Medical Device Daily Executive Editor

DENVER – The envelope, please.

And the winner is ... . ValveXchange (Aurora).

Closing out last week’s 2007 edition of BioWest 2007 was the presentation of a Venture Showcase, a four-person panel of seasoned entrepreneurs listening to six brief developmental-company presentations and then selecting the one they liked the most.

ValveXhange was the award-winner in the competition which was sponsored by a Denver law firm.

And Medical Device Daily also would have picked ValvXchange as the run-away best, based on: 1) its being a device company (yay!), 2) its possibilities for offering large positive clinical impact for heart disease patients and 3) its potential for doing very much better what two mature technologies already do.

But underline – twice – potential.

Still only at the benchtop-testing stage, ValveXchange’s bioprosthetic heart valve offers an ingenious combination of tissue valve and mechanical valve technology and in doing so avoids the well-known disadvantages of both types.

The valve – invented by Ivan Vesely, PhD, and licensed from the Cleveland Clinic Foundation – is a sort of razor/razor blade concept involving implantation of a “docking station” into which can be placed, and then later replaced if need be, the tissue valve leaflets.

This combination avoids the major large problem of the tissue valve sector, that such valves wear over time, or the person grows, and so replacement is required, that procedure being more risky as a person ages.

And the combination avoids the key problem of a mechanical valve which, though lasting indefinitely, requires a lifelong follow-on regimen of anticoagulation therapy with the concomitant pharma side-effects.

Prior to his Showcase presentation, Larry Blankenship, CEO of ValveXchange, told MDD that the valve system’s bovine pericardial leaflets are “a shameless copy” of the well-established Perimount tissue valve from Edwards Lifesciences (Irvine, California), but no longer patent-protected.

Thus, the ValveXchange system, he said, offers “the best of both [tissue and mechanical valve] worlds.”

Edwards, the largest maker of tissue valves, would be one of the major players that the ValveXchange valve would threaten. Similarly, the valve could take large market share from St. Jude Medical (St. Paul, Minnesota), a major maker of mechanical valves, since the docking station part of the system does not require the anti-coagulation follow-on regimen. That therapy is required only to deal with the sheer-stresses of mechanical valve leaflet movement, not the docking station of the ValvXchange valve, according to Blankenship.

And in their Showcase presentation, ValvXchange executives noted that the tissue valve change-out can be done in a less-invasive manner, through the chest wall in under 30 seconds on a beating heart.

Another advantage of the technology: as a “me-too” valve, it would be automatically reimbursable, Blankenship told MDD.

ValvXchange has received three $200,000 SBIR grants from the National Institutes of Health, expects a Phase II grant of $1.6 million for follow-on development and was taking advantage of the Showcase opportunity to seek venture funding to take it through the various development and regulatory stages.

Winning the Showcase award, ValvXchange walked away with a $10,000 prize from law firm sponsors, Faegre & Benson, to further back product development.

Blankenship laid out a clear regulatory timeline that the company hopes will take it to global sales by 2012, noting a variety of points along this timeline for potential exits. (Blankenship noted that the company has already been contacted by some interested buyers, while not disclosing any names.)

But let’s not leave out the other five showcase participants with our MDD order of preference (most interesting to least, our bias again being the more device-oriented firms.)

•Sierra Neuropharmaceuticals (Boulder), developing a system for delivering psychotropic drugs directly to the brain using a pump made by Medtronic (Minneapolis), for neurological problems resistant to standard therapies.

Key advantages of the system, according to Sierra CEO Don Abrams, is “delivery of the drug where needed,” via the spinal cord, thus bypassing the blood-brain barrier and avoiding the systemic side effects of such pharmaceuticals.

Abrams reported that the company has demonstrated proof of concept in five animal models and that its initial targeted application is epilepsy. He said that the company is pointing for an IND meeting with the FDA in February

•mBiosystems (Boulder), developing a point-of-care diagnostic system using a fluorescence assay platform, as a spin-off from Precision Photonics (Boulder), which is retaining major equity ownership.

Chris Mayall, PhD, founder and CEO, said the prototype system produces results in 15 minutes for 20-plus assay targets with broad applications in world health applications. He said the company is seeking $10 million to take the system from its current video cassette-sized “black box” format to final instrumentation.

•Ventrus Biosciences (Greenwood Village), developing topical treatments for gastroenterology problems such as anal fissures and hemorrhoids.

Ventrus held a pre-IND meeting with the FDA in June and hopes for that approval next year, saying the market it is pointing toward has a $20 million a year market potential.

•Nanodisc (Boulder), developing a research tool that Michael Artinger, president/CEO, described as “a suitcase for membrane band receptors.”

Artinger said that the targeting of membrane-associated drugs offers research aids for vaccine applications, protein arrays, drug validation, toxicology and imaging.

•Solex biofuels (Fort Collins), a developer of alternative fuel technology – based on growing and harvesting algae (algae!!??), developed out of Colorado State University (Fort Collins) – with company president Doug Henston referring to the resultant fuel as “green diesel.”

The system employs “plastic panels in a water bath,” the algae used described by Henston as “agnostic,” meaning not dependent on one particular species, and the system able to provide large quantities. He said the system uses 95% less water than other types of biofuel production and that the company is developing partnerships with industrial producers of CO2.

Thus far angel-funded, Solex is seeking A-round funding of $20 million.

Alltold, the Venture Showcase served to highlight the broad variety of med-tech developers that are taking root in this region that describes itself as the eastern “bookend” of the Rockies.

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