Innovative Technology Designed to Treat Intrauterine Fibroids and Polyps
Boston Scientific Corporation has signed a definitive agreement to acquire IoGyn, Inc., a pre-commercial stage company. The transaction is expected to close within days. IoGyn has developed and received U.S. Food and Drug Administration (FDA) clearance for the Symphion System, a next generation system for hysteroscopic intrauterine tissue removal including fibroids (myomas) and polyps. This acquisition enables the pairing of the Symphion System with the Boston Scientific Genesys HTA System for abnormal uterine bleeding, to create a compelling set of gynecologic surgery products.
The Symphion System broadens the Boston Scientific portfolio of minimally-invasive approaches for surgeons to treat debilitating gynecologic conditions that affect millions of women worldwide. The Symphion System's hysteroscopic approach resects the growth within the uterus and removes the tissue through its recirculating and filtering fluid management system. An alternative approach that uses "power morcellation" during laparoscopic procedures was noted in a recent FDA safety communication to worsen the spread of a rare cancer, sarcoma, within the abdominal cavity. In contrast, the Symphion System treats fibroids and polyps within the uterus and evacuates the tissue under suction. Boston Scientific is not aware of any reported cases of sarcoma spreading by the surgical removal of tissue within the uterus.
Hysteroscopic removal of symptomatic fibroids and polyps is less invasive and typically safer than common surgical approaches like hysterectomy, and is also designed to preserve a woman's ability to have children.
Fibroids and polyps, which affect an estimated two million women in the U.S. per year, are benign uterine growths that are symptomatic about a quarter of the time, and can cause pain and cramping, incontinence, constipation, excessive bleeding and infertility. Hysteroscopic removal involves the trans-cervical insertion of specialized tools into the uterus under direct visualization to remove targeted tissue. Boston Scientific estimates the current worldwide hysteroscopic market segment at $80 million, with projections that it will grow to more than $200 million by 2020.
"IoGyn offers minimally-invasive approaches that we believe are more cost-effective for patients, surgeons and the health care system," said Karen Prange, senior vice president and president, Urology and Women's Health, Boston Scientific. "This new technology platform is designed to address unmet patient and physician needs, and we believe it represents a truly differentiated improvement compared to existing technologies in the fast-growing hysteroscopic fibroid removal market segment. Among its features, the Symphion System includes a closed-loop fluid management system designed to prevent potentially dangerous fluid overload in the patient, and a radio frequency approach that facilitates rapid tissue removal."
"The Symphion bipolar hysteroscopy system enables the gynecologic surgeon to provide an efficient, reliable and accurate hysteroscopic surgery," said Dr. Andrew Brill, director, Minimally Invasive Gynecology at California Pacific Medical Center in San Francisco.
Prior to the acquisition, Boston Scientific held approximately 28 percent equity ownership, in addition to notes receivable of approximately $8 million. Total consideration included a net cash payment of approximately $65 million at closing to acquire the remaining 72 percent of IoGyn and repay outstanding debt. Boston Scientific expects the transaction to have an immaterial impact on its adjusted earnings per share in 2014 and 2015, and to be accretive starting in 2016. On a GAAP earnings per share basis, Boston Scientific expects the transaction to be slightly accretive in 2014 as a result of a non-cash acquisition-related gain on its previously held equity investment, immaterial in 2015 and 2016, and to be less accretive than adjusted earnings per share thereafter as a result of acquisition-related net charges and amortization, which will be determined following the closing.