Small Bone Innovations, Inc. to Acquire S.T.A.R. Total Ankle Replacement Technology

Business Wire, Jan 29, 2008

* S.T.A.R. Ankle is a mobile-bearing total ankle system

* SBi to be first into the US market upon final FDA approval

* More than 10,000 implanted in 27 countries

NEW YORK -- Small Bone Innovations, Inc. (SBi), a single-source provider of innovation, products, technology and education for the small bone & joint sector of the orthopedics industry, has entered into definitive agreements to acquire Link America, Inc., d/b/a LINK[R] Orthopaedics, The Scandinavian Total Ankle Replacement system, known as the 'S.T.A.R.[R] Ankle', and certain assets related to the S.T.A.R. Ankle from Waldemar Link GmbH & Co. KG of Hamburg, Germany ('Waldemar Link').

The value of the transaction is not being disclosed. The acquisition is subject to the satisfaction of certain closing conditions. Both companies are privately held. Outside North America, both Waldemar Link and SBi are committed to continue to provide the highest level of service to all customers throughout the existing global distribution network.

The S.T.A.R. Ankle is manufactured by Waldemar Link, and was first designed as an anatomic non-constrained, resurfacing prosthesis in 1978 by Hakon Kofoed, MD, President Elect of the European Foot & Ankle Society and Associate Professor of Orthopaedics at the University of Copenhagen, Denmark.

It was designed to be less invasive, bone conserving and tissue preserving and a significant improvement over the prostheses of the early 1970's that required resection of large portions of bone and sacrificed soft tissue integrity.

Anthony G. Viscogliosi, Chairman, CEO & President of SBi, said: "The current version of the S.T.A.R. Ankle has been used clinically since 1990 throughout the world in 27 countries with over 10,000 implantations. There have been at least 30 clinical papers written and countless presentations given over the past three decades on the S.T.A.R. Ankle."

According to Mr. Viscogliosi, there are an estimated 65,000 ankle procedures done in the United States annually, including an estimated 18,000 arthrodeses and ankle replacement procedures for which the S.T.A.R. Ankle could be used in properly selected patients, if and when it receives FDA approval.

A US IDE (Investigational Device Exemption) Clinical Trial was initiated in 2000 as a prospective, multi-center, concurrently controlled study, and remains ongoing while FDA completes its review of the PMA (Pre-Market Approval) application for the S.T.A.R. Ankle. SBi believes this represents the most rigorous study ever undertaken in the United States for an ankle joint replacement prosthesis.

The study follows patients for a minimum of 24 months. The two principal investigators were Roger Mann, MD and Michael Coughlin, MD. There were 10 sites that enrolled S.T.A.R. Ankle patients in the Pivotal Trial and a larger group in the Continued Access study.

The PMA application was accepted for filing by the FDA in March 2006. An FDA Panel recommended approval with conditions on April 24, 2007.

SBi believes that, if and when the device receives final approval by the FDA, the device would be the first and only FDA approved, non-cemented mobile bearing total ankle replacement prosthesis available to patients in the United States.

"Currently, there are no FDA approved mobile bearing ankles for use in the United States. The only total ankle replacements available in the US are of the two-part, constrained, fixed bearing design that do not restore full, natural motion, and in order for those ankles to be used in accordance with FDA approved labeling, they should be fully cemented in place," Mr. Viscogliosi said.

Massimo Calafiore, President of Link America, said: "We are very pleased to have entered into this agreement with SBi. Throughout the process SBi demonstrated focus, continuing enthusiasm and commitment to this opportunity."

Andy Greenberg, Managing Director of Link America, said: "The US IDE Clinical Trial has required a tremendous decade long commitment from all the surgeons and staffs involved - who agreed to participate for no other reason than to attempt to improve the lives of patients. Helmut D. Link, Chairman of Link America, and I want to thank everyone personally for their efforts."

The inventor of the S.T.A.R. Ankle, Dr. Kofoed, noted: "The experience from the 1970's showed significant individual differences between a patient's ankle pathologies and that patients need more than a 2-piece device. A 3-piece mobile-bearing ankle prosthesis allows the ankle to find its own direction and accommodate patient variability."

About Small Bone Innovations, Inc.

Small Bone Innovations, Inc. (SBi) was founded in 2004 by Viscogliosi Brothers, LLC, (VB), a New York-based merchant banking firm that specializes in the musculoskeletal/orthopedic sector. VB created SBi as the first company to focus purely on small bones & joints. By integrating established companies and professionals in the field, SBi offers a broad, clinically proven portfolio of products and technologies to treat trauma and diseases in small bones & joints.