SHPI Receives FDA Clearance To Market MiniLoc Safety Infusion Set
MiniLoc(TM) Safety Infusion Set is SHPI's second entry into the growing safety Huber needle market. The Company's first safety Huber needle product, LiftLoc(R) Safety Infusion Set, has been marketed in the U.S. since 2002 and has emerged as one of the leading safety products in the field. While both product lines incorporate a Huber type needle with an integral safety needle device, MiniLoc(TM) Safety Infusion Set is based upon a new proprietary technology that enables state-of the-art protection in an ultra-low profile device. MiniLoc(TM)'s small footprint, needle forward design and enhanced angled tubing make the product easy to dress, facilitate placement in dual lumen ports, and provide excellent site visibility. The product's proprietary design enables controlled, easy engagement of the safety mechanism. MiniLoc(TM) has a smooth comfortable base that is designed for patient comfort, as well as specially lubricated needles that significantly reduce needle penetration force.
"Our new MiniLoc(TM) Safety Infusion Set product line provides an excellent opportunity to expand our safety Huber needle franchise and accelerate market penetration with what we believe is a 'best in class' entry in the growing safety Huber needle market," commented Jeff Soinski, President and Chief Executive Officer. "This innovative product was designed and developed with direct input from oncology nurses, the primary end-users of Huber needles, so we are confident it will be well-received in the market."
Mr. Soinski continued, "We are pleased to announce our second FDA marketing clearance in 2005, as the introduction of innovative new products is an important part of our growth strategy. Earlier this year, we announced 510(k) clearance for our SecureLoc(TM) Safety Introducer Needle product line, the first commercial application of our SecureLoc(TM) platform technology. We plan to ship MiniLoc(TM) through our existing U.S. distribution channels this summer and anticipate that this new product line will be an important contributor to our top and bottom line growth, as we extend our safety Huber needle portfolio and leverage the manufacturing, sales and marketing and customer service infrastructure we have established for LiftLoc(R)."
Huber needles are used to access surgically implanted, subcutaneous ports for vascular access on a repeated basis over an extended period of time. As such, they are hollow-bore and potentially blood-filled at the time of removal, with a significant need for an effective safety solution. A primary use of Huber needles is the infusion of chemotherapeutic agents for cancer patients.