Novel technology designed to provide real-time perfusion monitoring
CASTLE PINES, Colo. — Proximo Medical, LLC today announced a partnership with PEDRA™ Technology, a Singapore based medical device innovator focused on the treatment of peripheral artery disease (PAD), for marketing and commercialization of its perfusion monitoring technology.
Proximo Medical is a fractional commercial organization for start-up medical device technologies and international medical device companies wishing to enter the U.S. market. The company provides market validation, an experienced national sales team and scalability to deliver patients and physicians the best care in a cost-effective model.
“Physicians and their industry partners have directed significant resources to determining the optimal treatment for patients with PAD, be it a balloon, a stent or another treatment. Far less time has been spent asking the question “Has the treatment I have chosen for this individual patient really improved outcomes”? The reason for this was that we did not have an easy-to-use, real-time method for assessing the quality of the intervention. PEDRA Technology has developed a new device that could possibly revolutionize the management of patients with PAD,” states Paul Hayes, vascular surgeon, Addenbrookes Hospital, Cambridge, United Kingdom, and lead investigator of the first-in-man study of the technology.
The development of PEDRA Technology’s perfusion monitoring system is intended to give physicians real-time feedback to enhance decision-making in the angiography suite, providing clinicians with the data to determine the appropriate treatment path. The product is not available for sale in the U.S.
“As a medical device innovator located outside of the U.S., with a product in prototype development, there are significant challenges navigating the U.S. clinical and regulatory system and developing the appropriate commercialization strategy,” states Kareen Looi, CEO, PEDRA Technology. “We are pleased to partner with Proximo Medical, and to work with their marketing and sales team, proven professionals in the vascular space. This relationship will advance our ability to establish the PEDRA Technology monitoring system as an essential PAD treatment tool, one that augments angiographic guidance, improves patient care and reduces the cost burden on the health care system.”
Early indications in a single-center observational study in Cambridge, United Kingdom demonstrate that PEDRA Technology’s monitoring system is able to provide real-time perfusion feedback in correlation with interventional procedures, and is an easy fit into the angio suite workflow. The system projects a quantitative signal of foot tissue perfusion, with early data pointing to a potential intra-procedural perfusion target for positive patient outcomes.
“Proximo Medical is increasingly asked to help validate proof of market for international organizations entering the U.S. The system can be complicated and overseas medical device innovators are looking for a proven team to advance technologies, especially when it addresses an unmet need in the interventional suite,” states Brett Martin, CEO, Proximo Medical. “With perfusion monitoring technology, a doctor can adjust his interventional strategy in real-time, in response to a dynamic vascular environment, with the potential benefit of improving limb salvage and reducing re-admissions.”