A Medical Device Daily

Small Bone Innovations (SBI; New York), a provider of products for the small bone and joint sector of the orthopedics industry, said it has agreed to acquire Link Orthopaedics (Rockaway, New Jersey), the Scandinavian Total Ankle Replacement (STAR) system, and certain assets related to the STAR Ankle from Link’s sister firm, Waldemar Link (Hamburg, Germany).

Financial terms of the deal were not disclosed.

The STAR Ankle is not FDA-approved, though a pre-market approval (PMA) application for the device was accepted for filing in March 2006 and a FDA panel recommended approval with conditions last spring (Medical Device Daily, April 26, 2007).

According to the company, the STAR Ankle was designed as an anatomic non-constrained, resurfacing prosthesis in 1978 by Hakon Kofoed, MD, president elect of the European Foot & Ankle Society (Dublin, Ireland) and associate professor of orthopedics at the University of Copenhagen (Denmark). The device 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,” the company noted.

“The experience from the 1970s showed significant individual differences between a patient’s ankle pathologies and that patients need more than a two-piece device. A three-piece, mobile-bearing ankle prosthesis allows the ankle to find its own direction and accommodate patient variability,” Kofoed said.

According to Anthony Viscogliosi, president/CEO and chairman of SBI, the current version of the STAR Ankle has been used clinically since 1990 in 27 countries with more than 10,000 implantations. He added that there have been at least 30 clinical papers written and “countless” presentations” given over the past 30 years on the technology.

SBI said an investigational device exemption (IDE) trial was initiated in the U.S. in 2000 and remains ongoing while FDA reviews the PMA for the STAR Ankle.

The IDE trial is a prospective, multi-center, concurrently controlled study. It follows patients for at least two years. The two principal investigators were Roger Mann, MD, and Michael Coughlin, MD. There were 10 sites that enrolled STAR Ankle patients in the trial and a larger group in the “continued access” study, the company said.

SBI says that, if approved, the device would be the only FDA-approved, non-cemented mobile bearing total ankle replacement prosthesis available in the U.S.

“Currently, there are no FDA approved mobile bearing ankles for use in the United States. 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 in order for those ankles to be used in accordance with FDA approved labeling, they should be fully cemented in place,” Viscogliosi said.

In other dealmaking activity:

• SurModics (Eden Prairie, Minnesota), a provider of surface modification and drug delivery technologies, reported that Merck (Whitehouse Station, New Jersey) has exercised an option to develop and sell an additional investigational compound using SurModics’ I-vation sustained drug delivery system under a license and research agreement the companies signed in June (MDD, June 28, 2007).

Merck will lead and fund development and commercialization activities. SurModics will receive a licensing fee and payment for its development activities. In addition, SurModics will be eligible to receive development milestones associated with the development and attainment of U.S. and European regulatory approvals in connection with a candidate compound. SurModics will be responsible for the manufacture and supply of clinical and commercial products. SurModics will also receive royalties on product sales.

• Medifacts Systems (Chicago) said it has granted an exclusive license for a genetic test patent to the Mayo Clinic (Rochester, Minnesota). The test is designed to detect Alpha Thalassemia mutations and their use as predictors of blood-related disorders, according to Medifacts.

Through the agreement, Mayo Medical Laboratories will make the test available to patients worldwide, the company said.

Thalassemia is an inherited blood disease particularly prevalent among Mediterranean, Middle Eastern, Pacific Islanders, Asian and African people. The genetic defect that causes a reduced rate of synthesis for hemoglobin is believed to provide some protection against malaria in malaria-prone areas. However, it can lead to anemia, which is the characteristic presenting symptom, and other health complications involving the spleen, gall stones, and heart failure. There is no cure for thalassemia and the best treatment available today consists of frequent blood transfusions with iron chelation therapy administered subcutaneously.

Medifacts also provides archival computer systems for medical examiners, pathology, surgery, and institutions with research and/or teaching responsibilities. The system archives medical images including DICOM images, audio and video, and accompanying data.