A Medical Device Daily

Global bio-nanotech company pSivida Ltd. (Perth, Australia) and development partner Alimera Sciences (Alpharetta, Georgia) reported that regulatory agencies in the UK, Canada and India have approved the commencement of Phase III clinical trials of the Medidur device for the treatment of diabetic macular edema (DME).

These international clinical sites are opening in conjunction with the trial sites already under way in the U.S. The Medidur development plan has been granted Fast Track status in the U.S. by the FDA.

Medidur, an injectable device, delivers the steroid fluocinolone acetonide (FA) directly to the back of the eye and is designed to treat DME, a common, blinding eye disease that is a leading cause of vision loss in people below 65 years of age worldwide. It affects approximately 10% of diabetics, with more than 500,000 people in the U.S. and millions worldwide having the disease.

There are no FDA-approved drug treatments for DME at present, and the standard of care consists of laser surgery that pSivida said is often ineffective and at best, generally provides temporary relief of symptoms.

The company said sustained delivery of FA to the back of the eye has been shown to reduce edema in patients with DME, reduce the progression of their diabetic retinopathy, and most importantly, at three years, provide a “clinically significant” increase in many patients' vision. These results were generated in a 198-patient clinical trial conducted in the U.S. with the Retisert product by pSivida partner Bausch & Lomb (Rochester, New York). Retisert, a surgically implanted device, delivers FA to the back of the eye.

“Medidur is a simple injectable device that does not require surgery. We hope the Phase III studies with the Medidur device will show similar efficacy to previous trials with sustained-release FA,” said Gavin Rezos, CEO of pSivida. “We believe the initiation of the international phase of the studies is an important milestone which will both accelerate recruitment and enable physicians, patients, and regulatory authorities in different countries to gain experience with the product before approval is sought.”

Alimera Sciences specializes in the development of over-the-counter and prescription ophthalmology pharmaceuticals.

New Asian offices opened by Battelle

Battelle (Columbus, Ohio), a provider of contract R&D, technology commercialization and laboratory management services, has taken another step toward broadening its presence in the international marketplace by opening offices in Japan and South Korea.

The company said that although it has relationships in both countries that date back decades, the new offices mark its first full-time presence in the region.

“Battelle has had tremendously valuable relationships in Japan and South Korea in the past, but these new offices enhance our capabilities to meet customer needs and to use science and technology to solve important problems in Asia,” said Rich Adams, president and CEO of both Battelle-Japan (Tokyo) and Battelle-Korea (Seoul, South Korea).

The opening of the two new offices is part of a growing international presence for the company and is a likely precursor to further entries into the Asian marketplace, Adams said.

Battelle-Japan marks a new chapter in the 35-year relationship between Battelle and Mitsubishi. Battelle owns 60% of the joint venture; Mitsubishi the other 40%. The office is located in Tokyo.

Battelle-Korea is a wholly owned subsidiary of Battelle.

“These offices give us access to growing markets that could represent up to half of R&D spending worldwide within 25 years,” said Carl Kohrt, president and CEO of Battelle.

First PiGalileo use in Australia

PLUS Orthopedics USA (San Diego) said that Dr. Jan Koenig of Mercy Medical Center (Rockville Centre, New York) performed the first-ever demonstration in an Australian hospital of the company's PiGalileo Computer-Assisted Orthopedic Surgery system. St. George Hospital is now the first facility in that country to be able to provide patients this technology for total knee replacement surgery.

The PiGalileo system combines computer-assisted surgery and robotic instrument positioning technologies to assist the surgeon in total knee replacement procedures.

Koenig is director of orthopedics at Mercy Medical Center and also is president and co-founder of Orthopaedic Excellence of Long Island, a multi-specialty orthopedic group practice. He has been a leader in the area of robotic computer-assisted surgery for total knee replacement in the U.S.

“The improved surgical accuracy provided by computer-assisted surgery has been well documented in the scientific literature,” said Koenig. “There is no doubt that the PiGalileo system will improve surgical accuracy and therefore improve surgical outcomes for those patients in Australia who are undergoing total joint replacement surgery.”

PLUS Orthopedics said surgeons who use the PiGalileo technology are provided real-time intra-operative feedback to help improve precision, potentially leading to better implant alignment and positioning.

Surgery with the PiGalileo system aims to position the knee implants optimally, thereby reducing the potential for misalignment and future complications.

More than 80 PiGalileo systems are installed worldwide, and have supported more than 10,000 surgical procedures.

PLUS Orthopedics USA is a wholly owned subsidiary of PLUS Orthopedics Holding AG (Rotkreuz, Switzerland), a manufacturer of implant systems for the hip, knee and shoulder joints, as well as products for the treatment of orthopedic trauma.

BioMag signs Thailand distributor

BioMag (Orangevale, California) said it has entered into a memorandum of understanding with Bangkok RIA Group (BRIA; Bangkok, Thailand), a laboratory, manufacturer and distributor of diagnostic services.

BRIA will make a formal application to the Health Ministry of Thailand to obtain approval to initiate clinical trials for BioMag's HTS-MTP Diagnostic System, including the company's HIV and hepatitis B assays.

Upon completion, BRIA will assist in the commercialization of the products in Thailand.

Through its wholly owned Biospectrum Technologies subsidiary, a company that has designed and patented what it termed “revolutionary diagnostic equipment and immunoassays,” BioMag said it will identify market inadequacies and fill those needs with new technologies and highly specific and sensitive assays that are qualitative and quantitative, easily performed and cost-effective.

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