Vicapsys Life Sciences Vicapsys Life Sciences

Distribute, contract, own

Three parts of one platform, each feeding the next. Licensed distribution carries the products; a tribal 8(a) teaming partner opens the federal channel; owned FDA-approved brands fill it.

On this page: Wholesale distribution · Federal and tribal channel · Puerto Rico supply · NitroMist · VICAPSYN · Sources

Wholesale distribution

Stateline Distributors of Puerto Rico, Inc. — a Vicapsys company since September 3, 2026.

Stateline Distributors of Puerto Rico, a Vicapsys company

Puerto Rico. Stateline is a licensed wholesale drug distributor headquartered in San Juan, compliant with the federal Drug Supply Chain Security Act (DSCSA), holding a Puerto Rico wholesale drug distributor (WDD) license and a specialty biologics license, and serving more than 400 active healthcare accounts across the island. A licensed pharmacist of record is on staff, and every product shipped carries full DSCSA documentation.

All 50 states. Through its title-model agreement with Drugzone Pharmaceuticals, Inc., licensed in all 50 states and accredited by the National Association of Boards of Pharmacy (NABP), and venture alliances with other large-scale drug distributors, Stateline has access to more than 15,000 pharmaceutical SKUs. Stateline takes title; Drugzone stores and ships under one DSCSA chain of custody, so every state is reachable without building licensed warehouses one by one.

What changed in 2026. Before Vicapsys, Stateline had no access to limited-distribution or generic specialty drugs. It now carries those SKUs into its Puerto Rico accounts at DACO pricing and to underserved communities on the mainland, including government contracts through the company's 8(a) teaming partner.

Accounts
400+ active healthcare accounts in Puerto Rico
Product access
15,000+ pharmaceutical SKUs through Drugzone and venture-alliance distributors
Reach
All 50 states on the Drugzone title model
Licenses
Puerto Rico Department of Health: wholesale drug distributor (droguería) license D-000772 and biological products license PB-020165, both valid through August 18, 2027

Licenses on file

Both licenses are issued by the Puerto Rico Department of Health under the Puerto Rico Pharmacy Act, Law 247 of September 3, 2004, as amended, and its regulations, for the Stateline establishment in the Mario Juliá industrial park, San Juan.

Puerto Rico Department of Health wholesale drug distributor license D-000772 issued to Stateline Distributors of Puerto Rico, Inc.

Wholesale drug distributor (droguería)

License No. D-000772 · Issued August 6, 2025 · Valid August 19, 2025 to August 18, 2027
Pharmacist-in-charge (farmacéutico regente): Angel L. Meléndez Díaz, Puerto Rico pharmacist license 3407

View certificate
Puerto Rico Department of Health biological products license PB-020165 issued to Stateline Distributors of Puerto Rico, Inc.

Biological products

License No. PB-020165 · Issued August 21, 2025 · Valid August 19, 2025 to August 18, 2027
Conservation and registration of biological products (specialty biologics)

View certificate

Federal and tribal channel

A contracting advantage in federal health, through a teaming agreement with a tribally owned, SBA-certified 8(a) partner.

The rule

Federal law sets government-wide goals: 23% of prime-contract dollars to small businesses and 5% to small disadvantaged businesses. Agencies are scored on meeting them.5

The vehicle

The SBA 8(a) program lets an agency award a contract to a certified firm without competition ("sole source"), up to $4.5 million, or $7 million for manufacturing, for an ordinary 8(a) firm.5

The tribal exception

Firms owned by federally recognized tribes or Alaska Native Corporations may receive sole-source awards above those caps; a written justification is needed only above $25 million ($100 million at DoD).5 At the Indian Health Service, the Buy Indian Act adds a separate preference for Indian-owned enterprises.6

How Vicapsys fits

Vicapsys's tribal 8(a) teaming partner is the prime contractor. Stateline supplies the licensed, DSCSA-compliant product to IHS and tribal programs, VA medical centers and military treatment facilities; for NitroMist, it would be the only FDA-approved source.

