For Immediate Release
In2Bones USA Announces FDA Clearance on Two Key Implant Systems
Memphis, Tenn. (AUGUST 8, 2017) – In2Bones Global, Inc. today announced that its In2Bones USA, LLC subsidiary has received U.S. Food and Drug Administration (FDA) clearance for its new Fracture and Correction System. The System will be marketed under the 5MS™ Fracture Repair System and the CoLag™ Locking Compression Screw System brand names.
The 5MS Fracture Repair System is a comprehensive plate and screw system that addresses both fractures and deformities of the 5th metatarsal bone (5th toe) of the foot. Unlike competitive systems, the 5MS System features an array of anatomically contoured plates and fracture-specific screws that provides surgeons more options to customize the needed repair.
The new System offers surgeons multiple design and performance improvements compared with traditional plate products, plus the versatility of interchangeable screws and plates, and specially designed surgical instruments – all to enhance surgical technique and treatment efficacy.
“Fractures of the 5th metatarsal are the most common in athletes of all skill levels. The 5MS™ System’s unique plantar fracture plate design may address many of the healing complications seen from other methods of treatment,” says Kevin Varner, M.D. of Houston Methodist Orthopedics and Sports Medicine.
The CoLag Locking Compression Screw System is an entirely new concept in orthopaedic bone fixation. Differential, dual-pitch screw threads combined with a low-profile head create a compression lock between the bone fragment and fracture, significantly improving compression compared with competitive headless screws.
“Bone fragment stability and compression are important factors in healing. The CoLag System creates the compression of current headless screws while offering the stability, fixation and ease of removal of screws with heads,” says Keith Heier, M.D., Past President of OrthoTexas Orthopedics & Sports Medicine. “This design may be one of the most significant advances in screw fixation in the past 25 years.”
As is true with all In2Bones USA products, the 5MS and CoLag implants are delivered in individual, pre-sterilized packaging, and are UDI compliant and fully traceable.
The past twelve months have been busy for the company. In August 2016, In2Bones USA, LLC and In2Bones, SAS (Lyon, France) merged to form In2Bones Global, Inc., a Delaware corporation headquartered in Memphis. Since the merger, and in addition to these two new Systems, the company has launched several innovative products including the NeoView® PEEK Distal Radius Plate, the NeoSpan® SuperElastic Compression Staple, the Reference Toe System™, AlloAid® PIP, AlloAid® Nail and the CoLink™ Forefoot Plating System.
“At In2Bones, our goal is to advance the science of extremity surgery,” says Alan Taylor, President and CEO of In2Bones Global. “Our development pipeline is robust and will provide growth opportunities for us around the world.”
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About In2Bones USA, LLC
Located in Memphis, Tennessee, In2Bones USA, LLC is a designer, manufacturer and distributor of medical devices for the treatment of disorders and injuries of the upper (hand, wrist, elbow) and lower (foot and ankle) extremities. For more information, visit www.i2b-USA.com and www.colagscrews.com.
About In2Bones, SAS
Located in Lyon, France, In2Bones, SAS is a specialty orthopaedic company that develops and distributes upper and lower extremity products to enable surgeons to alleviate pain and restore motion for their patients. For more information, visit www.In2Bones.com.
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements made in this press release, other than statements of historical fact, are forward-looking statements. Forward-looking statements reflect management’s current view of future performance, results, and trends and may be identified by their use of terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “will,” and other similar terms. The company wishes to caution readers that actual results might differ materially from those described in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties impacting the business, including increased competition, technical obsolescence, regulatory issues, general economic conditions and other risks.
Susan Duensing, CBC