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Conformis Next-Generation Identity PS Knee System Gets FDA Nod

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Zacks Equity Research
·3-min read
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Conformis, Inc. CFMS recently announced receipt of the FDA’s 510(k) clearance for its next generation iTotal Identity Posterior Stabilized (“PS”) Knee System. With this, the iTotal Identity PS becomes the latest-approved personalized knee technology from Conformis, after iTotal Identity cruciate-retaining total knee replacement implant.

Notably, the earlier generation of full knee replacement of iTotal line was iTotal PS, which was commercially launched in 2016.

With the latest regulatory approval, Conformis aims to addresses the huge knee implant market across the globe.

Significance of the Approval

Per management, the iTotal Identity PS Knee System provides a patient-specific pre-operative surgical plan with a comprehensive set of iJig instruments and patient-matched implants as a part of the knee system’s latest features. For investors’ note, iJigs are personalized single-use patient-specific instrumentations.

The latest addition to the knee system will also enable surgeons to expand their patient pool and offer better treatment.

Industry Prospects

Per a report by Market Data Forecast, the global knee-reconstruction devices market was estimated to be $7.23 billion in 2019 and is projected to reach $8.95 billion in 2024 at a CAGR of approximately 4.4%. Factors like rising elderly population, increasing prevalence of arthritis and technological advancements are likely to drive the market.

Given the market potential, receipt of the regulatory approval seems to be strategic for the company.

Recent Developments

Conformis had been witnessing a slew of developments in its business before the pandemic-led disruption took its toll.

During the first quarter 2020 earnings call, the company had confirmed that it had been experiencing an uptick in its order rate prior to the March reduction in scheduled orthopedic procedures. This resulted from favorable feedback and uptick in the company’s new hip franchise, but primarily due to the positive feedback and interest in the latest Identity Knee launch.

Further, the company stated that product sales in new countries as well as growth in the U.K. helped to partially offset the negative impact of the pandemic.

Price Performance

Shares of the company have gained 21.9% in the past three months versus the industry’s 29.8% growth and the S&P 500’s 26.3% rise.



 

Zacks Rank & Stocks to Consider

Currently, Conformis carries a Zacks Rank #4 (Sell).

Some better-ranked stocks from the broader medical space include Quest Diagnostics Incorporated DGX, Hologic, Inc. HOLX and QIAGEN N.V. QGEN.

Quest Diagnostics’ long-term earnings growth rate is projected at 7.6%. It currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Hologic’s long-term earnings growth rate is estimated at 7%. The company presently has a Zacks Rank #2.

QIAGEN’s long-term earnings growth rate is estimated at 12.2%. It currently sports a Zacks Rank #1.

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