麻豆传媒 postdoctoral fellow Caitlin Pierlot is calm and matter-of-fact about winning the . But for her start-up company Biofix Medical Technologies, the $45,000 prize is a big deal, and could help to transform the treatment of orthopaedic patients 鈥� particularly those with spinal fractures and osteoporosis.
What Biofix has developed is an injectable glass ionomer cement, or GIC. GICs have been used in dentistry for many years for fillings and restorations. These conventional GICs contain aluminium, however, which is safe for use in the mouth but is toxic for bones.
Biofix was created to develop and market the product technology that company co-founders Dr. Pierlot (CEO), Brett Dickey (CTO and a current PhD student at 麻豆传媒) and Dr. Daniel Boyd (professor of biomaterials at Dal) have been developing in their lab.聽 聽
Avoiding aluminium
The cement Biofix has developed contains a proprietary glass material, acid and water but no aluminium, so it is not toxic to bones. Until now, the challenge has been to get an aluminium-free cement that provides the right combination of handling properties 鈥� so it can be injectable 鈥� and the mechanical strength needed for orthopaedic applications.聽 The Biofix cement offers both.
鈥淭he novelty of the technology in the cement composition is that it enables you to decouple the handling properties from the mechanical strength,鈥� explains Dr. Pierlot. 鈥淲e have been able to patent both the glass component and the overall cement.鈥�
Each year, over 700,000 people in the US alone suffer from spinal compression fractures 鈥� the most common fracture for people suffering from osteoporosis. So the need is great. Until now, conventional treatments have been bed rest, painkillers or an invasive surgery. Other bone cements are available, but they use 50-year-old technology based on polymerization, which can cause a host of toxic reactions in the body.
鈥淲e took a new approach by developing a GIC that can be used outside of the oral environment,鈥� says Dr. Pierlot.聽 鈥淥ur cement offers superior technology for use in the minimally invasive treatment of osteoporotic spinal fractures. Patients will be able to go into a hospital or clinic, lie on a bed and be given a local anaesthetic. The cement would then be injected, using a hollow needle similar to a biopsy needle, directly into the vertebrae of the spine. The cement sets in place, the fracture is stabilised, and the patient will be able to walk out. It will be an outpatient procedure.鈥�
Looking ahead
Biofix has its product and its eyes fixed on its first market: the U.S. The next step is to submit the cement to the U.S. Food and Drug Association (FDA) for approval in the 510(k) medical device category by the end of 2017.
鈥淭he FDA should be our toughest hurdle,鈥� says Dr. Pierlot. 鈥淥nce we have 510(k) approval, we expect to carry out clinical trials and then gain regulatory approval in Europe and Canada. It鈥檚 a long process, but we believe in the product and it has the potential to be huge.鈥�
The BioInnovation win gives Biofix $15,000 in seed funding and a further $30,000 in in-kind services, such as marketing and mentoring support.