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MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Student athletes from the University of Wyoming (UW) are being asked to volunteer in a clinical study to further development of the BrainPulseTM device by Jan Medical. UW is a Division I athletics university with over 400 student athletes. The study began in early December 2016 and over 200 male and female student athletes have enrolled so far. The research team at Jan Medical is working with the school’s sports medicine and athletic departments to collect concussion data. Participation in this study is completely voluntary and is being conducted under a well-defined clinical protocol. “Concussion research has exploded nationally over the last few years. Although student athletes are not required to enroll in the study, the high rate of participation so far signifies the importance of concussion research among our athletes,” said Matthew Boyer, DO, Medical Director and Head Team Physician for Primary Care and Sports Medicine at University of Wyoming. “We appreciate all of our athletes whom have donated their time for this project.” The study device, BrainPulse by Jan Medical, utilizes a novel, non-invasive approach to obtain neurophysiological parameters that can provide clinically useful information for diagnosis of brain pathologies such as stroke and traumatic brain injuries. The BrainPulse system operates using a passive headset and small computer. The headset, similar to a bike helmet, sits on top of the head and uses highly responsive sensors to detect movement of the skull via vibrations on the surface of the skin. These vibrations, produced by heartbeat and blood flow into the brain, are naturally occurring in every person. Each sensor includes a small crystal that reacts to motion, which is then recorded by the computer. Since the headset is a monitoring device only, no energy such as electricity, radiation or heat, is being generated or transmitted to the participant’s head. The BrainPulse technology is the first of its kind and has received de novo clearance by the FDA as a cranial motion measurement device. Both concussed and non-concussed student athletes will participate in the recording phase of the clinical trial to produce an accurate side-by-side analysis. Participation will involve at least one recording with the BrainPulse device, and some athletes will complete multiple recording sessions depending on their exposure to injury. Each recording session lasts approximately three minutes and requires the participant to sit still during that time period. All information collected in the voluntary study will be considered confidential. The evaluation of symptoms, physical examination, neurological baseline testing and device recordings will be entered in a database to determine clinical outcomes and assess the BrainPulse device efficacy. “Correlating this device to concussions objectively will be groundbreaking for future implications including rehabilitation care, classroom activity and return to sports activity,” stated Ryan Pinson, M.Ed. ATC / LAT, Director of Sports Medicine at University of Wyoming. “Our number one goal is optimal healthcare for the student athletes, and I feel we are making breakthroughs with innovation and research.” “We are excited to work with Jan Medical in their effort to progress diagnosis and management of athletically related concussions with the BrainPulse device,” commented Cole Vertz, MS ATC / LAT, Associate Athletic Trainer and Director of Rehabilitation at University of Wyoming. The specific purpose of this study at UW is to collect data to improve BrainPulse algorithms that aid in the diagnosis of concussion. All information collected may aid doctors in understanding specific conditions of the brain that result from concussion or other traumatic brain injuries, establishing the areas of greatest benefit for this emerging technology. To learn more about the BrainPulse device, visit http://www.janmedical.com/education/concussion/. University of Wyoming Athletics competes at the highest level of collegiate sports – the NCAA Division I level. UW is a founding member of the Mountain West Conference and offers 17 NCAA Division I sports, including nine women’s sports and eight men’s sports. Of Wyoming’s 17 sports, 15 compete as members of the Mountain West. The Wyoming wrestling program competes as a member of the Big 12 Conference and the men’s swimming and diving program competes as a member of the Western Athletic Conference. Over 400 student-athletes represent Cowboy and Cowgirl Athletics. The University of Wyoming is the only four-year institution of higher education in the state of Wyoming, making the entire state of Wyoming Cowboy and Cowgirl fans. Jan Medical is a medical device start-up dedicated to providing physicians critical data for accelerating and expanding therapy while improving the diagnostic experience for patients with brain disorders. Its proprietary platform technology, BrainPulse, uses accelerometers on a non-invasive headset to detect skull motion resulting from pulsatile blood flow into the brain. The BrainPulse is currently involved in research projects to study the brain pulse patterns and develop algorithms for concussion, vasospasm and other indications. CAUTION: The Jan Medical BrainPulse system is a FDA cleared device that is investigational for concussion evaluation limited by federal (US) law to investigational use.


