NIA Small Business Showcase: iFIT Prosthetics, LLC
Current prosthetic devices are costly and time-consuming to manufacture, rendering them unaffordable to many patients. Additionally, the limb undergoes drastic reductions in volume during the first year of amputation, causing patients discomfort and requiring several sessions to make adjustments to the prosthetic socket to achieve a precise fit.
iFIT Prosthetics, LLC, has developed an immediate-fit prosthesis that requires no casting, scans, or molds; is fit and aligned in a single session; saves time and stress for patients with its full adjustability; reduces overall costs for prosthetists; and boosts quality and cost values. The company’s clinical research testing has shown that this new design enhances comfort during standing and walking and is cooler in temperature than a conventional prosthesis.
An estimated 185,000 new amputations occur each year in the United States, with 66.2% being transfemoral or transtibial amputations from both dysvascular and traumatic causes. This means that 122,470 people have a lower-limb amputation in a given year. This number is increasing: In 2005, an estimated 1.6 million people in the United States were living with limb loss, and the total is expected to more than double to 3.6 million by 2050. Costs for lower-limb prostheses vary widely, from $5,000 for a basic device to $50,000 for more advanced devices. The global lower-limb prosthetic market is estimated to be $7 billion. Increasing incidences of injuries and road accidents, along with a rising number of diabetes-related amputations around the world, are poised to drive the global market.
The iFIT system offers value to patients, providers, and payors, as it is modular and mass-produced with a high level of quality controls that ensure consistent strength and durability. The prosthesis can be properly fit and aligned in less than 2 hours―the patient walks out of the clinic with their prosthesis. This reduces the tooling and manufacturing overhead costs for prosthetic facilities and increases the efficiency of the prosthetist.
This is a patient-centered device that adjusts to and accommodates volume fluctuations from daily edema changes in patients with heart or renal disorders. It accommodates longer-term limb changes related to limb maturation after limb loss, so it can serve as an ideal preparatory or definitive device. The prosthesis exceeds International Organization for Standardization (ISO) standards for strength and durability. For large healthcare systems, such as the Veterans Health Administration, it can reduce overall prosthetic costs while enhancing access to high-quality, state-of-the-art prosthetic care. This prosthesis is ideal for international relief efforts in areas where no prosthetic facilities exist. The iFIT prostheses can be shipped in bulk and fitted with a minimum of tools in any setting, including hospitals, clinics, and mobile medical centers (tents). A large number of people can be fitted successfully and efficiently with high-quality, comfortable prostheses that will stand up to rugged and continuous use without breaking.
iFIT has the capacity to produce up to 1,500 prostheses per month.
- 2019: A two-week comparative study demonstrated the superiority of the iFIT transtibial socket in terms of comfort and stability
- 2020, Q1: The iFIT transtibial socket demonstrated higher satisfaction and better temperature regulation in two trials, one in the United States and one in Jamaica
- 2020, Q2: A clinical study demonstrated the iFIT transtibial socket’s superiority in terms of stability, ambulation, and sitting comfort in comparison with a conventional socket
- Research partnerships with key opinion leaders, pharmaceutical companies, and disease foundations
- Awarded $7 million in highly competitive grants from NIA, the Michael J. Fox Foundation, and the Alzheimer’s Drug Discovery Foundation (ADDF)
- Built a strong team and advisory board
- In the first half of 2022, completion of the validation of CogniMIR™ expected
- In the second half of 2022, the launch of CogniMIR™ expected
- Building additional biopharmaceutical partnerships
iFIT has raised close to $5 million in nondilutive NIH Small Business Innovation Research (SBIR) funding to date.
iFIT has obtained four patents—US 8491667, US 8470050, US 8845755, and US 10,398,577—with a fifth in review. These patents cover a rapid-fit prosthetic device that is immediately fitted on the residual limb and aligned for optimal gait without a specialized lab or tools. The prosthesis features overlapping flaps on the outer socket that have a closure mechanism to adjust the device. The iFIT logo is also trademarked.
Product Development and Regulatory Strategy
iFIT is fortunate to collaborate with an engineering firm in Wisconsin with considerable expertise, Advanced Design Concepts (ADC). ADC has worked with iFIT for more than 8 years and can design and prototype any concept regarding prosthetics. ADC offers expertise in injection molding and materials science and can manufacture and ship finished prostheses efficiently and cost-effectively.
iFIT is registered with the U.S. Food and Drug Administration (FDA). However, prosthetic devices are Class I devices and therefore do not need FDA approval. ADC handles the regulatory aspect of managing prosthetic design, production, quality control, and shipping.
iFIT devices are clinically tested at the University of Pennsylvania in the Department of Physical Medicine and Rehabilitation biomechanics laboratory. The University of Pennsylvania has clinically tested more than 90 participants with both the transtibial and transfemoral sockets. The feedback gathered from clinical testing is shared with the engineers at ADC for improvements to the design and development of future prototypes.
iFIT is requesting funding to effectively penetrate the prosthetic market over the next 3 years. iFIT will hold educational workshops/prosthetic conferences, increase advertising, and promote via social media. The company aims to get an influencer’s endorsement, grow within the amputee support group/chat room/forum, and utilize digital marketing with search engine optimization (SEO). iFIT will hire sales reps with an integrated delivery network (IDN)–specific focus: amputee, prosthetics, and veterans affairs. The company also plans to have several prosthetists on staff. With the funds requested, iFIT will effectively penetrate the market through an enhanced partnership with Allard Distributing Ltd.
N27 W23655 Paul Road
Pewaukee, WI 53072
- Chief Executive Officer: Timothy Dillingham, M.D., M.S.
- Vice President of Business Development: Josh Mullins
- Lead Engineer: Jim Marschalek, M.S.
- Accounting: Sarah Spencer
Point of Contact:
Timothy Dillingham, M.D., M.S.
Email Timothy Dillingham
Conference Selected for Showcase: Digital RESI (June 2020)