need for post-operative interventions) who needed another surgical procedure or oral steroids post surgery.

We note that both PROPEL and PROPEL mini has gained significant traction within a short span of time. These products are the first and only steroid releasing sinus implants approved by the FDA for use in patients following ethmoid sinus surgery. An FDA approval for the frontal sinuses will significantly expand Intersect ENT's total addressable market over the long haul.

Apart from the PROGRESS trial, Intersect ENT is conducting trials namely NOVA and RESOLVE II. In early July, the company started enrolling patients for the NOVA trial, which is a follow-up of the PROGRESS study. NOVA is aimed at treating the frontal and the maxillary sinuses, especially in the office setting.

Intersect ENT has also developed a clinical study called EXCEED II to evaluate NOVA in the maxillary sinuses, following balloon dilation in the office setting. The company plans to review this study with the FDA in the near future.

The RESOLVE II is a 300-patient pivotal Phase III clinical study of the RESOLVE investigational steroid releasing implant designed to treat patients with recurrent sinus obstruction in the office setting.

We believe that Intersect ENT's focus on developing new cost-effective products for sinusitis will improve its growth prospects. Meanwhile growing demand for PROPEL and PROPEL mini will drive meaningful top-line growth. In order to expand reach, Intersect ENT is expanding its sales force. The company expects to employ roughly 75 territory managers by the end of 2015.

Zacks Rank & Key Picks

Intersect ENT carries a Zacks Rank #2 (Buy). Other favorably stocks in the same sector are Nevro Corp NVRO , RTI Surgical RTIX and Masimo MASI . All the companies sport a Zacks Rank #1 (Strong Buy).

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MASIMO CORP (MASI): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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