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PLC Systems 2012 Financial Results Feature RenalGuard Sales up 157% for the Fourth Quarter and 96% f

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By Business Wirevia The Motley Fool

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PLC Systems 2012 Financial Results Feature RenalGuard Sales up 157% for the Fourth Quarter and 96% for the Full Year

MILFORD, Mass.–(BUSINESS WIRE)– PLC Systems Inc. (OTCBB: PLCSF), a medical device company focused on innovative technologies for the cardiac and vascular markets, today reported financial results for the three and 12 months ended December 31, 2012.

Highlights of the fourth quarter of 2012 and recent weeks include:

  • Revenues were $485,000 in the fourth quarter of 2012, compared with $189,000 in the fourth quarter of 2011, an increase of 157%
  • Shipped first stocking orders to Brazil and made continued progress across Latin America to secure regulatory approvals for RenalGuard
  • Continued to broaden awareness of Contrast-Induced Nephropathy (CIN) with presence at Transcatheter Cardiovascular Therapeutics (TCT) 2012, a key medical conference
  • Raised $4.0 million in gross proceeds from an equity financing in February 2013

Management Commentary

“RenalGuard sales during the fourth quarter showed a marked improvement as we filled a large stocking order to Discomed, our distributor in Brazil,” commented Mark Tauscher, president and chief executive officer of PLC Systems. “We worked for more than a year to secure the necessary approvals from Brazilian regulatory authorities, and are making progress in our efforts to receive regulatory approvals across Latin America via our distributor Girlow USA.”

Mr. Tauscher added, “We continue to enroll patients into our pivotal trial to support a Premarket Approval filing for RenalGuard with the U.S. Food and Drug Administration to reduce the onset of CIN. We raised $4.0 million in gross proceeds in an equity offering during the first quarter of 2013. Of the estimated 7.0 million diagnostic and interventional imaging procedures performed worldwide each year that involve the use of contrast agents, we believe that 15% or approximately 1.0 million patients could be considered at-risk for CIN and thus benefit from RenalGuard.

“We are continuing work to expand the awareness of the serious damage to kidneys that may result from CIN. During the fourth quarter of 2012, we had a well-attended booth at an important medical conference, the Transcatheter Cardiovascular Therapeutics meeting in Miami. Although the meeting was held in the U.S., the majority of attendees were from countries where we have distribution, …read more
Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

Advaxis Announces Abstract Accepted for Oral Presentation at SITC Cancer Immunotherapy Clinical Tria

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By Business Wirevia The Motley Fool

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Advaxis Announces Abstract Accepted for Oral Presentation at SITC Cancer Immunotherapy Clinical Trials Workshop

PRINCETON, N.J.–(BUSINESS WIRE)– Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced that an abstract has been accepted for oral presentation at The Society for Immunotherapy of Cancer (SITC) Cancer Immunotherapy Clinical Trials: Concepts and Challenges workshop being held April 4-5, 2013 at the National Institutes of Health Campus (Masur Auditorium) in Bethesda, MD.

The abstract titled “Early Therapeutic Cancer Vaccine Clinical Trial Development” will be presented Thursday, April 4 at 10:30 am during Session 1 by Dr. Robert Petit, VP of Clinical Development and Medical Affairs at Advaxis, and will describe Advaxis’ experience with conducting early clinical trials with therapeutic Lm-LLO immunotherapies.

“The selection of our abstract for presentation at SITC provides an opportunity for Advaxis to share our experience in introducing Lm-LLO immunotherapy in a global clinical trial setting where there is great medical need,” commented Dr. Petit. “We are working toward a future when immunotherapy can fully take its place alongside conventional treatments in the global battle against cancer.”

About Advaxis, Inc.

Advaxis is a clinical-stage biotechnology company developing the next generation of immunotherapies for cancer and infectious diseases. Advaxis immunotherapies are based on a novel platform technology using live, attenuated bacteria that are bio-engineered to secrete antigen/adjuvant fusion protein(s) designed to redirect the powerful immune response all human beings have to the bacteriumto the cancer itself.

In April 2012, Advaxis’ lead construct, ADXS-HPV, was selected as the Best Therapeutic Vaccine (approved or in development) at the 5th Annual Vaccine Industry Excellence (ViE) Awards by the vaccine industry and the journal Expert Reviews of Vaccines. The ViE awards, sponsored by Novartis Vaccines and Diagnostics, were created to recognize the accomplishments and contributions of companies and individuals in the vaccine industry over the previous 12 months. Additional information is available at the World Vaccine Congress website.

ADXS-HPV is being evaluated in 5 clinical trials for HPV-associated diseases: recurrent/refractory cervical cancer (India), locally advanced cervical cancer (GOG/NCI US study, Clinical Trials.gov Identifier NCT01266460), CIN 2/3 (US study, Clinical Trials.gov Identifier NCT01116245), head & neckcancer (CRUK study, Clinical Trials.gov Identifier NCT01598792), and anal cancer (BrUOG study, Clinical Trial.gov Identifier NCT01671488). Over fifteen (15) distinct constructs are in various stages of development, developed directly by the Company and through strategic collaborations with recognized centers of …read more
Source: FULL ARTICLE at DailyFinance