MedShape Solutions Inc.

Full article reprinted from Start Up - August/September 2009

Start-Up -- Imagine an implanted device that can be inserted through a small opening in the body but expands to a much larger size once inside. Moreover, it's a permanent device that can adjust to changing conditions within the body following implantation. In other words, an active implant as opposed to a static implant. Such is the biocompatible, shape-memory polymer technology being developed by MedShape Solutions. The company is initially focused on sports medicine, with an emphasis in rotator cuff and shoulder repair and anterior cruciate ligament repair. Read more...

MedShape Solutions Inc.

Full article reprinted from Start Up - August/September 2009

Board of Directors: Jack Blair (formerly Smith & Nephew); Paul F. Hills (Hills Capital Management); Greg Dane (Georgia Institute of Technology); Tom Hills (Hills Capital Management)

Imagine an implanted device that can be inserted through a small opening in the body but expands to a much larger size once inside. Moreover, it's a permanent device that can adjust to changing conditions within the body following implantation. In other words, an active implant as opposed to a static implant. Such is the biocompatible, shape-memory polymer (SMP) technology being developed by MedShape Solutions Inc.

The company is initially focused on sports medicine, with an emphasis in rotator cuff and shoulder repair and anterior cruciate ligament (ACL) repair, representing a combined total of approximately 850,000 procedures worldwide and translating into roughly an $850,000 million market worldwide. "Ultimately, with our shape-memory polymer technology, we believe we can address an over $2.5 billion marketplace that currently exists by essentially replacing static implants with dynamic implants," says Chris Fair, MedShape's COO.

The founders of the start-up felt they could improve on existing technology for orthopedic implants by collaborating on basic research at the University of Colorado, where co-founder and CTO Ken Gall was an associate professor of materials science and mechanical engineering before transferring to Georgia Institute of Technology in 2007.

"Shape-memory technology appeared to add great clinical benefit to orthopedic implants," Gall recalls. "Essentially, our shape-memory material is created though proprietary chemistries and processing. We can deform the implant into a temporary shape, then once it is implanted and activated it will remember its original shape. When we manufacture the material, we know exactly the dimensions of the material before and after deployment."

In April, the company received its first 510(k) clearance, for the WedgeLoc suture anchor for rotator cuff and shoulder repair. All other pending approvals are anticipated to be 510(k). "To the best of our knowledge, we have the only FDA-cleared device using a shape-memory polymer," says Kurt Jacobus, MedShape's president and CEO. He expects CE mark for the WedgeLoc in the second quarter of 2010.

Surgeons who use WedgeLoc will have a choice of several sizes for each implant. "Our device takes less than a second to deploy," Gall notes. The surgeon triggers the deployment mechanically, by twisting a knob and then pushing the knob on the disposable inserter. This sends a mechanical input to the material that forces the material to take its new shape. To ensure proper placement after deployment, the surgeon will pull and/or tug on the sutures, without the need for any additional mechanical fastening elements or hinges.

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Companies mentioned in this article:

Arthrex GMBH

Cayenne Medical Inc.

ConMed Corp.

ConMed Linvatec

Johnson & Johnson

DePuy Mitek Inc.

KFx Medical Corp.

MedShape Solutions Inc.

Serica Technologies Inc.

Smith & Nephew PLC

Smith & Nephew Inc.

Synovis Life Technologies Inc.

Pegasus Biologics Inc.

University of Colorado

About Start Up

No publication reviews leading edge companies and technology better than START-UP. Each issue of START-UP profiles the most important new product companies, identifies the hottest technology areas, reviews funds flowing into private companies and investment trends, and reports on university tech transfer licensing. Industries covered: pharmaceuticals, biotechnology, medical equipment & devices, and in vitro diagnostics.