Investment in medical/health issues is a long-term proposition, requiring the kind of “patient capital” that ultra-wealthy investors, such as those using family offices, are well able to provide. We talk to those making a health treatment focused on male contraception.

Dr Darlene Walley, CEO of NEXT Life Sciences, the maker of the male contraceptive product Plan A™ is on something of a mission. The firm is developing a “hydrogel” called Vasalgel®

This filters sperm from the vas deferens while allowing fluids to pass. The product, according to the Plan A™ website, is designed to provide contraception for more than 10 years and can be administered in a medical office setting with the option for reversal on demand.

There’s a lot at stake. 

“More than 20 per cent of women cannot deal with oral contraceptives,” Dr. Darlene Walley said. “People want something that is safe and reliable.”

“There literally has not been an innovation in male contraception in decades, in some people’s lifetimes,” Dr Walley told Family Wealth Report. “This area is vastly overdue for innovation and we look forward to a world where there are non-hormonal, easily reversible options available for men so they can more actively participate in family planning and reproductive autonomy.”

The Vasalgel offering is non-hormonal and it is a reversible treatment – an important consideration for men who don’t necessarily want any change to be permanent, she said. A large majority of men who want to exert more control over childbirth do not want a vasectomy.

The development of such treatments is an example of how health issues – such as reported here around testosterone treatment – that affect men are gaining ground. Investment in medical/health issues is a long-term proposition, requiring the kind of “patient capital” that ultra-wealthy investors, such as those using family offices, are well able to provide.

“There are investors that are looking to make social change,” Dr Walley said. “We have great investors, such as family offices.”

The founder and executive chairman at  Plan A™, LR Fox, and former CEO of Category Creating Industries, has a family office of his own, and incubates companies in the life sciences space.  As for Dr. Darlene Walley, she is a former CEO of medical technology companies, boasting more than $1 billion in total of exits, including Cooke Pharma, HillTop Research, OraPro, Dow Pharmaceutical Sciences and EltaMD). Dr Walley works with startups, investment firms, and serves on the board of directors of several companies. She holds 12 patents, largely dealing with consumer health products, and over 15 publications. 

Other prominent figures at Plan A™ are Steve Bacich, president and chief operations officer, and a former CEO of a large contraceptive company, Conceptus, and Dr Charles Carignam, chief medical officer, former CMO of Endosurgery at Boston Scientific. The “scientific leadership” group for Plan A™ includes a range of PhDs in fields such as medicine. Plan A™ also has a medical advisory board drawn from the senior medical profession and key opinion leaders, as well as the recent addition of former FDA chief counsel Peter Barton Hutt to the advisory board. Plan A™ has been supported by investors such as Transform VC, Ryan Breslow’s The Family, Terrasys Innovation, Seaside Ventures, Unruly Capital, BlackWing, Suncoast, Mystic, Break Trail, SpaceStation, StartUpHealth, Particular Ventures, Visit Healthcare and Unpopular Ventures.

Approvals and performance
Plan A’s delivery system has been approved for clinical trials in Canada and Australia.  Those clinical trials were 100 per cent successful,” Dr Walley said. “Plan A’s™ delivery and reversal device recently received patent approval. Plan A is a medical device and the leadership team has met with the FDA to green light our pathway to approval.”   

“We are in constant, proactive communication with our investors, updating them about our latest clinical trial results and other efforts,” Dr Walley continued. 

Because the Plan A™ procedure is performed differently than a vasectomy, there are minimal risks of side effects, the firm said. The Vasalgel forms a hydrogel in the body.  Hydrogels have been used in many parts of the body and are not rejected since the body recognizes a hydrogel as itself; similar substances are used in other medical procedures.

FWR asked Dr Walley about the FDR regulatory process.

“At Plan A™, we are fortunate in that [it is] a medical device, which has a shorter path than a new drug. We have been in communication with the FDA and, in fact, recently had famed former FDA chief counsel Peter Barton Hutt join our advisory board. 

There are more developments.

“Apart from Plan A™, we are also working on a solution to erectile dysfunction that will be beneficial for men who cannot tolerate the current treatment options. We have exciting products in our pipeline to address exciting reproductive health products for men and women,” she said. 

(Editor's note: We like to talk to investment firms and businesses working on innovative ideas, treatments and products of the kind that typically require "patient capital" of the sort that family offices and wealth managers are well placed to provide. These articles shed a light on the qualities that such investors bring to the table - a point sometimes lost in public debate. If you have an interesting story to tell on such issues, email tom.burroughes@wealthbriefing.com)