A Medical Device Daily

CoreSpine Technologies (Minneapolis) an emerging spinal device company reported the completion of the company’s initial cadaver evaluations.

CoreSpine’s first product in development is a complete nucleus removal device that seeks to remove the nucleus pulposus from the lumbar disc space, while not damaging the annulus or endplates. In addition, its design characteristics allow the device to be used in multiple surgical approaches, including the preferred posterior approach.

“This set of successful evaluations illustrates that the prototype has made progress towards a device that addresses the clinical needs for safe and complete nucleus resection,” said John Sherman, MD, medical director for CoreSpine. Sherman continued, “The device created a larger nucleus cavity than the rongeur and damage to the annulus and endplates was minimized.”

“We’re pleased with the data that was generated from the labs. As Dr. Sherman stated, the results of the initial work are promising and will be used to guide the near-term engineering refinements, “said Britt Norton, co-founder of CoreSpine. “CoreSpine has submitted data and information for presentation at international spine meetings in 2008,” Norton added.

In other new ventures:

• The Cleveland Clinic (Cleveland) and the Medical Device Innovations (MDI) business incubator in Oregon have formed a company called Clear Catheter Solutions (Cleveland), which aims to develop medical devices to improve post-surgical wound drainage. The company will use intellectual property from the Clinic and MDI to continue developing a portfolio of products to keep surgical drains clear and functioning optimally. Clear Catheter’s products, once developed, would be spun out into new companies, said Christopher Coburn, executive director of CCF Innovations, the Clinic’s technology commercialization arm in an interview with Crain’s Cleveland Business.

“We would expect that we would have specific product-focused companies coming out of this,” Coburn said.

The new company might have a physical presence in Cleveland, but even if it doesn’t, it is probable that its spin-offs would, Coburn said. Clear Catheter will not have its own employees. Clear Catheter could begin spinning off companies soon, Coburn said, though he noted that more money must be raised first.

MDI, which approached the Clinic about the collaboration, will handle most of the company’s daily operations, while the Clinic will focus on providing intellectual property and product validation services, Coburn said.

He declined to say how much of the company the Clinic owns.

Surgical procedures sometimes can disrupt the local flow of blood and lymphatic fluids, which can cause fluid buildup that, can disrupt healing and slow a patient’s recovery. Surgeons often improve drainage by establishing temporary, passive drains in or near a surgical site to allow fluid to escape, but the drains often clog, which negates their value and opens a path for infection.

• PainCare Holdings (Orlando), a provider of pain-focused medical and surgical solutions and services, and MedeFile International (Cedar Knolls, New Jersey) a company specializing in portable electronic medical records management solutions, reported that that they have formed a partnership to market the MedeFile system, a personal electronic medical records management solution, direct to consumers nationwide.

PainCare will be granted exclusive rights to market the MedeFile system direct to consumers in exchange for a 50% share of revenues generated strictly from PainCare’s marketing activities. With plans to produce a national television infomercial scheduled to begin airing in January 2008, PainCare has agreed to also support this marketing initiative with direct response advertising on the Internet and via direct mail.

According to Randy Lubinsky, CEO of PainCare, “Through its business relationship with our subsidiary Integrated Pain Solutions (IPS), MedeFile’s management team has spent considerable time educating our corporate leadership on the tremendous benefits and competitive differentiation of the MedeFile system. In light of PainCare’s underpinning mission to improve the standard of patient care in the U.S., we quickly determined that the MedeFile system represented a true patient-empowering solution that could yield material enhancements in the universal management of health records - particularly for those with chronic medical issues requiring care by multiple physicians. Consequently, PainCare believes that there is an opportunity to leverage the MedeFile system’s many distinct user benefits and advantages to produce a new, potentially lucrative revenue channel for PainCare.”

MedeFile has developed a system for gathering and digitizing medical records so that individuals can have access to a comprehensive set of their medical records. MedeFile’s primary product is the MedeFile system, a highly secure system for gathering and maintaining medical records. The system is designed to gather all of its members’ actual medical records and create a single resource that is accessible 24 hours a day, seven days a week.