BPH is an enlargement of the prostate that affects 110 million men worldwide and may cause symptoms that impact a patient's qualify of life, such as pain and a frequent need to urinate.1,2 The likelihood of having BPH increases with age and more than 12 million symptomatic men in the U.S. are currently being treated for the condition with medications or procedural approaches.3,4
Treatment with the Rezūm system is typically performed in a physician's office without general anesthesia and uses water vapor to remove excess prostate tissue thereby alleviating obstruction to flow, which helps reduce BPH-related symptoms. A study published in the March issue of the Journal of Urology demonstrated that over a three year period, patients treated with the Rezūm system had clinical progression rates that were five times lower than reported rates of patients treated with daily, long-term medications.5 Additional clinical data from a randomized controlled trial demonstrated that patients treated with the Rezūm system had a 51 percent reduction in their symptoms at 24 months post-treatment and maintained a 50 percent reduction in BPH symptoms at three years post-treatment.5,6,7
"The Rezūm system is an innovative therapy for men with symptomatic BPH that helps patients with a minimally invasive approach while reducing the cost and unwanted side effects that comes with taking maintenance medications," said Dave Pierce, senior vice president and president, Urology and Pelvic Health, Boston Scientific. "When compared with other minimally invasive BPH therapies, patients treated with the Rezūm system spend less time in the doctor's office and have longer lasting improvement in their symptoms."
Patients with symptomatic BPH are generally first treated with medications that can have side effects including nausea, dizziness and sexual dysfunction.8 As the prostate continues to enlarge, men may undergo surgery which can result in worsening stress urinary incontinence and erectile dysfunction. Clinical studies have demonstrated that treatment with the Rezūm system, in addition to reducing symptoms of BPH, preserves sexual function.9 The system was cleared by the U.S. Food and Drug Administration in 2015 and has CE mark. More than 20,000 patients have been treated with the Rezūm system.
"We are excited to announce this agreement with Boston Scientific," said Bob Paulson, president and chief executive officer, NxThera. "Their strong leadership in the field of urology will help drive the Rezūm system forward and ensure that more men have access to this treatment option."
The Boston Scientific Urology and Pelvic Health portfolio includes a range of treatment options for men's and women's urological and gynecological conditions. Upon completion of the transaction, this system will complement the Boston Scientific portfolio of laser therapy systems for the treatment of symptomatic BPH, which includes the Greenlight XPSTM Laser Therapy system and holmium platforms.
The acquisition of NxThera is expected to be immaterial to Boston Scientific adjusted earnings per share (EPS) through 2020 and accretive thereafter. The transaction is expected to be dilutive (or less accretive, as the case may be) on a GAAP basis, due to amortization and transaction and integration costs. The company expects to complete the transaction in the second quarter of 2018, subject to customary closing conditions.
4Dymdex Consulting, BPH Market Report, 2013