Positive Clinical and Technical Outcomes of Asleep DBS With the ClearPoint System Recently Presented
MRI Interventions, Inc. (OTCQB:MRIC) today announced that outcomes data from the use of its ClearPoint® Neuro Intervention System in "asleep" deep brain stimulation (DBS) surgery were presented during the 2013 Annual Meeting of the Congress of Neurological Surgeons (CNS) in San Francisco.
In an Original Science Program talk entitled "Application Accuracy of a Second Generation Interventional MRI Stereotactic Platform: Initial Experience in 101 DBS Electrode Implantations," Dr. Paul Larson, neurosurgeon at the University of California, San Francisco (UCSF), presented accuracy results from a prospective study of 60 patients who underwent asleep DBS with the ClearPoint System at UCSF between August 2010 and March 2013. Highlights of the study included:
98% of electrodes were placed with a single pass into the brain;
No electrodes have required repositioning;
The average accuracy of the electrode placement was 0.6 millimeter;
Average surgical times were 3 hours 4 minutes for bilateral cases and 2 hours 23 minutes for unilateral cases.
"Almost every electrode was placed with a single pass to the brain," Dr. Larson stated after his presentation, "meaning we hit the target the first time in each of those cases. More importantly, we hit the correct target based on the fact that no patients have returned for repositioning. We were able to do this through real-time image guidance enabled by ClearPoint."
During a reception sponsored by MRI Interventions on Monday, October 21, Dr. Fiona Gupta, neurologist at Hackensack University Medical Center (HUMC), presented clinical outcomes of asleep DBS with the ClearPoint System at HUMC. Dr. Gupta collected data regarding 11 patients, with an average post-operative follow-up of 15 months. Highlights from Dr. Gupta's presentation included:
Patients' motor symptom scores improved an average of 72% on the Unified Parkinson's Disease Rating Scale (UPDRS), when comparing their pre-operative "off medication" UPDRS scores to their post-operative "on medication" UPDRS scores;
Patients' post-operative Levodopa dosages decreased by an average of 71% from their pre-operative dosages.
"We've been very impressed with the outcomes we have seen so far," said Dr. Gupta. "My patients have had dramatic improvement in their movement scores. Many of these patients would not have had the awake surgery, so these results were made possible by iMRI asleep DBS."
Dr. Jill Ostrem, neurologist at UCSF, also presented preliminary data at the reception regarding outcomes with asleep DBS from a UCSF clinical study.
"While our data is preliminary at this point, I can say that the patients we've assessed so far are doing very well," Dr. Ostrem stated. "Initial clinical outcomes are in line with outcomes in conventional awake procedures, which is exactly what we want to see at this point."
About the ClearPoint System
The ClearPoint System is a navigation platform designed to allow real-time, direct visualization during minimally-invasive neurosurgical procedures. ClearPoint software works with MRI to assist surgeons in planning a target and trajectory, and the SmartFrame® targeting device enables the MRI-guided alignment and insertion of surgical instruments. The ClearPoint System has been used to enable asleep deep brain stimulation procedures, laser ablation therapy and brain biopsy, and is currently involved in five clinical trials investigating direct drug delivery in the brain.
The ClearPoint SmartFlow® cannula is presently FDA-cleared for injection of cytarabine, a chemotherapy drug, to the ventricles or removal of CSF from the ventricles during intracranial procedures. Delivery of other therapeutic agents using the SmartFlow cannula is investigational.
About MRI Interventions, Inc.
Founded in 1998, MRI Interventions is creating innovative platforms for performing the next generation of minimally invasive surgical procedures in the brain and heart. Utilizing a hospital's existing MRI suite, the company's FDA-cleared and CE-marked ClearPoint® System is designed to enable a range of minimally invasive procedures in the brain. MRI Interventions has a co-development and co-distribution agreement with Brainlab, a leader in software-driven medical technology, relating to the ClearPoint System. In partnership with Siemens Healthcare, MRI Interventions is developing the ClearTrace® System to enable MRI-guided catheter ablations to treat cardiac arrhythmias, including atrial fibrillation. Building on the imaging power of MRI, the company's interventional platforms strive to improve patient care while reducing procedure costs and times. MRI Interventions is also working with Boston Scientific Corporation to incorporate its MRI-safety technologies into Boston Scientific's implantable leads for cardiac and neurological applications. For more information, please visit www.mriinterventions.com.
Forward-Looking Statements
Certain matters in this press release may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements by their nature address matters that, to different degrees, are uncertain and involve risk. Uncertainties and risks may cause MRI Interventions' actual results and the timing of events to differ materially from those expressed in or implied by MRI Interventions' forward-looking statements. Particular uncertainties and risks include, among others: demand and market acceptance of our products; our ability to successfully expand our sales and clinical support capabilities; availability of third party reimbursement; the sufficiency of our cash resources to maintain planned commercialization efforts and research and development programs; future actions of the FDA or any other regulatory body that could impact product development, manufacturing or sale; our ability to protect and enforce our intellectual property rights; our dependence on collaboration partners; the impact of competitive products and pricing; and the impact of the commercial and credit environment on us and our customers and suppliers. More detailed information on these and additional factors that could affect MRI Interventions' actual results are described in MRI Interventions' filings with the Securities and Exchange Commission, including, without limitation, MRI Interventions' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 13, 2013. Except as required by law, MRI Interventions undertakes no obligation to publicly update or revise any forward-looking statements contained in this press release to reflect any change in MRI Interventions' expectations or any change in events, conditions or circumstances on which any such statements are based.
CONTACT: MRI Interventions, Inc.
