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Vitti Labs

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uuid006d8bb

Namestring
Vitti Labs
Legal namestring
Vitti Labs, LLC
Websiteurl
vittilabs.com
Company typeenum
Private
Founded yearint
2019
Descriptiontext

Vitti Labs is a privately held LLC headquartered in Liberty, Missouri, founded in 2019 to manufacture human cellular and tissue-based products (HCT/Ps) for clinical use. The company operates as an AATB-accredited, cGMP-certified, and FDA-registered (21 CFR Part 1271) tissue bank that produces 361 HCT/Ps under minimal-manipulation processing guidelines from bio-ethically sourced US birth tissue. Its commercial portfolio centers on birth-tissue-derived materials, mesenchymal stem cell (MSC) products, and extracellular vesicle preparations for homologous use by medical professionals across clinical settings.

The company runs an R&D pipeline that targets an unusually broad set of indications: VL-OV11 is in Phase II for infertility (POI/PCOS); VL-PX10 and VL-P22 are in expanded access for Covid and pulmonary fibrosis / Long-Haul Covid / COPD; UCT-MSC plus biomaterials and UC-Blood Biomolecules are in pre-clinical development for Crohn's Disease, Duchenne Muscular Dystrophy, and Autism; and a MSC Exosomal Eye Serum is in pre-clinical for age-related macular degeneration and glaucoma. Quality control rests on third-party lot testing covering sterility (USP 71), endotoxin, environmental controls (USP 1116), and broad pathogen screening, with execution anchored by university research partnerships and IRB studies.

Vitti Labs distributes exclusively through a direct enterprise field-sales motion to medical professionals in the United States; pricing is quote-based and not publicly disclosed, and the website is restricted to medical-professional viewers. The company is owner-operated with no disclosed institutional funding, parent entity, or public ownership, and no revenue, headcount, or transaction data is available in the source material. Revenue mechanics are anchored on one-time HCT/P product sales, with the pipeline positioned as a future driver of clinical-trial and expanded-access revenue rather than near-term commercial scale.

Short descriptiontext

Vitti Labs is an AATB-accredited, cGMP-certified, FDA-registered tissue bank in Liberty, Missouri that manufactures bio-ethically sourced 361 HCT/P products (birth tissue, MSCs, extracellular vesicles) for medical professionals and runs a clinical-stage regenerative medicine pipeline across multiple indications.

Operating statusenum
Operating
Ownership categoryenum
Headcount rangeband
1–10
akta.pro rankint
HeadquartersMiami, United States
HQ citystring
Miami
HQ countrystring
United States
HQ regionstring
North America
Markets served

Serves global market

Offices1 record

Each record includes

City, Country, Type, Description, Source

Keyword5 values
regenerative medicine manufacturing, human tissue products, cellular therapy products, tissue banking services, birth tissue products
Industry3 codes
PRIMARYHLAGAGAF
Analytical Development & QC Testing (Release/Stability/Potency)
Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Biopharma Manufacturing Services (Biologics/Cell & Gene)
SECONDARYHLAGAEAI
Sample Logistics, Biorepository & IVD Kit Management (Trial Support)
Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Central Labs & Clinical Diagnostics Services (Trial Support)
SECONDARYHLAJADAF
Clinical Trials Authorization & Oversight (GCP)
Healthcare & Life Sciences/Public Health, Government & Regulators/Medicines & Healthcare Product Regulators (Drugs/Biologics/Devices)
NAICS code2 codes
  • Biological Product (except Diagnostic) Manufacturing325414
  • Pharmaceutical and Medicine Manufacturing3254
SIC code2 codes
  • Biological Products, (No Disgnostic Substances)2836
  • Pharmaceutical Preparations2834
Product category
Regenerative Medicine Manufacturing
Social media profiles1 record
GTM motion1 record

Each record includes

Type, Description, Source

Revenue model1 record
1HCT/P Product Sales
TypeOne Time License
Description

Revenue from manufacturing and selling human cellular and tissue-based products (HCT/Ps) for homologous use in clinical settings. Products include birth tissue-derived materials for medical professionals supporting patient quality of life.

