Small Bone Innovations has completed its acquisition of Link America Inc., developer of an ankle replacement system, from Waldemar Link Gmbh & Co. No financial terms were disclosed for the deal, which was first announced in early 2008. SBI was formed in May 2004 by the principals of Viscogliosi Brothers LLC, to developer and acquire technologies in the small bone and joined sector.
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
The specialized hospital supplies business opened by Waldemar Link in Hamburg on January 1, 1948 became Waldemar Link GmbH & Co. KG, a leading, privately-owned international company in the manufacture of orthopedic implants and surgical instruments.
In the 1960s, Waldemar Link developed its first prosthetic joints for the hip and knee and grew to become one of the world’s leading companies with global distribution. Helmut D. Link manages the company today – the second generation of his family to do so.
As LINK® Orthopaedics, the company has provided a comprehensive range of orthopedic implant devices for joint replacement and reconstruction in the United States since 1976. This includes systems for both revision and primary hip and knee surgeries.
The company also offers high quality surgical instrumentation such as shoulder, hand and foot & ankle instrument sets.
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. Today, SBi has more than 140 employees at facilities in New York, NY, Morrisville, PA, and Bourg-en-Bresse, France, among other locations worldwide.
For more information on SBi, please visit: www.totalsmallbone.com
About Viscogliosi Bros., LLC
Established by Marc R. Viscogliosi, John J. Viscogliosi and Anthony G. Viscogliosi in New York City in 1999, Viscogliosi Bros., LLC (VB) was the first venture capital/private equity and merchant banking firm dedicated exclusively to the musculoskeletal/orthopedics sector of the health care industry. As principals of VB, the Viscogliosi brothers have a combined total of nearly half a century of experience analyzing and investing in the musculoskeletal/orthopedics sector.
VB’s mission is to create, build and finance companies founded on innovations developed by surgeons and uniquely focused on “life changing” musculoskeletal/orthopedic technologies. VB has worldwide surgeon, industry and trade relationships, and significant financial expertise in the musculoskeletal/orthopedic sector.
The Viscogliosi brothers have pioneered more than 170 financial, strategic and management initiatives for companies in the musculoskeletal/orthopedic sector, from start-up, seed and development stage all the way to exit. These initiatives have helped people live better lives through the orthopedic and spinal products developed, marketed and sold by the companies VB has assisted in developing and financing.
For more information about VB, please visit: www.vbllc.com