— Incorporated US subsidiary & hired US VP Operations
— Preparing pre-submission meeting with US-FDA
— Received Notice of Allowance for key patent by USPTO
InfanDx AG, a privately-held diagnostics company focusing on the development and commercialization of novel diagnostic solutions for newborns, today announced that it has set up US operations to gain access to the US market for its HypoxE® Test. The test is designed for the early detection of Hypoxic-Ischemic Encephalopathy (HIE) and is currently in clinical development.
For the implementation of its US strategy, the Company incorporated a wholly-owned subsidiary, InfanDx USA, Inc. based in Boston, MA. Dr. Achim Plum, CEO of the parent company InfanDx AG, will serve as President of InfanDx USA, Inc. To run all US operations, InfanDx hired Mr. Jordan deVos as VP of Operations, a seasoned industry expert with a track record in clinical trial management and business development.
InfanDx´ US operations will initially focus on the preparation and execution of a clinical trial for its HypoxE® Test in a US patient population to generate the data required for a planned submission to the US FDA and the potential clearance of the test. To this end, the Company has contracted GBC – Global BioClinical, a Seattle, WA, based CRO specializing in diagnostic clinical trials.
Supported by US clinical experts, InfanDx USA is currently preparing the clinical trial protocol and intends to approach the US FDA for a pre-submission meeting to discuss such protocol shortly.
Coinciding with the launch of its US operations, the Company received a Notice of Allowance by the USPTO for the key patent “Method of Diagnosing and Treating Asphyxia” (Patent Application Number 15/700,226). With a Notice of Allowance, the USPTO indicates its willingness to grant a patent subject to the payment of certain fees.
“We are off to a very good start in implementing our US strategy. Leveraging our network in the US, we could establish our local operations very quickly by putting together a strong team that we share a lot of history with. I am very happy that we could win Jordan to head our US operations. Having worked with him before, we know that he brings exactly the expertise and network we need at this stage,” said Dr. Achim Plum, CEO of InfanDx. “We are also very pleased that we could sign-up GBC as our CRO. Again, we have successfully completed several complex diagnostics studies with Mr. Neil R. Mucci and his team at GBC in the past.”
InfanDx AG is a privately held company focusing on the development and commercialization of novel diagnostic solutions for acute and critical care conditions in newborns.
The Company’s proprietary lead product in clinical development is the InfanDx HypoxE® Test designed for the reliable identification of hypoxic-ischemic encephalopathy (HIE) within the first hours of birth. HIE as a consequence of perinatal asphyxia (oxygen deficit during birth) can result in life-long disabilities. The long-term detrimental effects of HIE can be mitigated and even prevented by neuroprotective hypothermia treatment. However, this therapy must be initiated within six hours of birth to be effective, requiring suitable diagnostic methods to reliably and timely identify the affected newborns.
While standard-of-care diagnostic methods cannot deliver a conclusive diagnosis of HIE within this time frame, the rapid InfanDx HypoxE® Test is designed to support clinicians in the timely decision whether newborns require neuroprotective hypothermia treatment.
The Company is headquartered in Cologne, Germany, with a branch office in Berlin, Germany, and a wholly-owned subsidiary in Boston, MA, USA.
For more information, please visit: http://www.infandx.com/