Government MoU Signed with RGGGH

Establishing India's First Human Pancreatic Islet Transplant Program

iGN Biotech is pioneering cell therapy for Type 1 and Type 3C diabetes through human pancreatic islet transplantation—bringing a potential cure to 84 million diabetic patients in Southeast Asia.

249+ Human Islet Isolations
2 Granted Patents
80.6% Viability Rate
2x Higher Yield
iGN Biotech Logo

Supported By Government & Research Institutions

Entrepreneurship Development
Department of Biotechnology
Government of India
Indian Council of Medical Research
BIRAC - Biotechnology Ignition Grant (BIG)
The Challenge

A Critical Healthcare Gap

India has ZERO islet transplant centers despite being the diabetes capital of the world

🇮🇳

No Islet Transplant Centers in Asia

There are only 14 functional islet transplant centers globally—none in India or South-East Asia. Patients must travel abroad for this life-changing treatment.

14 Centers Worldwide
📈

Diabetes Epidemic

84 million adults in Southeast Asia live with diabetes. India alone has 74+ million diabetic patients, projected to reach 156 million by 2045.

74M+ Patients in India
⚠️

Wasted Pancreas Organs

Per 2023 NOTTO Report: 1,099 deceased donor donations, yet only 14 pancreas transplants performed. Most pancreata are discarded.

1,085 Organs Wasted
💀

6x Increased Death Rate

Patients with severe hypoglycemia face 6-fold higher mortality rates. Hypoglycemic unawareness in Type 1 diabetes is a neglected, life-threatening condition.

🏥

Limited Treatment Options

Current treatments only manage diabetes—they don't cure it. Insulin therapy costs ₹7-9 lakhs over 5 years with no improvement in quality of life.

🔬

Regulatory Hurdles

Complex regulatory pathways and lack of infrastructure have prevented islet transplantation from being established in India despite proven global success.

84M Diabetic Adults in SE Asia
156M Projected by 2045
128K Children with Type 1 Diabetes
0 Islet Centers in Asia
Our Solution

Human Pancreatic Islet Transplantation

A minimally invasive cell therapy that can achieve insulin independence and potentially cure diabetes

The Islet Transplantation Process

1

Pancreas Procurement

Deceased donor pancreas obtained through TRANSTAN organ allocation network

2

Islet Isolation

Proprietary isolation methodology optimized for Indian population

3

Quality Assessment

Viability testing, islet count, and quality control per GMP standards

4

Transplantation

Minimally invasive infusion into the liver via interventional radiology

Key Benefits

✓

Internationally Recognized

FDA-approved therapy with proven clinical outcomes worldwide

💉

Less Invasive

Minor procedure vs. major organ transplant surgery

💰

Cost Effective

₹10-20 lakhs vs. ₹30-35 lakhs for pancreas transplant

🔬

Microencapsulation Ready

Future path to eliminate immunosuppression needs

❤️

Improved Quality of Life

Patients achieve insulin independence and improved HbA1c levels

🩺

Reduces Complications

Studies show improvement in microvascular complications post-transplant

Our Innovation

One Technology, Two Cures

A breakthrough platform technology offering potential cure for two different diseases

Dual Disease Application

Our proprietary islet isolation and transplantation technology can address two distinct patient populations through different transplant approaches—offering hope to millions suffering from insulin-dependent diabetes.

Type 1 Diabetes

Allotransplantation — Islets from deceased donors transplanted to patients with autoimmune diabetes

Type 3C Diabetes

Autotransplantation — Patient's own islets isolated and re-transplanted after pancreatectomy

Complete Process Innovation

End-to-end methodology optimized for Indian population with published peer-reviewed results

Granted Patents

✓ Application no: 202341011751

A Method for Analysing Molecular Semaphore Before and After Islet Transplantation

Novel methodology for molecular analysis to predict and monitor transplant outcomes

