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| iTotal customized total knee replacements--Courtesy of ConforMIS |
Personalized 3-D printed joint implants may seem like a no-brainer. But troubled small-cap ConforMIS ($CFMS) has struggled to dig in its heels since a $135 million IPO last June. Last fall, the implant maker faced a recall due to packaging problems. And now the FDA has forced its hand on a regulatory submission for a hip implant--causing it to withdraw the application in the face of unanticipated questions.
ConforMIS plans to address the FDA questions and conduct associated testing; it's slated to resubmit for 510(k) clearance of its iTotal Hip in the second half.
"Submissions to the FDA have a fixed timeline," said ConforMIS President and CEO Philipp Lang in a statement. "To address the questions raised by the FDA, we have elected to withdraw our application for clearance, but we are planning for a resubmission in the second half of 2016."
The company had previously hoped to launch the iTotal Hip in late 2016. But it acknowledged that this timeline is no longer realistic. In the near term, it's focused instead on other products, knee replacement in particular.
"Our focus will be on the full commercial launch of our iTotal PS customized total knee replacement," Lang said. "iTotal PS nearly triples our addressable market. The ConforMIS iTotal PS was designed to address the shortcomings of traditional knee replacements, which come in a fixed set of sizes and shapes."
He continued, "Over 1,000 patients were treated with iTotal PS during the limited launch and feedback has been extremely positive. Surgeon interest since the start of the full commercial launch has exceeded our expectations."
ConforMIS is down about 40% so far this year, but it is up a bit recently from 52-week lows that it hit in late February. Its current share price of $10.30 remains well below its IPO share price of $15.
The company may not have long to get its act together--major joint implant maker Stryker ($SYK) has plunged into 3-D printing with a major new facility with an announcement earlier this year. And another major competitor, Smith & Nephew ($SNN) recently rolled out its own 3-D printed hip implant.
- here's the statement