Orthofix International NV won FDA 510(k) clearance for its internal fixation system G-beam Fusion for patients with Charcot foot. The beaming system can align, fixate and stabilize the foot by implanting beams in the lateral and medial foot columns. Charcot foot often is associated with unmanaged diabetes and can lead to nerve damage, deteriorated foot bones and eventual breakdown of the foot.
Boston Scientific Corp. has agreed to acquire private firm Nxthera Inc., a specialist in minimally invasive treatment of benign prostatic hyperplasia (BPH), for an upfront cash payment of $306 million, followed by as much as $100 million in possible milestone payments across the next four years. Boston Scientific is currently a minority investor in Nxthera and will make a $240 million net payment at closing, with milestones of as much as $85 million. The deal is expected to close in the second quarter of 2018.
Mardil Medical Inc. has completed a pair of first-in-human implants of its combination therapy Ventouch Triad device at Sanitorio Italiano in Asunción, Paraguay, among patients with type IIIb functional mitral valve regurgitation (FMR). The Ventouch Triad is designed to treat both the dilated ventricle and affected valve in FMR patients who often experience exacerbated heart failure without treatment.
Private company Colibri Heart Valve LLC reported the first two enrollees in the clinical early feasibility study of its second-generation expandable 24 mm and 27 mm transcatheter aortic valve (TAVI) system. The "package-to-patient" device has built on the earlier system that included a premounted, replacement aortic heart valve already precrimped to the balloon catheter, sheathed and sterilized so that it can be used directly from packaging. The newest device allows for adoption by additional patients, such as those with bicuspid aortic valves.
Johnson & Johnson Corp.'s (J&J) Medical Devices group has received a binding offer of $2.1 billion for its Lifescan Inc. business, signaling further moves away from the diabetes sector after its 2017 closure of Animas. Blood glucose monitoring (BGM) company and maker of Onetouch devices, Lifescan, reported $1.5 billion in 2017 net revenue. Platinum Equity investment firm made the offer; the deal's acceptance period closes June 15. Should Johnson & Johnson accept, the transaction is anticipated to close by the end of the year. Lifescan offers BGM and insulin delivery devices.
Cancer genomics firm Inivata Ltd. has launched a collaboration with Medstar and Medstar Georgetown Cancer Institute, bringing them into its Inivata Knowledge Accumulation Network (IKAN). IKAN has gathered together cancer centers around the world in an effort to evaluate circulating tumor DNA (ctDNA) and liquid biopsy capability using its Invision liquid biopsy platform. Medstar, Atrium Health's Levine Cancer Institute and the West Cancer Center are early joiners to IKAN.
Tae Life Sciences, a majority-owned subsidiary of Tae Technologies Inc., launched this week, forging ahead in development of its investigational accelerator-based platform hoped to treat head, neck and glioblastoma multiforme (GBM) cancer. Tae Life Sciences has licensed IP from Tae Technologies for the accelerator-based neutron beam technology for Boron Neutron Capture Therapy (BNCT), and aims to expand treatment capabilities for these difficult-to-address malignancies. In conjunction with its launch, Tae Life Sciences also inked a partnership deal with Neuboron Medtech Ltd. and closed a $40 million venture round.
Bariatric and gastrointestinal medical device firm Apollo Endosurgery Inc. has won FDA authorization to terminate its Lap-band lower BMI (LBMI) post-approval study due to long-term data on safety and effectiveness in already published evidence. LBMI's early termination will amount to about $5.1 million in savings for the company, expected over the length of the research. The study was anticipated to enroll as many as 325 patients at 20 sites; 181 patients had since the end of 2017 been enrolled at 13 clinical sites.
Diagnostics, gastrointestinal and pelvic device company, Laborie Medical Technologies, has executed a definitive agreement to acquire Cogentix Medical Inc., developer of neurostimulation, endoscopy, and urology technology and devices. The deal was set at a cash purchase price of $3.85 per Cogentix share and enterprise value of $214 million. The share price is a 28 percent premium above the average closing price of Cogentix's common stock across the last 30 days. Under the deal, Laborie will acquire all outstanding shares of Cogentix for a total consideration of about $239 million.
Integrated Diagnostics Inc. (Indidx) has raised the bar on lung cancer detection with publication of study results regarding its Xpresys Lung 2 (XL2) liquid biopsy test for early stage disease. The differential diagnostic test has been confirmed to provide accurate distinction between benign and malignant nodules, possibly avoiding unnecessary biopsy or surgery in early suspect nodules. The study was published online Feb. 26, 2018, in CHEST, the journal of the American College of Chest Physicians.