Grant Date March 2023
Term 20 Years
✓ Application no: 202341044774

A Method of Isolation and Characterization of Human Pancreatic Islet Cells

Proprietary islet isolation methodology optimized for the Indian population

Grant Date December 2024
Term 20 Years

Published Research Results

Cardiometry Journal, November 2022 — Peer-Reviewed

Metric iGN Method Standard Protocol 1 Standard Protocol 2
Viability (%) 80.6% Best 68.2% 78.1%
Total Yield (Million IEQ) 14.63M 2x Higher 7.28M 7.80M
Yield per Gram (Million IEQ) 1.47M 0.77M 0.85M
Regulatory Progress

Government Partnership & Approvals

Significant regulatory milestones achieved with Tamil Nadu Government and central authorities

2019

Government Proposal Submitted

Presented proposal to Government of Tamil Nadu, State Minister, and Health Secretary on the importance of bringing islet transplantation to India

✓ Completed
2020

Government Order G.O.(D) No:1493

Achieved the Government Order for the use of pancreas for islet cell isolation from the Government of Tamil Nadu Health and Family Welfare Department

✓ Approved
2022

MoU & CDSCO Application

MoU with MS Swaminathan Bio Incubation for Research Phase 1. Application to CDSCO for COBE 2991 registration. Ethics approval obtained.

✓ Completed
2024

Regulatory Approvals & GLP Establishment

Proceedings from State Authority & Director of Medical Services (Ref No 12695/2019). CDSCO acceptance for import under Form MD-17. ICMR application submitted. GLP lab established.

✓ Completed
2025

MoU with RGGGH & GMP Facility

MoU signed with Rajiv Gandhi Government General Hospital. Health Secretary and Minister approval secured. Special GO for Kings Institute space allocation in progress.

⟳ In Progress
2026

First-in-Human Clinical Trial

Target: First-in-human islet transplantation approximately 6 months post-GMP completion. NHM funding allocation expected Q2 2026.

◯ Planned
📋

G.O.(D) No:1493

Government Order for pancreas allocation

📋

Form MD-17

CDSCO import license for COBE 2991

📋

TRANSTAN Approval

Organ allocation authority letter

📋

Ethics Approval

Institutional ethics committee clearance

📋

ICMR Registration

Research phase registration submitted

📋

GLP Certificate

Good Laboratory Practice established

Market Opportunity

Massive Unmet Need

First-mover advantage in a market with zero competition and enormous patient population

Global Islet Transplant Centers

iGN Biotech will establish India as the first islet transplant center in all of Asia

84 Million

Adults living with diabetes in the IDF SEA Region — 1 in 12 adults

74 Million

Diabetic patients in India alone (Top 1 in SE Asia)

9.8 Million

Type 1 diabetes patients requiring specialized treatment

₹113 Million

Annual market potential in Tamil Nadu alone (75 transplants/year)

Treatment Comparison

Islet vs. Pancreas Transplant

Superior outcomes with lower risk and reduced cost

Outcome Islet Transplantation Pancreas Transplantation
Reduce/Eliminate Hypoglycemia ✓ Yes ✓ Yes
Improve HbA1c ✓ Yes Yes (depends on cases)
Insulin Independence ✓ Yes Yes (depends on cases)
Graft Rejection Risk No / Lower More common
Operative Morbidity Lesser Higher
Procedural Risks Minor procedural risk Major surgical risk
Immunosuppression Lower steroid dosage Heavy steroid regimen required
Cost (INR) ₹10-20 Lakhs ₹30-35 Lakhs
Leadership

World-Class Team

Combining deep scientific expertise with global islet transplantation experience

Dr. Nithyakalyani

Founder & Chief Scientific Officer
iGN Biotech Private Limited
PhD Medical Biotechnology Oxford University Trained ICMR Grant PI BIRAC BIG Grant

Pioneer in islet cell research in India. PhD in Medical Biotechnology from University of Madras. Trained at Oxford University UK under Prof. Paul Johnson. Former Chief Scientist at Apollo Hospital Chennai. Principal Investigator for ICMR grants worth ₹1.5 Cr+.

