German medical device company Protembis said today it will collaborate with the German Accelerator Life Sciences program as it looks to expand into the US and accelerate the clinical development plans for its cerebral embolic protection device.
The company said its expansion into the US will be aided by mentors from the GALS program, an initiative supported by the German Federal Ministry for Economic Affairs and Energy.
“We look forward to kicking off the first work streams with Protembis. We will work on strategic questions such as the regulatory pathway for the ProtEmbo Cerebral Protection System and reimbursement for the product,” GALS mentor Michael Bogenstaetter said in prepared remarks
The company is developing the ProtEmbo embolic cerebral protection device designed to minimize the risk of embolic cerebral lesions during minimally invasive cardiovascular interventions.
The system consists of a filter device designed to be introduced into the aortic arch to prevent embolic particles from migrating into the brain.
“We look forward to working with Protembis. The company’s intra-aortic deflection technology has enormous potential to make the growing number of TAVI/ TAVR procedures safer for patients worldwide. We are confident that GALS can add to Protembis’ success by assisting in the continued development of the company’s U.S. strategy,” German Accelerator Life Sciences CEO Christoph Lengauer said in a prepared release.
Protembis said it has completed preclinical testing of the device and won regulatory approval from Ireland’s Health Products Regulatory Authority to begin a safety and feasibility trial of the device during transcatheter aortic valve implantation procedures.
“Being accepted into the GALS program is very exciting and a testament to the ProtEmboSystem and our development strategy. The broad network and expertise of GALS represents a significant opportunity for the company and will accelerate our expansion into the U.S. market as well as help us establish further partnerships with U.S. companies and investors,” co-CEO & co-founder Conrad Rasmus said in a prepared statement.
“The plan is to establish a presence in Cambridge, MA and to conduct a pivotal trial including U.S. sites to make our technology available to patients and providers in the very important North American markets as well. With the first comparable product recently approved by the FDA, there is now a validated regulatory pathway to market in the U.S.,” co-CEO & co-founder Karl von Mangoldt said in a press release.