A Medical Device Daily

NIR Diagnostics (Campbellville, Ontario), a developer of hand-held spectroscopy-based instruments, reported a license and royalty agreement with Shaklee (Pleasanton, California) to develop, manufacture and distribute NIR's in vivo light-based technology and the HemoNIR CO-oximeter device. The agreement, still requiring various approvals, includes applications of NIR's light-based technology for the medical device and laboratory device and food supplement markets.

Shaklee will market NIR Diagnostics' multi-analyte light-based device to its distributors worldwide, with Shaklee to make an up-front payment of $2 million upon satisfaction of various conditions and a $1 million milestone payment upon completion of a food supplement device within one year.

NIR also will receive what it termed “an industry-standard royalty” from the sales of a food supplement device. If the prototype device is not completed within the one year, NIR will issue to Shaklee a purchase warrant for 13.3 million warrants exercisable into common shares of NIR.

NIR also has provided Shaklee with an exclusive license in certain countries to the HemoNIR CO-oximeter device, with NIR to receive a maximum payment of $1 million – $250,000 upon finalizing the rights in three Asian countries and additional options of up to $750,000 for three other regions. Shaklee and NIR will share revenues 50/50 from the sale of in vivo devices for medical applications from all sources.

“The basis of this agreement is the trend toward healthier dietary and lifestyle choices and the potential impact of a low cost, noninvasive consumer device to encourage those choices. Historically diagnostic devices, whether point-of-care or laboratory based, were considered to have only disease state application,” said Duncan MacIntyre, president/CEO and executive vice chairman of NIR.

The agreement is expected to become effective about July 31.

NIR develops optical, electronic and algorithm-related products in the field of in vitro and in vivo blood analysis.

In other agreement news: Geron (Menlo Park, California) reported a collaboration and license agreement with Corning (Corning, New York) for the development of synthetic surface matrices for the growth of human embryonic stem cells (hESCs) to replace the biological surface coatings widely used to grow hESCs.

Corning receives a license under Geron patents covering hESC growth and a sub-license under the foundational hESC patents held by the Wisconsin Alumni Research Foundation. The resulting products will be sold by Corning, with Geron receiving sales royalties.

Thomas Okarma, PhD, MD, president/CEO of Geron, said Geron is developing “new and improved approaches to hESC production. The availability of appropriate synthetic growth surfaces will benefit both Geron and the field of hESC research more broadly. Corning is a world-leader in cell culture surfaces, and we are excited to partner with the company in these efforts.”

hESC's, Geron said, have the ability to maintain pluripotency and proliferative capacity indefinitely in culture, allowing for scalable expansion of the undifferentiated cells prior to differentiation into therapeutic cell populations. Geron said its scientists have developed techniques for growing hESCs without feeder cells, increasing scalability while eliminating contamination by infectious agents from feeder cells.