15+ Publications
2 Patents
95% Equity

Prem Anand

Chief Executive Officer
iGN Biotech Private Limited
Director, Xtracut CMO, Acer Electric $5M+ Raised $7.7M Revenue Generated

Serial entrepreneur and growth strategist with 10+ years experience building and scaling businesses. Director of Xtracut since 2015. As CMO for Acer Electric & eBikeGo, generated $7.7M in revenue through digital marketing, onboarding 70+ dealerships and 8 master franchisees. Raised over $5M through multiple investment channels.

$7.7M Revenue
$5M+ Raised
10+ Years

Strategic Advisors

Dr. Balamurugan Appakalai

Scientific Advisor
230+ Publications, 249+ Isolations
University of Louisville

Prof. Dr. Anil Vaidya

Clinical Advisor
30+ years Multi-Visceral Transplant
Cleveland Clinic & Oxford University

Prof. Dr. Paul Johnson

International Advisor
15 years Oxford University
Pediatric Islet Transplant Surgeon

Prof. Dr. Thierry Berney

International Advisor
20 years Director
Pancreas & Islet Program, Geneva

PGIMER Chandigarh

Clinical Collaboration
Prof. Anil Bhansali (Endocrinology)
Prof. Ashish Sharma (Nephrology)

Letters of Support

📄

Prof. Dr. Anil Vaidya

Cleveland Clinic & Oxford

📄

Dr. Balamurugan

University of Louisville

📄

Mohan Foundation

Organ Donation Network

📄

Apollo Hospital

Transplant Team Support

📄

Chettinad Health

Clinical Partnership

📄

Golden Jubilee Biotech

Research Support

Product Pipeline

Development Roadmap

Clear path from proof-of-concept to commercial islet transplantation

2025

Proof of Concept

Human pancreas islet isolation in Indian population — first demonstration of the technology

2026

GMP Facility & First Clinical Trial

Establishment of cGMP facility at Kings Institute. First-in-human islet transplantation (Month 15 post-funding)

2027

Microencapsulation

Development of microencapsulated islets to eliminate need for immunosuppression

2030

Advanced Pipeline

3D bioprinting of islet organoids. Islet signature biomarkers for personalized medicine. Commercial scale operations

Investment Opportunity

Seed Funding Round

Join us in establishing India's first human pancreatic islet transplant program

The Ask

  • Raising ₹10-12 Crores ($1.2-1.5M)
  • Pre-Money Valuation ₹40-60 Crores ($5-8M)
  • Target Dilution 15-20%
  • Structure Milestone-Based Tranching

Use of Funds (4 Years)

  • GMP Infrastructure ₹2.5 Cr
  • Equipment (37 items) ₹2.5 Cr
  • Consumables & Reagents ₹2.0 Cr
  • Operations & Personnel ₹2.25 Cr

Capitalization Table

Shareholder Role
Dr. Nithyakalyani Founder & Chief Scientific Officer
Prem Anand Chief Executive Officer
Gautam Seetharaman Stakeholder
Dr. Balamurugan Appakalai Strategic Advisor
Seed Investors To be onboarded

Key Milestones

  • Month 0-6 GMP Build + Equipment
  • Month 6-12 Lab Standardization
  • Month 12-15 Regulatory Approvals
  • Month 15 First-in-Human Trial

Funding Tranches

  • At Close 50%
  • GMP Completion 30%
  • IND Filing 20%

Dr. Nithyakalyani

Founder & Chief Scientific Officer
PhD Medical Biotechnology Oxford Trained ICMR Grant PI
15+ Publications
2 Granted Patents
₹1.5Cr+ Grant Funding
10+ Years in Islet Research

Education & Training

  • PhD in Medical Biotechnology from University of Madras
  • Training at Oxford University, UK under Prof. Paul Johnson
  • Specialized training in human islet isolation and transplantation

Professional Experience

  • Founder & Chief Scientific Officer, iGN Biotech Private Limited (Current)
  • Chief Scientist at Apollo Hospital, Chennai
  • Pioneer in establishing islet research protocols for Indian population

