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, announced today that it has completed the acquisition of Link America, Inc., d/b/a Link Orthopaedics, The Scandinavian Total Ankle Replacement system, known as the ‘S.T.A.R.® Ankle’, and certain assets related to the S.T.A.R. Ankle from DERU GmbH and Waldemar Link GmbH & Co. KG of Hamburg, Germany (‘Waldemar Link’).
The agreement between the two companies was announced in January 2008, subject to certain conditions that have now been satisfied. The value of the transaction has not been disclosed. Waldemar Link will continue to manufacture the S.T.A.R. Ankle at its manufacturing facility in Hamburg, Germany.
Anthony G. Viscogliosi, Chairman & CEO of SBi, said: “The S.T.A.R. Ankle has been used clinically since 1990 with over 14,500 implantations performed worldwide. We are very excited to have the opportunity to introduce this product in the United States, after FDA PMA approval, based on widespread interest among U.S. surgeons in a three-part, mobile bearing, non-constrained, uncemented total ankle replacement system.”
Helmut D. Link, Chairman of Link America, said: “We are delighted to have completed the sale of the S.T.A.R. Ankle to SBi in cooperation with Anthony Viscogliosi who has fully recognized the unparalleled track record of our ankle replacement device and demonstrated total commitment to realizing the full potential of innovative technologies to solve unmet needs in orthopedics.”
Mr. Viscogliosi noted that an estimated 65,000 ankle surgeries are performed in the U.S. annually – according to a Wachovia Equity Research Report dated November 20, 2007. This includes an estimated 18,000 arthrodeses or ‘fusions,’ according to an article by D. Joshi published in Orthopedics This Week.
“Should we receive final approval by the FDA, the S.T.A.R. Ankle will be the first and only FDA-approved, three-piece, mobile-bearing, non-constrained, uncemented total ankle replacement prosthesis available to patients in the United States,” he said.
“Currently, there are no FDA-approved mobile bearing ankles for use in the U.S. The only total ankle replacements available in the U.S. are of the two-part, constrained, fixed bearing design, that do not restore full, natural motion, and must be fully cemented in place to be used in accordance with FDA 510 (k) cleared for marketing labeling,” Mr. Viscogliosi added.
Roger A. Mann*, MD, of Oakland Bone & Joint Specialists, Oakland, CA, the principal investigator in the FDA IDE study, and consulting surgeon at the Steadman-Hawkins Clinic in Vail, CO said: “The ankle is an extremely challenging joint to repair or replace, yet the experience with the S.T.A.R. prosthesis in the U.S. IDE Clinical Trial and the prior 18-plus years of European experience indicates that it is an effective option to fusion in carefully selected patients.”
According to Mr. Viscogliosi, fusion seeks to eliminate pain but it has high complication rates. “In fact, fusion does not restore true natural form, function or motion in the ankle. In nearly 100 percent of the time, after several years post-op, fusion leads to degeneration in adjacent joints, causing more pain and further loss of function,” he stated.
James A. Nunley II*, MD, Chief of Orthopedic Surgery at Duke University Medical Center, Durham, NC added: “The implant procedure for the S.T.A.R. prosthesis is tissue-sparing due to minimal bone resection compared to the available alternatives and its anatomic design recreates ankle motion more effectively than what I call sloppy hinged joints.”
Dr. Hakon Kofoed, the original designer of the S.T.A.R. prosthesis in Denmark, noted: “The implantation technique provides considerable room for tissue in-growth in both talar and tibial components. It also facilitates correction of more complicated cases with angular deformity, common after previous fracture.
“Also, the small amount of bone resection involved can mean that if the prosthesis needs to be removed and a salvage ankle joint fusion performed, the patient will not have a noticeable leg-length discrepancy,” he added.
According to Mr .Viscogliosi, the acquisition of the S.T.A.R. Ankle is a key step towards establishing SBi as a leader in helping to restore movement and quality of life to patients by solving unmet needs in small bone & joint arthroplasty and joint reconstruction.
“We have been encouraged by positive comments from surgeons and their patients in the clinical trial, as well as the much longer clinical experience in Europe. If and when final FDA approval is ordered, SBi is going to be the first and only company to market in the U.S. a three-part, mobile–bearing, uncemented ankle,” Mr. Viscogliosi said.
Thomas A. Crowley, President of SBi, noted that: “The effect of the final FDA approval order for this product will not only build market acceptance in the U.S., but we also hope it will stimulate higher adoption levels in countries whose medical authorities respect the validity and rigor of the clinical process the FDA requires – another reason for moving to acquire this system now.”
* Dr. Mann and Dr. Nunley provide consulting services to SBi