Neomend receives PMA from FDA for Progel Extended Applicator Spray Tip

Neomend, Inc., a leading innovator in sealant and adhesion-prevention products for the surgical marketplace, said it has received premarket approval (PMA) from the U.S. Food and Drug Administration for use of the company's new Progel^® Extended Applicator Spray Tip.

“Because Progel® is the only sealant designed specifically for thoracic surgeons, it is important to provide additional delivery choices that add to this technological advancement for patients”

The Progel Extended Applicator Spray Tip is a single-use medical device designed to be used with the Progel Pleural Air Leak Sealant. The new commercially available applicator is designed to deliver the only FDA approved pleural air leak sealant in the U.S. The Extended Applicator Spray Tip, which is available in two sizes, provides an additional delivery option when used as indicated during an open thoracotomy.

The new spray tip is intended to deliver Progel to visceral pleura during an open thoracotomy after surgeons use sutures or staples to close visible air leaks (≥ 2 mm) incurred in the visceral pleura during open resection of lung parenchyma. By bending the device's flexible tip, surgeons can direct Progel from the delivery tip in a stream or spray pattern to the targeted surface.

"The Extended Applicator Spray Tip makes applying Progel more convenient for thoracic surgeons," said David Renzi, the company's President and CEO. "With the longer, malleable tip they will be able to conveniently reach areas that might previously have been harder to access. The ability to position the delivery applicator spray tip provides an advantageous option for the surgeon in applying Progel easily and accurately."

Air leaks are the number-one complication associated with pulmonary surgery, and when left untreated can lead to additional complications and morbidity. "Because Progel^® is the only sealant designed specifically for thoracic surgeons, it is important to provide additional delivery choices that add to this technological advancement for patients," said Renzi.

Progel Pleural Air Leak Sealant was evaluated in a prospective, randomized, controlled multi-center trial and demonstrated significantly improved clinical outcomes. Published data shows that when used as indicated, Progel can effectively seal intraoperative air leaks, significantly reduce postoperative air leaks, reduce hospital length of stay, minimize associated complications and morbidities and provide incidental cost-of-care savings.

Progel Pleural Air Sealant has been used in the treatment of more than 27,000 patients in the U.S. alone since the product received PMA approval from the FDA in January 2010. Progel Pleural Air Leak Sealant is part of a line of unique hydrogel sealants to be commercialized by Neomend.

A second product, Progel Platinum Surgical Sealant, a recombinant version of the pleural air sealant, received the CE mark in January 2011 and was launched in the EU last June. Progel^® Platinum Surgical Sealant is a hydrogel polymer consisting of two components: a biocompatible synthetic protein of recombinant albumin (Albucult®*) and a cross-linking component of polyethylene glycol (PEG). Albucult® rAlbumin USP-NF is a product of Novozymes Biopharma UK Ltd. and Novozymes Biopharma DK A/S.

The Extended Applicator Tip is also CE marked and has been available in the EU since June 2011. In addition, Progel^® Adhesion Barrier sealant used in abdominal and pelvic surgeries, received CE Mark in December 2011.