22 Mar New treatment approaches in the SUI market aim to plug the leak!
Stress urinary incontinence is the unintentional and involuntary loss of urine caused by pelvic floor muscle weakness, prostate cancer surgery, pelvic nerve injury or damage. The National Association of Continence estimates that more than 25 million people experience bladder leakage everyday in the U.S alone.
85 percent of those affected are women as they are more likely to develop incontinence as a result of pregnancy and childbirth. Stress urinary incontinence, the most prevalent form of incontinence among women, affects an estimated 15 million adult women in the U.S alone. Approximately, 1 out of every 2 women over 65 have stress urinary incontinence.
There are numerous treatments for SUI in women such as behavior therapy involving pelvic floor exercises, bladder control training and lifestyle changes. Devices such as vaginal pessary and urethral inserts are also used; bulking agents and surgical procedures are often the most widely used surgical treatment options.
A report titled Urinary Incontinence Devices Market by Allied Market Research predicts that the worldwide Urinary Incontinence Device Market will be worth over $3.41 billion by 2023, growing at a CAGR of 11.3%. A rise in geriatric population, growing incidences of incontinence related disorder and its negative impact on quality of life and increased healthcare spending will drive the growth in the market. Lack of proper awareness and post-surgical complications may prevent the market from realizing its full potential.
There are companies which are challenging the available treatment options and coming up with path breaking, safe and convenient treatments for patients suffering from this disorder. We take a look at some companies that are at the forefront of innovation in this field.
Viveve Medical (NASDAQ: VIVE)
Market Cap: $40.78M; Current Share Price: 0.909 USD
The company which focuses on developing solutions for women’s intimate heath needs has created an international patented Viveve® System that is a cryogen-cooled, monopolar radiofrequency (CMRF) technology to uniformly deliver volumetric heating while gently cooling surface tissue to generate neocollagenesis in a single in-office session. This FDA-approved system is currently available for use in general surgical procedures for electrocoagulation and hemostasis.
It’s proprietary cryogen-cooled monopolar RF energy (CMRF) technology that allows improved depth of penetration while ensuring comfort and safety is minimally invasive and has over 703 installed systems worldwide, with over 33,000 treatment tip sold till date. The company has five ongoing positive clinical studies. It also manufactures an electrostimulation device for home use, named INCONTROL, that helps strengthen the pelvic floor muscles and calm the detrusor muscle.
It creates solutions for vaginal laxity, improvement of sexual function and SUI and has regulatory approvals in over 50 countries. It is conducting clinical trials for VIVEVE II for assessing the improvement of sexual function in women after vaginal birth and LIBERATE-International for the improvement of stress urinary incontinence in women. The company has received an Investigational Drug Exemption from FDA to conduct clinical trials for LIBERATE-U.S for the treatment of SUI.
Viveve has made a public offering of 13,333,334 shares of its common stock at $1.50 per share for net proceeds of $18.8 million, which it intends to use to fund its clinical trials and commercialization efforts.
As per its full year 2018 financial results, the company reported a preliminary revenue of $18.5 million while its cash and cash equivalents stood at $29.5 million as of December 31, 2018 as compared to $20.7 million as of December 31, 2017.
Cytori Therapeutics (NASDAQ: CYTX)
Market Cap: $3.56M; Current Share Price: 0.24 USD
Its proprietary Celution® System platform extracts stem and regenerative cells from adipose tissue known as Adipose-Derived Regenerative Cells (ADRCs) for developing cell therapies that target chronic life-threatening diseases. It acquired a nanomedicine platform technology that merges doxorubicin and docetaxel, two widely known chemotherapy agents, with liposomal encapsulation technology to improve patient outcomes. The company recently filed a New Drug Application (NDA) for Doxorubicin Hydrochloride Cytori for treatment of breast cancer, ovarian cancer, multiple myeloma, and Kaposi’s sarcoma.
It is currently conducting clinical trials for ECCI-50 for the treatment of male stress urinary incontinence named ADRESU.
It has overcome common transplantation issues such as cell rejection and transmission of diseases through use of its ADRC’s prepared from the patient’s own adipose tissue, thereby reducing the need for anti-rejection or immunosuppressant drugs and demonstrating improvement in angiogenesis, inflammation, and fibrosis. The company aims to provide the delivery of the treatment in a single sitting, eliminating the need for off-site processing and with improved tolerability and safety profiles.
The company was the recipient of Frost & Sullivan’s 2016 North American Cell Therapeutics Technology Innovation Award. It has a robust intellectual property rights portfolio consisting of 102 patents issued worldwide and over 65 applications pending.
The company has a global licensing agreement with Bimini Technologies for use of Cytori Cell Therapy technology for hair applications through Kerastem, it’s wholly owned subsidiary. It has a 30-year exclusive licensing agreement with Lorem Vascular for using Cytori Cell Therapy in Australia, China, Hong Kong, Malaysia, and Singapore. The company has received regulatory clearance for the Cytori Celution® System in China through this agreement.
As per its Q3, 2018 financial results, the company’s cash and cash equivalents stood at $6.8 million. In addition it received a $1.0 million royalty milestone from Bimini Technologies, LLC (Bimini) for its Puregraft® product line.
Cogentix Medical (Private)
The company manufactures two products targeted at SUI, one is urgent PC Neuromodulation system for treating Urinary Incontinence and Urge Incontinence that provides percutaneous tibial nerve stimulation (PTNS) and the other is Macroplastique, for soft tissue augmentation in endoscopic procedures, for the treatment of SUI.
The company also manufactures Primesight Endoscopy Systems that combine a high-performance endoscopic imaging technology with its EndoSheath® Protective Barrier. In addition, the company also produces PTQ® for the treatment of fecal incontinence and VOX® for vocal cord augmentation.
The company has over 40 patents issued and more pending worldwide. It has strategic partnerships with organizations such as National Association for Incontinence, Interstitial Cystitis Association and American Urogynecologic Society
The company has been acquired by LABORIE Medical Technologies for a total consideration of approximately $239 million, and is now its wholly owned subsidiary.
Darin Hammers, President and CEO of Cogentix Medical opines that, “This transaction helps us achieve our vision of creating value for our investors, patients and physicians in the urology and gynaecology markets,” he said. “LABORIE has a track record of success in these markets and we believe that the addition of our urology and gynecology assets to their existing product lines will ensure that our products are available to the many patients and physicians who may benefit from them. We believe that this transaction is also a compelling financial opportunity that delivers significant value to our investors who have supported our evolution to becoming a valued player in the urology market.”
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.