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1. Exogen Bone Stimulator 5th Metatarsal
2. Exogen 4000 Recall
3. Exogen Bone Stimulator For Arthritis

The Durham, NC-based company was founded in 2012, when a group of investors led by Essex Woodlands Health Ventures picked up a majority stake in Smith & Nephew’s ($SNN) biologics unit. Other investors, in addition to Smith & Nephew, include Spindletop Healthcare Capital, Pantheon Global, Ampersand Capital and Alta Partners.Bioventus’ offerings include Exogen, a noninvasive device that stimulates bone healing by using ultrasound waves to activate cells near the site of the break. Clinical data show that the treatment accelerated the healing of a broken tibia or radius by 38%. It also markets the joint injection therapies for osteoarthritis, Supartz inside the U.S.

And Durolane outside the U.S. In 2014, the company created its Surgical unit via its acquisition of Advanced Biologics’ OsteoAMP product line in 2014. OsteoAMP is a tissue-based bone biologic used by spinal surgeons to promote bone growth and healing. In 2015, Bioventus purchased bioresorbable bone graft maker BioStructures.Bioventus has shown upward momentum since 2013, growing its total net sales from $232.4 million to $242.9 million in 2014 and $253.7 million in 2015. Sales were driven by Exogen and Supartz, which together comprised 89% of sales in 2013, 87% in 2014 and 83% in 2015. The company is nearing profitability, having booked $65.4 million in net sales and a net loss of only $6 million in the quarter ended April 2.According to an SEC filing, the company expects its Active Healing products, Exogen and Supartz, will continue to dominate its sales, but that it will expand its Surgical offerings.

In the second half of this year, it plans to launch its GelSyn-3, a three-injection hyaluronic acid treatment to relieve pain from osteoarthritis of the knee.- here's theRelated Articles.

MANY FRACTURES ARE SLOW TO HEAL ON THEIR OWN. ONE IN 20 DON’T HEAL AT ALL.,Fractures are often frustratingly slow to heal. Between 5-10% of fractures fail to heal on their own, leaving patients to choose between either continual pain and immobility or surgery and lengthy rehabilitation.,The location, pattern or severity of some fractures can impede bone healing and increase your risk of healing failure. Common health and lifestyle factors such as obesity, diabetes and tobacco use may also interfere with healing. EXOGEN Turns Your Downtime Into Healing TimeEveryone needs a little downtime. But a bone fracture may give you a lot more downtime than you want—especially when fractures take far longer to heal than usual, or don’t heal at all.With the EXOGEN Ultrasound Bone Healing System, just 20 minutes each day of safe, painless treatment can amplify your natural bone-healing power for faster healing, and restore healing to a fracture that has failed to heal (called a nonunion).At Home, At Your ConvenienceProper daily use is essential for EXOGEN to work. We make that easy, too.The EXOGEN device is small, lightweight and simple to operate, with an internal usage monitor that automatically records the date, time and duration of each treatment so you can track your daily progress.EXOGEN has been proven to work—but only if you use it each day as prescribed.

Exogen Bone Stimulator 5th Metatarsal

That’s why the smartphone app is highly recommended to ensure your consistent daily use of EXOGEN. Easy-to-follow instructions, how-to-use videos and other also help ensure a hassle-free treatment experience. How It WorksBEFORE YOU START TREATMENT: If EXOGEN is prescribed for you, ask the prescribing HCP to provide your Bioventus sales representative with X-rays and a written evaluation of your diagnosed nonunion fracture before beginning EXOGEN treatment, documenting the lack of healing progression to union of your broken bone.DURING TREATMENT: As you use the EXOGEN device daily, the internal patient usage monitor will automatically record the date, time and duration of each treatment. This makes it easy to ensure you meet the 90% treatment compliance threshold. Compliance is confirmed by examining the returned device after you’ve completed your course of treatment.AFTER TREATMENT: Once you’ve used EXOGEN for 120 days or more as prescribed, your physician will take new X-rays to evaluate the progress in healing your broken bone.

Exogen 4000 Recall

The assessment of your results must be provided by your prescribing HCP, and submitted with a completed EXOGEN Performance Program assessment form. Claiming Your RefundIf the prescribing HCP has compared the two X-rays and determines that, after using EXOGEN as prescribed, you’ve not had evidence of bone healing, you can claim a refund of the amount you have paid to Bioventus by contacting the at 1-800-836-4080. Claims are accepted up to one year after you’ve obtained the EXOGEN device.Remember that all claims must be accompanied by:. the prescribing HCP’s written assessment.

a return of the prescribed EXOGEN devicePlease note that no refund can be given if an examination of the returned EXOGEN device shows that the device has been rendered inoperative or altered in any way.Summary of Indications for UseThe EXOGEN Ultrasound Bone Healing System is indicated for the non-invasive treatment of established nonunions † excluding skull and vertebra. In addition, EXOGEN is indicated for accelerating the time to a healed fracture for fresh, closed, posteriorly displaced distal radius fractures and fresh, closed or Grade I open tibial diaphysis fractures in skeletally mature individuals when these fractures are orthopedically managed by closed reduction and cast immobilization.There are no known contraindications for the EXOGEN device.

Exogen Bone Stimulator For Arthritis

Safety and effectiveness have not been established for individuals lacking skeletal maturity, pregnant or nursing women, patients with cardiac pacemakers, on fractures due to bone cancer, or on patients with poor blood circulation or clotting problems. Some patients may be sensitive to the ultrasound gel. Full prescribing information can be found in product labelling, at, or by calling customer service at 1-800-836-4080.†A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.©2019 Bioventus LLC. EXOGEN, Bioventus and the Bioventus logo are registered trademarks of Bioventus LLC.