RMS Medical Products Announces New FDA Clearance, Closure of Warning Letter, and Additional Recent Developments
- Updated FDA Clearance for antibiotics and immunoglobulins
- Resolution of FDA Warning Letter
- Current results
CHESTER, NY / November 30, 2017 / Repro Med Systems, Inc. dba RMS Medical Products (OTCQX: REPR) announces recent FDA events and other positive developments.
RMS received a comprehensive “Integrated Catch-Up Freedom Syringe Driver Infusion System” 510(k) K162613, which was cleared on September 1, 2017. It not only confirmed the science behind the RMS technology, but also validated the general and specific uses of the Freedom system, including the FreedomEdge® and the FREEDOM60™, for subcutaneous (SQ) medications, such as immunoglobulins, and intravenous (IV) medications, including antibiotics. As a result, the FDA has officially notified RMS that the Warning Letter issued on February 26, 2016 has been closed. Andy Sealfon, CEO of RMS, stated, “We are thrilled and excited that FDA has recognized the leading edge concept of a constant pressure infusion system, which must include everything in the fluid path to determine the performance consistent with the FDA’s definition of Infusion Pump. The final chapter of closing the Warning Letter confirms that FDA has found RMS to have adequately addressed all the concerns raised in the Warning Letter. This effort was conducted under the outstanding leadership of our Chief Medical Officer, Dr. Fred Ma.”
With this great news come great results: for the first 7 months of the current year, RMS is showing a 26.9% increase in Net Sales over the previous period. Mr. Sealfon commented, “I want to thank our partners and colleagues who stood by us and who recognized the clear superiority of our FREEDOM Infusion System and the outstanding performance of our RMS HIgh-Flo Subcutaneous Administration Needle Sets as well as our educational support we provide to clinicians and patients. While we continue to see growth and improvement in the domestic market, we are also continuing our expansion into Asia, Europe, and the Middle East and even have new sales in Africa. We are actively working on a number of clinical trials with major Pharmaceutical companies including ongoing studies in the USA, Canada, Germany, Russia, and France, among others.”
To prepare for the Company’s expansion, RMS is actively seeking out new talent and expertise to strengthen their team. Sealfon added, “I am honored to continue to lead our Company forward with the full support of the Board of Directors as we bring on and qualify additional resources to enhance our management team, Research & Development, Sales management, and Clinical Support. Most of you know my passion for understanding patient needs and designing solutions, and I am looking forward to reducing my day-to-day management activities, which will enable me to focus on our new technologies and products. I am dedicated to providing value to all our partners, patients and shareholders.”
About RMS Medical Products
The Company manufactures medical products used for infusions and suctioning. The Infusion product portfolio currently includes the FREEDOM60(R) and FreedomEdge™ Syringe Infusion Pumps, RMS Precision Flow Rate Tubing(TM) intended for both subcutaneous and intravenous medications, and RMS HIgH-Flo(TM) Subcutaneous Safety Needle Sets, which are well recognized by patients and clinicians for consistent flow rate performance, faster flow rates, and the assurance that each and every needle tip remains sharp and undamaged. These devices are used as an integrated system for infusions administered in professional healthcare settings as well as at home. The Company’s RES-Q-VAC line of medical suctioning products is used by emergency medical service providers in addition to a variety of other healthcare providers.
The Company’s website may be visited at www.rmsmedicalproducts.com.
This press release includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In addition to statements that explicitly describe such risks and uncertainties, readers are urged to consider statements labeled with the terms “anticipated,” “believes,” “belief,” “expects,” “intends,” “anticipates,” “will,” or “plans” to be uncertain and forward looking. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s reports and registration statements filed with the Securities and Exchange Commission.
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SOURCE: RMS Medical Products