The US Food and Drug Administration (FDA) has deferred approval for medical equipment company Medigus Ltd.'s application to begin a multi-center trial of its SRS endoscopy system for the treatment of Gastro Esophageal Reflux Disease (GERD). The FDA has requested that Medigus provide them with further information on its endoscope and SRS system.

Shmulik Shelah 4 Sep 07   10:31

Medical equipment company Medigus Ltd. said yesterday that the US Food and Drug Administration (FDA) has turned down its application to begin a multi-center trial of its SRS endoscopy system for the treatment of Gastro Esophageal Reflux Disease (GERD). The company had submitted a 510K application to secure FDA approval to commence marketing of its product.

At the beginning of August, Medigus announced that it would commence Phase III clinical trials ahead of the approval of its device in the US, and filed an application to begin a multi-center trial prior to obtaining marketing approval for its device.

The FDA has advised the company that its application has not been approved in its present format, and the company has been asked by the FDA to provide further information on its endoscope and SRS system," said Medigus in its notification to the TASE. The company added that it expected to complete the revision of its presentation within 10-12 weeks and that this would delay approval for its device by two to three months.

Published by Globes [online], Israel business news - www.globes.co.il - on September 4, 2007

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Hadasit, the technology transfer company of Hadassah Medical Organization, has developed a virtual reality (VR) system for the treatment of chronic pain and stroke rehabilitation. Hadasit has commenced Phase II clinical trials for its VR system following early clinical data which showed the VR system to help patients with pain and rehabilitation.

Globes correspondent 5 Sep 07   11:54

Hadasit, the technology transfer company of Hadassah Medical Organization has commenced Phase II clinical trials of its virtual reality (VR) system for the treatment of chronic pain and stroke rehabilitation at Hadassah University Hospital. The virtual reality system employs a patent pending technology designed to utilize brain plasticity and enhance learning processes in patients who are unable to use their arms, hands, or shoulders due to stroke or chronic pain.

Hadasit will recruit a total of 90 post stroke patients for its Phase II trial, who will be followed for one year. The company said that early clinical data, generated from a study with a small number of patients, showed that the virtual reality system helps patients suffer less pain in their weak arm and perform better than patients who are not treated by the system.

Shimon Shiri, a rehabilitation psychologist at Hadassah and an inventor of the system said, "Essentially, brain mirror neurons are activated when humans perform an action, or when they observe themselves or others perform the same actions. The virtual experience activates the mirror neurons and induces a therapeutic effect on the brain that reduces pain and increases function. By viewing the movement of the arm without pain, the brain undergoes a corrective learning process."

Hadasit added that it had a pipeline of other products based on on the virtual reality technology including a device that combines virtual reality and biofeedback to treat tension headaches and migraines.

Published by Globes [online], Israel business news - www.globes.co.il - on September 5, 2007

© Copyright of Globes Publisher Itonut (1983) Ltd. 2007

Medical device startup LifeWave Hi-Tech Medical Devices Ltd. Has signed a memorandum of understanding for a four-year distribution agreement of its Bedsore Treatment System (BST) and peripherals to Austria. LifeWave has now signed distribution agreements with six European Countries.

Michal Yoshai 2 Sep 07   11:16

Medical device startup LifeWave Hi-Tech Medical Devices Ltd. has announced a further distribution agreement for its Bedsore Treatment System (BST) and peripherals. The company said it had signed a memorandum of understanding for a four-year distribution agreement with a distributor in Austria which, if realized in full, will generate €4.6 million in revenue. The distributor also undertook in the agreement to forward an immediate order for 40,000 BST peripherals.

LifeWave has now signed distribution agreements with six countries in Europe, including Germany and Italy. The company said its success in extending its penetration of the European market represented important milestones in its development.

LifeWave also said that it was now negotiating the final terms of its distribution agreements with its European distributors and with Israel's Meuhedet Health service. The company also said it will be announcing the appointment of a new chairman to replace Aviv Bushinsky, who stepped down last week to avoid being sacked by the LifeWave board.

Published by Globes [online], Israel business news - www.globes.co.il - on September 2, 2007

© Copyright of Globes Publisher Itonut (1983) Ltd. 2007

Professor Roni Zeger of the Department of Biological Regulation at the Weizmann Institute of Science has released a study stating that live cells can absorb signals from cellular telephones. While the study does not shed light on the health effects of using cellular communications, it may enable future researchers to address health issues.

Shmulik Shelah 3 Sep 07   11:45

“Live cells can absorb signals from cellular telephones,” states a new study by Prof. Roni Zeger of the Department of Biological Regulation at the Weizmann Institute of Science. The study examined how live cells respond to radiation emitted by mobile telephones. Although the study sheds no light on the debate regarding the effects on health of cellular communications, the researchers hope that the present study’s results will enable future researchers to address health issues.

