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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
Founded 1997
Employees 50
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 Mitchell Seyedin, Ph.D., President and CEO; John Hart, Chief Operating Officer; Scott Gill, Chief Financial Officer; 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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Updated: Apr. 19, 2013

Description
ISTO Technologies, Inc. (www.istotech.com), based in St. Louis, MO , is an orthobiologics company developing innovative cartilage and bone regeneration products for spinal therapy, sports medicine and trauma. ISTO's primary focus is on the development of its cell-based cartilage platform technology with initial applications to repair and regenerate damaged cartilage in the knee and spinal disc.
Products / Services
The Company's leading cartilage product is DeNovo ET, a scaffold-free engineered tissue (ET). DeNovo ET is a hyaline-cartilage graft tissue implant manufactured for repairing cartilage defects in the knee. DeNovo ET is directly implanted onto a defect with biological glue and does not require the use of a scaffold. The Phase I/II clinical trial for DeNovo ET demonstrating long-term safety of the product has passed the 3-year mark. ISTO is now in final discussions with the FDA concerning a pivotal Phase III protocol and the company anticipates initiating a Phase III trial in late 2010. ISTO strategically partnered with Zimmer Holdings, Inc. (�Zimmer�) to develop DeNovo ET. Under the agreement, Zimmer will distribute this product. The second application for ISTO�s cartilage technology is a product called NuQu�, a minimally invasive juvenile chondrocyte therapy for early intervention and restoration of disc function in patients suffering from discogenic back pain. NuQu will be delivered through an injectable formulation as an outpatient procedure for patients that have not responded to other conservative treatments. The Phase I clinical trial of 15 patients was initiated in the first quarter of 2010. This human trial globally represents the first human study of juvenile chondrocytes for the treatment of intervertebral disc disease. Preliminary results in the 12 subjects treated as of eary August show no serious or unexpected adverse events. Enrollment will be completed in the third quarter of 2010 with 6 month follow-up data available on all 15 subjects expected by the first quarter of 2011. In addition to its cartilage programs, in 2008, ISTO commercially launched its first device product from its biomaterial platform technology, InQu�, an osteobiologic bone graft substitute and extender product that has received 510k clearances. InQu is a differentiated biomaterial scaffold of synthetic and biologic (hyaluronic acid) polymers mainly used in the spinal fusion applications where there is a significant need for bone grafting. This product is being distributed through a network of independent representatives.
Technology / Differentiation
Based on the fact that cartilage cells and tissue are immune-privileged, ISTO's platform technology for cartilage regeneration centers on the use of allogeneic cells that that are derived from juvenile source, typically less than 10 years old donors. ISTO believes that its� approach to cartilage regeneration holds a number of advantages over other cartilage programs in the market or in development for the following reasons: � Superior technology - ISTO utilizes allogeneic juvenile cells, which are proven to have superior capacity for cartilage regeneration compared to adult cells used in all the autologous based products/technologies. � Less pain to patient and lower cost � ISTO�s products require only one surgical procedure compared to two surgical procedures for most competing programs eliminating an extra surgical step and the associated costs. � Scalable, Proprietary expansion technology � ISTO�s patented cell-expansion process offers an economy of scale not found in competing products. ISTO believes it is the only company with a scalable technology that has the potential to address this very large unmet medical need for cartilage regeneration products. In addition, ISTO is presently the only company entirely devoted to a cell-based platform for cartilage regeneration a platform technology that can be leveraged into additional applications (i.e. hip, shoulder, ankle and spinal disc).
Market / Customers
Cartilage regeneration is considered the "Holy Grail" of orthopaedics. Cartilage covers the surface of bone in all of the joints (i.e. knees, hips, shoulders, ankles and spine) and works as a shock absorber for the joints. The lack of blood supply, or avascular nature of this tissue, generally limits the healing capacity of cartilage after injuries. Superficial cartilage injuries in the joints, such as the knee, may develop into larger defects that may break down both the cartilage and bone and result in osteoarthritis or require full or partial joint replacements. In the spinal disc, chronic degeneration of cartilage tissue, initiated within the disc nucleus, results in the loss of tissue, water content and disc height and subsequently damage to the annulus structure thereby causing back pain. According to a 1999 study by the CDC, disabilities caused by the loss of cartilage are greater than any other disease and the market opportunity for products that successfully treat these diseases is estimated to be several billion dollars. Joint diseases (Back/Spine Pain & Arthritis) are primarily the result of damaged or degenerated cartilage. Since adult cartilage has limited regenerative capacity and there is no widely-adopted FDA-approved cartilage repair therapy presently available, patients suffering with cartilage, problems are currently treated symptomatically often with ineffective long-term results. The market for an effective cartilage repair therapy, therefore, can be estimated to encompass over 1,000,000 procedures each year. Cartilage repair represents one of the greatest unmet medical needs and one of the most promising opportunities in orthopaedics to address the significant direct and indirect economic costs associated with osteoarthritis, lower back pain and other debilitating conditions caused by damaged or lost cartilage.
Revenue / Funding
Since inception in 1997, ISTO has raised approximately $45 million to fund its� research and development efforts. The Company�s major shareholders include Alafi Capital, LLC; Zimmer Holdings, Inc.; Ascension Health Ventures; Mid-America Transplant Services and Life Sciences Partners, B.V.
Status
Leading platform technology for cartilage regeneration - ISTO is the only company with a cell-based platform technology for cartilage regeneration. Some of the key advantages for ISTO�s cartilage technology include utilizing juvenile cartilage cells with superior biological activities over adult cells and a patented expansion process allowing for a scale of manufacturing and broader clinical applications not possible with the competing products in the market or in development. Significant Unmet medical needs and very large market opportunities - Cartilage regeneration is considered the �Holy Grail� of the orthopaedic industry. ISTO�s initial targets knee and spinal disc represent over one million potential patient procedures per year, in the U.S. alone and the Company believes that these markets represent a combined market opportunity of greater than $4 billion. Strong Near Term Revenue Growth � The Company currently generates revenue from two sources � InQu, a differentiated bone graft substitute and extender and DeNovo NT, a tissue allograft developed by ISTO and marketed by Zimmer. These programs are expected to see significant growth in the following years as clinical data becomes available. These programs will significantly reduce the amount of additional investments needed to fund future development and operations. Significant Proprietary Intellectual Property - The Company has developed a strong patent position and its patent strategy is to extend protection and to create a competitive advantage wherever possible. ISTO�s intellectual properties combine patents, trademarks and trade secrets for all of its development and clinical stage products. Some of ISTO�s key patents include: cartilage cell expansion technology, disc application of juvenile chondrocytes and differentiated biomaterial for bone and soft tissue repair. Experienced Management Team - ISTO�s senior management team has extensive experience in a variety of disciplines necessary to ensure the future success of the Company. Mitchell Seyedin, Ph.D., President & CEO, has over 25 years of senior management experience in biologics and biotechnology prior to joining ISTO in 2003. He oversees a senior management team with many years of deep and relevant experiences in the medical technology industry. ISTO has over 20 individuals with advanced degrees or certifications.


2013-05-25-11730