David Carlson, CFO, 901-522-9300
MRI Interventions, Inc. (OTCQB:MRIC) today announced that outcomes data from the use of its ClearPoint® Neuro Intervention System in "asleep" deep brain stimulation (DBS) surgery were presented during the 2013 Annual Meeting of the Congress of Neurological Surgeons (CNS) in San Francisco.
In an Original Science Program talk entitled "Application Accuracy of a Second Generation Interventional MRI Stereotactic Platform: Initial Experience in 101 DBS Electrode Implantations," Dr. Paul Larson, neurosurgeon at the University of California, San Francisco (UCSF), presented accuracy results from a prospective study of 60 patients who underwent asleep DBS with the ClearPoint System at UCSF between August 2010 and March 2013. Highlights of the study included:
98% of electrodes were placed with a single pass into the brain;
No electrodes have required repositioning;
The average accuracy of the electrode placement was 0.6 millimeter;
Average surgical times were 3 hours 4 minutes for bilateral cases and 2 hours 23 minutes for unilateral cases.
"Almost every electrode was placed with a single pass to the brain," Dr. Larson stated after his presentation, "meaning we hit the target the first time in each of those cases. More importantly, we hit the correct target based on the fact that no patients have returned for repositioning. We were able to do this through real-time image guidance enabled by ClearPoint."
During a reception sponsored by MRI Interventions on Monday, October 21, Dr. Fiona Gupta, neurologist at Hackensack University Medical Center (HUMC), presented clinical outcomes of asleep DBS with the ClearPoint System at HUMC. Dr. Gupta collected data regarding 11 patients, with an average post-operative follow-up of 15 months. Highlights from Dr. Gupta's presentation included:
Patients' motor symptom scores improved an average of 72% on the Unified Parkinson's Disease Rating Scale (UPDRS), when comparing their pre-operative "off medication" UPDRS scores to their post-operative "on medication" UPDRS scores;
Patients' post-operative Levodopa dosages decreased by an average of 71% from their pre-operative dosages.
"We've been very impressed with the outcomes we have seen so far," said Dr. Gupta. "My patients have had dramatic improvement in their movement scores. Many of these patients would not have had the awake surgery, so these results were made possible by iMRI asleep DBS."
Dr. Jill Ostrem, neurologist at UCSF, also presented preliminary data at the reception regarding outcomes with asleep DBS from a UCSF clinical study.
"While our data is preliminary at this point, I can say that the patients we've assessed so far are doing very well," Dr. Ostrem stated. "Initial clinical outcomes are in line with outcomes in conventional awake procedures, which is exactly what we want to see at this point."
About the ClearPoint System
The ClearPoint System is a navigation platform designed to allow real-time, direct visualization during minimally-invasive neurosurgical procedures. ClearPoint software works with MRI to assist surgeons in planning a target and trajectory, and the SmartFrame® targeting device enables the MRI-guided alignment and insertion of surgical instruments. The ClearPoint System has been used to enable asleep deep brain stimulation procedures, laser ablation therapy and brain biopsy, and is currently involved in five clinical trials investigating direct drug delivery in the brain.
The ClearPoint SmartFlow® cannula is presently FDA-cleared for injection of cytarabine, a chemotherapy drug, to the ventricles or removal of CSF from the ventricles during intracranial procedures. Delivery of other therapeutic agents using the SmartFlow cannula is investigational.
About MRI Interventions, Inc.
Founded in 1998, MRI Interventions is creating innovative platforms for performing the next generation of minimally invasive surgical procedures in the brain and heart. Utilizing a hospital's existing MRI suite, the company's FDA-cleared and CE-marked ClearPoint® System is designed to enable a range of minimally invasive procedures in the brain. MRI Interventions has a co-development and co-distribution agreement with Brainlab, a leader in software-driven medical technology, relating to the ClearPoint System. In partnership with Siemens Healthcare, MRI Interventions is developing the ClearTrace® System to enable MRI-guided catheter ablations to treat cardiac arrhythmias, including atrial fibrillation. Building on the imaging power of MRI, the company's interventional platforms strive to improve patient care while reducing procedure costs and times. MRI Interventions is also working with Boston Scientific Corporation to incorporate its MRI-safety technologies into Boston Scientific's implantable leads for cardiac and neurological applications. For more information, please visit www.mriinterventions.com.
Forward-Looking Statements
Certain matters in this press release may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements by their nature address matters that, to different degrees, are uncertain and involve risk. Uncertainties and risks may cause MRI Interventions' actual results and the timing of events to differ materially from those expressed in or implied by MRI Interventions' forward-looking statements. Particular uncertainties and risks include, among others: demand and market acceptance of our products; our ability to successfully expand our sales and clinical support capabilities; availability of third party reimbursement; the sufficiency of our cash resources to maintain planned commercialization efforts and research and development programs; future actions of the FDA or any other regulatory body that could impact product development, manufacturing or sale; our ability to protect and enforce our intellectual property rights; our dependence on collaboration partners; the impact of competitive products and pricing; and the impact of the commercial and credit environment on us and our customers and suppliers. More detailed information on these and additional factors that could affect MRI Interventions' actual results are described in MRI Interventions' filings with the Securities and Exchange Commission, including, without limitation, MRI Interventions' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 13, 2013. Except as required by law, MRI Interventions undertakes no obligation to publicly update or revise any forward-looking statements contained in this press release to reflect any change in MRI Interventions' expectations or any change in events, conditions or circumstances on which any such statements are based.
CONTACT: MRI Interventions, Inc.
David Carlson, CFO, 901-522-9300
