Usually when a med-tech company is looking for funding to develop its device, angel investors or venture capital firms are the first places where the company goes for support. But a developer of a clinical-stage medical device is taking a rather different and more public approach in raising money to get its technology to market.
After a rather convoluted trip along the regulatory pathway, Edap TMS SA (Lyon, France) received 510(k) clearance from the FDA to market the Ablatherm integrated imaging high-intensity focused ultrasound (HIFU) in the U.S. for the ablation of prostate tissue. The company said the treatment is shown to be a minimally invasive and effective option for prostatic tissue ablation with a low occurrence of side effects.
Boston Scientific (Marlborough, Mass.) will acquire the interventional radiology portfolio of Celonova Biosciences (San Antonio), a private company that also makes endovascular and interventional cardiology technologies, for an upfront payment of $70 million.
Edwards Lifesciences Corp. (Irvine, Calif.) is once again involved in a lawsuit concerning its transcatheter aortic replacement (TAVR) technology. However, the company is the defendant this time around, facing patient infringement claims made by Boston Scientific (Marlborough, Mass.).
Sunshine Heart Inc. (Eden Prairie, Minn.) hopes to have a bigger impact on class III heart failure patients by making its C-Pulse heart assist system wireless. The technology is currently being tested in animals and the company is in discussion with the FDA to have the device go through the agency's expedited access pathway program (EAP).
A University of California Los Angeles/Cedars Sinai Medical Center nephrologist has invented a portable device that could provide dialysis for end-stage renal disease patients. The technology Victor Gura designed is called the wearable artificial kidney (WAK) and could offer new hope for hemodialysis patients. Gura founded Blood Purification Technologies Inc. (Beverly Hills, Calif.), a private company, to get the product to market.
Helius Medical Technologies Inc. (Newton, Pa.) reported it is making progress with its attempts to bring a neuromodulation device to market that can help treat symptoms in multiple sclerosis (MS) patients. On Monday, the company said a pilot study evaluating its investigational portable neuromodulation stimulator (Pons) used to help treat the symptoms of MS, met all of its study objectives. A total of 14 subjects (seven-active and seven-sham control) received treatment with the non-invasive brain stimulation technology and concomitant physiotherapy.
