Revolutionizing Tissue Regeneration with a Groundbreaking Technology
BioChange is a tissue regeneration startup aiming to restore various body functions & damaged tissues using its innovative foam scaffold technology, CellFoam™. The stabilized 3D protein foam resembles the embryonic foam and is believed to restore transfer of bio-mechanical information between cells of the regenerating tissue.
Upon application to damaged tissue, it encourages reconstruction and functional regeneration processes that effectively reverse tissue deterioration. As the foam naturally degrades over time, typically within a few months, it facilitates complete absorption, leaving behind fully renewed, healthy tissue with the natural structure of youthful cells. CellFoam™ serves as a versatile platform technology with significant potential to rehabilitate a wide array of tissues and organs, marking a transformative advancement in regenerative medicine.
Certified ISO 13485 for Medical Device Manufacturing in June 2024, BioChange operates state-of-the-art ISO 7 Clean Room facilities, enabling the production of its innovative medical devices.
Extensive Patent Portfolio Across Global Markets
BioChange holds three patent families, encompassing 18 approved patents in the US, Europe, China, South Korea, Japan, and Israel. An additional 25 patents are currently in various stages of approval (national phase). These patents cover a groundbreaking composition of materials forming a unique foamy protein matrix that promotes tissue regeneration, along with methods for preparation and application based on this protein foam.
Diverse Medical Applications and Market Potential
BioChange's exclusive technology is strategically positioned for diverse medical applications, promising groundbreaking advancements that could revolutionize medical fields and enhance human well-being. Demonstrating efficacy in regenerating skin, bone, urethral, retinal tissues, and complex structures like periodontal tissue, BioChange aims to push boundaries further, aspiring towards complex organ regeneration inspired by nature's regenerative capabilities, such as salamanders regrowing limbs or repairing damaged eyes.
Key products currently under development include:
ReGum™ - Our innovative solution targets individuals affected by periodontal disease and receding gums. With nearly half of the adult population grappling with this widespread issue, ReGum™ aims to offer a comprehensive solution that surpasses current market options. Initial experimental results have shown unprecedented success in restoring periodontal tissue, encompassing bone, connective tissues, and soft tissue (Gingiva). ReGum™ holds a significant advantage over existing products.
Revolette™ - Specifically formulated to safely and effectively rejuvenate skin, Revolette™ caters to the aesthetic and plastic surgery markets. BioChange is currently advancing through the final stages of product development and actively pursuing strategic collaborations to expedite regulatory approval and market launch.
Beginning October 7th, BioChange has committed to harnessing its technology to create life-saving and regenerative treatments for soldiers wounded in combat. These efforts include developing a hemostatic solution to address severe bleeding on the battlefield, along with specialized products designed to repair tissues damaged by combat injuries and severe burns. Concurrently, the company has applied for research and development grants to bolster these vital projects alongside its core business endeavors.
Profitable Ventures in the Veterinary Market and Publication in Top Medical Journals
The company's products have shown impressive efficacy in feasibility studies for animal treatment, laying a crucial groundwork for future human applications. This advancement has spurred the creation of two innovative products poised to revolutionize the veterinary market.
ReGum™-Vet: Designed to address periodontal disease in animals, ReGum™-Vet has demonstrated unparalleled safety and efficacy results in dogs and cats. The results of a veterinary-clinical research were published in the prestigious scientific journal, Frontiers in Veterinary Science. Furthermore, the company consistently receives positive feedback from leading veterinarians worldwide, who report sustained improvement trends with no adverse events for at least two years post-treatment with our product.
VetFoam™ is an injectable scaffold engineered to support tissue growth, providing a minimally invasive alternative for treating urinary incontinence in female dogs. VetFoam™ encourages the strengthening and regeneration of the urethral tissue, achieving high success rates without adverse events. A clinical-veterinary study, published in the Journal of Veterinary Internal Medicine, demonstrated VetFoam™ as a long-term solution for urinary leaks, surpassing competing products on the market.
These products have gained successful adoption among prominent veterinarians in Israel, USA, Europe, Korea, and Australia. This widespread acceptance has contributed to the company's profitability and consistent customer growth quarter after quarter.
