Rx Safes, Inc., announced that it has formed a partnership with MIKA MEDICAL and MK GLOBAL, a leading Korean innovative medical device and distribution company, to exclusively distribute their proprietary, reusable needleless injection system in the U.S. market.
The agreement calls for Rx Safes to further develop the product by integrating its autonomous fingerprint interface into the device, allowing only authorized patients and healthcare workers the ability to administer controlled substances including serious pain medications, through painless injection. Rx Safes will own all of the new intellectual property rights developed as part of this initiative and MIKA, which is an ISO:13485 certified manufacturer, will manufacture the new fingerprint activated needleless device for Rx Safes.
“The MyDOSE product is a reusable needleless injection system that will feature the company’s autonomous fingerprint technology, so only authorized patients and caregivers can inject medication for pain, once authenticated by the device. This is another innovative application of our company’s technology into an existing medical device, and is consistent with our company mission to secure the storage and dispensing of potentially dangerous medications,” noted Lorraine Yarde, CEO at Rx Safes, Inc.
The Injectable Drug Delivery Market exceeds $326 billion presently and is expected to grow to $574 billion by 2020. Through this new partnership, Rx Safes will be developing the world’s first fingerprint activated needleless injection system, and will be well positioned to capture its share of this growing market. Needleless injection systems have been slowly gaining traction and the FDA has approved certification of these devices in the areas of flu vaccinations and insulin administration because they are designed to deliver medications efficiently and pain-free, without breaking or puncturing the skin. “There is a real need to ensure individuals are actually authorized to inject controlled medications as part of a pain management program whether recuperating from surgery or otherwise treating withdrawals from addiction,” noted Rx Safes’ Board Member, Dr. Susan Kutzner. “The company believes that this product will revolutionize pain free administration of controlled medications and will be adopted quickly by the healthcare community,” Dr. Kutzner added.
To date the FDA has required needleless injection systems be paired with a pharmaceutical formulary in order to be awarded FDA 510K certification. The company has started discussions with a high profile pharmaceutical company that concentrates on manufacturing pain medications. The company expects to file for certification with the FDA for this product once that relationship is finalized, possibly as soon as early next quarter.