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Milestone Scientific Announces Distribution Agreement for Epidural Instrument in China
Milestone China Agrees to Guaranteed Minimums Following CFDA Marketing Clearance
LIVINGSTON, NJ, December 11, 2014 -- Milestone Scientific Inc. (OTCQB: MLSS), a medical R&D company that designs, patents, incubates and commercializes a growing portfolio of innovative injection technologies, today announced that through its minority owned subsidiary, Milestone Medical, exclusive licensee of Milestone Scientific’s epidural and intra-articular instruments, it has entered into a distribution agreement with Milestone China for its epidural instrument. Milestone China will oversee sales and distribution of the instrument in China and other parts of Asia. Under the agreement, Milestone China has agreed to certain minimum purchases following CFDA marketing clearance as a condition of the distribution agreement. Year one minimum purchase is 250 instruments; year two is 550 instruments and year three is 750 instruments. CFDA marketing clearance can be sought only following FDA marketing clearance in the United States, which is not expected before mid-2015.
As previously announced, Milestone China is a joint venture distribution company between Milestone Scientific and a team headed by a senior healthcare executive from China. The focus of Milestone China is to supply and distribute medical and dental instruments, and disposables to China and other Asian markets. Lidong Zhang, Chief Executive Officer of Milestone China, previously held senior executive positions with leading healthcare distribution companies in China, including President of China National Medicines Corporation, Ltd. (CNMC), a billion dollar distributor of medical products in China. He also served as President of China National Pharmaceutical Logistics Co. Ltd, and Vice President of China National Bio-tech Group. He also served as Chairman of National Medicines Prospect Dentech (Beijing) Co. Ltd.
Lidong Zhang, Chief Executive Officer of Milestone China, commented, “We look forward to working closely with Milestone Scientific and Milestone Medical to introduce the epidural instrument across China. The number of annual epidural procedures is growing rapidly in China—but with that growth comes inherent risks associated with this procedure. Women in China and around the world suffer a wide array of complications with conventional epidurals – ranging from severe pain to wet tap to paraplegia and even death. We believe this instrument will not only be a commercial success, but will positively impact the lives of millions of women in China.”
In clinical studies, Milestone’s platform technology was able to reliably identify pressure characteristics of the different tissues, including the decrease in pressure in the epidural space. Practitioners using Milestone’s instrument correctly identified the epidural space 100 percent of the time (Gelber, Gebhard, et al. Regional Anesthesia and Pain Medicine, 33:4; 2008). Within seconds, the location of the needle can easily be determined, with lower pressures indicating the needle is in the correct location.
Leonard Osser, Chief Executive Officer of Milestone Scientific, added, "Milestone China is an ideal distribution partner, as the principals have extensive expertise and proven track records launching new medical devices in China. Moreover, they have committed to meaningful minimum purchases following CFDA marketing clearance, which further reinforces their confidence in the market for our instruments.”
About Milestone Scientific Inc.
Milestone Scientific Inc. is a leading medical research and development company that designs and patents innovative injection technology. Milestone's computer-controlled systems make injections precise, efficient, and virtually painless. For more information please visit our website: www.milestonescientific.com.
Safe Harbor Statement
This press release contains forward-looking statements regarding the timing and financial impact of Milestone's ability to implement its business plan, expected revenues and future success. These statements involve a number of risks and uncertainties and are based on assumptions involving judgments with respect to future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond Milestone's control. Some of the important factors that could cause actual results to differ materially from those indicated by the forward-looking statements are general economic conditions, failure to achieve expected revenue growth, changes in our operating expenses, adverse patent rulings, FDA or legal developments, competitive pressures, changes in customer and market requirements and standards, and the risk factors detailed from time to time in Milestone's periodic filings with the Securities and Exchange Commission, including without limitation, Milestone's Annual Report for the year ended December 31, 2013. The forward looking-statements in this press release are based upon management's reasonable belief as of the date hereof. Milestone undertakes no obligation to revise or update publicly any forward-looking statements for any reason.
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