Boston Scientific Announces Acquisition of Cosman Medical

Boston Scientific Corporation announced that it has acquired Cosman Medical, Inc., a privately held Burlington, Mass. manufacturer of radiofrequency ablation (RFA) systems. The Cosman Medical team and products will become part of the Boston Scientific Neuromodulation business, which offers a range of Spinal Cord Stimulator (SCS) systems to treat patients with chronic pain, and Deep Brain Stimulation systems* for the treatment of Parkinson's disease, dystonia and essential tremor.

"This acquisition is a natural extension of our current product portfolio and will help us provide physicians and patients more options to address chronic pain with non-opioid therapeutic treatments," said Maulik Nanavaty, senior vice president and president, Neuromodulation, Boston Scientific. "The addition of the Cosman Medical product line, which is built on industry-leading technology and known for its high-quality, expands our capability to provide innovative solutions for the treatment of chronic pain."

One in three Americans suffer from chronic pain and more than 100 million people are partially or totally disabled by pain. In the United States, it is the number one cause of disability in adults.1,2 RFA is a versatile outpatient procedure with a more than 50-year track record of providing relief for patients with chronic pain. It works by applying heat to small areas of nerve tissue to interrupt pain signals. SCS works by sending electrical signals to the spinal cord, masking pain signals from reaching the brain. In the continuum of care for pain, RFA is typically used prior to SCS. While many patients with chronic pain find effective relief from RFA, others progress to SCS to manage pain.

"We are pleased to join the Boston Scientific team and help expand access to leading treatments for chronic pain," said Eric Cosman, Jr, PhD, scientific director, Cosman Medical. "This acquisition comes at a time when our society is recognizing the impact of relying extensively on opioids to treat pain and is looking for additional approaches. Our mutual commitment to innovation and quality will help us deliver solutions."

The expansion into RFA follows the recent Boston Scientific launch of the Precision Montage™ MRI Spinal Cord Stimulator (SCS) System which offers customized relief to patients with chronic pain while also enabling safe access to full body magnetic resonance imaging (MRI) in a 1.5 Tesla environment when conditions of use are met. MultiWave™ Technology enables delivery of multiple waveforms, including burst and higher rates, intended to help respond to changes in pain over time. The launch expanded the suite of Boston Scientific products that leverage the Illumina 3D™ algorithm, a three-dimensional, anatomy-driven computer model designed for simple point-and-click pain targeting to support physicians in treating chronic pain. In addition to the new Precision Montage MRI SCS System, the portfolio includes the Precision Spectra™ System, which is designed to provide broad coverage for pain with 32 contacts, and the Precision Novi™ System, the smallest high-capacity non-rechargeable device.

Boston Scientific currently expects the net impact of this transaction on adjusted earnings per share to be break-even in 2016 and accretive thereafter and more dilutive on a GAAP basis as a result of acquisition-related net charges and amortization. Specific terms of the transaction were not disclosed.

A press release can be found from Boston Scientific website.

FDA approves exablate neuro system for essential tremor treatment

Insightec announced that the FDA has approved its Exablate Neuro system for the non-invasive treatment of essential tremor (ET) in patients who have not responded to medication.

Exablate Neuro uses focused ultrasound waves to precisely target and ablate tissue deep within the brain with no incisions or implants. The treatment is done under Magnetic Resonance Imaging (MRI) guidance for real time treatment monitoring. The patient experiences immediate tremor improvement following the outpatient procedure. The treatment carries minimal risk of infection, bleeding or other surgical complications. The treatment requires a single session with no anesthesia, allowing patients to quickly return to normal activity.



Essential tremor is the most common movement disorder, affecting more than 5 million people in the United States, and millions more worldwide. Hand tremor is the most common symptom, but tremors can also affect the head, arms, voice, legs, and torso. For these patients, performing everyday tasks presents a challenge and impacts their quality of life.

This approval by the FDA was based on clinical data from a randomized, double-blind, multi-center clinical study designed to evaluate the safety and efficacy of non-invasive thalamotomy with MRgFUS. A total of 76 patients were enrolled in the study and randomly assigned to receive the Exablate treatment (56 patients) or the sham procedure (20 patients), the exact same procedure but without any ultrasound energy. Patients in the placebo treatment arm were later allowed to undergo an Exablate Neuro treatment. Patients treated with the Exablate Neuro showed nearly a 50% improvement in their tremors and motor function three months after treatment compared to their baseline score. Patients in the control group had no improvement, and some experienced a slight worsening after the sham procedure before they crossed over into the treatment group. A year following the procedure, the patients who underwent the Exablate Neuro procedure retained a 40% improvement in these scores compared to baseline.

