Isto Technologies
HCID Member | Medical Devices & Tech
1155 Olivette Executive Parkway, Suite 200
St. Louis, MO 63132 USA
phone: (314) 995-6049
fax: (314)995-6025
Symbol Private
Exchange Private
Founded 1997
Employees 35
www.istotech.com
Research Sector Medical Devices & Tech
Summary Description
Cell-Based Technologies and Biomaterials for Orthopedics Treatment
Management
Joseph Feder, Ph.D., Chairman of the Board; Mitchell Seyedin, Ph.D., President and CEO; Scott Gill, Chief Financial Officer; Blake Miles, Vice President, Sales; Penny White, RAC, Vice President, Regulatory Affairs & Quality Assurance; Gary Gage, P.E., Vice President, Program Management
Keywords
orthopedics, cartilage and bone regeneration, regenerative technologies, spine and knee therapy, injectable cell therapy, disc nucleus repair, live cartilage implant, bone graft extender, spine fusion, bone growth, biologics, biomaterials, osteoarthritis

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Description
ISTO Technologies, Inc. ("ISTO" or "the Company") is a privately-held orthobiologics company focused on developing breakthrough products designed to regenerate and restore damaged cartilage and bone for sports medicine trauma and spinal therapy indications. ISTO's discrete cell-based and biomaterial platforms encompass a number of technological breakthroughs that are poised to advance the practice of medicine by offering solutions for unmet and/or largely unsatisfied clinical needs.
Products / Services
The Company's current program and product portfolio is as follows: Product Offering Pipeline Products Application Technology DeNovo ET Engineered cartilage grafts for knee injuries Cell-based NuQu Injectable cartilage cells for disc regeneration Cell-based Marketed Products Application Technology InQu Spine fusion extender Biomaterial based DeNovo NT Cartilage repair Tissue allograft The Company's leading cell-based product is DeNovo ET, an engineered cartilage tissue derived from juvenile chondrocytes using ISTO's cell-based platform technology. DeNovo ET is a scaffold-free living cartilage graft designed to repair and restore joint function in the knee. Cartilage regeneration is considered the "holy grail" of the orthopaedic industry and the Company believes the DeNovo ET program potentially represents a revolutionary cost-effective off-the-shelf solution for restoring function to damaged joints. ISTO's cell-based development pipeline also includes NuQu, a cell-based injectable formulation of juvenile chondrocytes for regeneration of the nucleus in the spinal disc. Pre-clinical data suggests that when NuQu is injected into the nucleus, it has the potential to regenerate a damaged disc nucleus. NuQu has been developed for use in conjunction with a non-invasive outpatient procedure. InQu is a differentiated biomaterial scaffold of synthetic and biologic polymers. ISTO's hybrid scaffold represents a new class of biomaterials that combine what ISTO believes to be the most effective properties of synthetic polymers and biologic materials to create a product with a superior structure over currently available scaffold implants, which translates into a product with better handling characteristics, a controlled resorption rate and extreme compatibility with host cells. Pre-clinical studies have demonstrated that InQu effectively supports bone regeneration. DeNovo NT is a particulated human articular cartilage which is marketed and distributed by Zimmer. ISTO is responsible for processing the tissue for this program under its registration as a Tissue Bank. It is primarily intended to provide additional clinical experience concerning shipment, storage and the use of juvenile cartilage in humans.
Technology / Differentiation
ISTO's mix of clinical stage, development stage and marketed products includes DeNovo ET, engineered cartilage to repair and restore joint function in the knee, which the Company anticipates commencing a pivotal Phase III trial by the end of 2009; NuQu, an injectable formulation of juvenile cartilage cells for nucleus regeneration of the spinal disc, which is planned to enter Phase I/II human clinical trial during 2009; and InQu, an osteobiologic bone graft substitute and extender launched in Q1-2008.
Market / Customers
In recent years there has been a paradigm shift from the use of purely metallic implants, which simply replace or augment damaged musculoskeletal tissue, to biologically active products that aid in the healing and regeneration process. According to Epsicom Business Intelligence, a global market research firm, the global orthobiologics market grew 38% in 2007, reaching $4.2 billion, and is poised to grow at a nearly 17% compounded annual growth rate through 2012. Orthobiologics products dynamically interact with musculoskeletal tissue to facilitate the healing of bone, cartilage, menisci, tendons and ligaments affected by disease or injury. Many experts believe that the use of orthobiologics products will transform the orthopaedic industry over the next decade. ISTO's innovative products are well positioned to capitalize from these industry-wide changes.
Funding
Major investors include Alafi Capital Company, LLC, Ascension Health Ventures, LLC, Life Science Partners, Mid-American Transplant Services, and Zimmer, Inc.
Status
1.)Phase III application for DeNovo ET submitted to FDA in January 2009 2.)Received notification in April 2009 from the (FDA) allowing the company to proceed with a Phase I clinical study for NuQu 3.)Received 510(k) approval for InQu in 2007 and launched commercial sales in April 2008. 4.)ISTO reported positive preclinical data on the use of NuQu for spinal disc repair at the 23rd Annual Meeting of the North American Spine Society in October 2008. 5.)Awarded the 2008 North American Frost & Sullivan Award for Product Innovation for the InQu Bone Graft Extender and Substitute scaffold.


2009-07-04-4386