Grants, Investments, and Strategic Partnerships
BioChange has successfully secured funding from various sources, both domestically in Israel and internationally. Notable sources of funding include:
Moreover, BioChange has attracted investments from venture capitalists and private investors, notably including Mauro Vyshinsky, a distinguished figure in dermatological aesthetics with a proven track record of investing in over 30 biotech and MedTech startups, including successful ventures like Alma Lasers and Ventor.
Additionally, Quadrascope, an American equity fund specializing in Longevity science is an active investor at BioChange.
Strategic Partnerships with Leading Academic and Medical Institutions
BioChange has formed significant collaborations with renowned institutions globally, including Stanford University and the University of Milan. Domestically, the company has established partnerships with esteemed universities and medical institutions in Israel, such as Tel Aviv University and Bar-Ilan University.
An Accomplished and Diverse Team of Experts
The BioChange team features accomplished professionals with extensive expertise spanning business and medical domains. Key figures include
Ishay Attar, Founder, Chairman and CTO, a seasoned biotech entrepreneur and biomedical engineer renowned for founding four successful biotech ventures, two of which were acquired by major American corporations.
Dr. Iris Shichor, CEO brings proven leadership as the founder and CEO of an innovative medical device company specializing drug-device combination products for brain delivery (securing millions in funding and achieving successful clinical trials).
Dr. Keren Sinik, VP of Operations, contributes profound knowledge in research, development, and medical product management.
Dorit Yaron, VP Manufacturing &Managing Director of Veterinary Business Unit, brings demonstrated proficiency in process development and establishing production lines.
Hilit Hochman, VP Sales & Marketing, brings extensive experience in the medical industry, Specializing in Marketing strategy and commercialization of Dental and Aesthetic products in the global market.
Dr. Shani Cohen, Director of Research & Development, is a recognized authority in tissue engineering and drug Delivery.
Dr. Yuval Eitan, Director of Technologies and Innovation, who has a background in tissue engineering and previous experience as Head of the molecular pathology laboratory at "Haemek" Medical Center.
The Need & Challenge
Regenerative medicine aims to repair damaged tissues, with the ultimate goal of growing functional organs to replace non-viable ones. Our body's tissues, such as skin, muscle, and nerves, consist of cells and an extracellular matrix (ECM) that provides structural support and facilitates communication between cells. The ECM plays a crucial role in tissue function, including growth, wound healing, and formation of connective tissues. While tissues naturally develop from embryonic stages to adulthood, their regenerative capacity diminishes significantly once matured, leading primarily to aging-related breakdown and deterioration, especially when damaged by injury, infection, or disease.
Periodontal disease exemplifies a prevalent condition resulting in irreversible tissue deterioration. Approximately one in five individuals are at high risk of developing this condition, which weakens and damages the tissues surrounding the teeth, becoming a leading cause of tooth loss among adults over 30 years old. Characterized by chronic inflammation, periodontitis manifests through symptoms such as swelling, redness, sensitivity, and escalating pain as it progresses. Over time, the disease erodes bone and tissues around the teeth, causing receding gums, exposed tooth roots, cavities, and even tooth displacement or loss. Furthermore, research has linked periodontitis with systemic diseases such as cardiovascular conditions, neurodegenerative disorders, and diabetes, significantly increasing risks of heart attacks, strokes, and similar events among affected individuals.
Despite ongoing efforts, current treatments for periodontitis often fail to effectively halt disease progression or achieve meaningful tissue regeneration. Consequently, there remains an urgent need for advanced therapies that can effectively repair periodontal tissues and prevent further deterioration.
The Solution
BioChange has a cutting-edge technology named CellFoam™, enabling the development of innovative treatments for a diverse range of damaged tissues. CellFoam™ comprises of a biological foam scaffold acting as a replacement of the extracellular matrix for damaged tissues. The unique structure and biomechanical properties of the CellFoam™ matrix, that resembles the foamy extracellular matrix of an embryonic tissue, encourages the regeneration of the damaged tissue.
BioChange focuses on the ReGum™ product, designed to restore periodontal tissue with a great market potential and a short regulatory pathway for approval. Following an FDA approval, the company aims to advance its more ambitious goals in tissue and organ restoration.
