Introduction
The desire to fight aging has spawned BioChange establishment on 2017 and the development of the CellFoam™ technology for tissue regeneration and repair. We raised initial capital, a team of talented people and built a laboratory at Yokneam with a clean room for clinical production at Or Akiva.
BioChange has developed a breakthrough technology that stimulates tissue regeneration. As we age, tissues degenerate naturally or in an accelerated way, by disease or trauma. Damaged tissues lose their ability to regenerate and recover, often leading to organ loss. From aged skin and soft tissue deformations, through urinary incontinence, periodontal loss and chronic obstructive pulmonary disease, BioChange has unlocked the path to resolve unmet medical needs.
The CellFoam™ is an injectable tissue scaffold, that mimics the natural Extra Cellular Matrix (ECM). The natural scaffold component of the tissue is what provides it with a solid physical structure. In tissues, the cells attach themselves to the structure and thrive if the structure is healthy, degenerate when the ECM is fragmented. The CellFoam™ technology is a semi-synthetic substitute made of cross-linked protein foam, capable of stimulating tissues and organs to regenerate naturally. It is bio-engineered to reboots tissue's protein production machinery. Self-cells are "persuaded" to believe they are in a healthy ECM environment, thus growing a healthy functional tissue. The CellFoam™ scaffold eventually degrades within the body into amino acids, after about 3 months of a remodeling phase, as healthy and functional tissue is formed.
The product will answer the major unmet need of collagen regeneration for soft tissue repair in general, and specifically in aesthetic dermatology and plastic surgery.
Successful funding history and lucrative partnerships
BioChange operates a biomaterial R&D lab and manufacturing set up in Or-Akiva (25msqr ISO7 clean room), producing for the clinical phase. The company secured funding from various sources such as an R&D deal with a major strategic player, grants from IIA and SME Horizon 2020, partnership with leading institutions, e.g. the University of Milan and BEL. Also, an investment from Mr. Mauro Wjuniski, one of the leading market experts in aesthetic dermatology and serial angel investor (invested in over 30 medtech start-up and EXIT-ed several such as Alma lasers and Ventor). The company is now ready for the clinical phase and requires further funding to execute clinical studies and regulatory approvals of its leading product.
Pipeline development strategy
CellFoam™ is our patented tissue scaffold platform technology for guided tissue regeneration. It has already achieved outstanding pre-clinical results that prove the scaffold's ability to stimulate tissue repair and recovery in various different organs. The new tissue formed is notably healthy & lively with architecture of a young, naturally formed tissue. We aim to develop a strong organic pipeline, all based on our proprietary technology and know-how. Some of our future developments are initiated in collaboration with top-tier academia and industry partners such as University of Stanford, University of Milan and various other undisclosed biotech and pharma companies. The first product to reach the clinical phase is the Revolette™, a game changer in the field of aesthetics and plastic surgery. Other products for the treatment of urinary incontinence, for periodontal disease and for the treatment of COPD are in pre-clinical phase, after successfully completing clinical veterinary studies.
Besides the clinical products, our technology will soon be made available for the scientific research market. CellFoam™ is the optimal scaffold for bio-printing and can become the “Intel-inside” of the tissue engineering industry. 3D bioprinting techniques have shown great promise in various fields of tissue engineering and regenerative medicine. Yet, creating a tissue construct that faithfully represents the tightly regulated composition, microenvironment, and function of native tissues is still barely possible. CellFoam™ perfectly mimics the natural tissue construct, enabling cellular adhesion and tissue growth.
The company holds one granted patent in the USA and additional two patent families in national phase. Plus one provisional patent application.
In-market product for the veterinary care
BioChange’s has already brought to market a veterinary product that solves the unmet problem of canine urinary incontinence (VetFoam™). The product offers a minimally invasive treatment option with high success rates and no adverse events. It remodels the urethra to become thicker and more functional. Readouts from a veterinary clinical study were published at the Journal of Veterinary Internal Medicine in mid 2020. A newer product is soon finishing clinical phase with already promising results in treating periodontal disease, the largest unsolved need in pet-care.
The pet-care market is booming in recent years, as companion pet become like family members. VetFoam™ offer new innovative products pipeline to our companion animal patients. By doing so we achieve two important goals: helping animals who suffer from diseases, sometimes with unmet needs, and providing more validation to the platform technology. In addition, these products provide the company with cash flow, while reducing the amount of capital raised on our way to achieving our clinical goals.
The need of our leading human product- Revolette™
As the skin ages, the collagen fibers degrade and lose physical integrity. From age 18 and on, about 1% of the collagen is lost every year. Collagen becomes fragmented over time, its total amount decreases (skin thinning and sagging). This is irreversible regardless of various products that claim to help. In some cases, such damage is accelerated due to disease, trauma, surgery or fat loss. In other words, we are all getting older, looking wrinkled and saggy and there is nothing in the medical arsenal to undo that.