vittilabs.com
Marketing channels3 records

Each record includes

Title, Type, Stage, Description, Source

Distribution channels1 record

Each record includes

Title, Type, Scope, Target buyer, Description, Source

Cost components6 values
Personnel, Operations, Technology or R&D, Supply Chain, Marketing or Sales, Infrastructure
GTM typeB2B
B2B
Offering typeHardware or Manufacturing
Hardware or Manufacturing
Core offering1 text field

Vitti Labs manufactures and supplies bio-ethically sourced human cellular and tissue-based products (HCT/Ps) regulated as 361 HCT/Ps for homologous use in clinical settings. The portfolio serves medical professionals in clinical practice and supports an investigational pipeline of therapeutic candidates (infertility, Covid/pulmonary, Crohn's, DMD, autism, ophthalmology) processed under AATB, cGMP, and FDA-registered standards.

Differentiator
Functional benefit
Problem solved
Product overview1 text field

Vitti Labs is an AATB accredited, cGMP certified, and FDA registered tissue bank offering a portfolio of bio-ethically manufactured human birth tissue products (HCT/Ps) regulated as 361 HCT/Ps for homologous use in clinical settings. The company provides a comprehensive portfolio including core HCT/P products along with multiple therapeutic candidates in its pipeline: VL-OV11 for infertility, VL-PX10 & VL-P22 for Covid and pulmonary conditions, UCT-MSC + Biomaterials and UC-Blood Biomolecules for neurological/autoimmune conditions, and MSC Exosomal Eye Serum for ophthalmology applications. Manufacturing follows minimal manipulation guidelines with third-party lab testing for sterility, endotoxin, and environmental controls.

Product and service6 records
1Human Cellular and Tissue-Based Products (HCT/Ps)
CategoryRegenerative Medicine / Tissue Products
Description

Industry-leading portfolio of human cellular and tissue-based products regulated as 361 HCT/Ps under 21 CFR 1271.3(f)(1) for homologous use in clinical settings, manufactured via minimal-manipulation processing and bio-ethically sourced from U.S. donors. Sold to medical professionals and healthcare providers through a direct sales channel.

2VL-OV11
CategoryRegenerative Medicine / Investigational Therapeutic
Description

Named Vitti Labs therapeutic candidate for Infertility (POI/PCOS), currently in Clinical Trials Phase II under investigational status.

3VL-PX10 and VL-P22
CategoryRegenerative Medicine / Investigational Therapeutic
Description

Named Vitti Labs therapeutic candidates for Covid, pulmonary fibrosis in Long-Haul Covid patients, and COPD; reported as in expanded access for pulmonary fibrosis per source.

4UCT-MSC + Biomaterials
CategoryRegenerative Medicine / Investigational Therapeutic
Description

Investigational Umbilical Cord Tissue Mesenchymal Stem Cells product combined with biomaterials, targeted at Crohn's Disease, Duchenne Muscular Dystrophy, and Autism; in pre-clinical safety and efficacy studies per source.

5UC-Blood Biomolecules
CategoryRegenerative Medicine / Investigational Therapeutic
Description

Investigational Umbilical Cord Blood Biomolecules product targeted at Autism treatment; in pre-clinical safety and efficacy studies per source.

6MSC Exosomal Eye Serum
CategoryRegenerative Medicine / Investigational Therapeutic
Description

Investigational Mesenchymal Stem Cell Exosomal Eye Serum targeted at Age-Related Macular Degeneration and Glaucoma; in pre-clinical development per source.

Scale indicator3 records

Each record includes

Type, Value, Description, Source

Partnership1 partner
1University Research Partners
Strategic tierCoreTypeStrategic or Co-development Partner
Description

Vitti Labs conducts clinical research through university partnerships for therapeutic development including IND Applications and IRB Studies. Research focuses on human birth tissue bioavailable materials, mesenchymal stem cells, and extracellular vesicles for treating pulmonary disease, fertility, ophthalmology, and neurodegenerative diseases.

vittilabs.com
Recent move6 records

Each record includes

Date, Type, Title, Description, Source

Expansion highlight5 records

Each record includes

Type, Description

Peers10 records
TypeOthers
Description

Public provider of temperature-controlled supply chain solutions for the life sciences industry, including cell and tissue logistics. Comparable as a biorepository-adjacent infrastructure provider supporting cell and tissue therapy supply chains.

TypeBroad incumbent
Description

Large public medical device company with significant advanced wound management and regenerative medicine portfolio (including acquired Osiris assets). Comparable as a scaled commercial channel and competitor in regenerative wound and tissue markets.

