Uromedica - incontinence

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Uromedica gets capital for R&D, FDA OKMinneapolis / St. Paul Business Journal - by

Uromedica Inc., a firm that's developed medical devices to treat incontinence, has raised about $5.25 million in capital to develop a new product and seek regulatory approval for two others.

The recent round of fundraising was led by a hedge fund, which Uromedica declined to name.


Uromedica is preparing to wrap up clinical trials on two of its products for treating incontinence, one targeting men and the other women, said company CEO Tim Cook. Both devices use a small balloon to bolster the muscles surrounding the bladder, a process that prevents the bladder from leaking.

The market is larger for women, who make up about 85 percent of the patients who suffer from incontinence. The company's device targeting men can be used to treat patients who have undergone prostate surgery.

Both products are fully implantable, but can be adjusted after surgery.

Uromedica plans to submit a plan for its first two products to the U.S. Food and Drug Administration for review next month, Cook said.

Uromedica also will use the funding to further develop a product that would be used to treat fecal incontinence.

The company's products are distributed in Europe through Fridley-based medical device giant Medtronic Inc., which owns a stake in the company. Uromedica is projecting revenue of about $2.5 million for this year.

Plymouth-based Uromedica has raised more than $15 million in capital since its founding
 








Uromedica seeks light at the end of a (very long) FDA tunnel

Dr. Jeffrey Shuren, director, Center for Devices and Radiological Health, Food and Drug Administration
If the Food and Drug Administration has been too cozy with medical device companies in recent years, as some critics charge, Uromedica Inc. must have missed the memo.

Since 2000, the Plymouth, Minn.-based company has been haggling with the FDA over its balloon device to treat urinary incontinence. Ten years and several clinical studies later, Uromedica is still waiting for FDA approval though the company is already selling the device in Europe. In November, the agency said it could not yet OK Uromedica’s Pre-Market Approval application, which it filed in August 2008.

So last week, Uromedica formally appealed the FDA’s decision to Dr. Jeffrey Shuren, the new director of the agency’s Center for Devices and Radiological Health (CDHR). Uromedica is the medical device industry’s first appeal heard by Dr. Shuren, who assumed the job in January.

The company, however, isn’t holding its breath. The man Dr. Shuren replaced, Dr. Daniel Schultz, resigned last summer amid criticism that the FDA approved medical devices over the objections of its staff scientists. Schultz has long been a lightening rod for consumer advocacy groups like Public Citizen and the National Research Center for Women and Families.

For example,the Star Tribune in Minneapolis reported in 2008 that he encouraged Acorn Cardiovascular Inc. of New Brighton, Minn. even though an FDA advisory panel recommended the agency deny its PMA application for its cardiac support device. A subsequent FDA dispute resolution panel also declined to approve the device. But with Schultz’s help, Acorn eventually reached an agreement with the FDA for another clinical study, the paper reported.

However, Acorn president Steve Anderson denies Schultz acted out of the ordinary.

“As CDRH Director, Dan was required to work with the two panels to define a clinical study which met the data requests of the panels,” Anderson wrote in an e-mail to MedCity News. “This study would then have to be conducted and, if successful, Acorn would have had to go through a full PMA review process with the FDA with no guarantees whatsoever on success. The idea that this process meant that Dan was supporting Acorn is completely false and shows a lack of understanding of the process.”

In early 2009, nine staff whistle-blowers wrote to the Obama administration and Congress, accusing the FDA of improperly approving devices despite serious safety concerns. The letter prompted Congressional investigations and calls to toughen the FDA’s PMA and 510(k) approval programs.

So it’s probably safe to say Uromedica still has a tough road to climb. Already, a former FDA scientist is accusing Shuren and the agency of retaliating against him after he raised concerns about how a CT scanner might expose patients to harmful radiation.

“Given this whistle-blower environment, I doubt Dr. Shuren will overrule his staff,” said Mark DuVal, a Minneapolis-based lawyer representing Uromedica.

Still, DuVal hopes Dr. Shuren will refer the case to an advisory panel, a decision that might come over the next three to four weeks. If not, Uromedica and the FDA will resume their regulatory dance. But given the length of time and the lack of investor cash, one has to wonder if Uromedica will ever win over an agency beset by scrutiny and doubt.
 


NAFC supports PMAA of Uromedica's ACT device for SUI, speaks to FDA
2. April 2010 08:37


On March 24, Nancy Muller, executive director of The National Association For Continence (NAFC), spoke to the Food and Drug Administration (FDA), in support of a Premarket Approval Application (PMAA) of Uromedica, Inc.'s Adjustable Continence Therapy (ACT®) device to approve its usage in the U.S. The ACT is designed to treat female stress urinary incontinence (SUI).

Since 2002, two Uromedica minimally invasive post-operatively adjustable devices, the ACT and the ProACT™ (a similar technology for use in incontinent men), have been available in Europe, Australia, Canada and selected countries in Asia and South America, with over 3,000 ACT implants and approximately 7,000 ProACT implants to date and no reports of serious adverse events. The difference in the ACT and ProACT (women and men, respectively) is the four to six centimeter longer tubing for the men. Everything else is identical.

The ACT® device consists of an inflatable balloon connected to a subcutaneous filling port. Once the complete device is implanted, the device can be post-operatively adjusted through the skin with a small gauge needle in an office setting with no further surgery. Based upon the patient's individual needs, fluid can be added or withdrawn from the balloon via the subcutaneous filling port either during the surgery or years later. The ACT device protects against unintentional urine leakage by applying increased pressure to the bladder and keeping the patient dry. This device can be repeatedly adjusted as needed for optimal functionality for the patient.

"Stress urinary incontinence is the most common type of incontinence in women younger than 60," stated Muller to the FDA panel. "From the phone calls, letters and e-mails we receive daily, at our national headquarters, I can attest to the fact that women limit their activities, as a result of symptoms, placing them at risk of isolation, depression and an unhealthy sedentary lifestyle. We must offer these sufferers an acceptable alternative between irreversible, problematic surgery and 'Kegels.' Approval by the FDA [for ACT] will help put a safe, simple and minimally invasive treatment for recurrent female SUI in reach to women who would otherwise simply give up following surgical failures."

For the past nine years, Uromedica has continually established assurance of safety and effectiveness through pre-clinical, biocompatibility and human clinical data for the ACT device. The company has great hopes that the FDA will approve this device based on existing evidence without further delay.


SOURCE National Association For Continence
 







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