Regenerative Medicine · Hollow-Organ Reconstruction

One platform. Various organ reconstruction procedures. No tissue harvest.

WeaveBio is developing BLSF, a bilayer silk fibroin scaffold designed to replace tissue grafts, regenerate, and resorb. The platform is built to eliminate the need for autologous tissue harvest in urethral, bladder, and other hollow-organ reconstructive surgeries.

Organ reconstructive surgeries still utilize tissue grafts that are harvested from the patient.

For decades, reconstructive teams have rebuilt damaged hollow organs by harvesting tissue from elsewhere in the patient: buccal mucosa from the cheek, bowel from the intestine, skin from the thigh. The harvest works, but it increases operative time, creates a second wound, drives donor-site morbidity, and produces outcomes that vary with surgeon experience and patient anatomy.

WeaveBio is building the alternative: an off-the-shelf, animal-free, engineered scaffold designed to deliver the same regenerative outcome, without taking anything from the patient.

50K+

Patients per year in the United States undergo a separate tissue-harvest surgery before reconstruction can begin.

5

Pipeline programs, leading with urethral stricture repair and extending through bladder, urinary diversion, tracheal, and esophageal reconstruction.

1

One off-the-shelf device. Replaces two surgeries with one, eliminating the harvest.

The Platform

BLSF: Bilayer Silk Fibroin. Engineered for regeneration.

BLSF is a fully synthetic, animal-free scaffold built by combining two engineered films of silk fibroin. The outer film is impermeable, a fluid barrier that supports epithelial regrowth. The inner film is porous, a substrate that guides cell ingrowth, tissue infiltration, and neovascularization. Together they form a tunable construct that integrates with native tissue, supports regeneration, and resorbs as the patient's own tissue takes over.

BLSF can be engineered for use in indications as different as urethra, bladder, and trachea. Porosity, mechanical properties, and resorption window are each tunable to match the regenerative biology of the target organ.

Off-the-shelf. Sterilizable. Animal-free. One manufacturing process. Multiple indications. Economies of scale designed in from the start.

Porous inner layer of the BLSF scaffold, foam surface
Porous inner layer · cell ingrowth & vascularization
Impermeable outer layer of the BLSF scaffold, film surface
Impermeable outer layer · fluid barrier

Standard of Care vs. BLSF

Two surgeries or one.

Today's gold standard rebuilds the urethra with tissue harvested from the patient's own cheek: an additional surgical site, an additional wound, and an outcome that varies with surgeon experience. BLSF is engineered to replace tissue grafts with an off-the-shelf device, eliminating the need for harvest surgeries.

Standard of care

Buccal graft urethroplasty

2 surgical sitesInner cheek (harvest) + urethra (repair)
  1. Harvest mucosa from the inner cheek
  2. Excise the strictured segment
  3. Suture graft into the urethra
  4. Catheter, then heal two separate wounds
Additional surgical siteDonor-site morbidityLonger OR timeGraft quality variesTwo wounds to healNever becomes native organ tissue
WeaveBio

BLSF scaffold

1 surgical siteUrethra (repair) only
  1. Place the off-the-shelf BLSF scaffold
  2. Native tissue integrates & regenerates
  3. Scaffold resorbs as organ tissue takes over
No tissue harvestSingle surgical siteOff-the-shelfUniform quality across all scaffoldsDesigned for faster recoveryBecomes native organ tissue

The Pipeline

Five programs. One platform. Staged advancement.

WB-101 advances across three urology indications on a single BLSF device. Platform-expansion programs (WB-102–105) extend the same scaffold technology into bladder, conduit, tracheal, and esophageal repair.

ProgramIndicationPreclinicalIDE-enablingPhase 1Phase 2/3
WB-101aUrethral stricture2.3–6.3M US men affected (women a minority)
WB-101bHypospadias1 in 250 male births (~7,600 / yr)
WB-101cPeyronie's disease4–6.5M US men affected
Platform expansion · research
WB-102Bladder augmentation
WB-103Urinary conduit
WB-104Tracheal stenosis
WB-105Esophageal atresia

Filled dots indicate progress within each stage. WB-101 spans three urology indications on one BLSF SKU; WB-102–105 are research-stage platform extensions. Prevalence figures sourced from the WeaveBio Unified Market Opportunity model (US AUA, HCUP-NIS, CMS claims, KOL interviews); hypospadias shown as birth prevalence.

Team & Advisors

An experienced operating team, backed by a deep clinical and scientific bench.

WeaveBio is led by an operating team with decades of combined experience across drug, device, and combination-product development, and advised by a bench drawn from leading programs in reconstructive urology, regenerative medicine, biomaterials, and reimbursement strategy.

Leadership

Vikas Agarwal, PhD
Vikas Agarwal, PhD
Chief Executive Officer
24+ years in biotech device & combination products; 10+ years in urology.
Johnson & Johnson Cephalon TARIS Biomedical
John Nagel
John Nagel
Chief Business Officer
Business development & commercialization across specialty pharma and biotech.
WARF Therapeutics Cephalon sanofi aventis
Carlos Estrada, MD, MBA
Carlos Estrada, MD, MBA
Co-Founder
Pediatric & reconstructive urologist; deep KOL network.
Boston Children's Hospital Harvard Medical School
Joshua Mauney, PhD
Joshua Mauney, PhD
Co-Founder, Scientific Lead
Biomaterials subject-matter expert; hollow-organ regeneration.
UC Irvine Boston Children's Hospital

Advisory Board

Jessica DeLong, MD, FACS
Jessica DeLong, MD, FACS
Clinical Advisor
Reconstructive urologist & KOL.
University of Wyoming Juniper Biomedical Lahey Hospital & Medical Center
Steven Lu
Steven Lu
Device Advisor
Regenerative-medicine device development.
Leyland Consulting Ocular Therapeutix Secant Group
Kristen Mittal
Kristen Mittal
Regulatory & Reimbursement Advisor
Medical-device regulatory & payor strategy.
Johnson & Johnson Mittal Consulting Stryker

"One platform. Three indications underway. A pipeline that extends across hollow-organ reconstruction."

Contact Us

BLSF is ready to advance into the clinic. We are actively seeking investors and strategic partners to raise our Series A and advance into first-in-human (FIH) studies.

Location
United States
Website