To date, more than 20,000 patients have benefited from Stretta for GERD – and approximately 3,500 have benefited from Secca for bowel incontinence. A substantial and growing body of clinical literature underscores the efficacy and long-term effectiveness of these therapies.
Mederi acquired these FDA approved systems, along with the intellectual property and other assets of the original developer in the fall of 2008, and has since redesigned the RF generator and relaunched all products for worldwide distribution. Stretta, Secca and the MDRF1 Generator have FDA 510(k) clearance, a CE Mark, and various registrations in countries that require additional regulatory approval. Mederi is also Quality ISO 13485 certified.
The robust intellectual property in Mederi's portfolio includes over eighty issued US patents and thirty-three pending US and foreign applications. While the majority of Mederi’s 80 patents and filings cover commercial products for the treatment of GERD and bowel incontinence, patent submissions also cover certain design features of the Stretta and Secca devices, including elements to prevent reuse.
The Market Opportunity
Gastroesophageal Reflux Disease (GERD)
MEDERI’s primary efforts with the Stretta system target the estimated 10-20% of the population of the Western world that suffers from GERD symptoms weekly. Although studies vary on the prevalence of this disorder, a conservative estimate based on the available data suggest that there are 40 million adult patients just in the US, where GERD is a highly prevalent disease. Various studies have shown that approximately 30% of the overall GERD population does not respond to medication, and are classified as “refractory” GERD sufferers. When looking at the opportunity in the US alone, there are approximately 12 million refractory sufferers who are the principal targets for Stretta, as medications offer little or no relief. Many sufferers who are not refractory may also choose an alternative to lifelong medications with potentially serious side effects, opening up an even larger market opportunity. These 12 million patients equate to a market potential for Stretta of $17 billion in the US alone. Outside the US, the disease prevalence is similar, offering a corresponding opportunity for market potential balanced by economic restrictions in other countries.
The Market Opportunity
Bowel Incontinence or BCD (Bowel Control Disorder)
The market for fecal incontinence is not as clearly defined, in part because the social stigma of the disease results in widespread under-reporting. Additionally, the lack of effective treatment alternatives is thought to have led to large numbers of silent sufferers. The best data shows that up to one in 13 adults in the US (7.5%) suffer from FI, and studies also show this number increases in women who have given birth. These 18 million patients equate to a market potential for Secca of $25 billion in the US alone. Outside the US, the disease prevalence is similar, offering a corresponding opportunity for market potential balanced by economic restrictions in other countries.