"STTR Phase II funding validates research to an industry partner and additional investors. Seeing the explosive growth of our product, we are very optimistic that the CRP investment generated many new manufacturing jobs and will have a sizable economic impact."
– -Michael Bottlang, Ph.D, R&D Director, Apex Biomedical LLC
Traumatic brain injury (TBI) is a form of acquired brain injury, occurring when sudden trauma causes damage to the brain. TBI can result when the head suddenly and violently hits an object, or when an object pierces the skull and enters brain tissue. (Source)
Brain Protection by WaveCel, shown in an impact of a head model, whereby raw egg yolks are used to illustrate shear forces inside a fluid-filled skull. Left: With a standard helmet, the rotational force of a realistic oblique impact will readily break the yolks. Right: WaveCel absorbs rotational forces and effectively protected the yolks.
Head injuries from bicycling in the United States results in over 300,00 emergency department visits per year. While wearing helmets while cycling can help, helmets are optimized to protect the skull, not the brain. “Rapid Head Rotation” is the term associated with Wavecel’s approach to cycling TBI and concussions. Rotational acceleration is the rapid spin of the head caused by impact; where the skin twists around the skull and the brain twists inside the skull. Higher rotational accelerations carry a greater risk of causing brain injury and sustaining a concussion. While this is also a frequent occurrence in boxing, in the highest incidents of brain injury, bicycle accidents surpass football injuries, by far. This is just a glimpse into the statistics that caused Wavecel to attempt preventative and defensive methods of highly reactive engineering into everyday helmets.
Wavecel technology provides rotational damping which mitigates forces that cause brain injury in real-world crashes. Cells flex to divert the impact force away from the head, then distribute the crash force from the site of impact throughout the matrix of cells to absorb impact energy, dampening access to the head, and resulting in up to 98% less predicted risk of injury. This technology was developed through Phase I, and Phase II Small Business Technology Transfer (STTR) awards, and a grant through the NIH Commercialization Readiness Pilot (CRP) Program, from the National Institute of Neurological Disorders and Stroke (NINDS). Wavecel’s principal investigator, Michael Bottlang, notes that STTR Phase II funding helped to validate their research to a leading industry partner, the Trek Bicycle Company.
After the team successfully completed their Phase II project period, Stephanie Fertig, SBIR Program Director for the NINDS, was the first to inform and advise Dr. Bottlang on the Commercialization Readiness Program (CRP), it’s requirements, and its benefits. In 2015, the CRP aimed to facilitate the transition of previously funded SBIR and STTR Phase II projects to the commercialization stage by providing additional support for technical assistance not typically supported through Phase II or Phase IIB grants or contracts—including preparation of documents for a Food and Drug Administration (FDA) submission, development of an intellectual property strategy and/or planning for a clinical trial. For Wavecel (known as Apex before the CRP process), the program helped to translate their proven helmet concept into mass-produced commercial WaveCel helmets, which required the development and optimization of a robust production process that allows US-based manufacturing of high quality at a competitive pricing.
Figure 2: WaveCel helmet components
Four specific milestones were achieved:
- Streamlined the manufacturing process to achieve a cost-point suitable for bicycle helmets
- Developed custom production machines that allow WaveCel production in large quantities (>300,000 units / year)
- Created a quality management system to ensure that the WaveCel product meets requirements
- Test WaveCel helmets internally and by external labs for validation / publication
Dr. Bottlang adds, “Without CRP support, there would have been a high likeliness that the entire project would have ended due to unexpected and large challenges typical for any start-up.” The CRP was a pilot program beginning in 2015 and ending in 2017. (HHS recently re-authorized the CRP until FY2022.)
Wavecel was rigorously tested by universities and research labs in the US and abroad, including Virginia Tech and the University of Strasbourg (France). In the first year on the market, $20 million in sales was generated through 1,700 TREK dealers in up to 90 countries. Helmets for children, snow and cold weather recreation, sports—specifically football, and military are now in development and expected to launch by 2021.
Helmet Impact Testing (HIT) facility at the Legacy Research Institute, where WaveCel helmets were extensively tested
Apex Biomedical Company
Location: Portland, OR
Company Website: https://wavecel.com/
SBIR Profile: http://bit.ly/2GG99dk
Company Website: https://wavecel.com/
Contact: Michael Bottlang, Principal Investigator, Apex Biomedical LLC firstname.lastname@example.org