UPDATE: The story below has been updated to reflect that the vitamin-e infused liner is a product in development and has not been cleared by the FDA.
Steering clear of the metal-on-metal hip implant controversy that has embroiled the likes of Zimmer and Johnson & Johnson, a Warsaw, Indiana startup will soon be introducing a total hip implant that aims to be a better, cheaper alternative to those produced by larger players in the field.
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Iconacy recently won clearance for the Food and Drug Administration to market the I-Hip. The product was designed by four orthopedic surgeons who will be clinically testing the product by being the first to implant it, said Tom Allen, Iconacy’s president and CEO. The product contains a highly cross linked polyethelene liner licensed from Mass General and Cambirdge Polymer Group. The cross linked polyethlenes show less wear than standard ones.
A future product, currently in development, uses a Vitamin E infused polyethlene also licensed from Mass General Hospital and the Cambridge Polymer Group, Allen said and has several clinical benefits such as a better interlocking mechanism.
The vitamin-infused polyethlene is very durable and is stable even as people age, according to the Cambridge Polymer Group. And the design of that product is aimed to make it easy for surgeons to maneuver the implant, especially removing the liner if it has worn out or whether an adjustment needs to be made.
In designing the I-Hip like traditional implants instead of the metal-on-metal implants that have now become a major liability to some orthopedics manufacturers, Iconacy has been prescient.
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One of the surgeons who designed i-Hip said “absolutely not” to developing a metal-on-metal device.
“He said it over three years ago – he knew something that we didn’t,” Allen said.
Yet, he frankly admits that Iconacy is not trying to reinvent the wheel. Instead it is combining clinically proven technologies with advanced material technologies. Add to that a lean, state-of-the-art manufacturing process – and where else to produce orthopedic implants than Warsaw, also known as the orthopedic capital of the world – and you have a product that aims to be both clinically effective and financially viable.
Allen said the company is currently discussing how to price the i-Hip but said that it will be lower than $7,000 to $9,000 charged by competing devices made by Zimmer, Johnson & Johnson’s DePuy, Stryker and others.
“We are going to de able to deliver our product cheaper because of our lean operations and (because we are) taking advantage of modern technology as far as machine operations go,” Allen said.
The company has raised $3 million in seed capital to get the regulatory nod, but will need to raise money again by January. In this same time period, the i-Hip will be clinically tested. Once the money is raised and the tests completed, he expects the company to do a full commercial launch.
Allen declined to say how much money Iconacy is seeking as well as what he is telling investors regarding the exact size of the market Iconacy is chasing.
“Baby boomers are entering the (age) when our joints wear out,” Allen said. “The market is increasing and we are playing in a big market – several billions of dollars. We have (revenue) forecasts that we have shared with investors but are not at liberty to share with anybody.”
A 2010 report forecast that the U.S. hip and knee replacement markets would grow to be $14.8 billion by 2015, with the knee market claiming majority of that share.