Grants & Awards

  • Principal Investigator, ICMR Grants worth ₹1.5 Crore+
  • BIRAC BIG Grant Recipient
  • EDII-TN Entrepreneurship Support
  • Department of Biotechnology Recognition

Intellectual Property

  • Patent #424697: Method for Analysing Molecular Semaphore Before and After Islet Transplantation (Granted 2023)
  • Patent #555971: Method of Isolation and Characterization of Human Pancreatic Islet Cells (Granted 2024)

Key Publications

  • Islet Isolation Methodology - TMR Publishing
  • Enzyme Comparison Study - Cardiometry Journal (2x yield improvement)
  • GJIMS Islet Short Communication 2022
  • Genomic & RNA Analysis - Islet Histology
  • Acta Scientific - Gene Expression Study
  • Microencapsulation Gel Optimization
  • Islet Pathology Analysis

Prem Anand

Chief Executive Officer
Director, Xtracut CMO, Acer Electric Serial Entrepreneur
$7.7M Revenue Generated
$5M+ Funds Raised
10+ Years Experience
20+ Team Size

Current Positions

  • Chief Executive Officer, iGN Biotech Private Limited
  • Director, Xtracut (2015 - Present) - Chennai, India
  • Chief Marketing Officer, Acer Electric India & eBikeGo (2023 - Present)
  • Partner & CTO, Street FZC (2022 - Present) - Dubai, UAE
  • Chief Marketing Officer, Truliv CoLiving & Holiday Homes (2024 - Present)

Key Achievements

  • Generated $7.7M in revenue through digital marketing efforts for Acer Electric
  • Onboarded 70+ dealerships (avg ₹75 lakhs) and 8 master franchisees (avg ₹1.5 crore) in 4 months
  • Strategized and raised over $5M through multiple investment channels
  • Directly contributed to 5,000+ seat admissions annually for SRM Institutions, generating $30M+ lifetime revenue yearly
  • Launched 3 plugins on Zoho Marketplace with 300+ paid subscribers across Europe, US, and APAC

Industry Experience

  • Healthcare - Hospitals, Clinics & Individual Surgeons (including Liver Transplant Division, Apollo Hospitals)
  • Education - Schools, Universities & Online Education (SRM, VELs, SSN, IIM Kochi, and more)
  • Hospitality - Hotels, Restaurants, Backpacking Hostels (The Leela Palace, Crowne Plaza, The Park)
  • Automobile & EV
  • SaaS & Manufacturing
  • Government Bodies - Tamil Nadu, Sharjah & Saudi Arabia

Skills & Expertise

  • Management: Running a fully bootstrapped 20+ member agency since 2015
  • Strategy: Data-driven approach with detailed KPI and metrics mapping
  • Marketing: Brand Positioning, Performance Marketing, SEO, CRO, Social Media
  • Technology: Zoho Suite, Marketing Automation, CRM, WordPress, Azure & AWS
  • Design: Branding, UI/UX, Photoshop, Illustrator, Figma, After Effects

Career Milestones

  • 2014: Built SRM's website from scratch as a final year project
  • 2015: Founded fully bootstrapped agency as one-person company
  • 2016: Rebranded Rohini Silver Screen, achieved massive organic growth, trending on Twitter
  • 2017: Led branding for The Leela Palace, Crowne Plaza, Ramada Plaza, The Park
  • 2018: Pivoted to healthcare, managed digital marketing for Apollo Hospitals Liver Transplant
  • 2019: Launched 3 Zoho Marketplace plugins with 300+ subscribers globally
  • 2022: Powering admissions for top South Indian educational institutions
  • 2023: Appointed CMO for Acer Electric, generated $7.7M revenue

Dr. Balamurugan Appakalai

Strategic Advisor
PhD 230+ Publications World Expert
230+ Publications
249+ Isolations
25+ Years Experience
99 Deceased Donor Isolations

Current Positions

  • Strategic Advisor, iGN Biotech Private Limited
  • Professor of Pediatrics, University of Louisville
  • Director, Islet Biology & Transplantation, Novak Diabetes Institute

