Renovia, Inc., a firm that develops and markets specialty products designed to improve quality of life and provide effective treatment for women with pelvic floor disorders, has gained U.S. Federal Drug Administration (FDA) clearance for its next-generation therapeutic device.
Announced November 25, 2019, receipt of the 510 (k) clearance paves the way for a more effective treatment for women who suffer from mixed urgency urinary incontinence. It is the next step in delivering first-line therapeutic and diagnostic assistance for such complaints in the form of digital and app technology. An estimated 20 million American women suffer from some type of urinary incontinence, according to reliable statistics. The disorders can have a negative effect on quality of life as well as lead to other “potentially severe” conditions.
Renovia’s Co-founder, Chairman and Chief Executive Officer Marc Beer, noted that Renovia “is thrilled” by the new clearance. “Over the past two years,” he said, “the Renovia team has taken the peer-reviewed mechanism of action of the existing leva® device and completely reimagined it in a patient-centric form factor. The next-generation leva® combines our clinically-established and patented technology with a new discreet form factor and a completely redesigned app interface.”
The new device will utilize Renovia’s patented movement-based sensor and app technology, designed to provide women with “real-time” feedback as they perform prescribed pelvic floor strengthening exercises. It represents a design improvement over the company’s currently-available device, which has proved effective in providing significant improvement in three specific areas: performance of pelvic floor muscles, decreasing severity of patient-reported UI symptoms, and “condition-specific quality of life.”
A Record of Success
The Renovia announcement is just the latest in a string of successful corporate achievements for Marc Beer, acknowledged as a leader in the corporate development of innovative therapies for patients with rare and debilitating medical conditions. He co-founded Renovia in 2016 with Ramon Iglesias, M.D., and Yolanda Lorié, successfully securing Series A financing through capital funding by health care venture capital.
It is this concentration on meeting challenges that characterize Beer’s 25 years of experience in the realm of biotechnology, devices, pharmaceuticals, and diagnostics. He views himself as “a realist and a pragmatist,” and he devotes a great deal of energy to identifying positive methods for helping others. Although he stresses that his work does not consume his life completely, Beer also admits that work holds “a position of priority” in his mind. He focuses “the proverbial laser beam” on the “enterprises that I found and continue to guide.”
His string of successes in this specialized domain is impressive:
- Founder and Chairman, LumeNXT LLC, in collaboration with Medtronic (NYSE:MDT), 2018. The surgical device company is a privately-held firm with proprietary technology that pioneered non-tethered light-emitting diode (LED) illumination. Its product is currently the only such battery-driven product on the market.
- Chairman, Minerva Neurosciences, 2013–2018. A biopharmaceutical company specializing in development of a product portfolio for the treatment of central nervous system disorders.
- Chairman, Good Start Genetics, 2010–2017. The company was founded as an information-solutions company to deliver relevant state-of-the-art genetics data to growing families. Later acquired by InVitae Corporation (NYSE:NVTA), the firm continues to provide reproductive health screening and patient preimplantation genetic testing.
- Chairman, Myolex (Skulpt), 2015–2017. A firm that specialized in development and validation of devices aimed at clinical trial applications for neuromuscular disease in the market of high-performance athletics.
- Chief Executive Officer, ViaCell, 2000–2007. The company’s goal was to enable widespread treatment using human cells as medicine. Target diseases for the innovative technology included cancer, cardiac conditions, diabetes and infertility.
- Vice President, Global Marketing, Genzyme, 1996–2004
- Vice President, Sales & Marketing; Corporate Officer, Biostar, Inc. 1994–1996.
- Director, Sales Training and Development, Abbott, 1988–1994.
A committed family man as well as a dedicated businessman, Beer says that one of his great disappointments – and a lesson he never forgets – was his association with ViaCell. He describes the company’s effort to manufacture stem cells as one of his “most passionate builds.” The effort failed, he says, even though the technology had the backing to make it successful. Despite putting in place a “very robust commercial organization,” he notes that the experience drove home to him the necessity of making realistic assessments.
He admits that, even though he had secured “a cash flow engine” for development, he underestimated the time needed to effect change in the industry, adding that a new platform might now require up to 25 years to establish gene therapy or stem cells as a robust category.
That makes the recent FDA approval for Renovia that much sweeter in Beer’s eyes.
New Help Available for Women
Renovia has already completed a “multi-center, pilot randomized controlled trial (RCT) using the next-generation leva® digital therapeutic device,” according to Samantha Pulliam, M.D., the company’s chief medical officer. She added that the company will release and publish the results of that trial in the coming months, but that the findings are already being used to advance the design of a larger and more comprehensive study planned for 2020. The first RCT included only 60 subjects, but research pointed to statistically significant results among users of the new-generation device compared to a control group employing only traditional Kegel exercises.
Jessica McKinney, PT, Renovia’s vice president of medical affairs and clinical advocacy, noted, “We are, thankfully, seeing increased attention being paid to women’s health issues, including pelvic floor health. Last year’s release of the ACOG (American College of Obstetricians and Gynecologists) led WPSI (Women’s Preventive Services Initiative) opinion reinforcing the importance of annual screening for urinary incontinence is a great example.”
While “pelvic floor muscle exercises are the widely accepted first-line conservative treatment” for stress, urinary urgency and mixed UI disorders, she added that some women experience difficulty identifying and contracting the right muscles to make such exercises effective. Also, she noted that the requirement for regular performance of such exercises can be challenging. The Renovia device will reduce the effort required to perform the prescribed exercises, and it will provide reminders so that the regimen will fit better into a care routine for modern women. It should also be of benefit for women who want to avoid surgery or drug treatment for pelvic floor muscle disorders.
With the FDA approval, the next-generation device is also slated for release in 2020 and will become available to women by prescription. The Renovia team, however, notes that use of the device is not recommended for everyone, and that women should rely on the advice of a trusted medical adviser, physical therapist or primary health care provider. McKinney echoes the comments of Dr. Pulliam and Marc Beer when she says, “I couldn’t be more excited about helping bring products like the next-generation leva® digital therapeutic device to market.”
Seeking a New Standard of Care
Renovia’s commitment, since its founding in 2016, has been to develop a “product pipeline” that would improve the therapeutic and diagnostic potential of targeting treatment for a common women’s health concern. The FDA clearance is a validation of that effort and an acknowledgment of the dedication and hard work of Beer and his associates.
With a history of success and hard lessons learned along the way, it represents one more step taken by visionary and innovative corporate executives and a dedicated staff of players. This state-of-the-art app and data management technology offers a very specific answer to a specific health issue, but it also represents another step along the pathway to better health care for more people through technology and development.
And that is one of Marc Beer’s ongoing dreams: He welcomes the challenges inherent in responding to the need for “a true standard of care” to improve the lives of countless citizens.
He says, “A focus on innovation can provide good results, but it costs money. I think that the responsibility of attracting investors to a business can help executives focus their attention on cash flow positivity. My ability to achieve it in my businesses lets me advise others on its importance.” Beer notes that he has never failed to “finish the task of raising funds,” and he deems that a priority. “In health care,” he says, “failure to raise capital means that patients who need help cannot get it.”
Beer wants to assure that the most vulnerable get the help they need!