The study examined both the intracellular and intercellular communications system. The Human Genome Project discovered that each cell has 200 “switchboards” which transfer incoming signals to the cell nucleus. The intracellular route is based on a chain of five to eight receptor proteins that forward the signal. The signals are mainly external physical stimuli, such as heat, or the identification of various molecules. In the latter case, the receptors transmit a message to the “addressee” within the cell.

According to Zeger, the study found that there are a number of “extensions” for each communications channel, and that each extension handles designated signals, which are sent to the ‘addressee” in the cell for expression. He adds that understanding these channels can help researchers understand disruptions in intracellular communications and help develop more effective treatments with few side effects for various diseases, including cancer.

The researchers claim that cellular telephone radiation might be one factor that activates the intracellular communications system, which enables living cells to respond in various ways to different radiation strengths and frequencies. The results cannot determine whether the use of cellular telephones carries any health risk. The study was conducted on cells exposed to radiation in the cellular frequency range for 45 minutes.

Published by Globes [online], Israel business news - www.globes.co.il - on September 3, 2007

© Copyright of Globes Publisher Itonut (1983) Ltd. 2007

Mazor Surgical Technologies Ltd has obtained US Food and Drug Administration approval for SpineAssist for all spinal surgical implant procedures. SpineAssist is a robotic system that enables surgeons to accurately place implants with reduced radiation exposure during surgery.

Yaniv Magal 4 Sep 07   17:59

Mazor Surgical Technologies Ltd. has obtained US Food and Drug Administration (FDA) approval for its SpineAssist for all spinal surgical implant procedures. The permit covers both open and minimally invasive surgical procedures.

SpineAssist is a robotic system that enables surgeons to accurately place implants with reduced radiation exposure during surgery. The system uses CT images taken before the surgery to direct the surgeon to precise location for the implant without the need to cut open the back and expose the spine.

Mazor went public last week.

Published by Globes [online], Israel business news - www.globes.co.il - on September 4, 2007

© Copyright of Globes Publisher Itonut (1983) Ltd. 2007

Teva Pharmaceuticals Industries Ltd. has received a decision by a US District Court in New Jersey on a patent infringement suit brought against it by Novartis. The Court has denied the motion filed by Novartis, which has opened up the way for Teva to launch a generic Famciclovir product for the treatment of shingles and genital herpes.

Gil Shlomo 6 Sep 07   16:23

Teva Pharmaceutical Industries Ltd. has received decisions on three products, as it awaits an impending decision on Protonix, a fourth drug.

On Wednesday, Teva announced that a US District Court in New Jersey denied a motion filed by Novartis for a preliminary injunction related to Teva's Famciclovir tablets, AB. Famciclovir is the generic equivalent of Novartis's shingles and genital herpes treatment Famvir.

Teva's abbreviated new drug application to market its Famciclovir tablets (in doses of 125 mg, 250 mg, and 500 mg) has already been granted final approval by the US Food and Drug Administration (FDA).

As the first company to file an abbreviated new drug application for Famciclovir, Teva has been awarded a 180-day period of marketing exclusivity, which will begin to run from the date of first commercial marketing.

Novartis had brought a patent infringement suit against Teva in April 2005 regarding the generic version, though a trial date has not been set. Teva had agreed not to launch a generic Famciclovir product until the conclusion of today’s hearing.

The brand product had annual sales of approximately $200 million in the US for the twelve months ended June 30, 2007, based on IMS sales data.

Separately, Forest Laboratories, Inc. and H. Lundbeck A/S of Denmark said that the US Court of Appeals for the Federal Circuit affirmed a 2006 decision which determined that the US patent covering the active ingredient in anti-depressant Lexapro is valid, and upheld the injunction preventing Teva subsidiary Ivax’s proposed generic product launch. The patent expires in 2012.

Today, Teva announced that the US Food and Drug Administration (FDA) has granted final approval for the company's abbreviated new drug application to market its generic version of GlaxoSmithKline plc's cardiovascular agent Coreg (Carvedilol). The company said that shipment of this product will begin immediately.

The brand product had $1.7 billion in US sales for the twelve months through June.

Teva will be back in court tomorrow to hear the outcome of its bid to launch a generic version of Wyeth's Protonix for the treatment of gastroesophageal reflux disease. Protonix has annual sales of around $2.5 billion.

Teva’s market cap hovers around $33.37 billion. Teva develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients.

Published by Globes [online], Israel business news - www.globes.co.il - on September 6, 2007

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