Orthopedics start-up Active Implants Corporation has raised $10 million from its current investors, whom were not named, in its third financing round. The company, which has raised $25 million to date, is headquartered in Memphis and has a research center in Netanya.
Active Implants has two products: the TriboFit Buffer hip implant, which has already been placed in 1,200 patients in Europe; and the NUsurface meniscus implant, a shock absorbing cushion for the knee designed restore function by redistributing the load similar to the function of the natural healthy meniscus. This product is undergoing a clinical trial and is due to reach market in 2015.
While the TriboFit Buffer hip implant is in a competitive market, the NUsurface meniscus implant is targeting a niche market with no current solution. The meniscus is basically a shock absorber for the knee, and damage to it results in severe pain and erosion of the bone and cartilage. In cases of severe knee damage, the entire kneecap is replaced, but the procedure is only advised for active adults, because the artificial knee is limiting for young persons, and there is a risk that a second implant will be needed later.
The NUsurface meniscus implant is implanted through a mini-open procedure in conjunction with routine arthroscopy, without the need to replace the kneecap. Although Active Implants has EU CE Mark approval for the product, it decided not to begin sales until it completes a large clinical trial to demonstrate the product’s safety, performance, and clinical advantages.
Active Implants is undertaking a multicenter trial that will include 100 patients, 35 of whom have already been recruited. The proceeds from the round will be used to finance this trial. The trial will be carried out in Europe and Israel, but not in the US, and the trial results cannot therefore be used to register the product with the US Food and Drug Administration (FDA).
Active Implants has apparently decided that FDA approval procedures are too arduous, and it prefers to defer them until it has sales and cash flow in Europe.
Active Implants was founded in 2004 by Amiram Steinberg, who previously founded Implant Ltd. (formerly DIScure) and Limber Ltd., and Steven Bradshaw, an American medical devices executive.
Active Implants also announced that president and CEO Michael Mainelli has stepped down, and has been replaced by director Henry Klyce. Klyce is a serial entrepreneur, who founded Surgical Dynamics, sold to United States Surgical Corporation for $135 million, and St. Francis Medical Technologies, which was sold to Kyphon, since acquired by Medtronic Inc. (NYSE: MDT), for $500 million.