Ramjee G.,Jan Medical | Ramjee G.,London School of Hygiene and Tropical Medicine | Wand H.,University of New South Wales
AIDS and Behavior | Year: 2014

We investigated geographical variations of three sexually transmitted infections (STIs) namely chlamydia, gonorrhea and syphilis in the greater Durban area, so as to optimize intervention strategies. The study population was a cohort of sexually active women who consented to be screened in one of three biomedical studies conducted in Durban. A total of nine local regions collectively formed three clusters at screening, five of which were previously defined as HIV hot-spots. STI cases were geo-coded at the census level based on residence at the time of screening. Spatial SaTScan Statistics software was employed to identify the areas with a disproportionate prevalence and incidence of STI infection when compared to the neighboring areas under study. Both prevalence and incidence of STIs were collectively clustered in several localized areas, and the majority of these locations overlapped with high HIV clusters and shared the same characteristics: younger age, not married/cohabitating and multiple sex partners. © 2013 The Author(s).


Objective To estimate the potential impact of using hormonal contraceptives on rates of infection with human immunodeficiency virus type 1 (HIV-1) and pregnancy by theoretically removing the use of hormonal contraceptives from a study population. Methods A prospective cohort study included 3704 HIV-negative women who were enrolled in two biomedical trials that tested two vaginal microbicides (PRO 2000 and Carraguard®) for the prevention of HIV-1 in Durban, South Africa, in 2004-2009. Cox proportional hazards regression models along with partial population attributable risks (PARs) and their 95% confidence intervals (CIs) were calculated to assess the relative population-level impact of the use of hormonal contraceptives on HIV-1 seroconversion rates and on pregnancy rates. Findings Women who reported using hormonal contraceptives at enrolment in the trial had a higher risk of HIV-1 seroconversion (adjusted hazards ratio: 1.24; 95% CI: 0.97-1.58) than women who reported using other types of contraceptives at enrolment. At the population level, the use of hormonal contraceptives (pills or injectables) at baseline and during study follow-up accounted for approximately 20% (95% CI: 16-22) of HIV-1 seroconversions. However, the partial PAR indicated a relative impact of 12% (95% CI: 9.0-15.7). On the other hand, 72% (95% CI: 66-77) of the pregnancies could have been avoided if all women had used hormonal contraceptives. Conclusion Women using hormonal contraceptives need comprehensive counselling on simultaneous prevention of HIV-1 infection.


Naidoo S.,Jan Medical | Wand H.,Kirby Institute
Sexually Transmitted Infections | Year: 2013

Background and objectives Trichomonas vaginalis is known to be the most common, curable, sexually transmitted infection among sexually active women and may be associated with the acquisition and transmission of HIV. The purpose of this analysis is to determine the prevalence and incidence of T vaginalis and assess risk factors associated with T vaginalis infection in a cohort of women participating in a clinical trial. Methods We analysed data from women participating in a phase III vaginal diaphragm trial conducted in two communities in Durban, South Africa from 2003 to 2006. A total of 3492 women were screened and 1485 women meeting the respective study eligibility criteria were enrolled. T vaginalis infection was determined at the initial screening visit and at quarterly visits among the enrolled women. Sexual behaviour and sociodemographic data were collected as per the study protocol. Combined data were analysed using STATA V.10.0. Results At baseline, prevalence of infection was 6.5%. The overall incident rate was estimated to be 8.6/100 women-years. Prevalent T vaginalis infection was associated with having a concurrent chlamydial infection and incident infections were associated with increased number of sex partners. Conclusions T vaginalis infection was found to be relatively high among this cohort of women. Given the association of this infection with HIV, there is an evident need for T vaginalis screening and treatment in populations at risk for both infections.


