MILESTONE: strona spółki
1.02.2017, 11:55
MMD Regulatory Update Regarding Epidural Instrument and Disposables in the United States
The Board of Directors of Milestone Medical Inc. (WAR: MMD, "the Company", "the Issuer"), today provided update on its previously announced submission of its 510(k) application with the U.S. Food & Drug Administration (FDA) for marketing clearance of its epidural instrument and disposables in the United States. The Management Board of Issuer expects to receive U.S. Food & Drug Administration (FDA) marketing clearance for its epidural instrument in the first half of 2017.
The Board of Directors of the Issuer states that the Company completed its regulatory submissions and is prepared, along with its regulatory advisors, to respond to any further questions from the FDA. In advance of marketing clearance, the Issuer has been cultivating relationships with key opinion leaders, who have been supportive and recognized the advantages of its technology. The Company completed its COMPASS Study (CompuFlo(R) Assessment Study), a randomized, controlled, parallel group, multicenter, pivotal study to assess the safety and effectiveness of the epidural space verification with the CompuFlo(R) Epidural Computer Controlled System. The clinical trial for the epidural instrument reached an enrollment of 400 patients and consisted of two separate arms: (i) pain management; and (ii) labor and delivery. Both arms were compared against the current medical standards of care. The goal of the pivotal Investigational Device Exemption (IDE) clinical trial was to demonstrate the accuracy of the CompuFlo technology in identifying and confirming the epidural space location. The Company submitted what it believes to be the favorable results of this study to the FDA in its 510(k) application for marketing clearance of its epidural instrument and disposables for birthing and pain management. The epidural instrument has already obtained CE mark approval and may now be marketed and sold in most European countries and many other countries accepting CE approved instruments. The Company has entered into a limited number of European and Middle East distributor arrangements for its epidural instrument and plans to develop an international marketing network of independent distributors upon receipt of FDA approval. Milestone Scientific Inc., the majority shareholder of Issuer, recently completed a public offering of shares and warrants for gross proceeds of $3.0 million, which will allow the Company to accelerate sales and marketing activities related to the planned launch of its epidural instrument. Milestone's epidural injection instrument using CompuFlo(R) pressure sensing technology provides an objective tool that consistently and accurately identifies the epidural space by detecting the difference in pressure between the ligamentum flavum and the extraligamentary tissue. In studies, the CompuFlo(R) technology has been shown to be effective in correctly identifying the epidural space. Knowing the precise location of a needle during an epidural injection procedure provides a measure of safety not presently available to doctors using only conventional syringes, where the epidural space is identified by relying on the subjective perception of loss of resistance to saline.
The Board of Directors of the Issuer states that the Company completed its regulatory submissions and is prepared, along with its regulatory advisors, to respond to any further questions from the FDA. In advance of marketing clearance, the Issuer has been cultivating relationships with key opinion leaders, who have been supportive and recognized the advantages of its technology. The Company completed its COMPASS Study (CompuFlo(R) Assessment Study), a randomized, controlled, parallel group, multicenter, pivotal study to assess the safety and effectiveness of the epidural space verification with the CompuFlo(R) Epidural Computer Controlled System. The clinical trial for the epidural instrument reached an enrollment of 400 patients and consisted of two separate arms: (i) pain management; and (ii) labor and delivery. Both arms were compared against the current medical standards of care. The goal of the pivotal Investigational Device Exemption (IDE) clinical trial was to demonstrate the accuracy of the CompuFlo technology in identifying and confirming the epidural space location. The Company submitted what it believes to be the favorable results of this study to the FDA in its 510(k) application for marketing clearance of its epidural instrument and disposables for birthing and pain management. The epidural instrument has already obtained CE mark approval and may now be marketed and sold in most European countries and many other countries accepting CE approved instruments. The Company has entered into a limited number of European and Middle East distributor arrangements for its epidural instrument and plans to develop an international marketing network of independent distributors upon receipt of FDA approval. Milestone Scientific Inc., the majority shareholder of Issuer, recently completed a public offering of shares and warrants for gross proceeds of $3.0 million, which will allow the Company to accelerate sales and marketing activities related to the planned launch of its epidural instrument. Milestone's epidural injection instrument using CompuFlo(R) pressure sensing technology provides an objective tool that consistently and accurately identifies the epidural space by detecting the difference in pressure between the ligamentum flavum and the extraligamentary tissue. In studies, the CompuFlo(R) technology has been shown to be effective in correctly identifying the epidural space. Knowing the precise location of a needle during an epidural injection procedure provides a measure of safety not presently available to doctors using only conventional syringes, where the epidural space is identified by relying on the subjective perception of loss of resistance to saline.