Besides the natural process of soft tissue deterioration, a tissue injury such as breast lumpectomy or tumor removal surgery, is most common. The results of these kinds of injuries and treatment surgeries is, in most cases, unpleasing aesthetically, lead to scars and deformed tissue which often require sequential surgeries for reconstruction. Current treatment options rely on fat grafting which is a surgical procedure and also has a low success rate and limited availability.
Soft tissue fillers, also known as injectable implants, help to create a smoother and/or fuller appearance by temporarily filling the treated area and providing a volumetric effect. Most dermal fillers of the biodegradable type, suffer either from a temporary effect since they contain materials that are absorbed by the body over time (normally few months to two years) or from un-natural outcome. Permanent fillers such as silicon or PMMA are now rarely used and considered unsafe. They sometimes lead to serious adverse clinical outcomes, including recurrent hematomas, edema, hypertrophic scarring, nodule formation and cancer. New biomaterials for soft tissue augmentation are in demand given the limitations of current materials and the surge in demand from the aging population.
The Solution
BioChange's first product for humans is intended to regenerate collagen and repair skin, also to contour soft tissue body defects. Currently, none of the existing products are providing these needs. Our product has achieved superior efficacy in stimulating collagen production compared to currently available products in the market. Growing younger skin in an aged adult is achievable. In body contouring, the product presents a robust alternative for permanent silicone implants or fat grafting as it is designed to gradually degrade and be replaced by newly grown natural tissue, free of any foreign material. It will provide a long overdue replacement to permanent silicone implants, which are currently undesired due to their problematic safety profile.
The CellFoamTM technology is a proprietary injectable scaffold made of cross-linked protein foam that optimally supports and stimulates cellular in-growth and guides tissue regeneration. The protein is rich with cellular attachment sites, which are exposed in large, due to the foamy structure.
Endogenous (self) cells are triggered to believe they are growing into a natural, younger version of their own ECM.
The Technology
BioChange’s technology will revolutionize the market of soft tissue repair with its CellFoam™ powered, RevoletteTM product. Developed for aesthetic dermatology and plastic surgery, for facial, body contouring and collagen stimulation, it is going to be the first product ever to provide a significant stimulation of long-lasting collagen.
Appearances in Media
https://www.imcas.com/en/academy/show/8755/innovation-tank-2019-start-up-competitor-biochange
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Over 15 years of combined industry and academic experience leading interdisciplinary and multicultural teams combining preclinical trials, immunology, biochemistry, protein engineering and protein purification. Keren previously served as a scientific team leader at Adicet Bio Israel. She holds a B.Sc in Biotechnology engineering (summa cum laude), M.Sc in Biology (cum laude) and a Ph.D. in Immunology, from the Technion, Israel Institute of Technology.
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Yuval was the head of the molecular pathology lab in Ha‘emek Medical Center for over nine years, after leading research in nephrology in Rappaport faculty of medicine. Yuval holds a PhD in Tissue Engineering from the Technion, Israel, a BSc, MSc (molecular genomics, cum laude) from Technion, and post-doctoral fellowship in Biology (population molecular genetics), in Haifa University.
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Heading the Center for Aesthetic Dermatology in Sourasky Medical Center (TA) and his successful private clinic.
Renowned physician and opinion leader in his field. Expert in skin rejuvenation, dermal fillers, organizer of the SCAR international conference.
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Former USA CEO and co-founder of Alma Lasers, an aesthetic dermatology company which was later acquired by Fosun Pharma for Millions of dollars; an expert in dermatology marketing. Served on the board of several companies. He is an active investor in BioChange and mentor to our management.
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Former CTO of Elastagen, an Australian class 3 medical device company for tissue repair products based on the human protein tropoelastin, acquired by Allergan in 2018. Instrumental in leading to the acquisition and subsequently directed the tech transfer. Accomplished Engineer with significant experience in all aspects of pharmaceutical / medical device production, research, scale up and design. B.Sc. Chemical engineering, M.Sc. Material engineering.
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Dr. Rina Lev is a scientific regulatory and clinical affairs consultant with over twenty years of experience in the medical device industry. During this time, Rina has led multidisciplinary projects in the clinical, regulatory and QA field. Rina holds a M.Sc., in Clinical Biochemistry from Tel Aviv University and a Ph.D. in Clinical Neurophysiology from the Faculty of Medicine from the Technion.
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Main previous achievements and experience include seasoned med-tech executive and physician with more than 10 years of experience at Merck, Teva, Schering-Plough and MetaCure; in medical affairs and product launch, clinical strategy, pre-commercial evaluations, evidence generation and BD.
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Over 20 years of experience in clinical pulmonology. Heading the Pulmonology Clinic in Carmel Medical Center (Haifa). Expert in chronic pulmonary diseases. M.D. from Technion, Israel Institute of Technology.
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Dr Barkai brings more than 20 years of expertise in the biotech arena where he worked as director, manager and consultant of numerous companies. He participated as founder (‘Bonus Biogroup’) and CSO (‘Pluristem Therapeutics’).
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