Treating BPH without impotence, incontinence or inpatient hospital stays

You’ve seen the commercials—the guy at the football game climbing the stadium stairs, going back and forth to the bathroom, only to miss the big touchdown. Or how about the one where the guy keeps getting up in the middle of the night to go to the bathroom? Night after night, year after year.

More than 75 million men worldwide seek treatment for benign prostatic hyperplasia (BPH)—the non-cancerous overgrowth of the prostate in aging men. Yet the vast majority of those men manage their condition with modestly effective drugs or without any treatment at all. Why? Because definitive surgery to treat BPH can lead to impotence or incontinence, and requires a prolonged hospital stay. Known as “TURP” surgery, the procedure is invasive and performed under general anesthesia. The post-operative period requires days-to-weeks of catheterization. Longer-term, the procedure carries a very real risk of permanent impotence and incontinence.

Because of these risks, as few as 1% of eligible patients opt for the TURP procedure; most continue to suffer with the symptoms, temporizing them with drugs and adapting their lifestyles to the frequent urgency. But a revolutionary new technology called UroLift means that BPH sufferers need not resign themselves to a life of discomfort and inconvenience.

Medical device maker NeoTract recently announced FDA clearance of UroLift technology for the treatment of BPH—the first treatment that is truly minimally invasive and effective. The procedure can be performed in as little as 60 minutes under local anesthesia. The UroLift device offers patients a potentially transformative advance in the treatment of BPH: delivering durable efficacy that is approximately twice that of drugs. And there have been no reports of sexual dysfunction or incontinence associated with the UroLift procedure.

According to a recent paper published in the Journal of Sexual Medicine, not only did UroLift preserve normal sexual function, it was reported to improve sexual function for men with severe erectile dysfunction. The final results from NeoTract’s LIFT study have been published in the Journal of Urology, and a group of patients has now been followed for five years post-treatment and continue to show good relief of BPH symptoms. Full results of the company’s pivotal LIFT study were presented at the 2013 American Academy of Urology annual meeting.

The company is making significant progress on the reimbursement front as well, announcing this week that the UroLift procedure has received Medicare and Medicaid outpatient billing codes that take effect April 1, 2014. Hospitals will soon be able to provide relief to BPH sufferers and will receive Medicare reimbursement for the UroLift implant procedure using these newly issued specific Healthcare Common Procedure Coding System (HCPCS) codes.

NEA first invested in NeoTract in 2006, partnering with seasoned entrepreneurs Josh Makower and Ted Lamson to create a company dedicated to transforming the treatment of BPH. With an enormous and largely untapped market, UroLift’s FDA clearance has launched the company into its next phase of growth. Medicare and Medicaid reimbursement will further accelerate the company’s growing commercial traction in the United States, and we are excited about the future of this company and the benefits it provides for the patients it serves.

Neotract’s recent progress, more than eight years after our initial investment, underscores the importance of ‘patient capital’ in healthcare investing, along with a few other key points:

• There are no shortcuts to clinical evidence. Breakthroughs take time and effort, but the ROI is significant - investing the time and money in rigorous clinical testing produces definitive results that will open up new markets, enabling the confidence of physicians, patients and payers.
  
• Carefully build a syndicate of trusted and experienced investment partners. Seeking the best valuation is one element, but it is more important to assemble an investment group that shares your conviction and long-term vision and won’t bail out when challenges arise. At NeoTract we’ve been fortunate to work alongside like-minded partners Johnson & Johnson Development Corp., Greenspring Global Partners and QuilVest.
  
• Never stop building the team. Required skills change, and it often takes several attempts to get the right people in the right roles.

NeoTract will no doubt encounter new hurdles as they commercialize UroLift, but we have high confidence in the company’s ability to execute on the opportunity, create disruptive change in the market for BPH therapy, and improve the lives of patients. We look forward to our continued partnership with CEO Dave Amerson, CTO Ted Lamson and the broader NeoTract team and our co-investors. NeoTract is poised to change clinical practice by providing safe and sustained relief from BPH to a broad universe of patients.