A Medical Device Daily

Medtronic Mediterranean (Beirut, Lebanon) reported the Middle East launch of the Arabic-language version of Medtronic's Paradigm real-time insulin pump and continuous glucose monitoring system, a progressive therapy available for patients who use insulin to treat diabetes.

The company said the Paradigm system is the first integrated insulin therapy to display real-time continuous glucose readings and trend graphs, allowing patients to make immediate self-management decisions to improve their glucose control after confirming readings with a fingerstick measurement.

The system's continuous glucose sensor is a tiny electrode that is inserted under the skin using the Sen-Serter, a small device that Medtronic said makes sensor insertion easy for patients or their caregivers. The sensor measures glucose in the interstitial fluid found between the body's cells, and is typically discarded and replaced after three days of use.

Glucose measurements obtained by the sensor are relayed every five minutes from a transmitter to the external insulin pump, which displays three-hour and 24-hour trend graphs, as well as arrows to indicate how quickly glucose is moving up or down. An alarm alerts patients when glucose levels become too high or too low.

"In order to manage diabetes properly, patients must continually understand what affects their glucose patterns and take action to regain control as quickly as possible," said Khalid Al-Rubeean, MD, director of University Diabetes Center at King Saud University (Riyadh, Saudi Arabia). "Timely information coupled with precise insulin delivery is why this integrated insulin therapy has the potential to revolutionize diabetes management."

The Paradigm real-time system integrates an external insulin pump with continuous glucose monitoring (CGM). The system's glucose sensor takes as many as 288 daily glucose readings per day — providing nearly 100 times more information than three daily fingerstick readings provide, according to the company.

Medtronic said that current standards for assessing glucose control include A1C tests and fingerstick measurements, adding that "both have limitations." The company said an A1C test, which measures glucose control over a three-month period, "is important for long-term management, but it is only an average and does not reveal day-to-day glucose fluctuations that can damage the body."

In turn, it said, fingerstick measurements "only reveal a glucose value at a single moment in time [and] as a result, patients are unable to detect approximately 60% of low-glucose (hypoglycemia) events and have difficulty assessing glucose fluctuations while they sleep."

Medtronic said that in contrast, real-time CGM "allows patients to view glucose trends throughout the day and night, and understand how fast, and in what direction, their glucose levels are heading."

Japanese distribution deal for Spectral

Spectral Diagnostics (Toronto) said it has entered into an exclusive distribution agreement in Japan with Toray Medical for Spectral's EAA diagnostic system.

Toray Medical will market and sell the EAA Endotoxin Activity Assay for the detection of endotoxemia and the subsequent risk for sepsis in conjunction with its Toraymyxin blood purification device, which removes endotoxin from the bloodstream. Toray Medical also will distribute the EAA diagnostic as a stand-alone product.

"This new arrangement is a significant expansion of our existing alliance with Toray Medical, which over the past three years has focused on establishing the value of our EAA diagnostic in combination with Toray's blood purification device," said Dr. Paul Walker, president and CEO of Spectral Diagnostics. "This alliance will strengthen our presence in Japan and provide us with access to other Asian countries."

Motonaga Tanaka, president of Toray Medical, said, "By using Spectral's EAA diagnostic to measure endotoxin levels in combination with the utilization of our blood purification system, we rapidly identify patients in need of treatment and track their progress on a timely basis leading to better patient care."

This is the third major distribution agreement for EAA that Spectral has signed in 2007.

China distribution accords for JJB

AMDL (Tustin, California), which through its wholly owned Jade Pharmaceutical (JPI) subsidiary is an international biopharma company developing pharmaceutical and diagnostic products, said that JPI's subsidiary, JJB, has signed set of regional distribution agreements in China for its new anti-aging and skin care injectable product under the brand name Goodnak.

The product is the first in a new line of anti-aging and skin-care products currently under development by JJB.

JJB signed exclusive, one-year renewable distribution and agency agreements with Changsha Hongli Co., Wenzhou Limeikang Trade and Xiamen Larry Beauty Technology Co. The agreements cover the key cities in Hunnan, Zhejiang and Fujian provinces in southern China that have a combined population of nearly 135 million.

The agreements require these new distributors to purchase a minimum of $7.12 million worth of the Goodnak product during the one-year period of the contracts

Jade Pharmaceutical has operations in Shenzhen, Jiangxi and Jilin, China.

Hong Kong/Macau distribution for Today Sponge

Synova Healthcare Group (Media, Pennsylvania) said it will begin distributing and selling its Today Sponge non-hormonal contraceptive product in Hong Kong and Macau through Hind Wing Co. (Hong Kong). This represents the first time Synova has made the Today Sponge available to women outside North America.

Synova said it expects to begin shipping to Hind Wing, which it said is one of the largest pharmaceutical trading companies in Hong Kong, before year-end.

Hind Wing's selling network represents professional and consumer products in private and government hospitals, medical clinics, independent pharmacies, pharmacy chains, family planning association clinics, department and baby stores.

Stephen King, chairman and CEO of Synova, said, "The Today Sponge can be an important contraceptive option for women in many markets around the world. Given Hind Wing's impressive distribution network, professional sales team, and experience in marketing contraceptive and medical products, we believe that it will prove to be a successful distribution partner for Synova."