Channels. Indian Health Service (tribal 8(a) sole source; Buy Indian Act) · Veterans Affairs (Federal Supply Schedule plus sole source) · Department of Defense and the Defense Logistics Agency (Federal Supply Schedule; National Stock Number) · Public Health Service, Coast Guard, Bureau of Prisons and HHS (Federal Supply Schedule; agency solicitations). Covered-drug prices to VA, DoD, PHS and the Coast Guard are capped at the Federal Ceiling Price.

Veterans Affairs pharmacy obligations are an estimated $16.1 billion in fiscal 2025 and Defense Health Program pharmaceuticals $4.9 billion.3 4 The Indian Health Service serves about 2.8 million people with a fiscal 2026 program level of about $8.1 billion.4

Puerto Rico specialty and oncology supply

Brand-name products for 400+ accounts and infusion centers at DACO pricing.

The program. Stateline is bringing brand-name oncology and specialty products to its Puerto Rico accounts and infusion centers at DACO pricing, sourced through manufacturers' Authorized Distributors of Record (ADRs), with NDC and DSCSA data flowing from manufacturer to ADR to Stateline. A brand-oncology procurement program was initiated in September 2026; additional manufacturer portfolios are in negotiation through authorized distributors.

What DACO is

Puerto Rico's Department of Consumer Affairs (Departamento de Asuntos del Consumidor). Under Regulation 3707 it issues price orders at every level of drug distribution — manufacturer, wholesaler and pharmacy — with maximum prices built from cost plus a reasonable margin at each level.7

Why it matters

Buying at the regulated Puerto Rico price through an ADR, rather than through a mainland wholesaler's markup, keeps the wholesaler margin at Stateline and lets it price competitively on the island. DACO procurement pricing closely mirrors 340B pricing relative to wholesale acquisition cost, a discount class the GAO has estimated at 20–50% off list.9

The island: 3.2 million residents, about 1.36 million people on the Plan Vital Medicaid program and about 900 pharmacies.7 8

Owned products: NitroMist®

An FDA-approved product coming back to market. Definitive purchase agreement signed September 2026; closing follows FDA acknowledgment of the NDA transfer.

Product
NitroMist® (NDA 021780), nitroglycerin lingual aerosol, 400 mcg per metered spray; 90-spray and 230-spray bottles
Indication
Acute relief of an attack, or acute prophylaxis, of angina pectoris due to coronary artery disease
History
Approved 2006; marketed in the U.S. from 2011; voluntarily discontinued in 2022 by a prior owner for reasons unrelated to safety or efficacy10
Prior performance
Peak sales of about US$40 million a year under prior ownership, under the direction of Humberto Borque, who now leads the relaunch for Vicapsys

Why it is different. An alcohol-free, propellant-driven metered dose designed to withstand freeze-thaw and heat cycling in field, EMS, military and rural storage, where conventional nitrates fail. The NDA remains approved, so the relaunch needs stability, fill and validation work, not new clinical trials.

The relaunch. NitroMist returns as a deliberately limited-distribution product on a narrow formulary, with preferred-formulary placement at the pharmacy benefit managers. Channels: Stateline's commercial accounts and the federal and tribal channel. A second indication is planned.

Pedigree. NitroMist was brought to market by Joe Krivulka, founder of Reliant Pharmaceuticals, the company GlaxoSmithKline bought for US$1.65 billion.11 He spent his career taking the drugs Big Pharma forgot and making them famous. NitroMist was one of them.

About NitroMist

Legacy biotechnology: VICAPSYN™

Retained upside, held directly by Vicapsys Life Sciences, Inc.

An exclusive license from Massachusetts General Hospital to CXCL12-based immune-isolation technology targeting the foreign-body response, the mechanism behind implant rejection and fibrosis. The lead application, VICAPSYN, is encapsulated islet cell clusters for type 1 diabetes, designed to survive without systemic immunosuppression. A second direction, VYBRIN™, is anti-fibrotic use in post-surgical settings, on its own regulatory and preclinical path.

