Neurotechnology startup Neuros Medical Inc. reported encouraging results from the first in-human study of its device that blocks pain for amputees.
The Willoughby, Ohio-based company said that four of five patients in the study reported that its device reduced their pain to “zero,” according to a statement from the company.
Neuros is developing a device that uses a pacemaker-sized generator and an electrode to stimulate nerves to block pain from amputations — sometimes called stump pain — without the use of drugs. Last year, Neuros received a $1.2 million grant from the U.S. Dept. of Defense to further develop the device.
CEO Jon Snyder heralded the study’s results as indicating “a very bright future for the technology as a potential treatment for chronic pain,” in a prepared statement.
The company is working on a next-generation product that it will submit to the long-term safety and efficacy studies necessary to obtain regulatory approval to sell the device. Neuros is likely three or four years away from applying for FDA approval to sell the device.
Snyder anticipates closing a $6 million to $7 million Series B round “in the coming months” that will be used to add clinical and engineering staff, he said.
Created in October 2008, Neuros Medical closed a $1.8 million funding round in October 2009.
Here’s a roundup of recent clinical trial and scientific study news:
- Progesterone gel reduces rate of early preterm birth
A National Institutes of Health study has found that progesterone, a naturally occurring hormone, reduced the rate of preterm birth before the 33rd week of pregnancy by 45 percent among a category of at risk women. The women in the study had a short cervix, which is known to increase the risk for preterm birth. The study, published online in Ultrasound in Obstetrics & Gynecology, also found that infants born to women who had received progesterone were less likely to develop respiratory distress syndrome, a breathing complication occurring in preterm infants. Columbia Laboratories Inc. (NSDQ:CBRX) and Watson Pharmaceuticals Inc. (NYSE:WPI) heralded the results of the study, which used their Prochieve progesterone gel.
- Aethlon to submit updated IDE for Hemopurifier to FDA
In a letter to shareholders, Aethlon Medical Inc. (OTC:AEMD) CEO James Joyce wrote that the company is "close to submitting our updated [Investigational Device Exemption] to the FDA. The goal of our submission is approval from the FDA to initiate Hemopurifier human studies in the United States. Details regarding our FDA communications and clinical site locations can be expected through forthcoming news disclosures."
- Study shows PEM easy to learn
The American Journal of Roentgenology published original research from two separate studies this month demonstrating continued clinical acceptance of the Naviscan Inc. high-resolution breast PET scanner, otherwise known as a positron emission mammography (PEM) scanner. The first study concluded that breast radiologists can achieve a high level of diagnostic performance in interpreting PEM images after a 2-hour tutorial which can take months to achieve with MRI. The second study established a standard lexicon for the evaluation of PEM images making it simple to share a diagnosis. The research codes has a quality tutorial on team treehouse and you can check out the review herecoderseye.com/team-treehouse-review.
- Neuralstem ALS trial included in multiple presentations at American Academy of Neurology Meeting
Neuralstem Inc. (NYSE Amex:CUR) announced that the Phase I safety trial of its human spinal cord stem cells (HSSCs) in amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease) is the subject of three presentations at the American Academy of Neurology (AAN) Annual Meeting.
- Stent maker ITGI begins brain research
Israel-based ITGI Medical Ltd. (TASE:ITGI) announced that following the success of its feasibility research trial, it is now beginning the next stage of research with the end goal of regulatory approval for its stents in brain markers. Research will involve closing aneurysms, treating fistula in the venous arteries, treating arterial walls, sleep arteries, and the vertebrae leading to the brain, according to Globes.
- DMC first in midwest to implant Protecta
The Detroit Medical Center (DMC) Cardiovascular Institute (CVI) announced that it has achieved a significant breakthrough in cardiac heart-care by implanting the newly available "Protecta" defibrillator in a heart-care patient.
- Henry Ford announces first-of-kind robotics procedure
Henry Ford Hospital was the first hospital world-wide to use a new, robotically controlled ultrasound probe to help remove a cancerous tumor from a kidney. Current laproscopic procedure requires a surgical assistant to hold an ultrasound probe in the incision, while the surgeon is at the robotic console, where other robotic tools are being controlled. However, the ultrasound probe has to be moved manually by the assistant, with the surgeon’s direction. The new probe is controlled robotically by the surgeon, bringing greater accuracy to the process.
