MIAMI, May 10, 2012 (GlobeNewswire via COMTEX) — Internal Fixation Systems (otcqb:IFIX) announced today that it has entered into a distribution agreement with Intelligent Orthopaedics Ltd. (IO) to market its Staffordshire Orthopaedic Reduction Machine (STORM) which is a reusable device that is used to reduce (align) fractures of the tibia prior to surgical fixation. IO was formed in 2005 and specializes in the design, development, manufacture and distribution of orthopedic trauma devices specifically for the treatment of long bone fractures. IO is based in Stoke-on-Trent, Staffordshire in the UK and has ISO 13485 certification. The STORM is CE marked and also has FDA clearance to market.

“We are pleased to be able to add the STORM to our growing list of orthopedic trauma products. At a selling point of $29,999, the STORM will be priced approximately 40 — 50% below what competitors are charging for similar devices. This fits nicely with IFS’ commitment to bring innovative orthopedic products and devices to market for an affordable price,” said Internal Fixation Systems CEO, Stephen Dresnick. He went on to add, “We believe the STORM is easier to use as well as less expensive than other reduction/distraction devices currently on the market in the United States. Being able to market the STORM system to over 5,000 hospitals and 5,000 surgery centers around the United States will provide us with yet another product to add to our rapidly expanding product line.”

Susan Hartman, CEO of Intelligent Orthopaedics, said, “We are delighted to be able to partner with Internal Fixation Systems to introduce our unique range of products to trauma surgeons. STORM has been shown to shorten the overall OR time by 25% and reduce exposure to radiation by 50%. Internal Fixation Systems have established channels of distribution open to them that would otherwise take us years to develop.”

About IFS: Internal Fixation Systems, Inc. is a manufacturer and marketer of high quality, responsibly priced orthopedic, spinal and podiatric implants. We seek to prove that superior products and lower costs can go hand in hand. IFS focuses on widely used, market proven products used to treat common fractures. Our Advisory Panel, consisting of nationally recognized surgeons, provides input on how to improve our implant designs. The resulting products incorporate doctor requested enhancements and are priced at 40-60% less than the competition. IFS customers include ambulatory surgery centers, hospitals and orthopedic surgeons. Please contact us for more information about our product and business model.

STORM is a reusable surgical device that is used in the operating theatre to provide the surgeon with a simple but innovative approach to reducing challenging unstable lower limb fractures prior to fixation. STORM provides precise and controllable axial traction; a simple lock wheel system allows large and fine adjustments to correct rotation and the unique translation arms correct angulation and translation.

The risks of radiation exposure to medical staff are well documented. It has been reported that orthopaedic surgical assistants are generally at greater risk than the lead surgeon23 therefore it is desirable to employ methods and systems that minimise the exposure to radiation for all. Using STORM enables the surgeon to accurately control the six degrees of freedom and at each stage of the fracture reduction process the STORM device holds the fragments securely minimising the need to take additional x-ray images to check the position. The STORM device then holds the reduction while the chosen method of fixation is applied minimising the need for the surgical assistant to assist in maintaining the reduction.

STORM is used to reduce fractures throughout the tibia including the plateau, shaft and pilon. As well as being used to reduce fresh fractures, STORM has also proven to be a valuable tool to reduce fractures where treatment has been delayed.

“We are delighted that this independent study involving eight centres has supported and reinforced earlier studies showing that using STORM not only assists the surgeon to achieve anatomical reductions of challenging tibial fractures but that it also saves time”, commented Susan Hartman, Chief Executive Officer, Intelligent Orthopaedics Limited, the designers and manufacturers of STORM. “As we prepare to build on our current customer base to introduce STORM and its benefits to more surgeons, confirmation of the savings both to the budgets and the health and safety risks will be of interest to those affected”.

Mark Payton, Mercia Fund Management, a key investor in Intelligent Orthopaedics added: “Healthcare economics is not a nice to have but an essential pre-requisite of any medical device, on a global basis. STORM, and its associated consumables, through its accurate fracture reduction both improves patient outcome as well as providing a marked reduction in time in surgery. This is translating to the rapid evaluation and adoption of this robust and innovative device in clinics across Europe and now in the US. This independent report is a testament to the innovative product portfolio Intelligent Orthopaedics has introduced to clinicians across Europe and the US.”

-ENDS-

Presented at Skills Workshop, Ortho Trauma OP Update, 15 and 16 September 2011, MHH, Hannover
Arch Ortho Trauma Surg, 2003 June. Tasbas etal. Which one is at risk in intraoperative fluoroscopy? Assistant surgeon or orthopaedic surgeon?
Journal of Orthopaedic Trauma, 1997 August. Mehlman etal. Radiation Exposure to the Orthopaedic Surgical Team
About Intelligent Orthopaedics
Intelligent Orthopaedics Ltd (IO) specialises in the design, development, manufacture and distribution of orthopaedic trauma devices specifically for the treatment of long bone fractures. Its core patented product “STORM” (Staffordshire Orthopaedic Reduction Machine) is a reusable device that is used to realign fractures of the tibia prior to surgical fixation. STORM is currently in use in hospitals in the UK, Europe and the USA.
Based in Staffordshire, UK, the company has ISO13485 certification; all products are CE marked and have FDA clearance to market.
The company was spun out of Staffordshire and Keele Universities and the University Hospital of North Staffordshire in 2005 and is supported by venture capital funding, where the major investors is Mercia Fund Management.
For more information, please visit http://www.intelligent-orthopaedics.com/, call + 44 (0)844 8004405 or email info@io-uk.com
For the USA only:
STORM FDA Listing Number: E337519