Brief summaries of recent medtech market and industry developments. This month we cover China’s switch to a centralized billing system, St. Jude Medical’s RESPECT PFO closure trial, FDA’s approval of HeartWare’s LVAD, and end-of-the-year medtech M&A.
Solace Therapeutics Inc.’s Solace Bladder Control System is a small, lightweight, polyurethane balloon device that fills with air once it is placed within the bladder, where it floats unobtrusively at the top of the organ, not blocking the urethra. The device is designed to eliminate or reduce involuntary urinary leakage by acting as a “shock absorber” to reduce the temporary peak pressure changes in the bladder that cause urinary leakage.
Baxter’s offer of $4 billion for Swedish hemodialysis manufacturer Gambro may be one of the largest medtech acquisitions of the year, but Baxter CEO Bob Parkinson describes the deal as a bolt-on for Baxter’s existing market in renal therapy. Of course the magnitude of the deal makes it “an adjacency with a capital A”, Parkinson quipped.
Yale had teamed up with Medtronic in one new FDA-funded project to improve post-market surveillance and use of registries. Duke University and the University of Washington have also received grants.
In less than a month, the US Food and Drug Administration (FDA) recently approved three spine PMAs, two for cervical disc replacement devices, and there are two more cervical discs in the queue for near-term PMA approval. All of this activity suggests the $122 million US cervical disc market is about to gear up.
Transcutaneous electrical nerve stimulation technology has been used for decades to noninvasively treat acute and chronic pain in the muscles, joints, back, and neck. Now, InControl Medical LLC is employing it in the form of an intravaginal probe combined with patient biofeedback and quantitative physician feedback to treat one of the largest and fastest growing female health care problems, stress and mixed urinary incontinence.
In the latest of a series of deals in what many industry executives and analysts consider to be the next blockbuster device product market, Boston Scientific became the third major vascular player to buy its way into the renal denervation space with its recent acquisition of Vessix Vascular for a sum that could amount to $425 million. With this deal, Boston Scientific joins Medtronic, which led the way in 2010 with its stunning potentially billion dollar acquisition of Ardian, followed earlier this year by Covidien’s acquisition of Maya Medical.
Competition breeds innovation, and the ear, nose, and throat (ENT) market, once a fairly quiet arena, is now positioned to host some spirited activity that should lead to new technologies. Several large device manufacturers have recently moved into the ENT space, and the sinus treatment segment of the market has become one of the focal points for emerging competitors, as companies work toward less-invasive treatment options.
Angel- and venture-backed medtech start-ups are working to fill the tremendous unmet need for alternative device options for treating (not just managing) female urinary incontinence a condition that has a significant impact on quality of life for millions of women. In this issue we profile Floelle, InControl Medical, NexHand, and Solace Therapeutics.
