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Cleveland Clinic Inks Separate Research Pacts with FTA Therapeutics, Aspect Medical Systems

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The Cleveland Clinic recently entered into separate research partnerships with a pair of biomedical corporations designed to tap into the clinic's biomedical engineering expertise and medical records database with the goal of commercializing various products and services.

Under the first collaboration, Cleveland Clinic has taken an undisclosed equity stake in clinical-stage pharmaceutical company FTA Therapeutics and plans to co-develop a variety of antimicrobial products, in an alliance that will also benefit FTA's development partner Pure Bioscience.

In the second agreement, the clinic has entered into a five-year comparative-effectiveness research collaboration with Aspect Medical Systems that will focus on improving post-operative outcomes.

Both agreements involve Cleveland Clinic Innovations, the clinic's technology-commercialization arm.

As part of the FTA Therapeutics deal, researchers from both organizations will work to develop dermatological, wound-care, and medical biofilm-control products based on silver dihydrogen citrate, an antimicrobial compound owned by San Diego-based Pure Bioscience.

Under an agreement inked between the companies last year, FTA is formulating and advancing to clinical trials several SDC-based products, including a non-alcohol based hand sanitizer; topical treatments for the prevention and cure of acne and nail and foot fungi; and a broad-spectrum vaginal anti-microbial. FTA also has the option to develop certain SDC-based wound care products.

FTA, whose name stands for "free-ion therapeutic agents," was co-founded by Francis Papay, chair of the Cleveland Clinic's Dermatology and Plastic Surgery Institute and head of its craniofacial and plastic surgery department; orthopedic surgeon Anthony Balsamo, a clinical professor at the Drexel University College of Medicine; and his son, Anthony Balsamo, Jr., an executive with Philadelphia-area consulting firm Vynamic.

Despite Papay's involvement with FTA, the company was not previously formally affiliated with the Cleveland Clinic; however, Papay's familiarity with the clinic's biomedical engineering and commercialization expertise likely played a role in forging the partnership.

"After a lengthy and thorough evaluation process, we are proud to announce that … the Cleveland Clinic, which has one of the largest biomedical engineering departments in the US, has agreed to work with FTA as part of FTA's development projects with Pure's SDC."

Now, however, in exchange for its services, Cleveland Clinic has taken an undisclosed equity stake in FTA. Pure announced the deal last week to publicize the fact that its development pact with FTA can now leverage the resources of one of the country's largest research hospitals.

"We contemplated FTA's relationship with [Cleveland Clinic] when we negotiated our contract with FTA," Michael Krall, Pure's president and CEO, told BTW this week. "Anything that's good for FTA is good for us.

"The big thing for us is just having Cleveland Clinic and its resources behind the technology development," Krall added. "Can you get any better? This helps validate the technology. [Cleveland Clinic] didn't just look at [the technology] for a week; they looked at it for quite some time. They were involved in the negotiation process between FTA and us, and we were involved in the negotiations between FTA and Cleveland Clinic."

The specific terms of the clinic's equity stake in FTA were not disclosed. A spokesperson for Cleveland Clinic Innovations said that it does not discuss the terms of its commercial agreements.

In a statement, Mark Coburn, executive director of CCI, said that Cleveland Clinic "is committed to advancing commercial-oriented innovation and transforming promising technologies into products," and that the clinic was "pleased to be working with FTA."

Improving Outcomes

Under Cleveland Clinic's collaboration with AMS, researchers from both organizations will use the clinic's electronic medical record system to identify anesthetic management practices associated with optimum outcomes.

The partners will then prospectively test the identified practices using "real-time decision support methods," AMS said.

AMS also said that it has signed a licensing agreement with Cleveland Clinic that "will cover any intellectual property that emerges from the partnership," though it did not elaborate. Calls to the company were not returned in time for this publication.

A spokesperson for the Cleveland Clinic said it would not speculate as to the type of IP that might stem from the collaboration, and said that the clinic's main focus would be on improving patient outcomes following surgery.

Specific terms of the partnership call for the researchers to compare records from more than 85,000 surgical patients treated at Cleveland Clinic with a baseline risk assessment system derived from 34 million patient records obtained from the Center for Medicare and Medicaid Services.

Another part of the collaboration calls for the partners to develop comparative-effectiveness methodologies in order to prospectively test how different anesthetic management interventions, decision support alarms, and clinician education initiatives impact routine clinical care, AMS said.

In a statement, Nassib Chamoun, president and CEO of AMS, said that the company "believes that anesthetic management decisions play a key role in enabling better patient outcomes.

“Through our collaboration with the clinic we will utilize our expertise in analyzing large clinical databases and the clinic's extensive clinical data registry to evaluate, on a patient risk and procedure-adjusted basis, how different approaches to anesthetic management impact patient outcomes following surgery," he said.

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