ReGum™ is a ground-breaking product that offers exceptional functionality, efficiency, and safety. Unlike competing products, which require complex and lengthy treatments with uncertain results, ReGum™ delivers an entire periodontal tissue restoration in a single treatment that enhances the tissue's long-term function. It is uniquely designed to address periodontal disease, particularly in the restoration of all tissue layers, including bone and gums. The product not only prevents the disease's progression but also reverses its effects and repairs the accumulated damages such as gums and bone retreat. It facilitates the return to a pain-free life, stronger teeth, and reduces the risk of systemic diseases.
This ReGum™ product is consists a cross-linked gelatin matrix stabilized into a foam structure. It is safe, biodegradable and designed for easy and quick use. The porous structure of the foam encourages cell regeneration, leading to a healthy and repaired self-tissue. ReGum™ requires no ancillary products, thus quickening the treatment process, mitigating the risks for adverse events and reducing costs.
Pre-clinical studies have demonstrated that using ReGum™ improves periodontal tissue repair by 100% compared to the standard treatment without ReGum™, achieving the unprecedented regeneration of both soft gum tissue and bone tissue in a single product. BioChange has launched a veterinary version of ReGum™ in 2023, called ReGum™-vet, which enjoys global growth in the veterinary market and confirms the safety and efficacy of the technology. Now, BioChange is aiming to prove this in humans as well.
BioChange is currently concluding the clinical development of ReGum™, the first-ever product designed to promote the real recovery of damaged periodontal tissue, with a safe, effective, and easy treatment. The product is expected to exhibit excellent clinical results, including shorter healing times and long-lasting tissue restoration.
An FDA approval of ReGum™ will be a revolutionary innovation in the treatment of periodontitis. It is expected to be the only product capable of solving the problem and healing the periodontal disease for the long term. Moreover, once approved, the pathway for BioChange's other products approval will be significantly shortened as is the time for market and commercialization worldwide.
The Technology
BioChange's innovative technology, known as CellFoam™, utilizes a matrix composed of biologically cross-linked protein, forming a unique 3D foam structure with exceptional biomechanical properties that resembles the embryonic tissue's extra cellular matrix, in oppose to all other scaffolds in the market that resembles a mature tissue's extra cellular matrix.
This matrix functions as a scaffold that mimics the natural extracellular matrix, providing robust support for tissue cells. The foam's structure offers a large surface area with multiple attachment sites, facilitating optimal cell growth and enhancing the healing process of treated tissues.
Over a period of approximately three months, the foam naturally degrades within the body, coinciding with tissue repair and resulting in the formation of new, healthy, and functional tissue to replace damaged areas.
CellFoam™ is a versatile platform technology capable of restoring a wide range of tissues. It can be administered in liquid form via minimally invasive injections or integrated into surgical procedures as a stable 3D structure tailored to enhance effectiveness for specific medical applications. For instance, ReGum™ is specifically designed for dental applications and is provided as a ready-to-use three-dimensional product for direct implantation by dental professionals.
BioChange's products currently address the thriving veterinary pet-care market, recognizing pets as beloved family members. The company offers an array of innovative products for our four-legged companions, including a dental product for treating periodontal disease and an injectable product for preventing urine leakage.
These veterinary products not only serve as a validation of the efficacy and safety of products in clinical development, but also stand as an innovative treatment for animals suffering from diseases without proper available solutions.
Leveraging its wealth of knowledge and experience, BioChange is committed to introducing the unique ability to improve human tissues regeneration. This innovation paves the way for a range of products that will provide long-term solutions across various clinical applications currently lacking proper resolution.
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An experienced Israeli biomed entrepreneur, joined BioChange as a CEO and brings her extensive experience in managing product development projects from concept to product. Previous to joining BioChange, Iris co-founded and managed SipNose LTD., which developed a novel Direct Nose-to-Brain Delivery platform where she led the development together with the business collaborations, licensing deals, and company’s investments. Before that, she served as VP of R&D at ClearFarma, and as a Senior Scientist at NanoCyte. She holds a Ph.D. from the Hebrew University of Jerusalem and a post-doctoral fellowship from the laboratory of Prof. Robert Langer (Harvard-MIT, HST), where she also been an Innovation Team member in MIT-Deshpande prestigious i-Teams course, a Sloan business school program.
