"The NIH SBIR program has been a great way to fund the development of a robust product and clinical pipeline, which we otherwise would not have been able to finance with private capital."
– Keith Lurie, MD, Advanced Circulatory, Founder and Chief Medical Officer
Advanced Circulatoryis a medical device company that develops a non-invasive, circulatory therapy called Intrathoracic Pressure Regulation, or IPR, to enhance blood flow in patients suffering hypotensive conditions like shock, brain insults like head injury and stroke, and cardiac arrest. As of March 2015, Advanced Circulatory was acquired by ZOLL Medical.
Keith Lurie, MD, an electrophysiologist and CPR expert, founded CPRx LLC in 1997, initially to address circulatory issues during cardiopulmonary resuscitation (CPR). Since then, the company has grown to employ 25 people, expanded their product portfolio, and changed their name to Advanced Circulatory in 2003.
The Burden of Cardiac Arrest
According to the American Heart Association, 900 Americans experience sudden cardiac arrest every day, with 95 percent dying before they reach the hospital; meaning that a patient has around a 5 - 7 percent chance of survival.
If the national survival rate for patients who experience cardiac arrest outside of a hospital increased to 9 – 10 percent, approximately 20,000 more lives could be saved per year.
Conventional CPR provides only 20 - 30 percent of normal blood flow. Advanced Circulatory has addressed this problem by developing an NIH-funded therapy called Intrathoracic Pressure Regulation (IPR) that helps increase blood circulation during CPR. The therapy is delivered via the ResQPOD Impedance Threshold Device (ITD). Over 1500 hospitals and emergency medical services (EMS) teams are currently using the therapy and the company expects the number to grow significantly with new data and products. The ResQPOD ITD received 510(k) clearance from the US Food and Drug Administration in 2003, as well as the CE mark for sales in Europe.
ResQPOD ITD – Increases Blood Flow during CPR
The ResQPOD ITDconnects to a facemask or advanced airway during CPR. The device has been shown in studies to double blood flow to the heart and increase circulation to the brain by 50 percent. Most importantly, when combined with high quality CPR, studies have shown that the ResQPOD increases neurologically-intact survival by 25 percent or more. The effect of the ResQPOD ITD is further enhanced when combined with an active compression decompression CPR (ACD-CPR) device.
The NIH helped to fund a large randomized controlled trial (ResQTRIAL) of the device combination. Published in The Lancet in 2011, this study showed a 52 percent increase in neurologically-intact survival when the device combination is used.
To learn more about the ResQPOD ITD, view the product descriptionon the company website.
ResQGARD ITD – Delivers IPR for Patients in States of Poor Blood Flow
IPR Therapy can also benefit other patients besides those in cardiac arrest. The ResQGARD ITDdelivers the same IPR Therapy, which lowers intracranial pressure (ICP) and increases blood flow to the brain and vital organs when patients breathe through it. Research studies have shown that the use of an ITD lowered ICP (Convertino et al, Resp Care 2011) and increased blood pressure by up to 30 percent (Smith et al. Jour Emerg Med 2011). Applications for the ResQGARD ITD are potentially broad. It can be used in cases where blood flow is compromised, such as trauma, shock, or in the future possibly brain injury to safely increase perfusion non-invasively and without the need for fluids or medications.
How NIH SBIR/STTR Has Helped the Company Grow
"NIH SBIR funding has been critical to the growth of the company," said Mike Black, CEO.
"This early-stage funding helped us develop our products and conduct pre-clinical and clinical studies to demonstrate their feasibility. And thanks to these grants we have been able to create several research and development jobs in our community. Without SBIR, Advanced Circulatory would likely not be a company."
Currently, Advanced Circulatory sells it devices to over 1,500 hospitals and EMS systems primarily in the US market through a network of distributors.
"We also have a strategic partnership with the US Army Institute of Surgical Research under the SBIR program that has been critical in helping us understand the impact of our therapy," says Black. "The SBIR program has helped us get to a point where outside investors were willing to invest in further growth of the company, particularly to commercialize the products developed through the SBIR program." The broad potential application of the company's therapy also means the possibility of more extensive licensing activity down the road.
ResQPOD ITD is used during CPR to help increase blood flow to the heart and brain.
ResQGARD ITD is a device patients breathe through to help treat low blood pressure
Future of Advanced Circulatory
Advanced Circulatory will continue to build out its robust pipeline of new products and potential applications of their IPR platform therapy. Right now the company is focusing on preparing for the launch of their new product, the ResQCPR System (ResQPOD and ResQPUMP combination) for use in CPR, which is currently awaiting premarket approval from the FDA. The company is also conducting clinical studies on brain injured patients to demonstrate the benefit of the therapy in that patient group, funded in part by the NIH SBIR.
"The next generation of of IPR Therapy will be delivered actively," says Black. "Right now, the ITD devices are passive, meaning they work based on breathing efforts or chest compressions used during CPR. The next generation of products will actively create a more consistent and effective vaccum in patients to enhance blood flow. We are conducting clinical trials and animial studies right now to learn more about these methods, and are excited about the potential they hold."
- 2013 Top 25 NIH grant recipients as published in the Minneapolis/St. Paul Business
- ResQPOD was inducted into the 2008 Space Technology Hall of Fame
- 2013 Tibbetts Recognition Award
Location: Roseville, Minnesota
Company Website: http://advancedcirculatory.com/
Contact: Lisa Owens (for questions), Office: 210-828-8224; Cell: 210-601-6647
Information for this success story was gathered through an interview that was conducted by Dr. Lenka Fedorkova, the NIH SBIR/STTR Program Manager and Betty Royster, the NIH SBIR/STTR Communications Coordinator.