LOS ANGELES, CA--(Marketwired - August 14, 2014) -
Endonovo Therapeutics, Inc. (OTCQB: ENDV
) ("Endonovo" or the "Company"), a developer of non-invasive bioelectronic therapies, announced today that it has retained Holland & Knight, LLP ("H & K") as its legal counsel and Emergo Group, Inc. ("Emergo") to assist the Company in obtaining FDA clearance of its non-invasive urinary incontinence treatment.
Endonovo's bioelectronic platform, which is based on Time-Varying Electromagnetic Fields ("TVEMF") originally developed in conjunction with NASA, uses a proprietary waveform to stimulate tissue. TVEMF technology is fundamentally different from other magnetic pulse devices; it is based on the physics of electricity and magnetism as well as the physiology of cells and tissues.
Holland & Knight will provide Endonovo legal and regulatory counsel to support the Company's efforts to obtain FDA clearance of its non-invasive bioelectronic therapies. H & K represents numerous medical device and biotechnology companies and is widely considered one of the leading firms in regenerative medicine.
Emergo will be assisting the Company through FDA regulatory process by identifying proper classifications, potential predicate devices and applicable regulatory requirements. The Company intends to seek FDA 510(k) clearance based on the comparison of the Company's non-invasive TVEMF technology to predicate devices used to treat urinary incontinence.
Urinary Incontinence Market:
As the populations of developed nations, including the US, Japan and Western Europe, continue to age, the number of urinary incontinence cases will rise dramatically. According to The National Association for Continence ("NAFC"), urinary incontinence affects 200 million people worldwide and 25 million adult Americans experience transient or chronic urinary incontinence, of which 75-80% are women. The NAFC estimates that 9-13 million women experience bothersome and severe symptoms.
Incontinence, a condition that can be cured or improved, can cause unnecessary social isolation, emotional problems, and expense. The Agency for Health Care Policy and Research (AHCPR) estimates that the annual costs of caring for people with urinary incontinence are $11.2 billion in the community and $5.2 billion in nursing homes. The majority of these costs are spent on managing the symptoms of urinary incontinence with products, such as pads and diapers rather than on treatments.
According to statistics on the NAFC website, 211,000 women had some type of surgery for stress urinary incontinence in 2010. The number of surgeries for treating urinary stress incontinence is estimated to increase by 47.2% by 2050.
"Urinary incontinence is becoming an increasing problem as the populations of developed nations continue to age. The majority of money spent on urinary incontinence is on pads and diapers, which is a huge burden to patients and the healthcare system. We are also seeing an increased use of surgery to treat urinary incontinence, which is invasive and expensive. Whereas, our bioelectronic treatment is non-invasive, which is an extremely attractive feature of our device," stated Alan Collier, CEO.
"We are excited to be working with Holland & Knight and Emergo Group to bring to market the first of several bioelectronic therapies," stated Collier. "We will also be working with Emergo Group and Holland & Knight to identify and formulate optimal regulatory strategies for other indications of non-invasive bioelectronic therapy."
About Endonovo Therapeutics
Endonovo Therapeutics, Inc. (OTCQB: ENDV) is a biotechnology company developing non-invasive, bioelectronic therapies and off-the-shelf, cell free regenerative products that no longer require the injection of stem cells. The Company is developing therapies for various inflammatory, autoimmune and degenerative diseases using biological molecules secreted from cells and Time-Varying Electromagnetic Fields (TVEMF) originally developed in conjunction with NASA.
Safe Harbor Statement
This press release contains information that constitutes forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, trends, analysis, and other information contained in this press release including words such as "anticipate," "believe," "plan," "estimate," "expect," "intend," and other similar expressions of opinion, constitute forward-looking statements. Any such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from any future results described within the forward-looking statements. Risk factors that could contribute to such differences include those matters more fully disclosed in the Company's reports filed with the Securities and Exchange Commission. The forward-looking information provided herein represents the Company's estimates as of the date of the press release, and subsequent events and developments may cause the Company's estimates to change. The Company specifically disclaims any obligation to update the forward-looking information in the future. Therefore, this forward-looking information should not be relied upon as representing the Company's estimates of its future financial performance as of any date subsequent to the date of this press release.