Posts Tagged ‘Medical’

Sonic Healthcare Acquires US Based Laboratories

Thursday, August 13th, 2009

Sonic Healthcare Limited (SHL) is pleased to announce that it has acquired Piedmont Medical Laboratory (PML), based in Winchester, Virginia, and Axiom Laboratories, based in Tampa, Florida. PML was established in 1991 and is a regional laboratory servicing an integrated network of community-based hospitals, physicians and health care providers, in the states of Virginia and West Virginia. The business has experienced steady revenue growth and has current annual revenue of ~US$11 million. PML will become part of Sonic’s existing Mid-Atlantic division, which is based in Chantilly, Virginia, close to Washington, D.C. The operations of PML are contiguous with those of Sonic’s Mid-Atlantic division and the merger of the two operations will add critical mass to Sonic’s operations in this region and will also provide the opportunity for significant synergy capture.

The purchase price for both businesses comprises upfront cash payments totalling US$20 million and a performance based earn-out of up to US$2.5 million payable over 2 years. The structure of the Axiom acquisition will provide tax deductions for goodwill amortisation over 15 years, with a total net present value to Sonic of ~US$1 million.

Sonic Healthcare’s CEO and Managing Director, Dr Colin Goldschmidt said: “Both Piedmont Medical Laboratory and Axiom Laboratories represent valuable synergistic acquisitions for Sonic. PML will serve to extend our service in the Mid-Atlantic area and will also offer operating synergies due to the close proximity to our current operation. Axiom adds further critical mass and growth potential for Sonic in the important Florida market.”

www.sonichealthcare.com

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Fermiscan Breast Cancer Test Approved in EU

Thursday, July 23rd, 2009

Fermiscan is pleased to announce that ‘The Fermiscan Breast Cancer Test’ has now been “CE Marked”. The CE Mark indicates that the test can be freely marketed anywhere in the European Union and that the company has satisfied the relevant Essential Requirements in the EU’s Medical and Healthcare Products Regulatory Agency directives that its product conforms and that it is fit for its intended purpose.

Fermiscan has begun to establish the necessary infrastructure in Europe to drive a commercial roll out of the test.

Fermiscan’s principal activity is the commercialisation of an innovative non-invasive diagnostic test for the detection of breast cancer.  The Fermiscan Breast Cancer Test is based on the discovery by an Australian scientist that a change can be detected in the molecular structure of hair from women with breast cancer and this change can be identified by using diffraction of X-rays generated in a synchrotron.

Fermiscan completed a major clinical trial of the Fermiscan Test in May 2008, with sensitivity (ability to accurately detect cancer) of 74% in women under 70, and with a higher sensitivity for younger women; and specificity (ability to accurately detect the absence of cancer – negative predictive value) of 99.5%.

Fermiscan is developing opportunities to licence and sell the Fermiscan Test internationally, particularly in Australia, Europe, Japan, South East Asia, and the United States.  Fermiscan owns and operates the Sydney Breast Clinic, one of the largest diagnostic breast clinics in Australia that for more than 30 years has been caring for over 10,000 women annually.  With clinical trials successfully concluded, commercialisation of the Fermiscan Test is progressing to plan in 2009.

www.fermiscan.com.au

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Phosphagenics Successfully Completes Phase 1 Trials

Tuesday, June 30th, 2009

Phosphagenics Limited (POH) today announced the successful completion of its Phase 1 Repeat Insult Patch Test (RIPT) demonstrating that the repeated application of its patented TPM/oxycodone formulation did not cause any significant erythema or sensitisation in humans. Erythema (skin reddening) and sensitization can typically occur when opioids are exposed to the skin and have until now been a limiting factor in commercialising transdermal opioids. With sales exceeding $US 1.5 billion annually, oxycodone is one of the world’s leading pain management drugs, being more potent than morphine with less adverse side effects. Currently it can be administered only orally or intravenously but Phosphagenics is working towards becoming the first company to offer patients suffering from chronic pain a gel or patch that will provide sustained-release of Oxycodone into the bloodstream. As part of these pre-clinical studies, the company conducted animal studies which established that its formula did not cause sensitisation. This was a crucial milestone in its opioid development program but it needed to be verified in humans before the compounds could be commercialized.

RIPT is the standard method for assessing whether a compound is an irritant and/or sensitiser. During the three week induction phase of the study, TPM/Oxycodone was applied every second day to the same area of the subjects’ back and covered with an occlusive dressing. The site of application was assessed every second day after patch removal, and scored for redness and erythema. During the challenge phase which occurred two weeks after the completion of the induction phase, the formulation was applied once to a new area of skin and assessed to determine whether an immune response had developed. The open label, single centre study was conducted at the Royal Adelaide Hospital under the guidance of Principal Investigator, Dr Guy Ludbrook. Fifty healthy, adult volunteers participated in the RIPT trial. The endpoints were the assessment of erythema and sensitisation.

These clinical results pave the way for an extensive Phase 1A pharmacokinetic study examining the transdermal delivery of Oxycodone from Phosphagenics’ TPM/Oxycodone in the recently announced patch systems and also in gels. These studies are expected to commence Q3/09.

www.phosphagenics.com

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