The core patent family, "Eluting Matrix and Uses Thereof," comprises four issued U.S. patents plus European, Japanese, Australian and Russian counterparts running to about 2033; a 2018 family is pending in the U.S. and at the EPO, with protection to about 2038 if granted. The next steps are a cGMP-manufactured product, a proof-of-concept study in non-human primates and a contract research organization for Phase 1; the program is led by Federico Pier, the company's former CEO. Massachusetts General Hospital remains a major legacy shareholder.

Patent-family scope per management; being confirmed with MGH. Any material developments will be described in the company's public disclosures.

About VICAPSYN

Sources and notes

Superscript numbers on this site refer to this list. Figures are as published by the cited sources.

  1. IQVIA Institute, Understanding the Use of Medicines in the U.S. 2025 (May 2025): U.S. net medicine spending $487 billion in 2024, up 11.4%.
  2. Drug Channels Institute, Economic Report on Pharmaceutical Wholesalers (2026 ed.): Big Three $933 billion projected for 2026; above 90% share.
  3. VA FY2026 Budget Submission, Vol. II: pharmacy obligations $16.10 billion FY2025 estimate, $18.28 billion FY2026 request.
  4. Defense Health Program FY2026 Budget Estimates: pharmaceuticals $4.93 billion FY2025, $5.25 billion FY2026; about 9.4 million beneficiaries. IHS FY2026 Congressional Justification: about $8.07 billion; about 2.8 million patients.
  5. 15 U.S.C. §644(g); 13 CFR 124.506 (8(a) sole-source thresholds; tribal and ANC exception); FAR 19.808-1 and 6.303-1(b) (justification above $25 million; $100 million at DoD).
  6. HHS Buy Indian Act regulations, 48 CFR Part 326 (final rule 2022).
  7. Puerto Rico DACO: Reglamento 3707; Orden 2014-14; Ley 7-2019 as amended by Ley 17-2026 (about 900 reporting pharmacies, Metro PR, January 7, 2026).
  8. El Nuevo Día (October 5, 2026): Plan Vital about 1.36 million beneficiaries (December 2025). U.S. Census Bureau: Puerto Rico population about 3.2 million.
  9. GAO-11-836 (September 2011), cited by USC Schaeffer Center (October 2021): 340B discounts of 20–50%.
  10. NovaDel Pharma Inc., Form 10-K for 2010 (Akrimax license; U.S. marketing from January 2011); FDA NDA 021780 (approved 2006).
  11. GlaxoSmithKline: acquisition of Reliant Pharmaceuticals for US$1.65 billion in cash (2007).
  12. Vertex Pharmaceuticals, press release, September 3, 2019: acquisition of Semma Therapeutics for US$950 million in cash.
  13. Vertex Pharmaceuticals, type 1 diabetes program updates, March 28, 2025: VX-264 discontinued; zimislecel with standard immunosuppression; filings expected 2026.
  14. Vertex Pharmaceuticals, zimislecel Phase 1/2 results (ADA and NEJM, June 2025).
  15. Alagpulinsa DA et al. American Journal of Transplantation 2019;19(7):1930–1940.
  16. Transplant Direct 2019;5(5):e447 (CXCL12 alginate microbeads in nonhuman primates).
  17. Provention Bio, November 17, 2022: FDA approval of Tzield®; TN-10 median delay 50 vs 25 months.
  18. Diabetes Research Institute, August 26, 2015: islets transplanted onto the omentum (BioHub pilot).
  19. CDC, National Diabetes Statistics Report: about 2 million Americans with type 1 diabetes.
  20. U.S. Patents 9,775,816; 9,849,094; 9,849,159; 10,580,262, "Eluting matrix and uses thereof."
  21. Sremac M, Luo H, Deng H, et al.; Poznansky MC. Xenotransplantation 2023;e12826 (CXCL12 microencapsulated porcine islets in non-human primates without systemic immunosuppression).
  22. Deng H, Zhang A, Pang DRR, et al. Cell Reports Medicine 2023;4(3):100959 (omental transplant site in non-human primates).

Company sources: press releases of September 22 and 25 and October 5, 2026; executed agreements; management figures (peak sales, SKU access) as stated by management.