PLC Provides Update on Financing Efforts and RenalGuard(R) Program
Signs distributors in China, Taiwan, Russia, Benelux, former SSR Nations and Portugal;
Engages advisor to raise capital and seek Renal Guard strategic partnerships;
Provides update on Italian trial, including latest results;
Reduces cost structure
FRANKLIN, Mass., Feb. 4 /PRNewswire-FirstCall/ -- PLC Systems Inc. (OTC Bulletin Board: PLCSF), a company focused on innovative cardiac and vascular medical device-based technologies, announced today that it has developed a new strategic plan for its RenalGuard® program and is implementing additional cost-saving measures as it continues to seek financing for the Company. Key elements of the plan consist of engaging a financial advisor to assist the company with developing partnerships and raising funds for its RenalGuard business, and reducing costs by outsourcing manufacturing of RenalGuard. PLC is continuing to focus on increasing RenalGuard sales opportunities, having signed three new distributors, and is continuing to support the on-going scientific trials of RenalGuard in Italy.
Said Mark R. Tauscher, chief executive officer of PLC, "We believe that our RenalGuard technology has significant value, and working with our Board, we have developed a strategic plan to explore available opportunities to realize and maximize this value for the benefit of the Company and its shareholders. We are hopeful that the steps we are taking will help expand RenalGuard's reach and raise visibility among potential partners who can assist us in bringing our innovative technology to more potential customers."
Financial Advisor Engaged
PLC announced that it has engaged Natixis Bleichroeder LLC as its financial advisor to assist with efforts to raise additional capital and to explore other strategic options for the RenalGuard program, including helping to identify and develop potential strategic partnerships.
Cost Structure Moves
In connection with its ongoing efforts to reduce costs, PLC also announced that it has reduced its U.S. staff by eight, or 33%. This reduction in force includes the RenalGuard manufacturing team. The company believes RenalGuard can now be more effectively and cost-efficiently manufactured through an external contract manufacturer, because the technology platform is stable, the manufacturing processes are compliant and the product design has benefited from hundreds of examples of usage to date. The new contract manufacturer selected to build RenalGuard is ISO 13485:2003-registered and FDA-compliant.
This step is expected to provide annualized savings of approximately $750,000, starting in the third quarter of this year. It will also entail a special charge of approximately $230,000 reflected in the first quarter of 2010 expenses for severance and termination pay.
New Distributors Signed
PLC has entered into three new exclusive distribution agreements to launch distribution of its RenalGuard System™ in the following countries: Russia, Belgium, the Netherlands and Luxembourg and all of the former Soviet Socialist Republic nations; Portugal; China and Taiwan. These established distributors of medical technology will join PLC's existing group of distribution partners worldwide who are working to build on the increased interest in using RenalGuard for its unique fluid balancing capabilities in a cath lab setting during cardiovascular imaging procedures for patients at higher risk of Contrast-Induced Nephropathy (CIN).
The new distributors are: Axle International, (headquartered in London, England) covering Russia, Benelux and the former SSR nations; Hsin Tung (Xiamen) Medical Co., Ltd., Xiamen, Fujian, China; covering China and Taiwan, and Endovascular Dispositivos Medicos Lda, Charneca de Caparica, Portugal, covering Portugal.
Hsin Tung will apply for the needed regulatory approvals for China and Taiwan and Axle International will apply for these approvals in Russia and the SSR countries. No new regulatory approvals are required in the other countries.
In addition to the countries served by these new distribution agreements, PLC has previously launched RenalGuard in Italy, Spain, Bangladesh and Pakistan and is working with its distributor in Brazil to register the product for sale in that country.
Clinical Trials Update
Two investigator-sponsored randomized clinical trials to evaluate the use of RenalGuard in the prevention of CIN are currently underway in Italy. The latest results of one of these, the MYTHOS trial, continues to reinforce RenalGuard's efficacy, with rates of CIN in the RenalGuard-protected group dramatically lower, at 3.7%, compared to 15% in the control group, based upon data from 114 of 120 patients. The MYTHOS trial, under the sponsorship of Drs. Antonio Bartorelli and Giancarlo Marenzi of the Centro Cardiologico Monzino-University of Milan (CCM), has completed its original 120 patient enrollment and analysis of the full data is being finalized. The sponsors, who are international experts on CIN, have determined to expand the trial up to 200 patients to gain even stronger scientific proof of the efficacy of RenalGuard in preventing CIN in affected patients.
Meanwhile, the second clinical trial of RenalGuard is ongoing at the Clinica Mediterranea in Naples, Italy, under the sponsorship of Dr. Carlo Briguori, another world-renowned expert on CIN prevention. This trial is anticipated to be completed in late 2010.
About PLC Systems Inc.
PLC Systems Inc. is a medical technology company specializing in innovative technologies for the cardiac and vascular markets. Headquartered in Franklin, Massachusetts, PLC pioneered the CO2 Heart Laser System, which cardiac surgeons use to perform CO2 transmyocardial revascularization (TMR) to alleviate symptoms of severe angina. PLC's newest product, RenalGuard, is approved for sale in the EU as a general fluid balancing device. Additional company information can be found at www.plcmed.com.
This press release contains "forward-looking" statements. For this purpose, any statements contained in this press release that relate to prospective events or developments are deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "will" and similar expressions are intended to identify forward-looking statements. Our statements of our objectives are also forward-looking statements. While we may elect to update forward-looking statements in the future, we specifically disclaim any obligation to do so, even if our estimates change, and you should not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Actual results could differ materially from those indicated by such forward-looking statements as a result of a variety of important factors, including that we may be unable to raise sufficient funds to implement our business plan and/or commence our planned U.S. clinical trial for RenalGuard, we may not receive necessary regulatory approvals to market our RenalGuard product or that such approvals may be withdrawn, the current clinical trials in Italy and the planned future U.S. clinical trial for RenalGuard may not be completed in a timely fashion, if at all, or, if these clinical trials are completed, they may not produce clinically significant or meaningful results or future results from clinical trials may differ from results to date, the RenalGuard product may not be commercially accepted, operational changes, competitive developments may affect the market for our products, regulatory approval requirements may affect the market for our products, and additional risk factors described in the "Forward Looking Statements" section of our Annual Report on Form 10-K for the year ended December 31, 2008, and our other SEC reports.
PLC Systems, PLC Medical Systems, PLC and CO2 Heart Laser, RenalGuard and RenalGuard System are trademarks of PLC Systems Inc.
Contact: Mary T. Conway Conway Communications 617-244-9682 email@example.com
SOURCE PLC Systems Inc.
Released February 4, 2010