“Results of this study show that Exablate Neuro is safe and effective for treating essential tremor. Finding the most effective way to manage tremor symptoms is crucial for patients. The patients we have treated show immediate tremor control, allowing them to regain ability to perform daily tasks such as eating and writing,” commented Dr. W. Jeffrey Elias, Director of Stereotactic and Functional Neurosurgery at the University of Virginia and Principal Investigator in the study.

Earlier this year, Exablate was also approved by Health Canada for essential tremor.

“This newly FDA approved device provides a new treatment option without some of the complications associated with surgery to offer patients with essential tremor. Furthermore, it holds promise for a range of neurosurgical procedures,” noted Andres Lozano, MD, Dan Family Professor and Chairman of Neurosurgery at Toronto Western Hospital, University of Toronto and Investigator in the study.

“I am confident that we have arrived at a tipping point for non-invasive medical treatment. Focused ultrasound has the unique ability to precisely ablate target tissue deep within the body. With Exablate Neuro, INSIGHTEC expands its Exablate product line with a system that signifies a new era for functional neurosurgery,” stated Maurice R. Ferré MD, INSIGHTEC Chief Executive Officer and Chairman of the Board.

Exablate Neuro also has CE mark for essential tremor, tremor dominant Parkinson’s disease and neuropathic pain.

A press release can be found from Insightec website.

FDA approves scalpel-free brain surgery for tremor pioneered

The Food and Drug Administration has approved the first focused ultrasound device to treat essential tremor, the most common movement disorder, in patients who do not respond to medication. The scalpel-free approach has been pioneered by Jeff Elias, MD, at the University of Virginia School of Medicine, who led an international clinical trial that demonstrated the safety and effectiveness of the device.

“This is a monumental day for people with essential tremor,” Elias said. “All patients want more options that are less invasive when they are faced with a surgical procedure. Also, this decision represents a great advance for focused ultrasound technology, which is now capable and available to treat disorders of the brain. Soon we are likely to see this incredible technology applied to other conditions and diseases of the brain.”

The technology focuses sound waves inside the brain to create heat, much like a magnifying glass focuses light. That heat can then be used to carefully interrupt circuits of the brain that are responsible for the tremor. With magnetic resonance imaging, Elias can monitor the location and intensity of the procedure in real-time – an important safety feature when making a precise lesion deep inside the brain. He can actually watch as the tremor reduces.

Elias oversaw an international clinical trial of the device tested in 76 patients with severe tremor who had not responded to medication. Fifty-six participants in the double-blind study received the procedure, while 20 others were in a control group that received a sham procedure. The results were dramatic: Overall, those treated saw their tremor reduced by half after three months and by 40 percent after a year.

That’s comparable to the results of deep-brain stimulation, an invasive surgery that involves placing electrodes inside the brain. Unlike with deep-brain stimulation, patients who receive the focused-ultrasound procedure are treated without incisions or the implantation of neurostimulator devices.

The most common side effects of the procedures were sensory changes like numbness or tingling as well as balance disturbance that tended to be transient. Nineteen of the 20 patients who received the sham procedure during the trial went on to receive the focused-ultrasound procedure.

The FDA approval of the ExAblate focused ultrasound device, manufactured by InSightec Inc., means UVA can make the procedure available to eligible patients. It is important to note, however, that insurance plans will not yet cover the procedure. Once a new technology is deemed safe by the FDA, the next step for device approvals involves the determination of payment and reimbursement. The cost at UVA has not yet been determined.

People interested in the procedure can get more facts about focused ultrasound.

The procedure cannot be used in patients who cannot undergo magnetic-resonance imaging, including those with implanted metallic devices such as a pacemaker. It is also not available for pregnant women, people with heart conditions or very high blood pressure, patients with kidney disease or clotting disorders, patients on blood thinners, patients with a history of strokes or brain tumors and people with substance abuse issues. There are other exclusions as well. Doctors at UVA will evaluate potential patients to determine their eligibility and then recommend the best course of treatment.

UVA is a world-leader in focused ultrasound research. Elias and other scientists are testing the capability of focused ultrasound to treat Parkinson’s disease, epilepsy, brain tumors, and benign breast tumors. The research has been supported by the Focused Ultrasound Foundation and the BIRD (US-Israel Binational Industry R&D) Foundation.

“This milestone was accomplished as the result of the leadership of Dr. Elias in a collaborative effort between academic institutions, industry and philanthropic organizations,” said Neal F. Kassell, MD, chairman of the Focused Ultrasound Foundation, which helped fund the studies leading to the approval.

A press release is available from UVA website.