Flow-FX
Revolutionary Orthopedics

For almost 20 years, orthopedic fixation has been in a state of comfortable stagnancy, with both its associated techniques and devices reaching a semi-generic status quo. Medical device developer Flow-FX is poised to revolutionize the field. The company’s specific focus is in developing orthopedic implants to treat osteoporotic fractures, bone infection, non-unions, and bone loss. Virtually no technology today addresses all of these problems effectively; Flow-FX’s solution specifically targets them with products that convert traditionally designed implants into medication delivery devices.

Lay of the Land

According to the International Osteoporosis Foundation, “Osteoporosis and low bone mass are currently estimated to be a major public health threat for almost 44 million U.S. woman and men aged 50 and older.” As the population ages, an increasing number suffer osteoporotic fractures and a new class of patients severely susceptible to this type of injury has arisen. In those patients, fixation often doesn’t fully stabilize their fractures or optimize the healing potential. Dr. Patrick Sweeney, Founder, and CEO, explains that “Flow-FX’s innovative implants are designed to deliver different types of bone void fillers and biologics that can improve the healing potential of diseased or injured bone”.

While much work has been done in Europe to support this innovation until recently no implants were designed specifically for the delivery of biologics. Traditionally, orthopedic implants have been screws, plates, and nails designed only to stabilize the bone and restore alignment, in hopes of speeding the healing process. While this method works for most patients, some require more comprehensive treatment approaches specific to their conditions. Flow-FX’s implants are designed for precision delivery of biologics, giving those patients better outcomes. The advances made in biologics over the last 15 to 20 years have been substantial, yet no effective way was developed to deliver them directly to the diseased bone at the appropriate time, whether the initial surgery or later in the healing process. This gap is precisely what Flow-FX’s product lines address. Traditional methods of bone void filler, used by the surgeon to spur healing and provide support for the injured bone, and biologic delivery are imprecise, frequently resulting in material expunged from the bone during subsequent implant placement. Flow-FX’s devices allow surgeons to deliver biologics with precision into the bone at multiple points through the shaft of the screw, improving the odds for the bone to heal more quickly and naturally, with a stronger end result.

The company’s other offerings include devices designed to deliver intraosseous antibiotics to treat chronic osteomyelitis. Flow-FX is currently designing a research strategy to validate this treatment potentially prompting a paradigm shift in orthopedic and podiatric healthcare delivery worldwide. Many sick patients, particularly those with vascular disease, are limited in their ability to respond to intravenous or oral antibiotics. An infected bone that doesn’t receive therapeutic levels of antibiotics will never heal. By delivering the antibiotics in such a localized manner, surgeons can reduce the risk of systemic toxicity while at the same time overcoming the resistance of organisms such as MRSA by increasing local concentrations of relevant medication.

Orthopedic and podiatric communities routinely deal with diabetic foot infections that fail all care, resulting in amputation and early death. Flow-FX believes its technology will address this problem dramatically while reducing healthcare costs worldwide. Flow-FX’s implants are equally applicable in standard surgeries, including hip fractures.

Flow-FX leverages all the assets at their disposal, in the medical, engineering and commercial expertise of its team, to bring this product to market. Ultimately though, our relentless focus is on the customers and the patients

In such cases, Flow-FX’s designs stabilize the bone while enabling 510[k]-cleared delivery of bone void filler.

Better Technologies for the Best Patient Outcomes

There are several products under development with Flow-FX’s patented intraosseous fluid delivery solution. Flow Needle™ is being introduced soon, as a Class 1 manual device. The tool will be useful in treating trauma patients and pediatric emergencies immediately while they work with the FDA to gain clearance as a longer-term solution for intraosseous fluid delivery in the treatment of bone infections.

Flow-FX also has a range of long orthopedic nails under development, including a modular nail that will make both the manufacturing and distribution of orthopedic nails more efficient. The modular design will allow the surgeon not only to customize the nail for the patient in the operating room but to deliver medication through it.



Almost everything that Flow-FX does is focused around medication delivery, including Flow-Drill™, their proprietary Class I, 510(k)-exempt manual drill. The Flow-Drill™ is placed over a guide wire, allowing elegance and precision lacking in current avascular necrosis and subchondral decompression techniques. It provides an HMT attachment with a modified LUER fitting, making it compatible with many of the commercially available driver handles on the market right now. It also offers direct attachment of a syringe for more seamless biologics delivery. Variable sizes will allow the surgeon multiple options for devices appropriate to the lesion while creating multiple pathways for vascular growth.

