A Medical Device Daily

Reliant Technologies (Mountain View, California) has received multiple approvals in the Asia Pacific region for the sale of its Fraxel SR1500 laser, which it terms “the latest innovation in aesthetic laser medical technology.”

This extension of the Fraxel line of skin resurfacing products has regulatory authorization for commercial sale in Australia, New Zealand, Indonesia, Vietnam, Malaysia, Hong Kong, Japan and the Philippines, and clearance also is expected in Korea, Singapore, Taiwan and Thailand later this year.

The Fraxel SR1500 is used for the treatment of pigmented lesions, melasma, periorbital wrinkles, acne scars, surgical scars, skin resurfacing and soft-tissue coagulation.

The laser combines advancements in optical technology with medical software offering physicians a treatment option that penetrates up to 30% deeper, the company said, “delivering consistent dosage control and optimizing lesion depths with spot size determined by indication.”

Eric Stang, president/CEO of Reliant, said the continued development of Fraxel lasers responds to a rapidly growing consumer demand for safe, effective and predictable skin treatment options.“ Whether we suffer from serious skin problems or simply want to feel better about how we look as we age, we want options. We want a treatment we know delivers results with the least amount of recovery time and the lowest risk of side effects,” said Stang.

The company said that the Fraxel SR1500 marks initial expansion of the Fraxel family of lasers, launched in 2004. The new software engine is driven by an algorithm that allows the physician to more precisely focus on specific areas of repair while controlling the collimated depth of penetration. The algorithm refers to a database populated with data from thousands of histology slides that determine appropriate lesion depth and width, based on physician-selected settings.

“The Fraxel laser is effective for facial, neck and chest rejuvenation and acne scars because of the characteristic changes that it induces in the skin with microthermal zones of injury followed by repair,” said Zakia Rahman, clinical instructor of dermatology at Stanford University (Palo Alto, California). He said it is “particularly appealing when treating Asian or similarly pigmented skin, as the laser targets water, not melanin, thus avoiding the risk of hyper-pigmentation.”

Chinese device firm sets $100M notes sale

China Medical Technologies (Beijing) reported a proposed offering, subject to market and other conditions, of $100 million principal amount of convertible senior subordinated notes, due 2011, to qualified institutional buyers. The company also will grant the initial purchaser an option to buy up to another $25 million principal amount of notes to cover overallotments. Concurrent with the offering, the company plans to enter into a simultaneous share repurchase program of about $30 million.

China Medical said it intends to use the remaining proceeds for general corporate purposes and for the acquisitions of businesses, products and technologies that it believes will complement its existing business.

China Medical manufactures products using high-intensity focused ultrasound for the treatment of solid cancers and benign tumors and advanced in vitro diagnostics products using chemiluminescence technology, to detect and monitor various diseases and disorders.

Abiomed adds to Japan agreement

Abiomed (Danvers, Massachusetts) reported signing a five-year distribution agreement with Medix Japan , a distributor of cardiac assist devices.

Building on an eight-year relationship with Abiomed, Medix also said it intends to initiate clinical trials in Japan during Abiomed’s FY08.

The agreement provides for distribution of Abiomed’s AB5000 and Impella products and includes a minimum purchase of Impella products of $11 million within the first 18 months following regulatory approvals in Japan. The balance of the purchase commitment is for Abiomed’s other products and begins in Abiomed’s 1Q08.

“Interventional cardiologists and cardiovascular surgeons in Japan can now look forward to incorporating the Impella and AB5000 product platforms into their treatment of patients in acute heart failure,” said Yasu Matsuoka, president of Medix. “Our regulatory and specific cardiovascular expertise and distribution partners make our partnership with Abiomed an ideal fit.”

He added, “We believe that this technology will have a profound effect on patient care and are totally committed to working with our government officials and the Abiomed team to bring these products to the Japanese market as rapidly as possible.”

Michael Minogue, president/CEO of Abiomed, said Japan represents a sizeable market for his company’s recovery technologies. “Heart recovery is one of the main priorities in Japan, and their physicians often provide some of the most elaborate evidence-based scientific publications in the world.

Abiomed manufactures the AB5000 circulatory support system and the BVS 5000 biventricular support system for the temporary support of all patients with failing but potentially recoverable hearts. It offers the minimally invasive Impella Circulatory Support System in Europe.

Elbit unit wins FDA OK for StemEx study

Elbit Medical Imaging (EMI; Tel-Aviv, Israel) reported that its subsidiary Gamida Cell , in which EMI holds a 25% stake, has reached an agreement with the FDA for a special protocol assessment (SPA) for the design of a pivotal registration study of StemEx for the treatment of hematological malignancies. Gamida Cell is developing StemEx in a joint venture with Teva Pharmaceutical Industries (Jerusalem).

StemEx is composed of ex-vivo expanded cord blood stem/progenitor cells, which are transplanted in combination with non-expanded cells from the same cord blood unit. Stem cell transplantation is a treatment for high-risk hematological malignancies. It is thought to provide an alternative source of stem cells for these patients by enabling the use of cord blood for transplantation.

The Phase I/II study of StemEx, conducted at the M. D. Anderson Cancer Center (Houston), showed safety and trends of efficacy. The new study, set to begin soon, will be managed by Yael Cohen, Gamida Cell’s medical director responsible for the design of the pivotal study.

StemEx was granted an FDA Orphan Drug designation in March 2005.

Gamida Cell is developing a line of cell therapy products for the treatment of debilitating and fatal diseases with unmet clinical needs. Gamida Cell says it has an additional product in “advanced” pre-clinical development for the treatment of heart disease.

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