Australian company Simplify Medical recently raised $21 million in a Series B round to support two pivotal clinical trials and commercialize its polymer/ceramic cervical device in Europe. The investment was led by Life Sciences Partners and included Sectoral Asset Management and existing investor M.H. Carnegie.
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Simplify enters a crowded replacement disc market.
However, the company is banking that its nonmetal discs will provide a significant competitive advantage. Metal discs create artifacts that can reduce MRI image quality, forcing clinicians to use CT scans after surgery. Nonmetal discs could give clinicians more flexibility to use MRI over CT, eliminating radiation exposure and providing more detailed images.
“The radiation that patients get from a cervical spine CT scan is the equivalent of 400 to 450 chest x-rays,” said CEO David Hovda in a phone interview. “It’s quite a bit of radiation. If we can avoid that and enable patients to get follow-up MRIs and get more information from a diagnostic perspective, that’s a safety benefit for these patients that we don’t see currently exists.”
The approach is part of an ongoing effort to reduce patient radiation exposure. Emerging technologies like cardiac MRI and MRI-guided radiotherapy have shown the potential to minimize the use of CT, fluoroscopy and other radiation-driven imaging techniques.
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The ceramic cervical disc from Simplify Medical
The Simplify disc features polyether ether ketone (PEEK) polymer endplates and a ceramic core. In addition to allowing MRI imaging, Hovda notes the discs may be better suited for smaller patients and could avoid the wear associated with some metal devices.
“We developed the Simplify disc primarily as a means of having better MRI imaging,” said Hovda. “But as an added benefit, there is no metal wear. The only wear we envision is in the PEEK, which has a good biocompatibility profile.”
The disc received its CE Mark in late 2015, and Simplify began ramping up in the European market last year. According to the company, more than 700 patients have received Simplify discs. They hope the new financing will accelerate these efforts.
The funding will primarily support clinical trials in the U.S. Simplify received investigational device exemption (IDE) approval in 2015, and the company is conducting pivotal trials to test the device for both single and dual replacements.
“The vast majority of the capital will go towards our clinical trials,” said Hovda. “We are enrolling in both our one-level and two-level trials. We anticipate being completed with both in 2018.”
From there, the FDA requires two-year follow-up with patients before Simplify can apply for premarket approval. The company believes that once approved, non-metallic discs will become the go-to for clinicians.
“MRI is the preferred imaging for surgeons,” said Hovda. “It gives you a lot more information about soft tissue than CT scans. These non-magnetic materials don’t create the artifacts that force patients to get CT scans.”
