A Medical Device Daily

Cynosure (Westford, Massachusetts), manufacturer of an array of light-based aesthetic treatment systems, reported receiving premarket approval from the Korea Food and Drug Administration for its Cynergy vascular laser system with MultiPlex technology.

CEO Michael Davin said the approval to sell the system in South Korea represents the company's second major product introduction in that country this year.

“The Cynergy workstation with MultiPlex technology marks an innovative development in the treatment of dermatological vascular conditions through the use of laser-based technology,” he said.

Cynosure said the Cynergy workstation with MultiPlex technology is the first system to enable the rapid sequential emission of two wavelengths from the same fiber optic – a pulse-dye laser and an Nd:YAG laser – with a short time delay between the two pulses. It said the time delay increases the safety and efficacy of laser treatment.

In clinical studies, treatments using the Cynergy workstation with MultiPlex technology have shown an increased depth of penetration of energy and improved effectiveness in treating “port wine” stains and improved outcomes for facial and leg telangiectasia when compared to treatments using a pulse-dye laser or an Nd:YAG laser individually.

According to the company, the limited efficacy of either a pulse-dye laser or an Nd:YAG laser in the treatment of port wine stains, hemangiomas and spider veins made those conditions resistant to treatment. It said its MultiPlex technology “allows for customized, patient-specific treatments using these two lasers together, which improves efficacy, decreases treatment lengths and shortens patient downtime.”

Cynosure's Cynergy workstation with MultiPlex is distributed in South Korea by OrientMG (Seoul, South Korea). “As the only dual-wavelength, single fiber optic system available in the Asia Pacific marketplace, the Cynergy workstation with MultiPlex technology provides a distinct competitive advantage for our customers,” said Douglas Kim, president of OrientMG. “This technology enables our customers to offer a broader array of treatment options for vascular lesions, hair removal and skin rejuvenation.”

Hong Kong distributor for Inovise

Inovise Medical (Portland, Oregon) has signed an agreement with Goodwin Health Care (Hong Kong), a provider of emergency medical services (EMS) and hospital products, marking a milestone in the company's international expansion.

Goodwin, with more than 30 years of distributing medical equipment to the EMS, hospital and medical education communities, will distribute Inovise's Audicor 200, a non-invasive cardiac diagnostic technology that helps medical professionals quickly diagnose heart failure and other acute cardiac conditions.

Audicor combines heart sounds and electrocardiogram technology. Sensors containing miniaturized microphones record the heart's electrical and mechanical functions simultaneously. Findings are displayed on the screen and printed via Bluetooth to a printer.

Inovise has a subsidiary in Taiwan and partners with Nihon Kohden (Tokyo) to provide Audicor technology to clinicians in Asia.

“This [is] an exciting opportunity as we experience continued growth in the region,” said Patti White, CEO of Inovise Medical.

“We are very pleased to work with Inovise to introduce Audicor . . . to the emergency care sector in Hong Kong. It offers a good opportunity, as the local emergency care service is being upgraded continuously to a higher level,” said Tony Wong, general manager of Goodwin.

Progress made internationally, says Medistem

Medistem Laboratories (Scottsdale, Arizona) reported progress in its goal to establish a series of international laboratory and clinical facilities to conduct research and fee-for-service treatments using its stem cell-based therapeutic technologies.

Medistem, which describes itself as “committed to the ethical development of next-generation medical therapies from non-controversial adult stem cell sources,” said it is in negotiations to license its technology to laboratories and clinics in numerous locations around the world, including Germany, Switzerland, Bulgaria, Singapore and Mexico.

The company said the negotiations would grant the international licensees the ability to further develop therapies based on Medistem's adult stem cell technologies and enable fee-for-service patient treatments.

Medistem has executed a technology licensing and royalty agreement with the Institute for Cellular Medicine (ICM) in San Jose, Costa Rica, which enables ICM to culture stem cells and work with physicians to develop and deliver Medistem's stem cell technologies and therapies. ICM is in the process of obtaining its license from the Health Ministry in that country.

Medistem is focusing on the development of stem cell-based therapeutics for a number of neurological conditions that are difficult to treat, with plans to launch trials to develop therapies for stroke and for such conditions as Parkinson's disease and cerebral palsy.

The company also recently filed a U.S. patent application for stem cell-based technology to treat lower back disorders by preventing spinal disc degeneration.

Chronic back pain trials set

CardioVascular BioTherapeutics (Las Vegas) said it has signed a collaborative research and development agreement with the global clinical contract research organization, bioRASI, to initiate proof-of-concept studies in patients suffering chronic back pain.

Chronic back pain has recently been linked to blockage of blood vessels supplying the lower back, leading to a condition referred to as lumbar ischemia. The multi-site clinical study, to be performed in Russia and Eastern Europe, will enroll patients who have blockages in their lumbar arteries which lead to poor perfusion and chronic lower back pain.

The patients will receive CVBT's new drug candidate for lumbar ischemia, which has Cardio Vascu-Grow as its active ingredient.

Thomas Stegmann, MD, co-founder and chief clinical officer of CVBT, said, “Our new clinical collaboration with bioRASI in patients with blocked lumbar arteries is a natural extension of our ongoing clinical trials with no-option heart patients, who are receiving our drug candidate for advanced atherosclerotic disease of their coronary arteries.”

He said that in Russia the company will be able to rapidly assess its drug candidate “more economically than performing similar clinical trials in the U.S.”

Stegmann said, “Whether it is coronary heart disease, vascular consequences of diabetes, stroke, or intestinal ischemia, it is becoming accepted now by the medical community that if you can increase blood flow to the affected tissues the patients' condition should improve.”

Kuwait newest market for VeriChip

VeriChip (Delray Beach, Florida), a subsidiary of Applied Digital, said that its Hugs and HALO infant protection system has expanded its distribution to Kuwait.

Using wearable RFID tags placed on infants and mothers combined with electronic monitoring of exits, VeriChip's systems are designed to help protect newborns from possible abduction and to help ensure mothers are matched with the correct infants during their stay.

The Hugs system offers security against infant abductions while requiring little administration and training. The HALO Infant Protection System uses skin-sensing tag technology and is modular in design.

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