MICRO PANCREAS TECHNOLOGY

Betalin is developing a micro-pancreas to liberate hundreds of millions of diabetic patients from their daily insulin dependency.
The micro-pancreas responds to the patient’s blood glucose levels by releasing regulated therapeutic levels of insulin.

Innovation

Our innovation combines state-of-the art stem cell technology with a breakthrough in tissue engineering to create a fully functional engineered micro-pancreas (EMP).

This has the potential to be a long-term solution for the management of diabetes, and to supply daily insulin replacement.

Our micro-organ matrix (MOM) recreates and mimics the normal extracellular environment that surrounds β-cells in the pancreas and supports their supply of necessary nutrients and growth factors.

micro-pancreas

Background

About 500 million people worldwide are living with diabetes, a metabolic disorder caused by loss or dysfunction of beta(β)-cells in the pancreas and is associated with comorbidities and complications such as kidney and cardiovascular disease.

Currently, there is no long-term cure, and the only readily available treatment is replacement of insulin through injection, and careful control of sugar and carbohydrate intake to maintain blood sugar levels (glycaemia). There is a clear and urgent need to develop more advanced cell and/or regenerative therapies to restore normoglycemia in diabetic patients. Curing diabetes will require the restoration of β cell mass.

Transplantation of the insulin-producing unit of the pancreas, β-cell-containing islets, has been attempted in patients, with limited success: 70% of islets fail to engraft.

Importantly, isolated islets lack the molecular and structural microenvironment that is critical to their survival and function, and harvesting from cadaveric sources means high variability in quality and supply, making widespread adoption of the technique unfeasible.

Micro-pancreas Technology

Insulin producing cells derived from stem cells

plus

A tissue scaffold that provides supportive environment to the insulin producting cells

History Road Map

2015
License from Hebrew University
Prof. Eduardo Mitrani
Rights to technology to develop engineered micro-pancreas (EMP) acquired
End 2020
Pre-IND

Approaching regulators for First in Human studies

Sep. 2022
GLP animal studies

Viral clearance

Nov. 2022
GLP animal studies

Biocompatibility

Jan. 2023
Pivot

A strategic decision taken to dedicate the resources to proceed development of MOM and outsource cell source to scalable stem cell derived beta cells

2025
Completion of Pre-Clinical Studies
($5 Million)
M&A
potential
2027
Completion of Phase I
($10 Million)
2029
Completion of Phase II
($15-20 Million)
2032
Completion of Phase III Product Launch
($30-35 Million)

Novelty vs. state-of-the-art

Devices for monitoring blood glucose and implantable insulin pumps are incapable of reproducing the fine-tuned glucose sensing of natural islets.

Patients still experience erratic swings in blood glucose, and dangerous episodes of severe hypoglycaemia. Islet cell transplant, introduced in 1999, is a more invasive procedure, requiring lifelong immune suppression;

70-90% of patients still need insulin injections within 5 years.

The supply of islet donors is extremely limited and variable, as the main source is from human cadavers, making this a non-scalable solution for the up to 5m people worldwide who need islet transplantation.

Cell-based regenerative therapies for the millions of people suffering from diabetes are therefore desperately needed.

Stem cell derived β-cells provide a more sustainable and successful source of material than islets.

“Naked” β-cells do not represent a long-term solution, however: most of the infused β-cells die after weeks.

Benefits

Stable position in the body

Unlike naked insulin producing cells that due to their small size (20 to 50 microns) migrate throughout the body, each micro-pancreas includes about 200,000 insulin producing cells and does not migrate.

Reduction of cell mortality

The micro-pancreas technology, which applies scaffolds for cell support, leads to higher cell persistence and to significant increase of insulin production while reducing cell mortality.

Higher insulin production

The transplants will be more effective as the insulin secretion from the micro-pancreas is better regulated and insulin secretion from micro-pancreas lasts longer than the insulin secreted from cells alone.

Cost effectiveness

Lowering the amount of insulin producing cells per transplant and higher success rates significantly reduces the transplantation costs.

Simple process

With a commonly used device and under local anesthesia, the micro-pancreas is implanted subcutaneously into the patient’s abdominal or leg.

Limits surgery risks

The micro-pancreas is delivered into the patient by subcutaneous implantation, enabling integration into recipient's tissues, without the need for risky surgery.

Suitable for outpatient clinics

The micro-pancreas is suitable for outpatient clinics as the implementation does not demand expensive patient hospitalization.

Recognition

Raised funds from private investors, the Israel Innovation Authroity and the Horizon 2020 Framework Programme of the Eurpean Union.

the Israel Innovation Authroity and the Horizon 2020 Framework Programme of the Eurpean Union

International collaborations

Team

Betalin’s team is comprised of scientists, engineers, clinical experts, and a advisory board whose members include a Nobel prize winner and the President-Elect of the International Diabetes Federation.

The company is led by:

Prof. Arieh Warshel
(Israel)

Nobel Prize winner
in chemistry

Prof. Peter Schwarz
(Germany)​

President-Elect, Intern.
Diabetes Federation

Prof. Stefan Bornstein
(Germany)​

Director, Univ. Hospital
Carl Gustav Carus

Prof. Lonnie Shea
(USA)

Biomed Eng., Univ.
of Michigan

Prof. James Shaw
(UK)

Regen. Medicine for
Diabetes, Newcastle

Prof. James Shapiro
(Canada)

Developer of Edmonton
Protocol

Zohar Pinhasi
(USA)

C.E.O of Monster Cloud / Counter-Cyberterrorism Expert / Ethical Hacker / Ransomware Recovery Expert

Elli Yosef
(Israel)​

Global Business Strategist
Shuki Hershcovich

Shuki Hershcovich
(Israel)​

Chairman & Founder
Racheli Ofir

Racheli Ofir

CTO & CEO (PhD)
Experience: Dr. Ofir was the Vice President of Research & IP at Pluristem (cell therapies).
She has a deep understanding of molecular cell biology towards developing innovative cures as well as her extensive experience in navigating successfully through the interplay between basic / translational science, clinical trials, and regulatory processes.
Dr. Ofir has authored numerous peer reviewed articles on cell therapy and is an inventor of many patents.
She earned her PhD in cell biology from the Technion, where she completed her postdoctoral fellowship.
She also holds an MA in patent law from the University of Haifa.
Sharona Even Ram

Sharona Even Ram

Scientific Director (PhD)
Experience: Dr. Even Ram served as a principal investigator at the Embryonic Stem Cell Center in Hadassah Hebrew University Hospital.
Her research focused on stem cell differentiation into functional cells and development of cell therapy for regenerative medicine.
Dr. Even Ram has authored numerous peer reviewed articles and is a co-inventor on several patents.
Earlier, she completed a 6-year postdoctoral training as a Research Fellow at the NIH (National Institutes of Health) in Maryland, USA. She holds a PhD in molecular and cellular oncology, an M.Sc. in biotechnology from the Faculty of Medicine at the Hebrew University of Jerusalem, and a B.Sc. in biology from Bar-Ilan University.

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