TypeDirect peer
Description

Public regenerative medicine company (ORGO) selling living cell-based wound care products (e.g., Apligraf, Dermagraft) derived from human cells. Comparable in selling regulated cell/tissue products to hospitals and clinical specialists via field sales.

TypeEmerging player
Description

Clinical-stage cell therapy company developing allogeneic placenta-derived cell therapies and biomaterial products. Comparable as a peer using birth tissue (placenta/umbilical cord) as raw material for regenerative medicine applications.

TypeDirect peer
Description

Non-profit tissue bank providing allograft tissue for transplantation and regenerative medicine. Comparable as a peer AATB-accredited tissue bank with hospital/biotech distribution model.

TypeDirect peer
Description

Non-profit tissue bank that manufactures allografts from donated human tissue for orthopedic, spine, sports medicine and wound care. Directly comparable as an AATB-accredited tissue processor supplying hospitals and OEMs.

TypeDirect peer
Description

Public regenerative medicine company that processes and markets human placental tissue allografts (e.g., EpiFix, AmnioFix) for wound care and surgical applications. Closest direct competitor in the HCT/P birth-tissue space with overlapping homologous-use product strategy.

TypeBroad incumbent
Description

Public medical device company (IART) with a regenerative tissue technologies portfolio (e.g., Integra dermal regeneration templates, amniotic membrane products). Larger incumbent with overlapping hospital channel and wound/regenerative medicine focus.

TypeDirect peer
Description

Originally pioneered mesenchymal stem cell products (Grafix, OvationOS) from placental tissue; now part of Smith+Nephew. Highly comparable in MSC-based regenerative medicine product strategy and 361 HCT/P positioning.

TypeDirect peer
Description

Public cell therapy company (VCEL) commercializing autologous and allogeneic cell therapies (MACI, Epicel). Comparable as a specialized cell-based therapeutics company selling into hospitals and surgical specialists.

Market position
Strengths5 records

Each record includes

Headline, Details, Source

Weaknesses5 records

Each record includes

Headline, Details, Source

Competitive moat4 records

Each record includes

Type, Details

Key risks6 records

Each record includes

Headline, Details, Source

Key highlights6 records

Each record includes

Headline, Details, Source

Customer concentration

Classification, Details

Segment2 records

Each record includes

Title, Type, Primary, Description, Pain point addressed, Use case, Source

Ideal customer profile2 records

Each record includes

Profile, Firmographic size, Sales motion, Sales cycle length, Buying structure, Purchase trigger, Buyer persona, Geography, Industry vertical, Primary use case, Description, Pain points, Evidence proof points, Target buyer

Technology focused
Yes
API detail
Has APIbool
No

Docs URL, Description

AI maturity
App detail

Has app

Feature4 records

Each record includes

Title, Differentiator, Description, Source

Core technology
Revenue estimate
Valuation estimate
Number of profiles
No data
Compliance3 records

Each record includes

Name, Class, Description

Funding overview

Funding stage, Last funding date, Total funding USD

Funding rounds

Each record includes

Round, Amount USD, Date, Pre money valuation, Total investors, Investors, News

Investors

Each record includes

Name, Type, Date of entry, Rounds participated, Website

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

M&A

Each record includes

Name, Acquisition type, Announced date, Completed date, Status, Website, News

Investment

Each record includes

Name, Round, Announced date, Lead investor, Website, News

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

Vitti Labs

Regenerative Medicine Manufacturingvittilabs.com

Vitti Labs is an AATB-accredited, cGMP-certified, FDA-registered tissue bank in Liberty, Missouri that manufactures bio-ethically sourced 361 HCT/P products (birth tissue, MSCs, extracellular vesicles) for medical professionals and runs a clinical-stage regenerative medicine pipeline across multiple indications.

What Vitti Labs does

Vitti Labs is a privately held LLC headquartered in Liberty, Missouri, founded in 2019 to manufacture human cellular and tissue-based products (HCT/Ps) for clinical use. The company operates as an AATB-accredited, cGMP-certified, and FDA-registered (21 CFR Part 1271) tissue bank that produces 361 HCT/Ps under minimal-manipulation processing guidelines from bio-ethically sourced US birth tissue. Its commercial portfolio centers on birth-tissue-derived materials, mesenchymal stem cell (MSC) products, and extracellular vesicle preparations for homologous use by medical professionals across clinical settings.

