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| D Medical Industries LTD |
D MEdical Industries Ltd ( NASDAQ:DMED) receives FDA 510(k) clearance to market its Spring™ Universal Infusion Sets in US. Spring Universal Infusion Sets are compatible with most insulin pumps currently available in the market. Small Trader/Investor might take position for a small gains today and carry the position as well for investment gains.
Going beyond the minimum requirements of subcutaneous drug delivery, the Spring Universal offers best-in-class features such as a hidden, auto-retractable needle, 360° connector, and smallest one-click, all-in-one inserter.
Below is the detail of the report from MarketWire:
D. Medical Industries Ltd. (NASDAQ:DMED), a medical device company engaged through its subsidiaries in the research, development, manufacture and sale of innovative products for diabetes treatment and drug delivery, announced today that the U.S. Food and Drug Administration ("FDA") has granted its subsidiary, Spring-Set Health Solutions Ltd. (formerly "Medx- Set Ltd."), 510(k) clearance to market its Spring™ Universal Infusion Sets (formerly "Lighty DD Infusion Sets") in the United States.
The U.S. insulin pump and disposables market is large and growing. According to the American Diabetes Association, approximately 26 million diabetes patients live in the United States, constituting 8.3% of its population. Of those, experts estimate that 5.4%, or 1.4 million, suffer from Type 1 diabetes and 350,000 currently rely on insulin pump therapy. A recent U.S. Centers for Disease Control and Prevention report estimated that 1 in 3 Americans will have diabetes by 2050 if current trends continue.
The core of the Spring Universal Infusion Set is the proprietary Detach-Detect mechanism. In the case the base of the infusion set detaches from the user's body, a blocking mechanism is triggered which, in turn, creates an occlusion. This evokes an occlusion alarm in an insulin pump. This unique feature enables exceptional reliability for continuously controlled and monitored insulin delivery, providing additional safety and peace of mind - especially for athletes and the parents of pediatric patients.
While nothing can completely eliminate the intrusive feeling of the needle's insertion in the daily experience of the person with insulin-dependent diabetes, the Spring Universal Infusion Set has a number of incomparable features specifically focused on reducing the sensation of pain and discomfort. The sensation of pain is controlled by a combination of factors - the needle thickness (gauge), needle shape, speed of insertion, vibration, and tissue friction. Clocked at 12 m/sec, the all-in-one Spring Universal Infusion Set is currently the fastest available insertion mechanism. Besides the convenience of not having to pre-cock the trigger mechanism, the two springs (one responsible for the insertion, and the other for auto-retraction of the needle) enable lightning speed and accuracy. The base, which is attached to the body prior to insertion, enhances insertion stability, decreasing the possibility of the needle and cannula bending during insertion as well as reducing backfire vibration and sensation. The 28-gauge insertion needle is one of the thinnest available. It features a trocar tip, which allows for the speed and penetration trajectory similar to a shooting arrow. Most of the other insertion mechanisms currently available in the market use the five-edge bevel needle, which is typically recommended for slow intravenous insertion since each one of the five edges creates a more painful incision and the hole traps the tissue. In comparison, the trocar tip creates a fast and precise incision allowing for the cannula to smoothly enter without scarring the tissue. The insertion sensation is additionally soothed by the fact that the Teflon cannula (rather than metal needle) is pre-lubricated with medical silicone fluid, and the inserter needle is retracted at a spiral trajectory, further reducing the friction.
"This is design innovation with real value to all stakeholders in diabetes management," said Zoe Myers, a long-time insulin pump user and D. Medical's Chief Commercial Officer. "Why is the Spring Universal attractive to every insulin pump user? Ask anyone with insulin-dependent diabetes: Would you rather not look at a needle and would you like the peace of mind of knowing that your insulin is being accurately delivered?"
Efri Argaman, D. Medical's Chief Executive Officer, commented, "Launching our Spring Universal Infusion Sets in the United States, which represents an estimated annual market of US$ 730 million for infusion sets alone, via multiple distributors will allow us to introduce and promote the "Spring" brand name in the world's largest market for insulin delivery products at relatively low cost and low risk. With mass production for this important product already in place through our subcontractor, UPG (Suzhou) EPZ Co. Ltd., we expect the U.S. commercial launch to commence later this quarter."
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