ConforMIS Inc (NASDAQ: CFMS) is screaming for the top in the market this morning, and for good reason. The company announced that it received clearance from the FDA surrounding its knee replacement product. Here’s what’s going on:
CFMS Stock Gains On FDA Clearance
In the press release, ConforMIS said that it received 510(k) clearance from the FDA for its Identity Imprint Knee Replacement System. The system expands the range of options open to ConforMIS’ orthopedic surgeon customers and their patients by providing both cruciate retaining and posterior stabilized versions of the knee replacement system.
Importantly, the ConforMIS iTotal Identity knee replacement system is designed and manufactured individually to fit the unique size, shape, and curvature of each patient’s anatomy, the Identity Imprint product, now cleared by the FDA, combines predetermined implant sizes with standard and patient-specific surgical instrumentation.
As a result, the Identity Imprint will provide surgeons and patients with faster delivery times and intraoperative options that are more similar to standard knee systems.
CFMS went on to say that its Identity Imprint uses a proprietary 3-dimensional best-fit algorithm to select the implant that most closely meets the geometric and anatomic requirements of the patient based on the patients computed tomography (CT) scans.
The company also said that the Identity Imprint will be delivered using its sterile “surgery-in-box” system, which is expected to provide ambulatory surgical centers greater procedural efficiency and improved sterilization cost savings than the standard system.
In a statement, Mark Augusti, President and CEO at CFMS, had the following to offer:
Our Identity Imprint knee system is a tremendous new addition to our product portfolio that leverages our technical innovations and data from tens of thousands of personalized implant designs. It is a terrific option for those surgeons who want more traditional intraoperative flexibility and faster product availability. We will be able to provide a patient-matched Identity Imprint system in 3 weeks versus the six weeks lead time for the iTotal Identity fully personalized system.
This offering is extremely well-positioned to meet the needs of the ASC care setting, but will provide value to in-patient hospital care as well, especially in the post-COVID environment. Importantly, it also provides surgeons and their patients a new choice among Conformis’ world-class treatment options.
This News Is Huge
The news released by ConforMIS this morning is huge for the company and its investors. While the company’s customized knee replacement product is an exciting one, with each system designed and manufactured for each patient, it comes with challenges because of each system’s uniqueness.
The new Identity Imprint product is free from those challenges, giving it the ability to be produced and delivered faster, and when it comes to knee replacements, consumers aren’t willing to wait. So, this product is likely to be met with a much higher level of demand.
As a result, CFMS is likely to take a larger portion of the massive knee joint reconstruction market, one that’s expected to be worth more than $9 billion this year alone as a growing number of procedures are performed.
All in all, this approval gives the company the ability to compete in ways it hasn’t had in the past, giving it significant potential to generate revenue growth.
The Bottom Line
With the new Identity Imprint product now approved by the FDA, ConforMIS has all it needs to greatly expand revenue and compete with the major players in the global knee replacement space. All told, this is great news for investors, making CFMS stock one that’s hard to ignore.