The company runs an R&D pipeline that targets an unusually broad set of indications: VL-OV11 is in Phase II for infertility (POI/PCOS); VL-PX10 and VL-P22 are in expanded access for Covid and pulmonary fibrosis / Long-Haul Covid / COPD; UCT-MSC plus biomaterials and UC-Blood Biomolecules are in pre-clinical development for Crohn's Disease, Duchenne Muscular Dystrophy, and Autism; and a MSC Exosomal Eye Serum is in pre-clinical for age-related macular degeneration and glaucoma. Quality control rests on third-party lot testing covering sterility (USP 71), endotoxin, environmental controls (USP 1116), and broad pathogen screening, with execution anchored by university research partnerships and IRB studies.

Vitti Labs distributes exclusively through a direct enterprise field-sales motion to medical professionals in the United States; pricing is quote-based and not publicly disclosed, and the website is restricted to medical-professional viewers. The company is owner-operated with no disclosed institutional funding, parent entity, or public ownership, and no revenue, headcount, or transaction data is available in the source material. Revenue mechanics are anchored on one-time HCT/P product sales, with the pipeline positioned as a future driver of clinical-trial and expanded-access revenue rather than near-term commercial scale.

Vitti Labs firmographics

Firmographics
Name
Vitti Labs
Legal name
Vitti Labs, LLC
Website
https://vittilabs.com
Company type
Private
Founded year
2019
Operating status
Operating
Headcount range
1–10 employees
Short description
Vitti Labs is an AATB-accredited, cGMP-certified, FDA-registered tissue bank in Liberty, Missouri that manufactures bio-ethically sourced 361 HCT/P products (birth tissue, MSCs, extracellular vesicles) for medical professionals and runs a clinical-stage regenerative medicine pipeline across multiple indications.
Ownership category
akta.pro rank

Vitti Labs industry classification

Industry
Product category
Regenerative Medicine Manufacturing
NAICS
Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical and Medicine Manufacturing (3254)
SIC
Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)
akta.pro industry
PRIMARYHLAGAGAF
Analytical Development & QC Testing (Release/Stability/Potency)
Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Biopharma Manufacturing Services (Biologics/Cell & Gene)
SECONDARYHLAGAEAI
Sample Logistics, Biorepository & IVD Kit Management (Trial Support)
Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Central Labs & Clinical Diagnostics Services (Trial Support)
SECONDARYHLAJADAF
Clinical Trials Authorization & Oversight (GCP)
Healthcare & Life Sciences/Public Health, Government & Regulators/Medicines & Healthcare Product Regulators (Drugs/Biologics/Devices)

Keywords

  • Regenerative medicine manufacturing
  • Human tissue products
  • Cellular therapy products
  • Tissue banking services
  • Birth tissue products

Where Vitti Labs is headquartered

Location

Headquarters

HQ city
Miami
HQ country
United States
HQ region
North America

Offices1 record

Markets served

Vitti Labs business model

Business model
GTM type
B2B
Offering type
Hardware or Manufacturing
Cost components
Personnel, Operations, Technology or R&D, Supply Chain, Marketing or Sales, Infrastructure

Revenue model

  1. HCT/P Product Sales: Revenue from manufacturing and selling human cellular and tissue-based products (HCT/Ps) for homologous use in clinical settings. Products include birth tissue-derived materials for medical professionals supporting patient quality of life.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Vitti Labs product offering

Product offering

Core offering

Vitti Labs manufactures and supplies bio-ethically sourced human cellular and tissue-based products (HCT/Ps) regulated as 361 HCT/Ps for homologous use in clinical settings. The portfolio serves medical professionals in clinical practice and supports an investigational pipeline of therapeutic candidates (infertility, Covid/pulmonary, Crohn's, DMD, autism, ophthalmology) processed under AATB, cGMP, and FDA-registered standards.

Product overview

Vitti Labs is an AATB accredited, cGMP certified, and FDA registered tissue bank offering a portfolio of bio-ethically manufactured human birth tissue products (HCT/Ps) regulated as 361 HCT/Ps for homologous use in clinical settings. The company provides a comprehensive portfolio including core HCT/P products along with multiple therapeutic candidates in its pipeline: VL-OV11 for infertility, VL-PX10 & VL-P22 for Covid and pulmonary conditions, UCT-MSC + Biomaterials and UC-Blood Biomolecules for neurological/autoimmune conditions, and MSC Exosomal Eye Serum for ophthalmology applications. Manufacturing follows minimal manipulation guidelines with third-party lab testing for sterility, endotoxin, and environmental controls.

