A Medical Device Daily

CAS Medical Systems (Branford, Connecticut), a device company focused on non-invasive vital signs monitoring, said it has been awarded a Phase IIb Small Business Innovative Research (SBIR) grant by the National Institute of Neurological Disorders and Stroke (NINDS), a component of the National Institutes of Health (NIH).

The three-year, $2.8 million, grant will be used primarily to support advanced clinical outcome studies that focus on the company’s Laser-Sight technology, CAS said. This technology is incorporated into the Fore-Sight cerebral oximeter, which started shipping to distributors and customers in the second quarter of this year. Further clinical studies funded by this grant will be used to expand the clinical applications for Fore-Sight outside of the initial target market of high risk cardiovascular surgery, the company noted.

“The award of this peer-reviewed grant will enable us to provide physicians with expanded guidance for establishing cerebral tissue oxygen saturation threshold values in various medical situations. Studies with this funding are planned to begin within the next two months,” said Paul Benni, chief scientific officer for the company.

To date, CAS has been awarded six SBIR grants totaling $5 million from NINDS to support the development of its absolute cerebral oximeter.

CAS Medical Systems’ product lines include blood pressure measurement technology, vital signs monitoring equipment, blood pressure cuffs, apnea monitoring equipment and products for neonatal intensive care.

In other grant news, Spire (Bedford, Massachusetts) also reported getting a two-year, $870,000 Phase II SBIR grant from the NIH, National Institute on Deafness and Other Communication Disorders (NIDCD) to develop a high-power fiber laser capable of performing myringotomy and middle-ear surgery without the need for anesthesia.

The grant has been funded for $438,000 for the first year and the second year of funding is subject to the availability of funds and the satisfactory progress of the project, the company said. Myringotomy is a common procedure, typically performed in children under age 5, whereby the tympanic membrane (eardrum) is punctured to drain fluid and reduce the risk of ear infection. Roughly one million children undergo this procedure annually in the U.S., the company noted.

In the first phase of the project, Spire developed a one-watt fiber laser and demonstrated the capability of forming controlled openings in animal fascia tissue, which simulates tympanic membrane characteristics. The laser being developed in Phase II is expected to emit between five and ten times the power level of the Phase I laser, thereby making it a candidate for replacing conventional scalpel surgery (which requires anesthesia) with a procedure resulting in less trauma. The efficacy of the new myringotomy instrument will be evaluated at the Children’s Hospital (Boston), under the direction of Dennis Poe, MD.

Spire provides products and services to the solar energy, biomedical and optoelectronics industries.

In contract news, Misonix (Farmingdale, New York), a developer of ultrasonic technology for the treatment of cancer and other chronic health conditions, said it has extended its contract with Mentor (Santa Barbara, California) for domestic sales of its ultrasound assisted liposuction product, the LySonix 3000.

Mentor has agreed to minimum purchase order provisions for the LySonix 3000 for a term of one year, beginning September 30, and successive annual renewals upon mutual agreement by the companies.

Mentor supplies products for the global aesthetic market.

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