London-based startup A-Line Orthopaedics has developed a new spinal implant that could revolutionize an invasive treatment for upper cervical spine fractures, thanks to support from two Western University programs.
Backing from the Bone & Joint Institute's Catalyst Grants Program and the MSK Innovation Competition led to Tim Lasswell, now president of A-Line Orthopaedics, and Schulich Medicine & Dentistry professor Dr. Parham Rasoulinejad, commercializing their revolutionary product with an international medical device company.
Upper cervical spine fractures are the number one spinal injury in people over the age of 70, and only a small percentage of these patients qualify for surgical intervention because of the risks associated with the standard treatment, upper cervical spine fusion.
"It's very controversial whether or not you even operate on these patients today, based on the technical challenges of the spinal fusion surgery," Lasswell said. "If you opt for conservative treatment like a cervical brace, however, the fracture rarely heals, and the mortality rate is quite high."
In addition to operative risks and challenges, the anatomy that allows rotation in the neck is unique, and not well suited to screw placement - a requirement for spinal fusion surgery.
Bringing engineering expertise together with first-hand clinical insights, Lasswell and Rasoulinejad co-founded London-based startup A-Line Orthopaedics. Funded partly by the BJI's Catalyst Grants Program, they developed a new spinal implant that could revolutionize an otherwise invasive treatment for upper cervical spine fractures. The implant, the Edge Upper Cervical System, uses a clamp system that is safer, faster and less invasive than screw implants.
"Implants are often a compromise between how invasive the procedure is and how strong the fixation is," said Rasoulinejad who is also a member of BJI. "Our implant is less invasive and yet stronger than the current standard procedure. That's a rare combination."
2019 file photo of (left to right) Dr. David Holdsworth, Dr. Greg Marsh, Tim Lasswell, Eric Morse.
Having completed research and development steps along with validation of the market opportunity, problem and value proposition, the pair faced their next challenge - commercializing their product. BJI's Inaugural MSK Innovation Competition in the spring of 2019 could not have come at a better time.
The competition, created by the BJI in partnership with the Morrissette Institute for Entrepreneurship at Western's Ivey Business School, is designed to enhance, support and celebrate entrepreneurship and the commercialization of musculoskeletal innovations. Entrepreneurial MSK experts based in London are invited to participate in the five-stage competition, which includes a workshop, initial proposal, team selection, mentorship and a final pitch to a panel of judges. The annual event offers $30,000 to the team with the most promising project.
"The MSK Innovation Competition is designed to drive real change," said Eric Morse, executive director of the Morrissette Institute. "The competition connects BJI researchers and industry professionals. That collaboration and mentorship creates a pathway to commercialization and a model for engaging more researchers to get into market."
Lasswell and Dr. Rasoulinejad said the unique value of the competition was its ability to fund less-tangible costs associated with furthering commercialization efforts. In addition to providing the opportunity to secure funding, the competition can facilitate introductions to industry contacts, from the right lawyer and regulatory consultant to local mentors with shared experiences, they said. The contest is part of an evolving health-care innovation hub in London.
Lasswell and Rasoulinejad's hard-earned win took their research well beyond the academic setting. The funds they secured were used to work with regulatory consultants, perform literature reviews and compile data on competing products so that a pre-submission package could be reviewed by the U.S. Food and Drug Administration.
These efforts ultimately enabled them to have the Edge Upper Cervical System acquired by an international medical device company, and FDA approval is expected later this year.
The success of the Edge Upper Cervical System goes beyond the implant itself: this work will establish a path for future implant development and commercialization opportunities at Western, attracting highly qualified personnel to London and contributing to the economic growth of startup communities in Southwestern Ontario, Lasswell and Rasoulinejad said.
And the greatest wins are the improved outcomes their product will bring to patients and surgeons, including a 30-minute reduction in the operating time needed for the procedure.
"It's a win for the patient because the surgery becomes shorter, with potentially less blood loss and therefore lower intraoperative and postoperative complications," said Rasoulinejad. "It's a win for the surgeon because it means a less complex and less stressful process. And ultimately, it's also a win for health-care systems because reduced operative time means reduced complication rates and an overall health-care savings."
