Below you will find news and press releases from industry, government, and academia regarding product developments and medical/scientific research news.
Innovus Pharmaceuticals, Inc. (“Innovus Pharma” or the “Company”) (OTCQB Venture Market: INNV), an emerging commercial-stage pharmaceutical company that delivers safe, innovative and effective over-the-counter medicine and consumer care products to improve men’s and women’s health and respiratory diseases, today announced that it has entered into an agreement with ACON Laboratories, Inc. (“ACON Labs”). ACON Labs is a San Diego-based diagnostic product manufacturer who will supply Innovus Pharma with its U.S. Food and Drug Administration’s (“FDA”) cleared Urinary Tract Infection (“UTI”) test strips. Innovus Pharma will offer the UTI test strips, which provide results in 2-minutes, to its customers who buy its UriVarx™ product. UriVarx™ is clinically tested in patients with overactive bladder (“OAB”) and urinary incontinence (“UI”). Innovus Pharma is expected to launch the UTI strips under its UriVarx™ brand in Q1 2018. Read more.
Source: Market Insider, November 9, 2017
Axonics Modulation Technologies, Inc., developer of the first rechargeable sacral neuromodulation (r-SNM™) system for the treatment of overactive bladder (OAB) and bowel dysfunction, today announced the U.S. Food & Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) in accordance with 21 CFR 812 regulations allowing Axonics to conduct a pivotal study designed to gain FDA approval in the United States. “During 2017, as part of the IDE process, the FDA conducted a significant review of our product. A major focus of the technical review was the long-term safety of our implant. The fact that we were able to support our anticipated 15-year full system life-in-the-body claim based on our robust design and development processes, risk analysis and extensive validation testing is testament to the high-quality work of our team,” said Raymond W. Cohen, Chief Executive Officer of Axonics. “Given the demand in the U.S. market for SNM therapy, gaining FDA approval is our main focus. To that end, we fully intend to execute this well-designed pivotal study with velocity and in the best interests of patients.” Read more.
Source: Pharmaweb, November 7, 2017
Crohn’s and Colitis Canada is taking aim at a serious hurdle many Canadians with Crohn’s disease or ulcerative colitis face – accessing washrooms on the go. November is Crohn’s and Colitis Awareness Month, and the national charity is advocating that public washroom access is a right, not a privilege, and for the Canadians living with these chronic diseases, it’s a critical need. Crohn’s and colitis are debilitating, yet often invisible, autoimmune diseases. They cause the body to attack healthy tissue, leading to the inflammation of all or part of the digestive tract. Symptoms include diarrhea, internal bleeding, and abdominal pain, and result in the frequent and urgent need to use the washroom, in some cases over 20 times a day. Read more.
Source: CNW, November 1, 2017
November is National Bladder Health Month and, for a second year, the Urology Care Foundation, American Urological Association (AUA) and the Bladder Health Alliance – a coalition of groups representing physicians, patients and veterans – have teamed up to support Bladder Health Month. Designed to raise awareness about bladder conditions, encourage individuals to talk with their healthcare providers about the symptoms they are experiencing and to generate support for those affected by bladder health issues, this month-long awareness campaign was developed to increase an individual’s focus on “Getting the Facts, Getting Diagnosed and Taking Control” of their Bladder Health. Read more.
Source: Markets Insider, November 1, 2017
Roughly half of adult women may experience urinary incontinence, but few of them get diagnosed and treated despite a wide range of options to address the problem, doctors say. Women are particularly prone to stress urinary incontinence, when the pelvic floor muscles are too weak to support the bladder. As a result, urine leaks during coughing, sneezing or exercise. Childbirth is a common reason for weak pelvic muscles, and obesity worsens the problem. Urge incontinence, in contrast, doesn’t have a clear cause, although it can sometimes happen due to neurological problems, the authors note. Some women may get both types of incontinence at once or develop bladder problems due to a urinary tract infection. Read more.
Source: Reuters, October 24, 2017
Men: As you age, there’s a good chance you may get up several times a night to empty your bladder. The problem is that your bladder doesn’t empty completely. No matter how hard to you try, you can only deliver a trickle before returning to bed. In a few hours, you are up again. The process repeats itself all night. For many men, this frustrating scenario is the result of an enlarged prostate that is squeezing the urethra, which prevents the bladder from emptying completely. When the problem is caused by a noncancerous condition, it’s called benign prostatic hypertrophy (BPH). Until recently, the only way to free the urethra and restore urine flow was to have a physician cut or vaporize the prostate. But this surgery can leave men with a degree of incontinence or impotence. A new alternative that uses steam holds promise in treating BPH. Researchers developed an entirely new approach to treating BPH by using steam to kill prostate cells and shrink the prostate. The outpatient procedure is performed in about five minutes using a local anesthetic. Most men see improved urine flow in three to six weeks and dramatic improvement in three months. Read more.
Source: Cleveland Clinic, October 20, 2017