From Stick to Sphere: How Okon Pivoted, Fundraised, and Survived in Women’s-Health Therapeutics
Okon (“O-configuration”) set out to rethink intrauterine delivery by matching form to anatomy: a self-folding spherical stent delivered through the world’s thinnest inserter. It started in contraception, then pivoted to abnormal uterine bleeding (AUB) to reach patients faster with a therapeutic payload. Along the way, the company confronted every startup pothole at once—board conflict, cash drought, quality scare, facilities move, patent gaps, and a pandemic. In this talk, Keren Leshem shares the choices that kept the wheels on and the lessons any founder can steal on Monday.
Geometry, grit, governance—and a lot of LinkedIn: a real-world guide to building in women’s-health when classic VC won’t pick up the phone.
TL;DR
In a hurry? Here are the essentials at a glance:
Design around anatomy: a spherical, self-folding stent fit the ~2.4–2.5 cm uterine cavity better than 3.2 cm “sticks,” trading “more efficacy” for safer placement.
Pivot for impact: move from contraception (healthy users, low tolerance for AEs) to AUB to reach patients sooner with a therapeutic payload.
Stabilize the core: recruit a heavyweight chair, remove toxic voices, partner tightly with the CFO, and backfill founder roles before investor disclosure.
Cash is a stack: slash burn, chase non-dilutive grants, get prepayments, stretch vendors—and raise online from physicians, distributors (yes, Japan wired $1M), crowdfunding, and LinkedIn.
Manage quality like your life depends on it: treat a product complaint like a near-recall; fix root cause, lawyer up early, document everything.
Move what “can’t be moved”: renegotiate or relocate your GMP site if it resets momentum and cost.
Lead with values: hire and train women exiting trafficking; purpose powers teams.
Expect near-misses: a 18-month big-pharma pursuit can still die; keep momentum and options alive.
Strategy ≠ scripture: show a 3–5-year plan—and the humility to change it (often). Celebrate every win to compound credibility.
Session summary with Keren Leshem, CEO & Board Director, ViVac Pharma (Former CEO & Chair, Okon Therapeutics)
Start with anatomy, not legacy
Most uterine cavities are the size of a small strawberry—about 2.4–2.5 cm wide—yet many IUDs are ~3.2 cm across. That mismatch invites malposition and, in worst cases, perforation when a rigid “stick” meets a 3D, variable space. Okon’s answer was a self-folding spherical stent delivered through an ultra-thin inserter; the ball carries copper beads (or other payloads) and conforms without skewing, protecting the fundus. Comparative work showed similar contraceptive effect but materially better placement safety and fewer complications. The shift wasn’t about louder efficacy claims—it was about fit, safety, and a platformable geometry.
“Try putting a 3.2 cm stick into a 2.4 cm space—our geometry had to change before outcomes would.”
The insight unlocked a category: once the shape works, the payload can evolve.
From contraception to therapy—fastest path to patients
Contraception treats healthy users with near-zero AE tolerance; therapeutics can show risk-benefit sooner. Okon pivoted to AUB—affecting ~1 in 3 women over 40—because it offered a faster route to clinical impact. The same spherical stent delivered a compound to ablate endometrium, creating an office-based option between hormones and OR procedures. Mechanistically, the device folds in, seats safely, the beads melt to a conformal paste, and the lining is removed. It’s the same platform, now solving a different, urgent problem.
“We moved where we could get to patients sooner: same platform, different payload, clearer path.”
From there, the pipeline broadened—multiple women’s-health indications and even embedded sensing (microbiome, bleeding patterns) to make the implant data-enabled.
Headlines are easy; the hard middle isn’t
Press, awards, Davos stages—external optics were strong. Internally, sales lagged, the board was at war, the team was cynical, cash was effectively zero, and a founder-CMO opposed the pivot and left mid-raise. A French product complaint landed when a retrieval thread detached, the GMP lease expired, patents needed work—and then COVID hit. This is the real startup map: messy, non-linear, and humbling.
“The neat ‘build → fund → exit’ slide is fiction; the real slide has bumps, stalls—and weight gain.”
Naming the chaos made it fixable: stabilize governance and team, de-risk quality and facilities, rebuild cash, and upgrade the story from “device” to “drug-delivery platform.”
Stabilize governance and culture first
A heavyweight chair (Yale professor, former US med-tech chair) joined after a bold cold call, resetting board confidence overnight. Toxic doom-loop voices were exited, and the CFO became true deputy, sequencing burn cuts, prepayments, and terms management. Before disclosing the founder’s exit to investors, the team backfilled with an experienced global CMO, turning a red flag into a solution. Culture hygiene wasn’t cosmetic—it was existential.
“Without a board you trust and a team you believe in, there is no company—everything else is tactics.”
Momentum returned because decisions got faster, cleaner, and better signaled.
Cash when classic VC won’t play
Women’s-health therapeutics is chronically underfunded; waiting for a perfect VC round wasn’t a strategy. The team built a capital stack: non-dilutive grants (applied broadly and creatively), customer prepayments, stretched vendors, and a fully online raise. Physicians who loved the device invested; distributors—including a Japanese partner—wired $1M after two months; crowdfunding filled gaps. LinkedIn became the outbound engine: track engagers, DM context, convert to Zoom, close.
“LinkedIn became our best friend—people who didn’t know us yesterday became advocates (and investors) tomorrow.”
In total, roughly $15M came together—enough to execute—and the company’s digital footprint (press, patents, posts) compounded credibility.
Quality scares and “immovable” facilities
A product complaint (thread detachment) was treated like the near-recall it could become: empower the team to fix root cause, promote the people who solved it, engage counsel early, and document everything. In parallel, the “unmovable” GMP site moved—despite a landlord betting otherwise—lowering costs and changing luck. Sometimes progress is a new lease.
“You manage a complaint like your life depends on it—because it might.”
Both moves signaled control to regulators, partners, and staff.
Lead with values when it’s hardest
Even with cash tight, the company hired and trained women exiting trafficking into packaging and light manufacturing. Leadership personally bridged payroll to make it happen. Three women—two from Eastern Europe, one from Africa—started stable work with references for the next step. Purpose lifted a tired team and told partners who the company was.
“We didn’t wait for an exit to give back—we built giving into how we operated under pressure.”
Values weren’t a slide; they were an operating choice that improved execution.
The 18-month near-miss—and what to do next
Sixty to seventy big-pharma staff lived in the data room for a year and a half, a term sheet in hand—then “priorities changed.” The license shrank to a single-market pilot and fell off the roadmap, even after a bridge raise against the paper. It stung. But options existed because momentum did; a new strategic term sheet followed.
“Be relentlessly optimistic—and flexible on strategy; plans change, so keep options alive.”
The lesson: don’t build your runway around one whale. Build many lines in the water.
FAQ
Its spherical shape fits the uterine cavity better, reducing risks of perforation and malposition.
By quickly recruiting an experienced new CMO and reassuring investors about continuity and expertise.
Virtual meetings via Zoom, LinkedIn networking, crowdfunding, and engaging strategic investors and distributors.
Extremely important; it builds credibility and attracts investors and partners.
Yes, they improve team morale, company reputation, and contribute positively to society.
)