- Neurotech touts vision loss treatment implant study
Neurotech Pharmaceuticals Inc. announced that it was reported in the Proceedings of the National Academy of Sciences (PNAS) that its product candidate NT-501 slowed progression of vision loss in patients with geographic atrophy (GA) associated with dry age-related macular degeneration (AMD) in a Phase 2 study. NT-501 is an intraocular implant that consists of human cells genetically modified to secrete ciliary neurotrophic factor (CNTF) – a nerve growth factor capable of rescuing and protecting dying photoreceptors.
- Boston Scientific begins trial enrollment for Innova self-expanding stent
Boston Scientific Corp. (NYSE:BSX) announced the start of patient enrollment in the SuperNOVA clinical trial, an international, prospective, single-arm, non-randomized trial evaluating the safety and effectiveness of the INNOVA Self-Expanding Bare-Metal Stent System in patients with stenosis of the superficial femoral artery (SFA) or proximal popliteal artery (PPA). Enrollment is planned for up to 300 patients at 50 sites.
- Covidien touts gall bladder laparoscopy data
Covidien (NYSE:COV), announced interim results of its multicenter, international, prospective SILS Port laparoscopic cholecystectomy (removal of the gall bladder) post-market clinical study. "The interim results of this study show that single-incision gall bladder surgery appears to be as safe and effective as standard multi-port cholecystectomy," said primary investigator Dr. Jeffrey Marks.
- ICU Medical touts blood infection reduction data
ICU Medical Inc. (NSDQ:ICUI) announced that three different clinical studies presented at the Annual Scientific Meeting of the Society for Healthcare Epidemiology of America (SHEA) April 1-4 in Dallas showed that the MicroCLAVE neutral displacement needleless connector helps significantly reduce the risk of bacterial contamination and limit the incidence of hospital-acquired bloodstream infection when used in connection with an IHI bundle.
- Ventus touts Provent sleep apnea therapy study results
Ventus Medical Inc. reported positive results from a 19 center clinical trial using its FDA-cleared Provent sleep apnea therapy device to treat obstructive sleep apnea. Provent therapy uses the patient’s own breathing to create expiratory positive airway pressure (EPAP) to keep the airway open during sleep. The full results of this three month study were published in the April 2011 issue of the journal SLEEP, the publication of the American Academy of Sleep Medicine.
The following studies were presented at the American College of Cardiology 60th Annual Scientific Session.
- TYRX touts pacemaker implantation study
Surgical infections associated with pacemakers and defibrillators led to 3-fold increases in hospital stay, 55-118 percent higher hospitalization costs, 8 to 11 fold increase in mortality rates, and double the mortality after 1 year compared to pacemaker and defibrillator implantations where no infection occurred. Surprisingly, more than one-third of the excess mortality occurred after hospital discharge. Researchers from the Mayo Clinic, Johns Hopkins School of Medicine and TYRX Inc. presented the findings from a new study in Medicare beneficiaries of more than 200,000 pacemaker and defibrillator implantations with and without infection.
- On-X touts preliminary data from Proact heart valve trial
On-X Life Technologies Inc. (On-X LTI) announced today that preliminary results from a FDA IDE study of the On-X Prosthetic Heart Valve continue to show promise for patients who want relief from taking life-long anticoagulants while minimizing the risk of bleeding. Preliminary results of the PROACT study show that the On-X valve continues to demonstrate tolerance of low International Normalized Ratios (INR) in high-risk aortic patients as seen previously in worldwide studies.
- CardioDx touts angiography trial results
CardioDx announced that data presented at the ACC meeting demonstrate the ability of Corus CAD, a blood-based gene expression test, to identify obstructive coronary stenosis while adding independent information to coronary calcium scoring in patients undergoing CT angiography. In this study, the negative predictive value of Corus CAD for identifying obstructive coronary artery disease as assessed by CT angiography exceeded 95 percent.
- Cardio3 touts C-Cure stem cell therapy trial
The Belgian biotechnology company, Cardio3 BioSciences, a developer of regenerative and protective therapy treatment for cardiovascular treatment, presented detailed data from the Phase II clinical trial of C3BS-CQR-1 (C-Cure(R)), its novel stem cell therapy for ischemic cardiomyopathy at the ACC conference.
- LipoScience LDL cholesterol study data presented at ACC
LipoScience Inc., which is developing blood tests that use nuclear magnetic resonance (NMR) technology, announced presentations of two clinical studies “from the podium” at the ACC conference. These two presentations discuss the value of LDL particle measurements, including one which suggests LDL particles may be a more accurate measure of subclinical atherosclerosis than LDL cholesterol.
Material from MedCity News was used in this report.