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Joined BioChange in May 2019 and serves as Vice President of Operations. Keren has over 15 years of combined industry and academic experience leading interdisciplinary and multicultural teams in preclinical trials, immunology, biochemistry, protein engineering, and protein purification. Keren previously served as a Senior Scientist at Adicet Bio Israel. She holds a B.Sc. in Biotechnology engineering (summa cum laude), as 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 previously the head of the molecular pathology lab in Ha’emek hospital and leading research in nephrology in Rappaport faculty of medicine. He has vast experience in various techniques, including tissue engineering, molecular biology, molecular pathology, molecular genomics, cell and tissue culture, in vivo experimentation, imaging, and more. Yuval holds a BSc, MSc (molecular genomics, cum laude), and PhD (tissue engineering) in Biotechnology Engineering from the Technion, Israel Institute of Technology, and a post-doctoral fellowship in Biology (population molecular genetics), in Haifa University.
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Has served as Chief Medical Officer at BioChange since 2017 with 20 years of experience in aesthetic dermatology. He heads the Center for Aesthetic Dermatology at Sourasky Medical Center (TA) and runs a successful private clinic. Dr. Artzi is an international lecturer and serves as an expert advisor for worldwide leading companies in the field of Dermatology. He received his M.D. from the Technion, Israel Institute of Technology with expertise in Dermatology and lasers.
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Is an engineer. entrepreneur and angel investor with over 30 years of experience in aesthetic dermatology management and marketing. He was the former USA CEO and co- founder of Alma Lasers, which was acquired by Fosun Pharma for $240M. Mr. Wjuniski chairs the American Technion Society (ATS) Miami Leadership Council and is a member of the Technion Board of Governors and the ATS National Board of Directors. In the past ten years, as an investor, Mr. Wjuniski has provided seed funding to a number of Israeli companies, particularly in the area of biotechnology. Some of those companies generated high returns on investment, such as Ventor, which was acquired by Medtronic for $300M.
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Joined BioChange in 2021. Dorit brings to BioChange more than 30 years of global experience in process engineering combined with digital transformation in a variety of industries, including Refineries, Food & Dairy, Water Treatment and Power Plants, Fintech, and Blockchain. Dorit has deep knowledge and a proven track record in production process scale-up, automation, data analysis, and troubleshooting.
She holds an MBA in Chemical Engineering, and a B.Sc. in Chemical Engineering, all from the Technion, Israel Institute of Technology.
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Brings with her 17 Years experience in driving strategic marketing initiatives and global market expansion for medical devices and digital health.
Her passion is to maximize the market potential of each product or service, streamlining healthcare professionals’ work and enhancing efficiency.
Her accomplishments include establishing a global marketing strategy for an Israeli dental implant company (leading to a $95 million acquisition) and securing reimbursement for a life-saving digital remote monitoring product in lung cancer care.
She brings with her a core competencies cover marketing strategy, branding, product launch, medical devices, oncology, and more.
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Joined BioChange in 2021. She has extensive experience in multidisciplinary R&D and preclinical project management with hands-on practice in tissue engineering and biomaterials research and characterization.
She holds a B.Sc. and M.Sc. in drug delivery at the chemical engineering department at Ben Gurion University and a Ph.D. from the Biomedical Engineering faculty at the Technion, Israel Institute of Technology.
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Holds a dental degree, and a certificate in prosthodontics from the Hebrew University and Hadassah School of Dental Medicine in Jerusalem, Israel.
Acted as the Director of Pre-Doctoral Prosthodontics at the Harvard School of Dental Medicine, and received numerous awards, including the “Distinguished Junior Faculty Award” from the Harvard School of Dental Medicine.
Dr. Samet has been placing and restoring dental implants for over 20 years. Dr. Samet published over 20 articles in the professional literature. One of his articles, has become a part of the standard curriculum in over 100 dental schools in five continents.
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D.M.D., B.Sc., graduate of the Hebrew University and founder of Tel Aviv Dental Center- a specialist multidisciplinary dental center focused on utilizing cutting edge technology and novel techniques and materials for best treatment outcome.
Dr. Miller was involved in researching cortisol as an indicator for sjogren‘s disease with the Oral Health department at HU and has consulted for international dental companies such as 3m and Dentsply Sirona, as well as lecturing at Boston University and other international conventions.
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Expert in driving R&D to impact in complex and innovative technologies.
Ayala has 20 years of experience leading regulation, quality, risk management and technology estimation in medical device healthcare and security organizations. Guiding companies in every stage of the research and development process, ensuring that projects not only align with the strategic goals but also deliver tangible impact.
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