Patent
Jan Medical | Date: 2015-06-30

A system and method for detecting brain concussion includes detecting and measuring of acceleration at one or more points on a subjects head. Sensors, which can be accelerometers placed against the head, detect and measure natural motions of the patients head due to blood flow in the brain and resultant movement of tissue in the brain. The acceleration data are then analyzed, including as to frequency of motions of the skull at the subject location in a frequency range of about 1 to 20 Hz. An observation is then made, as compared with data corresponding to non-concussion, of a change in frequency response pattern exhibited when accelerations are plotted as a function of time or frequency, to identify probable concussion if the frequency response pattern indicates concussion. Preferably the observation and comparison are made by a computer using an algorithm.


Vascular conditions are detected non-invasively in the human body using a collection of information from small local regions of the vasculature. An array of accelerometers are attached to the head and blood flow sounds are recorded. Vibration signatures of vessel structures such as branches, aneurysms, stenosis, etc. using random, periodic, band limited or transient analysis provides a signature library for further processing. The signature library is used to localize the origin of recognized vascular features and the localized feature is presented to the physician in a clinically relevant manner.


Vascular conditions are detected non-invasively in the human body using a collection of information from small local regions of the vasculature, or from a specific signature or BrainPulse that can be derived from a patients heartbeat-induced cranium movements. An array of accelerometers or other sensors are engaged against the head of a patient and skull movements, preferably under 100 Hz, are recorded. Vibration signatures of vessel structures such as branches, aneurysms, stenosis, etc. using random, periodic, band limited or transient analysis provides a library for further processing. The signature library is used to localize the origin of the recognized vascular feature, and the localized feature is presented to the physician in a clinically relevant manner.


MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Jan Medical, developer of the Nautilus BrainPulse™, announced today that a clinical study published in this month’s issue of Neurocritical Care demonstrated that Nautilus BrainPulse is a highly sensitive skull accelerometry that can detect cerebral vasospasm “with clinically meaningful accuracy, therefore suggesting “promise in the ICU environment to detect as well as reject cerebral vasospasm as the cause of neurological deficits in subarachnoid hemorrhage.” Prinicipal investigator for the Nautilus BrainPulse study was Wade S. Smith, M.D., Ph.D., Director, UCSF Neuroscience ICU, Professor of Neurology, University of California, San Francisco. “What we need is a safe, noninvasive, user-independent method to detect cerebral vasospasm before it causes brain injury,” said Dr. Smith. “The technology needs to be simple, and portable, to be most effective in the Neuro Critical Care setting, by more immediately detecting vasospasm so we can aggressively prevent stroke with cerebral angioplasty and/or vasospressor therapy. Such a technology holds the promise to directly help patients and shorten the length of stay within the Neuro ICU.” “Our Nautilus BrainPulseTM system can rapidly provide critical information on a patient presenting with stroke symptoms, and it can also be used as a continuous monitor of changes to the cerebral vasculature. It is this latter ability, continuous monitoring, that provides a unique capability in detecting the onset of vasospasm,” added Paul Lovoi, Ph.D., CEO of Jan Medical. “This study has confirmed that our portable and continuous brain-sensing system can detect vasospasms quickly and noninvasively.” “Vasospasm” refers to a condition in which blood vessels constrict, leading to ischemia and irreversible brain injury by causing stroke. Cerebral vasospasm usually arises in the context of subarachnoid hemorrhage (SAH) from a ruptured cerebral aneurysm. Vasospasm typically materializes 4 to 10 days after SAH. The essential problem with vasospasm is that it causes stroke by shutting down blood flow to the brain. The current method used to detect vasospasm is transcranial Doppler ultrasound, a difficult to administer technique that is not able to evaluate all the brain’s blood vessels and requires specific technical expertise to perform the measurements. The brain has a normal pulse driven by the cardiac cycle. The impact of this pulse on the skull can in turn be detected and measured. The Nautilus BrainPulse is designed to measure the normal brain pulse as well as disruptions of the brain pulse. By digitizing the signal patterns from headset-mounted sensors measuring the skull’s motion, and extracting features from them, algorithms have been developed to identify normal and a variety of abnormal brain pulse patterns in recording sessions that take approximately 3 minutes. The device is portable, entirely non-invasive and provides analysis immediately once the recording session is completed. Jan Medical is medical device company dedicated to providing critical data for expediting and expanding therapy while improving the diagnostic experience for patients with brain disorders. Its proprietary platform technologies include the Nautilus BrainPulse™. Visit www.janmedical.com. CAUTION: THE JAN MEDICAL SYSTEM IS AN INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (UNITED STATES) LAW TO INVESTIGATIONAL USE.


MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Jan Medical, developer of the Nautilus BrainPulse™, announced today that a clinical study published in this month’s issue of Neurocritical Care demonstrated that Nautilus BrainPulse is a highly sensitive skull accelerometry that can detect cerebral vasospasm “with clinically meaningful accuracy, therefore suggesting “promise in the ICU environment to detect as well as reject cerebral vasospasm as the cause of neurological deficits in subarachnoid hemorrhage.” Prinicipal investigator for the Nautilus BrainPulse study was Wade S. Smith, M.D., Ph.D., Director, UCSF Neuroscience ICU, Professor of Neurology, University of California, San Francisco. “What we need is a safe, noninvasive, user-independent method to detect cerebral vasospasm before it causes brain injury,” said Dr. Smith. “The technology needs to be simple, and portable, to be most effective in the Neuro Critical Care setting, by more immediately detecting vasospasm so we can aggressively prevent stroke with cerebral angioplasty and/or vasospressor therapy. Such a technology holds the promise to directly help patients and shorten the length of stay within the Neuro ICU.” “Our Nautilus BrainPulseTM system can rapidly provide critical information on a patient presenting with stroke symptoms, and it can also be used as a continuous monitor of changes to the cerebral vasculature. It is this latter ability, continuous monitoring, that provides a unique capability in detecting the onset of vasospasm,” added Paul Lovoi, Ph.D., CEO of Jan Medical. “This study has confirmed that our portable and continuous brain-sensing system can detect vasospasms quickly and noninvasively.” “Vasospasm” refers to a condition in which blood vessels constrict, leading to ischemia and irreversible brain injury by causing stroke. Cerebral vasospasm usually arises in the context of subarachnoid hemorrhage (SAH) from a ruptured cerebral aneurysm. Vasospasm typically materializes 4 to 10 days after SAH. The essential problem with vasospasm is that it causes stroke by shutting down blood flow to the brain. The current method used to detect vasospasm is transcranial Doppler ultrasound, a difficult to administer technique that is not able to evaluate all the brain’s blood vessels and requires specific technical expertise to perform the measurements. The brain has a normal pulse driven by the cardiac cycle. The impact of this pulse on the skull can in turn be detected and measured. The Nautilus BrainPulse is designed to measure the normal brain pulse as well as disruptions of the brain pulse. By digitizing the signal patterns from headset-mounted sensors measuring the skull’s motion, and extracting features from them, algorithms have been developed to identify normal and a variety of abnormal brain pulse patterns in recording sessions that take approximately 3 minutes. The device is portable, entirely non-invasive and provides analysis immediately once the recording session is completed. Jan Medical is medical device company dedicated to providing critical data for expediting and expanding therapy while improving the diagnostic experience for patients with brain disorders. Its proprietary platform technologies include the Nautilus BrainPulse™. Visit www.janmedical.com. CAUTION: THE JAN MEDICAL SYSTEM IS AN INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (UNITED STATES) LAW TO INVESTIGATIONAL USE.

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