While many of these technologies sound like the stuff of medical science fiction, the reality is closer to home, thanks to Flow-FX. Tools and instruments were designed with compatibility and user-friendliness in mind. Another device, the 2-CAN, allows placement of biologics into long-bone fractures over the same guide wire later used by the fixation nail. Flow-Screws are inserted with a proprietary driver enabling biologic delivery but can be removed with a standard hex head driver for additional convenience. Designs focus on unique yet convenient solutions enabling the surgeon to deliver optimal care.

The Makings of Medical Innovation

Flow-FX was founded by Dr. Patrick Sweeney, a spine surgeon with 25 years of experience in orthopedics. He attributes much of his inventiveness and drive to improve patient care to his father, Dr. Howard Sweeney, a pioneer in arthroscopic techniques in the 70s and 80s. Howard Sweeney was a co-founder of the Arthroscopy Association of North America and the Orthopaedic Learning Center in Rosemont, Illinois. In private practice for more than 45 years, he served as Northwestern University’s team physician and surgeon for 38 years. At 92, he continues to instruct at the OLC and teach University of Chicago residents, along with teaching surgeons from developing countries through his Global Arthroscopy Foundation.

“Although Dad is a tough act to follow, he and my mother gave me the inclination and the tools to give back in some ways similar to him. They are both outstanding examples of the “Greatest Generation” and deserve much of the credit for anything I accomplish,” he said. A good portion of Sweeney’s career was during the time that Infuse™ solutions were available.

Impressed with how powerful a molecule it is and the effects it had at the right concentrations, Sweeney looked at how materials such as Infuse can be delivered precisely with minimally invasive surgery. The resulting suite of products included Flow-Nail™, Flow-Screw™, 2-CAN™, Flow-Needle™, and Flow-Drill™. Flow- FX’s current suite of products is designed to support bone health throughout the body.

"Flow-FX’s innovative implants are designed to deliver different types of bone void fillers can improve the healing potential of diseased or injured bone"

Based primarily in the U.S., Flow-FX today controls almost 20 U.S. patents along with a number of related European and Chinese patents. Due to the traditional design components of Flow-FX products, surgeons require minimal instruction on their use. All Flow-FX devices are aimed at providing higher-risk patients improved opportunity to heal. Useable as routine implants, they also allow the surgeon needed flexibility when challenges arise. Flow-FX hopes that in the future, a late-occurring infection or non-union will be treatable through implants already in place, rather than requiring additional surgeries. Current on-label usage for fracture treatment and bone void filler delivery will open the door to other methods that could potentially help the most challenging of patients. The addition of biologic delivery to orthopedic implants could potentially revolutionize healthcare and reduce costs worldwide.

Developmental Powerhouse

Flow-FX has a diverse set of competencies within their company, including people from the business world, engineering, and medicine itself. The medical personnel bring with them more than 20 years of experience each in treating patients; maintain the company’s core value of patient-focused treatment. Flow-FX’s veteran engineering experts guide the manufacturing, sourcing, and management of products. Ryan Wright, President at Flow-FX, comes from a retail and distribution background, with 25 years of experience in running a $400 million distribution company. He joined the company nine months ago to lend his business acumen to Flow- FX, commercialize their products, and expand their distribution. “Flow-FX leverages all the assets at their disposal, in the medical, engineering and commercial expertise of its team, to bring this product to market. Ultimately though, our relentless focus is on the customers and the patients,” states Wright. They maintain their patient-centric focus by first and foremost developing high-quality products. Second, Flow-FX provides exceptional levels of support and service to medical device reps and their customers, the hospitals and surgeons. Finally, the company places high value on the quality and regulatory aspects of medical device design and manufacturing, weaving them into every area of the business.

More recently, Flow-FX has been working with a sister company, ConnectSX, to implement a software system that not only tracks inventory from the manufacturer to the patient’s medical records but provides all electronic transactions and procedural knowledge along with it. ConnectSX has been awarded patents that make them a unique partner in the medical supply chain and device education areas. Flow-FX is currently working to incorporate that solution into its distribution network. Providing their patients with the best chance of success is essential to their operational fabric, and evident in everything they do from product design to distribution and training. Flow-FX’s goal is to improve healthcare for the world’s most challenging orthopedic patients while ensuring safe, reliable consistent service through every step of the value chain.