Bringing rare therapies to the patients who wait.
Israel Figa helps biopharma and medical-device companies navigate the United States — from orphan-drug strategy to specialty distribution and commercial launch. One specialist, accountable end to end.
Rare-disease products fail in the US for reasons that have nothing to do with the science.
A great therapy is necessary — but never sufficient. The gap between approval abroad and patients in America is operational, regulatory and commercial. That gap is where Israel works.
A regulatory maze
Orphan-drug designation, FDA pathways, and reimbursement codes behave differently for rare conditions. One wrong assumption can cost a launch window.
A fragmented channel
Specialty pharmacies, hub services, and limited-distribution networks must be aligned long before the first prescription is ever written.
A distant market
For a European or Israeli company, the US looks close on paper and far in practice — payers, prescribers and logistics all run on local rules.
A clear path from approval to access.
Every engagement follows four disciplined stages — no hand-offs, no diffusion of responsibility. You always know what happens next and who owns it.
Map the opportunity
We assess prevalence, competitive landscape, regulatory route and realistic US revenue before a dollar is committed.
Build the strategy
Orphan-drug positioning, pricing logic, and the regulatory & reimbursement narrative that payers will actually accept.
Assemble the channel
Specialty distribution, hub and patient-support partners selected and contracted around your specific therapy.
Launch & scale
Commercial execution, prescriber access and ongoing optimization — with one accountable partner throughout.
Everything between your therapy and the US patient.
Orphan-drug strategy
Designation strategy, prevalence modeling and the regulatory positioning that unlocks 7-year US market exclusivity.
Market access
Payer strategy, coding, coverage and the reimbursement architecture rare therapies depend on.
Specialty distribution
Design and management of limited-distribution and specialty-pharmacy networks built for low-volume, high-touch products.
Medical-device access
Commercialization for advanced devices addressing rare and ultra-rare indications in the US market.
US market entry
A turnkey bridge for European and Israeli companies entering the US — entity, partners, and go-to-market plan.
Commercial launch
Launch readiness, prescriber engagement and the day-one execution that determines a rare-disease product trajectory.
Therapeutic areas covered
Lysosomal storage
- Gaucher
- Fabry
- Pompe
- MPS I-VII
Complement-mediated
- PNH
- aHUS
- gMG
- NMOSD
Metabolic & genetic
- Urea cycle disorders
- PKU
- Wilson disease
- HAE
Immunological
- Primary immunodeficiency
- Rare autoimmune
- Orphan oncology
Outcomes that move a launch forward.
market exclusivity secured through orphan-drug strategy
from first engagement to a contracted US distribution network
of engagements handled directly by Israel — never delegated
“A rare-disease launch in the US is a chain of small, unforgiving decisions. My job is to make sure not a single link is left to chance — and to own every one of them with you.”
Israel Figa
Monroe, New York · USA
Founder & operator
Owner of consulting, distribution and marketing companies in pharma and advanced medical devices.
International bridge
Connecting European and Israeli innovators to the US healthcare system.
Direct accountability
Every engagement is led personally — your strategy is never handed to a junior team.
Fifteen years turning rare-disease ambition into US reality.
Israel Figa is a pharmaceutical entrepreneur based in Monroe, New York, focused on the hardest part of rare-disease medicine: getting an approved therapy into the hands of the small, scattered populations who need it.
His work spans regulatory strategy, specialty distribution and commercial launch — with a particular focus on companies abroad that need a trusted, accountable partner on the ground in the United States.
Let’s talk about your US opportunity.
The first conversation is free and confidential. Tell Israel where you are, and he’ll tell you — honestly — what the path to the US market really looks like.
- A direct conversation with Israel — not a sales team
- An honest read on feasibility and timeline
- No obligation, fully confidential