SOURCE: Spiracur

Spiracur

January 09, 2015 09:00 ET

Spiracur Receives FDA Clearance and CE Mark Approval of SNaP Plus Wound Care Cartridge

Company Enters Larger Hospital Market; Expands Global Presence

SUNNYVALE, CA--(Marketwired - Jan 9, 2015) - Spiracur today announced U.S. Food and Drug Administration (FDA) clearance and European CE Mark approval of the SNaP® Plus Wound Care Cartridge, a mechanically powered, single use Negative Pressure Wound Therapy (NPWT) solution for healing chronic and acute wounds. The company began shipping SNaP Plus Systems to customers on December 23, 2014.

Spiracur, developer of the SNaP (Smart Negative Pressure®) System, has provided an increasing number of clinicians with the only mechanically powered system within advanced wound care. The company's expanding family of lightweight, disposable SNaP Systems has been delivering clinically proven NPWT to patients who suffer from chronic or acute wounds for over four years.

The new SNaP Plus delivers all of the proven clinical advantages of the SNaP Wound Care System technology platform including reduced dressing application time; off-the-shelf availability for wound management efficiency; single-use for reduced risk of hospital acquired infections and cross contamination; and a documented improvement in patient satisfaction when NPWT is delivered through a SNaP system. The SNaP Plus is equipped with a larger cartridge capacity, at two-and-a-half times larger than the original SNaP cartridge, in order to meet hospitals' needs to manage higher volumes of wound exudate.

"We are successfully addressing the top wound care priorities for hospitals and long term care facilities with our SNaP Plus by helping to reduce budgets and control costs; decrease the chances of hospital-acquired infections; improve upon wound management efficiency; and increase the patient's comfort and mobility," said Chris Fashek, president and chief executive officer for Spiracur. "We are extremely pleased to have already shipped our first SNaP Plus Systems immediately following FDA clearance and CE Mark."

According to Dane Shackleford, Spiracur's vice president of sales, "With this key addition to our overall product platform offering, Spiracur is able to effectively meet today's hospital and long term care needs."

Spiracur's SNaP Plus offers proven healing combined with improved safety and ease-of-use, which is critical for hospitals and long term care facilities. Typical application times are less than 10 minutes, and the off-the-shelf availability eliminates rental paperwork or the burdensome procurement process. The single use cartridge requires two dressing changes per week, which frees up 33 percent of nurses' time1. The proprietary hydrocolloid dressing helps to maintain the wound seal in the presence of exudate or sweat and reduce periwound maceration, and the SecurRing® hydrocolloid provides fast, easy sealing on uneven skin surfaces or challenging body contours. Finally, the disposable SNaP Plus reduces the risk of infection and its integrated one-way flow valve improves exudate containment.

"As a result of the product launch of the SNaP Plus, we are expanding our direct sales force in the United States to accommodate the anticipated increased demand for our suite of products, and we will be signing new distributors throughout Europe this quarter," said Fashek. "The broader patient population we are able to address with the SNaP Plus, combined with our innovative advancements in NPWT on all of our products, opens up several new doors for Spiracur by enabling us to sell into new care settings and move into new geographic regions."

Today, Spiracur currently has more than 88 million commercial covered lives in the United States, and nearly 87 million U.S. Government covered lives made up of Medicare, the VA, Federal Employee Health Benefit Plans and Indian Health Services. The SNaP System and the new SNaP Plus Cartridge are reimbursed in all 50 states.

Several clinical studies have been published supporting the SNaP System as an effective alternative to electrically powered NPWT, including a comparative Randomized Controlled Trial (RCT) that also showed the small device makes a positive difference in patients' quality of life. Most recently, favorable data from the multicenter RCT comparing the treatment of venous leg ulcers (VLU) using the mechanically powered SNaP System to an electrically powered NPWT system was published in Advances in Wound Care. Data showed that wounds treated with the SNaP System were twice as likely to achieve 50 percent closure at 30 days compared to those treated with the leading EP NPWT system.

About Spiracur Inc.
Spiracur Inc., headquartered in Sunnyvale, Calif., is a privately held medical device company focused on the development of innovative wound healing technologies. Spiracur was founded out of the Stanford University Biodesign Innovation Program in 2007. Its first product, the SNaP Wound Care System for the treatment of chronic and acute wounds, is the result of patient and clinician feedback that current negative pressure wound therapies were too cumbersome. The company's ciSNaP® Closed Incision System with proprietary controlled tension relief is designed to improve healing of high-risk surgical incisions. Both devices have received 510(k) clearance from the U.S. Food & Drug Administration (FDA) and have received CE Mark approval. Spiracur's proprietary mechanically powered technology does not require batteries or electricity to operate. For more information, please visit http://spiracur.com.

Spiracur, Spiracur logo, SNaP, Smart Negative Pressure, SecurRing and ciSNaP are registered trademarks of Spiracur Inc.

1 Hutton DW, Sheehan P., Comparative effectiveness of the SNaP Wound Care System, Int Wound J 2011; doi: 10.1111/j.174-481X.2011.00775.x

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