Differentiator

Problem solved

Functional benefit

Products and services

  • Human Cellular and Tissue-Based Products (HCT/Ps) Industry-leading portfolio of human cellular and tissue-based products regulated as 361 HCT/Ps under 21 CFR 1271.3(f)(1) for homologous use in clinical settings, manufactured via minimal-manipulation processing and bio-ethically sourced from U.S. donors. Sold to medical professionals and healthcare providers through a direct sales channel.
  • VL-OV11 Named Vitti Labs therapeutic candidate for Infertility (POI/PCOS), currently in Clinical Trials Phase II under investigational status.
  • VL-PX10 and VL-P22 Named Vitti Labs therapeutic candidates for Covid, pulmonary fibrosis in Long-Haul Covid patients, and COPD; reported as in expanded access for pulmonary fibrosis per source.
  • UCT-MSC + Biomaterials Investigational Umbilical Cord Tissue Mesenchymal Stem Cells product combined with biomaterials, targeted at Crohn's Disease, Duchenne Muscular Dystrophy, and Autism; in pre-clinical safety and efficacy studies per source.
  • UC-Blood Biomolecules Investigational Umbilical Cord Blood Biomolecules product targeted at Autism treatment; in pre-clinical safety and efficacy studies per source.
  • MSC Exosomal Eye Serum Investigational Mesenchymal Stem Cell Exosomal Eye Serum targeted at Age-Related Macular Degeneration and Glaucoma; in pre-clinical development per source.

Companies that use Vitti Labs

Customer profile

Segments2 records

Ideal customer profiles2 records

Vitti Labs technology and API

Technology

Technology focussed Yes

API detail

Has API
No
API docs
API detail

Core technology

AI maturity

App detail

Feature4 records

Vitti Labs partnerships and signals

Strategic signal

Partnerships

One partnership is on record.

  • University Research PartnerscoreStrategic or Co-development PartnerVitti Labs conducts clinical research through university partnerships for therapeutic development including IND Applications and IRB Studies. Research focuses on human birth tissue bioavailable materials, mesenchymal stem cells, and extracellular vesicles for treating pulmonary disease, fertility, ophthalmology, and neurodegenerative diseases.

Scale indicators3 records

Recent moves6 records

Expansion highlights5 records

Vitti Labs competitors and assessment

Company assessment

Others

  • Cryoport Systems: Public provider of temperature-controlled supply chain solutions for the life sciences industry, including cell and tissue logistics. Comparable as a biorepository-adjacent infrastructure provider supporting cell and tissue therapy supply chains.

Broad incumbents

  • Smith+Nephew: Large public medical device company with significant advanced wound management and regenerative medicine portfolio (including acquired Osiris assets). Comparable as a scaled commercial channel and competitor in regenerative wound and tissue markets.
  • Integra LifeSciences: Public medical device company (IART) with a regenerative tissue technologies portfolio (e.g., Integra dermal regeneration templates, amniotic membrane products). Larger incumbent with overlapping hospital channel and wound/regenerative medicine focus.

Direct peers

  • Organogenesis: Public regenerative medicine company (ORGO) selling living cell-based wound care products (e.g., Apligraf, Dermagraft) derived from human cells. Comparable in selling regulated cell/tissue products to hospitals and clinical specialists via field sales.
  • Community Tissue Services: Non-profit tissue bank providing allograft tissue for transplantation and regenerative medicine. Comparable as a peer AATB-accredited tissue bank with hospital/biotech distribution model.
  • AlloSource: Non-profit tissue bank that manufactures allografts from donated human tissue for orthopedic, spine, sports medicine and wound care. Directly comparable as an AATB-accredited tissue processor supplying hospitals and OEMs.
  • MiMedx Group: Public regenerative medicine company that processes and markets human placental tissue allografts (e.g., EpiFix, AmnioFix) for wound care and surgical applications. Closest direct competitor in the HCT/P birth-tissue space with overlapping homologous-use product strategy.
  • Osiris Therapeutics (Smith+Nephew): Originally pioneered mesenchymal stem cell products (Grafix, OvationOS) from placental tissue; now part of Smith+Nephew. Highly comparable in MSC-based regenerative medicine product strategy and 361 HCT/P positioning.
  • Vericel Corporation: Public cell therapy company (VCEL) commercializing autologous and allogeneic cell therapies (MACI, Epicel). Comparable as a specialized cell-based therapeutics company selling into hospitals and surgical specialists.

