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Of product launches, lawsuits


By Omar Ford

Staff Writer

Nuvasive Inc. has received expanded 510(k) clearance for its Precice platform, which could allow the company to have a deeper reach into the limb lengthening and trauma markets. The expanded indication is one of several key drivers in the San Francisco-based company's growth that have occurred in the past few months.

Precice is now indicated for bone transport of long bones in addition to limb lengthening. Bone transport is a technique that allows for regeneration of bony tissue and is typically used to fill segmental bone loss due to trauma or infection, i.e., infected nonunions, segmental defect and chronic bone infections.

Prior to the expanded FDA clearance, the company's Precice system was indicated for limb lengthening of just the femur and tibia.

"This is much more patient friendly," Massimo Calafiore, president of Nuvasive Specialized Orthopedics, told BioWorld MedTech. "You don't have to deal with all of the issues related to external fixation. "The quality of life of a patient would change tremendously because [this approach] is much gentler compared to external fixation."

Calafiore said the new indication allows Nuvasive to treat more patients suffering from debilitating segmental bone defects.

The key to the Precice platform is the magnetic interaction between the intramedullary nail and external remote control. The technology includes an internal gear system remotely activated and controlled by permanent magnets.

Calafiore said the company has a CE mark for this indication.

Nuvasive gained access to Precice when it acquired Aliso Viejo, Calif.-based Ellipse Technologies Inc. for $380 million in early 2016. (See BioWorld MedTech, Jan. 7, 2016.) In addition to providing a pathway into new niche orthopedic and trauma markets, the Ellipse acquisition helps Nuvasive enter into the pediatric deformity market.

Nuvasive vs. Alphatec

The clearance comes on the heels of Nuvasive filing a lawsuit on Wednesday against former CEO Patrick Miles, who began working for its rival Alphatec Holdings Inc., as executive chairman. Miles began working with Alphatec, earlier this month. (See BioWorld MedTech, Oct. 3, 2017.) Nuvasive's lawsuit alleges Miles discouraged the company from undergoing an attempted bid at acquiring Alphatec. The complaint also alleges that Miles solicited Nuvasive employees to join him at Alphatec.

Alphatec released a statement denouncing the claims, calling the lawsuit "fictional" and "baseless." The Carlsbad, Calif.-based company said it would stand beside and support Miles.

Miles weighed in on the suit saying the allegations were false and "typical of a management team reacting to mass departures of key, spine-experienced executives."

Earlier this month, Joshua Jennings, an analyst with Cowen and Co. commented on Miles helming Alphatec.

"Nuvasive's loss will clearly help Alphatec, but the impact to Nuvasive should be manageable," Jennings said.

Key drivers for 2017 and beyond

The picture of Nuvasive has changed over the years. The company was founded in 1997 and focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions. It began commercializing its products in 2001.

In June 2016, the company gained attention when it revealed it would acquire Biotronic Neuronetwork for $98 million in cash. (See BioWorld MedTech, June 8, 2016.) The deal closed in July 2016. Through the acquisition, Nuvasive was able to offer intraoperative neurophysiological monitoring services to surgeons and health care facilities.

Biotronic helped drive growth in Nuvasive's surgical support unit, bringing in about $72 million in 2Q17, up about 19 percent over the previous quarter.

However, one of the biggest catalysts for Nuvasive was in September, when the company launched its Lessray software technology system. The Lessray system, comprised of a software algorithm and hardware components, is designed to help address over exposure to radiation in hospital operating rooms particularly in the case of minimally invasive spine surgery.

Prior to Lessray's launch, Cowen and Co. held a 51-physician survey to gauge interest in the technology.

"We view the company's guidance for $2 million to $3 million in 4Q17 Lessray sales . . . as conservative," Jennings said. "Our survey alone could represent that amount or more, as could simply recognizing revenue on the units used by the more than a dozen hospitals involved in the product's testing since last year."



Published  October 13, 2017

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