A Medical Device Daily

Aethlon Medical (San Diego) reported that it will pursue the commercialization of its first-generation Hemopurifier in India over the course of the next year. The company said the plan to initiate commercialization in India corresponds with its international objectives and parallels its effort to advance the Hemopurifier as a broad-spectrum counter-measure against bioterror and emerging pandemic threats in the U.S.

"We are going to implement strategies that offer the greatest likelihood of transitioning our science from the labs and into the marketplace," saidJames Joyce, CEO and chairman of Aethlon.

Aethlon describes the Hemopurifier as a first-in-class device designed to mimic the natural immune response of clearing infectious viruses and related toxins from circulation. Aethlon said the technology "is positioned to fill the void in treating drug- and vaccine-resistant viruses."

The company said that its strategy will focus on viral conditions of greatest concern to the citizens of India, plus opportunities to offer treatment access to the Hemopurifier within India's growing medical tourism industry.

Targeted conditions include dengue hemorrhagic fever (DHF), HIV/AIDS and hepatitis-C (HCV).

Noting that no regulatory barriers specific to the Hemopurifier exist in India, Aethlon said its opportunity to commercialize the technology thre will be based on obtaining clinical data sufficient to drive practitioner acceptance in the marketplace. The company said it will initiate further studies that demonstrate patient safety and support the Hemopurifier as a single-use device designed to remove viral pathogens from blood.

In previous initiatives in India, Aethlon demonstrated safety and early observations of efficacy in a 24-treatment study of dialysis patients co-infected with HCV. The study was performed by the Apollo Hospital (Delhi).

In separate studies, the company demonstrated in vitro that the Hemopurifier rapidly clears HIV and related toxins from blood. Aethlon said it has initiated discussions with the National AIDS Research Institute (NARI) regarding studies of HIV-infected patients. NARI is the government agency overseeing India's HIV-infected population, estimated at 5.7 million cases, the largest infected population of any individual country.

More recently, researchers at the National Institute of Virology (NIV) documented that the Hemopurifier is highly efficient in capturing infectious dengue virus. The device removed greater than 90% of live dengue virus from fluids in 30 minutes. The NIV is India's leading infectious disease research center and a collaborating laboratory of the World Health Organization (Geneva, Switzerland).

Aethlon said it will seek to acquire or build infrastructure in India to assist in establishing product distribution, managing clinical programs and training medical professionals in administering the Hemopurifier treatment technology. Once established, Aethlon said it may utilize its infrastructure to introduce other medical products into the Indian marketplace.

Last month, Aethlon said it had received approval to initiate clinical testing of the Hemopurifier in human studies to be conducted at Fortis Hospital (Delhi). The study will evaluate safety of the HemopurifierAE in up to 10 patients with end-stage renal disease (Medical Device Daily, June 28, 2007).

Pending patient accrual, the study is expected to begin in August. Dr. Vijay Kher, director of nephrology at Fortis, will be the principal investigator. Kher previously acted as principal investigator of the Hemopurifier study conducted at the Apollo Hospital.

Japanese reimbursement okayed for PillCam

Given Imaging (Yoqneam, Israel), which describes itself as "the global leader in capsule endoscopy," said that Japan's Chuikyo – the Central Social Health Insurance Committee — has approved reimbursement for the company's PillCam SB capsule endoscope.

Effective Oct. 1, Japan's entire adult population will be eligible for reimbursement of the PillCam SB procedure for small-bowel indications with obscure GI bleeding. The announcement follows approval received from the Ministry of Health, Labor and Welfare (MHLW) in April to market and sell the PillCam SB capsule endoscope in Japan.

Homi Shamir, president and CEO of Given Imaging, said, "This … means that patients in Japan who suffer from abdominal symptoms can now be diagnosed using PillCam SB, a proven patient-friendly, effective procedure. We are very pleased that Chuikyo issued its reimbursement decision well ahead of our expectations and will continue to work closely with our Japanese partners to educate gastroenterologists throughout the country and accelerate sales of PillCam SB.

Shamir said that Given will introduce the rest of its product line, including the PillCam SB 2, PillCam ESO 2, Agile patency and PillCam Colon into the Japanese market. At some future point.

Given Imaging has operating subsidiaries in the U.S., Germany, France, Japan and Australia.

China Sky One gets 'Innovative' recognition

China Sky One Medical (Harbin, China), a manufacturer of diagnostic and pharmaceutical products, said it has been recognized as an "Innovative Enterprise" by the government of Harbin. With the recognition, it will receive an annual grant of RMB 4 million for the next three years, beginning last month and continuing through June 2010.

The company said the grant will support its new product R&D efforts.

Yanqing Liu, president/CEO of the company, said, "We are pleased to be the only consumer healthcare company in Harbin to be recognized as an Innovative Enterprise and we are delighted to receive the annual grant, which we will put to good use enhancing our new product pipeline."

The Harbin Science and Technology Bureau recently named 10 local companies Innovative Enterprises and offered them grant money in order to encourage innovation in the region.

The government also set aside RMB 6 million per company for future investment in the area.