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Orthofix PhysioStim’s FDA Nod and CE Mark Boosts Prospects

Zacks

As a major breakthrough in the field of PhysioStim, Orthofix International N.V. OFIX has secured approvals from the U.S. FDA as well as the European CE Mark for its next-generation PhysioStim.

Per the company, the PhysioStim bone growth stimulators provide a non-surgical treatment option, particularly to patients with nonunion fracture beyond repair. In fact, such extremely critical conditions show no visible signs of healing.

The aforementioned Class III medical devices are built on Orthofix’s proprietary pulsed electromagnetic field (PEMF) technology platform. According to the company, PEMF signal creates a low-level electrical field at the fracture site, stimulating bone healing.

Orthofix sounds highly positive about PhysioStim, claiming the devices to have occupied a leading position as prescribed bone growth stimulators in the United States combined with spinal fusion stimulators. The company also stated that the PhysioStim devices will be accompanied by STIM onTrack, a new application for mobile devices. This app uses a first-to-market feature enabling physicians to remotely track and view patient adherence to their prescription.


Huge Market Prospect

We are certainly looking forward to this path-breaking achievement by the musculoskeletal healing device company in bone growth stimulation space, showing all indications to grow in leaps and bounds.

Going by a Grand View research report, the bone growth stimulator market size was valued at $1 billion in 2016 with more than 50 million Americans suffering arthritis. With arthritic problems rapidly rising due to aging and obesity factors, the patient population is likely to increasingly reach 78.4 million by 2040. Needless to add that this endemic arthritis is driving demand for bone growth stimulation products.

Taking global data into consideration, a Markets and Markets report states that the global bone growth stimulator market is estimated at $1.41 billion by 2022, witnessing a CAGR of 5.4%. The major growth propellers are growing patient preference for non-invasive and minimally invasive surgical treatments, increasing target patient population and procedural benefits offered by bone stimulation devices in bone fracture treatments.

In view of the above, we expect Orthofix to achieve a huge customer adoption rate for PhysioStim post the product launch in the United States and Europe.

Price Performance

Over the past three months, shares of Orthofix have outperformed the industry it belongs to. The stock has gained 11% compared with the industry’s 5.5% rise.

Zacks Rank & Key Picks

Orthofix carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the broader medical sector are Bio-Rad Laboratories BIO, PetMed Express PETS and PerkinElmer PKI.

Bio-Rad Laboratories sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. The company has a long-term expected earnings growth rate of 20%.

PetMed has a long-term expected earnings growth rate of 10% and a Zacks Rank of 1.

PerkinElmer has a long-term expected earnings growth rate of 12.3%. The stock carries a Zacks Rank #2 (Buy).

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