Emerging players

  • Celularity Inc. Clinical-stage cell therapy company developing allogeneic placenta-derived cell therapies and biomaterial products. Comparable as a peer using birth tissue (placenta/umbilical cord) as raw material for regenerative medicine applications.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

Vitti Labs social profiles

Digital presence

Vitti Labs compliance and trust

Trust signal

Compliance3 records

Vitti Labs financial estimates

Financial estimate

Revenue estimate

Valuation estimate

Vitti Labs leadership team

Management profile

Number of profiles

Vitti Labs funding detail

Funding detail

Funding overview

Funding rounds

Investors

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

Vitti Labs M&A and investment

M&A and investment

M&A

Investments

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

Frequently asked questions about Vitti Labs

What does Vitti Labs do?

Vitti Labs manufactures and supplies bio-ethically sourced human cellular and tissue-based products (HCT/Ps) regulated as 361 HCT/Ps for homologous use in clinical settings. The portfolio serves medical professionals in clinical practice and supports an investigational pipeline of therapeutic candidates (infertility, Covid/pulmonary, Crohn's, DMD, autism, ophthalmology) processed under AATB, cGMP, and FDA-registered standards.

Is Vitti Labs a public or private company?

Vitti Labs is a private company. It is classified as founder individual operated bootstrapped and is currently operating.

When was Vitti Labs founded?

Vitti Labs was founded in 2019. It employs 1 to 10 people.

Where is Vitti Labs based?

Vitti Labs is headquartered in Miami, United States, in the North America region.

How does Vitti Labs make money?

One revenue line is on record: HCT/P Product Sales.

Who are Vitti Labs's main competitors?

Cryoport Systems is listed as an others. Broad incumbents are Smith+Nephew and Integra LifeSciences. Direct peers are Organogenesis, Community Tissue Services, AlloSource, MiMedx Group, Osiris Therapeutics (Smith+Nephew) and Vericel Corporation. Celularity Inc. is listed as an emerging player.

Does Vitti Labs have an API?

No public API is recorded for Vitti Labs.

What industry is Vitti Labs in?

Vitti Labs's product category is Regenerative Medicine Manufacturing. Its primary akta.pro industry code is HLAGAGAF, Analytical Development & QC Testing (Release/Stability/Potency), with a secondary code of HLAGAEAI, Sample Logistics, Biorepository & IVD Kit Management (Trial Support). Its NAICS code is 325414 and its SIC code is 2836.

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Live signals
PR NewswireFDA Approves First IND of its Kind for Allogenic Exosomal Treatment of Female Reproductive Disorder - Primary Ovarian InsufficiencyVitti Labs announced FDA approval of its Investigational New Drug Application for EV-Pure, an allogenic exosomal product for treating Primary Ovarian Insufficiency, with clinical trials expected to begin patient recruitment early next year. The company claims this is the first IND for evaluating allogenic exosomes in this indication, a condition affecting approximately 1 in 100 women under 40 with no currently approved treatments available. Vitti Labs indicated plans to leverage this study to develop treatments for other reproductive disorders such as Polycystic Ovary Syndrome.PR NewswireVitti Labs Announces FDA Approval of IND Application for Phase II Clinical Trial of Combination Mesenchymal Stem Cell and Exosome Treatment of Novel Corona Virus Infection (COVID-19)The FDA has approved Vitti Labs' Investigational New Drug (IND) application to conduct Phase II Clinical Trials using a combination of umbilical cord mesenchymal stem cells and exosomes for treating acute respiratory distress syndrome (ARDS) associated with COVID-19, marking the first FDA approval for a therapy using both components together. The combination therapy is designed to suppress pro-inflammatory processes in the pulmonary system while reducing oxidative stress and alleviating pulmonary distress. The Phase II trial, expected to conclude in Q1 2022, follows overwhelmingly successful preliminary trials.