Cellf BIO

What Cellf BIO does

Cellf BIO is a privately held regenerative medicine company founded in 2014 and headquartered in Winston Salem, North Carolina. The company develops bioengineered sphincter technology, with its lead product, the BioSphincter, designed to treat fecal incontinence in adults. Cellf BIO targets an estimated addressable population of approximately 18 million adults in the United States — roughly 1 in 12 people — for whom the company states no effective permanent solution currently exists. The primary customer segment is fecal incontinence patients, particularly older adults and women following childbirth.

The BioSphincter is grown from autologous smooth muscle cells and neural stem cells retrieved from the patient's own gut via biopsy, eliminating rejection risk. The autologous construct is implanted in the area of the defective sphincter, where it is designed to integrate with the patient's gastrointestinal tract and restore normal physiological function of the ano-rectum. Cellf BIO maintains registered/granted patent protection on the platform technologies and processes underlying BioSphincter production. The same platform is described as enabling additional pipeline products for urinary incontinence and esophageal reconstruction, although those candidates have not been publicly named.

Cellf BIO is pre-revenue and pre-commercial. The company's contemplated revenue model is one-time implantable therapeutic sales of the BioSphincter through medical facility and healthcare provider channels, contingent upon completion of clinical trials and receipt of regulatory approval. The company markets its pipeline through a direct-to-consumer email interest list and downloadable brochures, with the only public contact channel being a general mailbox ([email protected]). No funding rounds, institutional investors, partnerships, or ownership structure are disclosed in available sources, and the company reports 1–10 employees.

Name

Cellf BIO

Website

https://cellfbio.com

Company type

Private

Founded year

2014

Operating status

Operating

Headcount range

1–10 employees

Short description

Cellf BIO is a privately held regenerative medicine company developing the BioSphincter, a bioengineered sphincter grown from a patient's own cells for fecal incontinence treatment. The company is pre-commercial, with sales contingent on clinical trials and regulatory approval.

Ownership category

akta.pro rank

Product category

Regenerative Medicine Implants

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Cell Therapy Developers (Autologous) (HLAAABAA)

Keywords

• Regenerative medicine therapies
• Bioengineered sphincter implant
• Fecal incontinence treatment
• Autologous cell therapy
• Digestive disorder therapeutics

Headquarters

HQ city

Winston Salem

HQ country

United States

HQ region

North America

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales

Revenue model

1. BioSphincter Product Sales: Cellf BIO will generate revenue through commercial sale of the BioSphincter medical device upon completion of clinical trials and regulatory approval. The product is a one-time implantable therapeutic.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels2 records

Core offering

Cellf BIO develops the BioSphincter, a bioengineered sphincter grown from a patient's own smooth muscle cells and neural stem cells retrieved via biopsy from the gut. The autologous sphincter is implanted in the area of the defective sphincter, forming a new continuum of the patient's gastrointestinal tract, and is intended to provide the only permanent solution for fecal incontinence. The product is in pre-commercial stage, with commercial sale contingent upon completion of clinical trials and regulatory approval.

Product overview

Cellf BIO is a regenerative medicine company offering a single core product, the BioSphincter, for fecal incontinence treatment. The company also has pipeline development for products targeting urinary incontinence and esophageal reconstruction, though these additional offerings have not yet been named or launched. The BioSphincter represents the company's primary commercial focus, with sales contingent upon completion of clinical trials and regulatory approval.

Differentiator

Problem solved

Functional benefit

Products and services

• BioSphincter

Segments1 record

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Scale indicators2 records

Recent moves4 records

Expansion highlights3 records

Direct peers

• AxoGen: AxoGen develops and commercializes peripheral nerve repair technologies, including processed nerve allografts. It is comparable to Cellf BIO as a peer in tissue-engineered implantable biologics that restore native physiological function, sharing similar regulatory pathways and surgical-specialty channels.
• Cook Biotech: Cook Biotech develops regenerative medicine products using extracellular matrix and tissue engineering technologies for wound care and surgical applications. It is comparable to Cellf BIO as a peer in tissue engineering and regenerative biomaterials used to repair or replace damaged anatomical structures.
• Atlantic Therapeutics: Atlantic Therapeutics develops non-invasive electrical muscle stimulation devices (e.g., Innovo) for stress urinary incontinence and pelvic floor disorders. It is a direct peer competing for the same incontinence patient population that Cellf BIO targets, but with a non-cell-based device approach.
• Vericel: Vericel develops autologous cell therapies (MACI for cartilage repair, Epicel for burns) using a patient's own cells. It is a direct peer in autologous cell therapy commercialization, sharing the same patient-biopsy-to-implant workflow and similar regulatory and manufacturing economics as Cellf BIO's BioSphincter.

Broad incumbents

• Coloplast: Coloplast is a global leader in continence care, ostomy, and wound care products. While not a cell therapy company, Coloplast is a directly comparable competitor in the fecal incontinence patient market that Cellf BIO targets and would likely be a major competitor or acquirer of BioSphincter technology.
• MiMedx: MiMedx processes and commercializes placental tissue allografts for wound care and surgical recovery applications. It is a comparable regenerative medicine peer in the surgical biologics space, with similar regulatory, reimbursement, and surgeon-channel dynamics as Cellf BIO's BioSphincter.
• Organogenesis: Organogenesis is a leading regenerative medicine company commercializing living cell-based therapies for wound care and surgical applications. It is comparable to Cellf BIO as an established player in autologous and cell-based regenerative medicine, providing a benchmark for clinical translation and commercialization of living cell therapies.
• Convatec: Convatec is a major medical products company with a focus on continence, ostomy, advanced wound care, and infusion care. It competes for the same fecal incontinence patient population that Cellf BIO targets with BioSphincter, and is a relevant peer in the addressable continence care market.
• Integra LifeSciences: Integra LifeSciences is a major medical technology company with a substantial regenerative technologies portfolio (Integra dermal regeneration templates, dural repair). It is comparable to Cellf BIO as a broad incumbent in regenerative tissue engineering serving surgical specialists in similar channels.

Emerging players

• Renovia: Renovia is an emerging women's health company developing digital therapeutics and devices (e.g., leva) for pelvic floor disorders including urinary incontinence. It targets an adjacent patient population to Cellf BIO's fecal incontinence focus, representing emerging non-surgical competition for sphincter-related disorders.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights5 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Cellf BIO