Flow-FX Selects Colombia for a First-In-Human Clinical Trial on its Flow-Screw Medical Device for Delivery of Intraosseous (IO) Antibiotics
Orlando, FL, July 22, 2018 — Flow-FX, a Mokena, IL company poised to catalyze dramatic changes in orthopedic surgery with the ultimate goal of significantly improving patient outcomes, has selected Colombia and bioaccess™ as its contract research organization (CRO) for a first-in-human clinical study on its innovative Flow-Screw medical device for the delivery of intraosseous (IO) antibiotics. The study will be conducted at Clinical La Misericordia in Barranquilla, Colombia and will be led by Dr. Carlos Severini —chief of orthopedic surgery and trauma at Clinica La Misericordia and at Clinica Regional de la Policía Nacional, Mired IPS and university professor at Universidad Libre.
With the Flow-Screw, the biologics era has officially begun in orthopedic surgery. This allows dramatic alteration in orthopedic and podiatric fracture care; just in time to address the steadily rising number of osteoporotic fractures as well as complex non-healing fractures. The patented Flow-Screw system with the Flow-Fx Side-Port cannula enables precise delivery of bone void filler and antibiotics to bones in the body.
The Flow-Screw will be tested in patients in Colombia for IO antibiotic delivery to the infected bones. The Flow-FX' first-in-human study will test the treatment of recalcitrant diabetic foot osteomyelitis with intraosseous delivery of vancomycin and/or tobramycin through the Flow-Screw system.
Treatment of diabetic foot osteomyelitis has a high failure rate due to the infecting organisms and the patient's physical status, including vascular disease. These patients have high subsequent amputation and death rate. Delivery of IO antibiotics is currently historically performed in human and veterinary medicine with few documented significant side effects such as compartment syndrome, embolus, infection or osteonecrosis. IO treatment for this condition will circumvent systemic limitations on antibiotic delivery while reaching high local concentrations that have the potential to overcome bacterial resistance mechanisms, penetrate the biofilm and minimize systemic levels and therefore toxicity.
bioaccess™ will assist Flow-FX to obtain ethics committee approval for its planned Flow-Screw first-in-human study. bioaccess™ will also handle the regulatory submission to help Flow-FX obtain Ministry of Health (INVIMA) study approval in Colombia. No specific time frame is being announced for the approvals, however, the companies expect to have all necessary approvals and paperwork in place to begin recruiting patients before the end of the fourth quarter of this year.
“The people of Colombia face the same treatment challenges with diabetic osteomyelitis that are faced by the United States and the entire world. Our work with Dr. Severini, La Clinica Misericordia, and bioaccess™ will help us change the paradigm for treating this healthcare crisis;” said Dr. Patrick Sweeney, Flow-FX' founder, and CEO.
Founded in 2011 by Patrick Sweeney, MD, Flow-FX is the culmination of his more than twenty years experience as a board-certified orthopedic surgeon, inventor, and entrepreneur. Built around Dr. Sweeney’s patents for methods and devices for delivering medicine to the bone, Flow-FX introduced its products to the market in February 2016 and is poised to catalyze dramatic changes in orthopedic surgery. Flow-FX' ultimate goal is to significantly improve patient outcomes. Flow-Screw and Flow-Nail—both 510k cleared for fracture fixation as well as delivery of injectable bone void fillers—are the world’s first patented devices available with their purpose and precision. Under the continued guidance of Dr. Sweeney, Flow-FX is currently exploring research designs for delivering antibiotics in a similar manner, with plans to further expand surgical indications of the product line in the future. More information at www.flow-fx.net.
bioaccess™ is an Orlando, FL clinical research organization (CRO) and market access consulting company with a mission is help innovative medical device companies conduct clinical research and commercialize their innovations in Colombia and the rest of Latin America. The company will provide Flow-FX with clinical research support services (e.g., regulatory submission, logistical support, project management, and study monitoring; among others). More information at www.bioaccessla.com.
bioaccess™ Press Contact:
Julio G. Martinez-Clark, CEO
Tel: +1 (954) 903-7210