ILSI-Biomed Israel

BrainStorm Raises $3.6 M To Launch Phase I/II Trial for ALS.

The recent appointment of Adrian Harel as the CEO of BrainStorm Cell Therapeutics (OTCBB: BCLI) signals the beginning of a new era both for the company and for its new top exec. BrainStorm, after several hurdle-crossing years of pre-clinical testing and validation of its autologous stem cell therapy, is about to become the first Israeli company to reach the clinical trial stage with a differentiated stem cell-based therapy. The company`s Phase I/II trial, expected to begin in the spring,...

Robots back breakthrough surgery.

SpineAssist – an Israeli invention – is revolutionizing delicate spinal surgery. Judy Siegel-Itzkovich spoke to the innovative company’s CEO. Many patients scheduled for a major spinal operation naturally worry that they might find themselves in a wheelchair due to a surgical error, or simple bad luck. While this happens only rarely, it is a possibility. The results of orthopedic surgery are as good as the specialist who performs it – but today, the risk is much reduced. Not only is there...

Mazor wins FDA approval for Emerald spine implants

Mazor Robotics Ltd. (TASE:MZOR) has obtained US Food and Drug Administration (FDA) marketing approval for its Emerald spinal implants. The company plans to begin marketing in the second half of 2011. Mazor's share price jumped 11 percent in heavy trading on the news, but fell back to a gain of 7.4 percent in afternoon trading to NIS 10.81, giving a market cap of NIS 204 million. The Emerald spinal implant is inserted by the company's robotic SpineAssist system for minimally invasive sp...

FDAnews Virtual Conference: Complying with FDA’s Unique Device Identification Rule; Feb 24 2011

The soon-to-be-issued FDA proposed rule requiring adoption of Unique Device Identification (UDI) has device manufacturers in a sweat. But an upcoming virtual conference for medical device companies promises to shed light. The FDA is about to unveil a proposed rule that could dramatically increase the volume and type of information you supply to the FDA. The new rule will require you to create a unique ID and label for every product that carries risk. The label will include name of manu...

Curepharma is looking to hire a QA & Regulatory Affairs manager

Curepharma is looking to hire a QA & Regulatory Affairs manager to be a part of the Botanical Drugs revolution. Can you handle this job ? Botanical Drugs are a fairly new FDA regulatory category - the future of the Pharma industry. To support our a diversified pipeline and a lead botanical drug candidate entering phase III, we are looking to hire a QA & Regulatory manager who can stand up to the challenge of setting procedures for game-changing drug developing and manufacturing processes. ...

Aiming for Near-Normal Blood Sugar Did Not Delay Combined Risk of Diabetic Damage for People With Long-standing Diabetes, NIH-Sponsored Trial Finds

In people with longstanding type 2 diabetes who are at high risk for heart attack and stroke, lowering blood sugar to near-normal levels did not delay the combined risk of diabetic damage to kidneys, eyes, or nerves, but did delay several other signs of diabetic damage, a study has found.  The intensive glucose treatment was compared with standard glucose control. These findings are from the NIH-funded Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial.  Although intensive t...

BioMed 2010 week Innovations: The New Generation of PainShield

NanoVibronix will present the second generation of PainShield – for the treatment of pain and chronic wounds using ultrasound waves Following the commercial success of the first generation PainShield device, for the treatment of (surprise, surprise) pain, especially one that stems from Trigeminal Neualgia, the Israeli company NanoVibronix now reveals the second generation of the device. This time, it has some extra capabilities to treat chronic wounds. NanoVibronix, based in Nesher, is develo...

Stem Cells as Seek-and-Destory Missiles against Cancer

As published in New Scientist, stem cells were succesfully modified to act as seek-and-destroy missiles against cancer in mice brains Stem cells are often viewed as the ultimate solution for regenerative medicine, and for a good cause. Given the correct cues, they can regenerate whole parts of the body, and even re-create an entire embryo (although that would require QUITE some understanding of the cues involved in the process). It seems, however, that now a new use has been found for the...

May 5th: Healthcare Reform Webinar

U.S. Health Care Reform Webinar - A Special Presentation for Israeli Pharma, Biotech and Medical Device Companies and Their Investors     Please register for this live webinar.   Meeting Description:    Drug and Biologics Manufacturers: Medicare and Medicaid drug coverage changes Annual fee for branded prescription drug manufacturers Biosimilars   Medical Device Manufacturers: Excise tax Essential Health Benefits Package   Heal...

OrSense Receives FDA Approval for Non-Invasive Oximetry Monitoring System

OrSense Ltd., developer of monitors for non-invasive measurements of various blood parameters, announced it has received U.S. Food and Drug Administration (FDA) approval for NBM-200MP, a non-invasive oximetry and low signal oximetry sensor.   Non-invasive pulse oximetry has become a standard of care in the operating and recovery rooms, intensive care units and emergency services, yet it has been known to provide erroneous oxygen saturation readings in situations of low perfusion, low...