Previous Experience

  • Director, University of Minnesota GMP Islet Core Facility
  • Led establishment of cGMP-compliant islet isolation protocols
  • Trained researchers worldwide in islet isolation techniques

Research Contributions

  • 249+ successful human islet isolations (99 deceased donors, 150 chronic pancreatitis)
  • Pioneer in developing novel enzyme formulations for islet isolation
  • Expert in both auto and allo islet transplantation
  • Developed protocols for optimizing islet yield and viability

Publication Highlights

  • 230+ peer-reviewed publications in islet biology and transplantation
  • Co-author on iGN's proprietary enzyme methodology research
  • Published in top journals including Diabetes, Transplantation, and Cell Reports
  • Contributions documented in "BALA Contributions to ISLET FIELD both AUTO and ALLO"

Role at iGN Biotech

  • Strategic guidance for GMP facility establishment
  • Protocol development and optimization advisory
  • Training and quality assurance guidance
  • Research collaboration and publication support
  • International network and partnership facilitation

Prof. Dr. Anil Vaidya

Clinical Advisor
Multi-Visceral Transplant 30+ Years Experience
30+ Years Experience
1000+ Transplants
2 World-Class Institutions
Global Recognition

Current & Previous Positions

  • Chair of Multi-Visceral Transplant at MGM Healthcare, Chennai
  • Former Co-Director, Cleveland Clinic Transplant Program
  • Consultant, Oxford University Hospitals NHS Foundation Trust

Areas of Expertise

  • Multi-visceral organ transplantation
  • Liver transplantation
  • Pancreas and kidney transplantation
  • Complex hepatobiliary surgery

Role at iGN Biotech

  • Clinical strategy and transplant protocol guidance
  • Regulatory pathway advisory
  • Clinical trial design consultation
  • Network facilitation with transplant centers

Prof. Dr. Paul Johnson

International Advisor
Oxford University Pediatric Islet Transplant
15+ Years at Oxford
Pioneer Pediatric Islet
100+ Publications
UK Islet Program Lead

Current Position

  • Professor of Transplant Surgery, University of Oxford
  • Lead, Oxford Islet Transplant Programme
  • Consultant Surgeon, Oxford University Hospitals

Areas of Expertise

  • Pediatric islet transplantation
  • Clinical islet transplantation
  • Beta cell replacement therapies
  • Immunology of transplantation

Role at iGN Biotech

  • Mentored Dr. Nithyakalyani during Oxford training
  • Technical advisory on islet isolation protocols
  • International collaboration facilitation
  • Research guidance and publication support

Prof. Dr. Thierry Berney

International Advisor
University of Geneva 20+ Years Director
20+ Years as Director
World Leading Program
200+ Publications
Geneva Islet Program

Current Position

  • Director, Pancreas & Islet Transplant Program, University of Geneva
  • Professor of Surgery, University of Geneva Medical School
  • Chief, Division of Transplantation, Geneva University Hospitals

Areas of Expertise

  • Clinical islet transplantation
  • Pancreas transplantation
  • Islet isolation and quality assessment
  • Immunosuppression protocols

Role at iGN Biotech

  • International standards advisory
  • GMP facility design consultation
  • Quality assurance protocol guidance
  • European collaboration facilitation

PGIMER Chandigarh

Clinical Collaboration
Premier Medical Institute Multi-Specialty
1962 Established
#1 Medical Institute
2 Key Collaborators
National Excellence

Key Collaborators

  • Prof. Anil Bhansali — Department of Endocrinology
  • Prof. Ashish Sharma — Department of Nephrology & Transplantation

About PGIMER

  • Postgraduate Institute of Medical Education and Research, Chandigarh
  • One of India's premier medical and research institutions
  • Ranked among top medical institutes in India
  • Established research collaboration in diabetes and transplantation

Collaboration Scope

  • Clinical trial site partnership
  • Research collaboration on islet transplantation outcomes
  • Patient referral network
  • Academic and publication collaboration