InsuLine History
InsuLine Medical Ltd was incorporated in Israel on Feb 27, 2007.
On August 4, 2010 the company became a public company in TASE. On January 2011 the company established a fully owned subsidiary in Germany (InsuLine Medical GmBH) and hired an experienced managing director for that company.
On May 2007 after receiving all regulatory approvals the company started to conduct feasibility studies on diabetics to demonstrate the technology principle. These initial studies indicated that controlled local heat on the infusion site of insulin can significantly improve the infused drug pharmacokinetic and pharmacodynamic profile. These studies led to the development of the company first product –InsuPatch™ for diabetics using insulin infusion pumps.
On August 2007 the company started IDE process with the FDA to validate the InsuPatch™ FDA regulatory path and conclude FDA study protocol required for the approval of InsuPatch™. This process was concluded on Dec 2009, with an agreed clinical protocol.
On February 2008 the company started the development of InsuPad™ product for MDI diabetics and on April 2008 the company received CE mark for its development and manufacturing processes of both InsuPatch™ and InsuPad™ products.
On Feb 2009 Roche started to conduct clinical study in Germany with the InsuPatch™. The final study report was concluded on October 2009. The results supported the previous positive results that the company achieved in clinical studies that were conducted by InsuLine. Additionally, the results showed that under 2 weeks daily life study at home InsuPatch™ reduced diabetics post prandial blood glucose level change
At the end of 2009 Yale University started to conduct a study with InsuPatch™ on juvenile diabetics. Interim positive results from that study were published first on October 2010 at ISPAD meeting followed by additional publication at DTM 2010 and ADA 2011. This study is supported by a JDRF grant for the development of super fast insulin needed for closed loop systems.
On October 2010 the company started the clinical study for the FDA approval of InsuPatch™. The study is conducted in clinical centers in Israel under the supervision of Prof. Itamar Raz together with Prof. Hulio Weinstein and at Mills Peninsula medical center CA, USA under the supervision of Prof. David Klonoff.
On November 2010 the company received product innovation award from Frost & Sullivan.
On January 2011 the company established a fully owned subsidiary in Germany and signed an agreement with Bad Mergentheim’s clinical study center FIDAM on the performance of a marketing clinical study with InsuPad™ product. The study started on June 2011 with the first model of InsuPad™ while the company finalizes the commercial version of InsuPad™.
On August 2011 the company submitted a request to list both InsuPad™ and InsuPatch™ product at the Medical Device aids list in Germany. This is required to receive reimbursement in Germany which can take from 2 to 9 months.
On May 2011 the company received from Barmer GEK principal reimbursement approval for InsuPad™ provided that the company will achieve positive outcome in a clinical study protocol that was designed together with Barmer and FIDAM. This study could take 8 months to complete. On September 2011 the company received Helsinki approval required for the performance of this study.