WEB NEWS Comments & Business Outlook
Milestone Scientific Receives China's SFDA Approval for The Wand® Handpiece
Follows Earlier Approval of STA System® Computer
LIVINGSTON, NJ--(Marketwired - May 08, 2014) - Milestone Scientific Inc. (OTCQB: MLSS), a leading medical research and development company that designs and patents innovative injection technology, today announced that the State Food and Drug Administration (SFDA) of the People's Republic of China has approved Milestone's The Wand® handpiece. This approval follows prior approval by China's SFDA of Milestone's STA Single Tooth Anesthesia System® computer (STA System). The SFDA had bifurcated approval of the STA System computer and The Wand® handpiece.
Leonard Osser, Chief Executive Officer of Milestone Scientific commented, "At long last, our STA System and The Wand handpiece have been granted registration approval by the State Food and Drug Administration of the People's Republic of China and we now have all necessary approvals to commence sales in China. We look forward to pursuing the Chinese market."
The patented, award-winning STA System is a computer-controlled, pressure-sensitive injection system, which provides dentists with audible and visual signals as to in-tissue pressure and needle location. Milestone's latest achievement in computer-controlled local anesthesia delivery makes the injection process more comfortable for both dentists and patients and allows for the painless delivery of local anesthetic. In addition to its general use for all dental injections, the STA System is uniquely capable of predictably and more comfortably administering "Single Tooth Anesthesia" into the Periodontal Intraligamentary (PDL) space. This injection results in the patient having no collateral numbness and no pain along with instant, predictable anesthesia. The benefit of this injection with the STA instrument is significant for the patient, the dentist and the business of dentistry.
Comments & Business Outlook
MILESTONE SCIENTIFIC INC.
YEARS ENDED DECEMBER 31, 2010 AND 2009
2010
2009
Product sales, net
$
9,749,968
$
8,549,060
Cost of products sold
3,531,452
3,458,279
Gross profit
6,218,516
5,090,781
Selling, general and administrative expenses
6,648,859
6,952,976
Research and development expenses
270,494
241,318
6,919,353
7,194,294
Loss from operations
(700,837
)
(2,103,513
)
Other income (expense)
Other income
183,673
777,609
Interest income
587
3,146
Interest expense
(95,135
)
(154,027
)
Amortized debt issuance
(2,796
)
(53,300
)
Total other income
86,329
573,428
Net loss
$
(614,508
)
$
(1,530,085
)
Net loss applicable to common stockholders
$
(614,508
)
$
(1,530,085
)
Loss per share applicable to common stockholders - basic and diluted
$
(0.04
)
$
(0.11
)
Weighted average shares outstanding and to be issued - basic and diluted
14,824,802
13,389,872
GeoTeam Note: Fourth Quarter 2010 vs. 2009 was $(0.02) vs. $0.01
Liquidity Requirements
As of December 31, 2010, the Company had cash and cash equivalents of $627,082 and a negative working capital of $6,685. The significant decrease in working capital of $1,632,758 in 2010 was caused by a delay in obtaining regulatory approval to sell our instruments and handpieces in China. Based on the initial purchase order from our distributor in China in 2009, the Company ramped up purchasing of parts in anticipation of significant sales in 2010 and future years. As a result of the delay in shipping, the advances to contract manufacturer has increased significantly, (current and long term), in 2010 as compared to 2009. Additionally, the accounts payable due to suppliers has also increased and is classified as current and long term. And finally, the accounts receivable from the China distributor has been classified between current and long term net of a reserve of doubtful accounts of $636,000.
The Company’s recurring losses and negative operating cash flows raises substantial doubt about its ability to continue as a going concern. The accompanying financial statements do not include any adjustment that might result from the outcome of this uncertainty.
